A Randomized, Open-label, Active-control, Phase 2/3 Study of First-line Intratumoral CMP-001 in Combination With Intravenous Nivolumab Compared to Nivolumab Monotherapy in Subjects With Unresectable or Metastatic Melanoma
Phase: PHASE2
Conditions: Melanoma, Advanced Melanoma, Metastatic Melanoma, Unresectable Melanoma
Sponsor: Regeneron Pharmaceuticals

Protocol CMP-001-011 
Checkmate Pharmaceuticals, Inc. 
CMP-001-011 
A RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROL, 
PHASE 2/3 STUDY OF FIRST-LINE INTRATUMORAL 
CMP-001 IN COMBINATION WITH INTRAVENOUS 
NIVOLUMAB COMPARED TO NIVOLUMAB 
MONOTHERAPY IN SUBJECTS WITH 
UNRESECTABLE OR METASTATIC MELANOMA 
Study Phase: 
Phase 2/3 
IND Number: 
16695 
Sponsor: 
Checkmate Pharmaceuticals, Inc. 
245 Main Street, 2nd Floor 
Cambridge, MA 02142 USA 
Issue Date: 
Original Protocol 11 September 2020 
Amendment 1 (Version 2.0) 04 February 2021 
CONFIDENTIALITY STATEMENT 
The information in this document contains trade secrets and commercial information that is 
privileged or confidential and may not be disclosed, unless disclosure is required by 
applicable laws and regulations. In any event, persons to whom the information is disclosed 
must be informed that the information is privileged or confidential and may not be further 
disclosed by them. These restrictions on disclosure will apply equally to all future 
information supplied to you indicated as privileged or confidential. 
Amendment 1 (Version 2.0) 04 February 2021 1 
Confidential 
VV-RIM-00384192-1.0 Approved - 11 Dec 2024 GMT-5:00
NCT04695977

Protocol CMP-001-011 
Checkmate Pharmaceuticals, Inc. 
 
INVESTIGATOR’S AGREEMENT 
 
A RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROL, PHASE 2/3 STUDY OF 
FIRST-LINE INTRATUMORAL CMP-001 IN COMBINATION WITH 
INTRAVENOUS NIVOLUMAB COMPARED TO NIVOLUMAB MONOTHERAPY IN 
SUBJECTS WITH UNRESECTABLE OR METASTATIC MELANOMA 
 
Protocol Number: CMP-001-011 
I have read this protocol and agree to the following: 
• I am thoroughly familiar with the appropriate use of the investigational drug, as 
described in this protocol, and any other information provided by the Sponsor 
including, but not limited to, the current Investigator’s Brochure provided by the 
Sponsor. 
• I will conduct the study in compliance with this protocol, with any future 
amendments, and with any other written study conduct procedures provided and 
reviewed and approved by the Sponsor or its representatives. 
• I will conduct the study in accordance with the current US Food and Drug 
Administration (FDA)/applicable local regulations, International Conference on 
Harmonization (ICH) guidelines, and any other applicable regulatory 
requirements as well as Good Clinical Practice (GCP) standards 
(CPMP/ICH/135/95); the ethical principles that have their origin in the 
Declaration of Helsinki, and that are consistent with the principles of GCP; and all 
local ethical and legal requirements and will complete the study within the time 
designated. 
• I will provide copies of the protocol and all pertinent information to all individuals 
responsible to me who assist in the conduct of this study. I will discuss this 
material with them to ensure they are fully informed regarding the drug and the 
conduct of the study. 
• I agree that the Sponsor or its representatives shall have access to any source 
documents from which electronic case report form (eCRF) information may have 
been generated. 
 
 
 
 
 
Printed Name of Investigator 
 
 
 
 
 
Signature of Investigator 
Date 
Amendment 1 (Version 2.0) 04 February 2021 2 
Confidential 
                                        VV-RIM-00384192-1.0 Approved - 11 Dec 2024 GMT-5:00

 
Protocol CMP-001-011 
Checkmate Pharmaceuticals, Inc. 
 
SPONSOR PROTOCOL APPROVAL 
 
 
 
 
 
 
 
 
 
 
 
 
Amendment 1 (Version 2.0) 04 February 2021 3 
Confidential 
 
 
                                        VV-RIM-00384192-1.0 Approved - 11 Dec 2024 GMT-5:00

Protocol CMP-001-011 
Checkmate Pharmaceuticals, Inc. 
Amendment 1 (Version 2.0) 04 February 20214  
Confidential 
 
 
PROCEDURES IN CASE OF EMERGENCY 
Emergency Contact Information 
 
Name 
Role in Study 
Address and Telephone Number 
Checkmate Pharmaceuticals, 
Inc. 
Sponsor 
245 Main Street, 2nd Floor 
Cambridge, MA, 02142 USA 
Phone: 617-682-3625 
IQVIA Biotech 
Medical Monitor 
24-Hour emergency 
contact 
IQVIA Biotech 
Email: CMP-001-011@novellaclinical.com 
Serious adverse events (SAEs) should be recorded on the SAE Report Form 
and completed and submitted to IQVIA Biotech Safety preferably via email to: 
Safety-Inbox.Biotech@IQVIA.com or by fax to +1-866-761-1274 
as back up within 24 hours of awareness. 
                                        VV-RIM-00384192-1.0 Approved - 11 Dec 2024 GMT-5:00

Protocol CMP-001-011 
Checkmate Pharmaceuticals, Inc. 
Amendment 1 (Version 2.0) 04 February 20215  
Confidential 
 
 
SYNOPSIS 
 
Name of Sponsor/Company: Checkmate Pharmaceuticals, Inc. 
Study Drugs: 
• 
CMP-001 in combination with nivolumab (OPDIVO®) 
• 
Nivolumab monotherapy 
Title of Study: A Randomized, Open-Label, Active-Control, Phase 2/3 Study of First-Line 
Intratumoral CMP-001 in Combination with Intravenous Nivolumab Compared to Nivolumab 
Monotherapy in Subjects with Unresectable or Metastatic Melanoma 
Study Center(s): Enrollment is anticipated at clinical sites in regions including (but not limited to) 
North America, Europe, and Asia Pacific 
Phase of Development: Phase 2/3 
Study Objectives: 
Phase 2 Objectives: 
Phase 2 Primary Objective 
• 
To determine confirmed objective response rate (ORR) for treatment with first-line 
CMP-001 in combination with nivolumab versus nivolumab monotherapy in subjects 
with unresectable or metastatic melanoma 
Phase 2 Secondary Objective 
• 
To evaluate the safety and tolerability of first-line CMP-001 in combination with 
nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic 
melanoma 
Phase 3 Objectives: 
Phase 3 Primary Objective 
• 
To evaluate progression-free survival (PFS) for subjects receiving first-line CMP-001 
in combination with nivolumab versus nivolumab monotherapy for unresectable or 
metastatic melanoma 
Phase 3 Secondary Objectives 
• 
To evaluate the safety and tolerability of first-line CMP-001 in combination with 
nivolumab versus nivolumab monotherapy in subjects with unresectable or metastatic 
melanoma 
• 
To evaluate the efficacy of first-line CMP-001 in combination with nivolumab versus 
nivolumab monotherapy in subjects with unresectable or metastatic melanoma 
Phase 3 Exploratory Objectives 
• 
To evaluate the effect of first-line CMP-001 in combination with nivolumab on 
injected and non-injected target lesions in subjects with unresectable or metastatic 
melanoma 
• 
To evaluate the pharmacodynamic effects of first-line CMP-001 in combination with 
nivolumab in subjects with unresectable or metastatic melanoma 
                                        VV-RIM-00384192-1.0 Approved - 11 Dec 2024 GMT-5:00

Protocol CMP-001-011 
Checkmate Pharmaceuticals, Inc. 
Amendment 1 (Version 2.0) 04 February 20216  
Confidential 
 
 
 
Study Endpoints: 
Phase 2 Endpoints 
Phase 2 Primary Endpoint 
ORR defined as the proportion of subjects with a confirmed objective response of complete 
response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors 
version 1.1 (RECIST v1.1) as determined by Blinded Independent Central Review (BICR) 
Phase 2 Secondary Endpoint 
Adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation or death 
and severity of AEs as assessed by the National Cancer Institute (NCI) Common Terminology 
Criteria for Adverse Events (CTCAE) version 5.0 
Phase 3 Endpoints: 
Phase 3 Primary Endpoint: 
Progression-free survival (PFS) defined as the time from the date of randomization to first date of 
documented progressive disease based on RECIST v1.1 by BICR or death from any cause, 
whichever occurs first 
Phase 3 Secondary Endpoints: 
• 
AEs, SAEs, and AEs leading to discontinuation or death, and severity of AEs as 
assessed by NCI CTCAE v5.0 
• 
Overall survival (OS), defined as the time from the date of randomization until death 
from any cause 
• 
Confirmed ORR defined as the proportion of subjects with a confirmed objective 
response of CR or PR based on RECIST v1.1 as determined by BICR 
• 
Duration of response (DOR) defined as the time from date of first documented 
response (CR or PR) to date of documented progressive disease, based on RECIST 
v1.1 as determined by BICR 
• 
Disease control rate (DCR), defined as the proportion of subjects who have a 
confirmed best response of CR or PR, or stable disease lasting at least 4 months, based 
on RECIST v1.1 as determined by BICR 
• 
Treatment response in non-injected target lesions based on RECIST v1.1 by 
Investigator 
• 
PFS, ORR, DOR, and DCR based on RECIST v1.1, and immune PFS, immune DOR, 
and immune ORR based on immunotherapy RECIST (iRECIST) as determined by 
Investigator assessment 
Exploratory Endpoints: 
• 
 
 
• 
Change from Baseline in blood concentrations of C-X-C motif chemokine 10 
(CXCL10) after treatment with CMP-001 
• 
Baseline, and change from Baseline, in tumor or blood measurements of biomarkers 
related to toll-like receptor 9 (data from Phase 2 portion of the study) 
                                        VV-RIM-00384192-1.0 Approved - 11 Dec 2024 GMT-5:00

Protocol CMP-001-011 
Checkmate Pharmaceuticals, Inc. 
Amendment 1 (Version 2.0) 04 February 20217  
Confidential 
 
 
 
Methodology: 
This is a randomized, open-label, active-control study of first-line CMP-001 administered by 
intratumoral (IT) injection in combination with intravenous (IV) nivolumab versus nivolumab 
monotherapy in subjects with Stage III or IV unresectable or metastatic melanoma who have not 
been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody for 
metastatic disease. 
The study will follow a Phase 2/3 design. The study will enroll eligible subjects into the Phase 2 
portion of the study; enrollment into the Phase 3 portion of the study will not proceed until the 
primary endpoint of Phase 2 is evaluated. 
The Phase 2 primary endpoint of ORR per RECIST v1.1 by BICR will be assessed approximately 
30 weeks after the last subject is randomized into the Phase 2 portion of the study. If the primary 
endpoint of Phase 2 is met, subjects enrolled in the Phase 2 portion of the study will continue to 
receive study treatment (in Arm A or Arm B) in the Phase 3 portion of the study, and enrollment 
will proceed in Phase 3. If the Phase 2 primary endpoint is not met, subjects enrolled in Phase 2 
may remain in the study and continue to receive study treatment until a reason for treatment 
discontinuation is met but no further subjects will be enrolled. 
An Independent Data Monitoring Committee will review safety and efficacy data throughout the 
study. 
Number of Subjects (Planned): 
A total of 450 subjects will be randomized into this Phase 2/3 study, including 140 subjects 
randomized into the Phase 2 portion and 310 subjects randomized into the Phase 3 portion of the 
study. Subjects will be randomized in a 1:1 ratio to either: 
• 
Arm A: CMP-001 in combination with nivolumab 
• 
Arm B: nivolumab monotherapy 
During the randomization process, treatment groups will be stratified based on: 
• 
TNM Stage American Joint Committee on Cancer (AJCC) Cancer Staging Manual 
Eighth Edition (M0/M1a/M1b versus M1c/M1d) 
• 
Tumor PD-L1 expression (≥5% versus <5%) 
Diagnosis and Main Criteria for Inclusion: 
Inclusion Criteria: 
Subjects enrolled in the study must meet all of the following inclusion criteria to be eligible: 
1. Histologically or cytologically confirmed unresectable Stage III or Stage IV melanoma per 
AJCC Cancer Staging Manual Eighth Edition. 
2. Measurable disease, as defined by RECIST v1.1 and both of the following: 
a. At least 1 accessible lesion amenable to repeated IT injection 
b. One or more measurable lesions at least 1 cm in diameter that are not intended for 
CMP-001 injection and can be followed as target lesions per RECIST v1.1 
3. Able to provide tissue from a core or excisional/incisional biopsy (fine needle aspirate is 
not sufficient). A newly obtained biopsy (within 90 days before the first dose of study 
treatment) is mandatory, but an archival sample is acceptable if no intervening therapy for 
melanoma/cancer was received. 
Note: for tissue sampling details, please refer to the Laboratory Manual. 
                                        VV-RIM-00384192-1.0 Approved - 11 Dec 2024 GMT-5:00

Protocol CMP-001-011 
Checkmate Pharmaceuticals, Inc. 
Amendment 1 (Version 2.0) 04 February 20218  
Confidential 
 
 
4. Adequate organ function based on most recent laboratory values within 3 weeks before the 
first dose of study treatment on Week 1 Day 1 (W1D1): 
a. Bone marrow function: 
− 
neutrophil count ≥1500/mm3 
− 
platelet count ≥ 100 000/mm3 
− 
hemoglobin concentration ≥9 g/dL 
− 
white blood cells ≥2000/mm3 
b. Liver function: 
− 
total bilirubin ≤1.5 × the upper limit of normal (ULN) with the following 
exception: subjects with Gilbert Disease total serum bilirubin ≤3 × ULN 
− 
aspartate aminotransferase and alanine aminotransferase ≤3 ×ULN 
c. Lactate dehydrogenase ≤2 × ULN 
d. Renal function: estimated (Cockcroft-Gault) or measured creatinine clearance 
≥30 mL/min 
e. Coagulation 
− 
International normalized ratio or prothrombin time (PT) ≤ 1.5 × ULN, unless 
subject is receiving anticoagulant therapy, as long as PT or partial thromboplastin 
time (PTT) is within therapeutic range of intended use of anticoagulants 
− 
Activated partial thromboplastin time or PTT ≤1.5 × ULN, unless subject is 
receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range 
of intended use of anticoagulants 
5. Eastern Cooperative Oncology Group Performance Status of 0 to 1 at Screening. 
6. Age ≥18 years at time of consent. 
7. Capable of understanding and complying with protocol requirements. 
8. Women of childbearing potential must have negative serum pregnancy test prior to dosing 
at W1D1 and be willing to use an adequate method of contraception (Section 4.3.2) from 
the time of consent until at least 150 days after the last dose of study treatment. 
9. Able and willing to provide written informed consent and to follow study instructions. 
Subjects unable to provide written informed consent on their own behalf will not be 
eligible for the study. 
Exclusion Criteria: 
Subjects presenting with any of the following will not qualify for entry into the study: 
1. Uveal, acral, or mucosal melanoma. 
2. Received prior systemic treatment for melanoma in the unresectable or metastatic setting. 
Prior adjuvant therapy is acceptable if the treatment course (of approximately 1 year 
duration) was completed and there was no recurrence within 6 months of the last dose of 
adjuvant treatment. 
3. Received prior therapy with CMP-001. 
                                        VV-RIM-00384192-1.0 Approved - 11 Dec 2024 GMT-5:00

Protocol CMP-001-011 
Checkmate Pharmaceuticals, Inc. 
Amendment 1 (Version 2.0) 04 February 20219  
Confidential 
 
 
4. Requires systemic pharmacologic doses of corticosteroids greater than the equivalent of 
10 mg/day prednisone within 30 days before the first dose of study treatment on W1D1. 
a. Subjects who are currently receiving steroids at a prednisone-equivalent dose of 
≤10 mg/day do not need to discontinue steroids prior to enrollment. 
b. Replacement doses, topical, ophthalmologic, and inhalational steroids are permitted. 
5. History of CTCAE v5.0 Grade 4 immune-related AE due to adjuvant CTLA-4 or PD-1 
blocking antibody. 
6. Not fully recovered from adverse events (to Grade 1 or less [per CTCAE v5.0], with the 
exception of persistent alopecia, adrenal insufficiency, and hypothyroidism) due to prior 
treatment. 
7. Active pneumonitis, history of pneumonitis that required steroids, or history of interstitial 
lung disease. 
8. Severe uncontrolled cardiac disease within 6 months of Screening, including but not 
limited to poorly controlled hypertension, unstable angina, myocardial infarction, 
congestive heart failure (New York Heart Association Class II or greater), pericarditis 
within the previous 6 months, cerebrovascular accident, and implanted or continuous use 
of a pacemaker or defibrillator. 
9. Known history of immunodeficiency. 
10. Known additional malignancy that has progressed or required active treatment within the 
past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma 
of the skin that has undergone potentially curative therapy, curatively treated localized 
prostate cancer with prostate-specific antigen level below 4.0 ng/mL, in situ cervical 
cancer on biopsy or a squamous intraepithelial lesion on Papanicolaou smear, thyroid 
cancer (except anaplastic), and adjuvant hormonal therapy for breast cancer >3 years from 
curative-intent surgical resection. 
11. Active autoimmune disease that has required systemic treatment in past 2 years; 
replacement therapy is not considered a form of systemic treatment. 
12. Untreated, symptomatic, or enlarging central nervous system metastases or carcinomatous 
meningitis (including leptomeningeal metastases from solid tumors). 
13. Prior allogenic tissue/solid organ transplant. 
14. Known or suspected active infection with severe acute respiratory syndrome coronavirus 2 
virus (SARS-CoV-2). 
15. Active infection requiring systemic therapy. 
16. Known or suspected infection with HIV, hepatitis B virus, or hepatitis C virus; testing is 
not required unless suspected. 
17. Received a live/attenuated virus vaccination within 30 days prior to the first dose of study 
treatment on W1D1. 
18. Received blood products (including platelets or red blood cells) or colony stimulating 
factors (including granulocyte colony stimulating factor, granulocyte/macrophage colony 
stimulating factor, or recombinant erythropoietin) within 30 days prior to the start of 
Screening. 
19. History of permanent discontinuation of nivolumab due to infusion reactions. 
                                        VV-RIM-00384192-1.0 Approved - 11 Dec 2024 GMT-5:00

Protocol CMP-001-011 
Checkmate Pharmaceuticals, Inc. 
Amendment 1 (Version 2.0) 04 February 202110  
Confidential 
 
 
 
20. Any concurrent uncontrolled illness, including mental illness or substance abuse, which in 
the opinion of the Investigator, would make the subject unable to cooperate or participate 
in the trial. 
21. Participation in another clinical study of an investigational anticancer therapy or device 
within 30 days before the first dose of study treatment on W1D1. 
Note: Participation in the follow-up phase (receiving no study treatment) of a prior study is 
allowed. 
22. Requires prohibited treatment (ie, non-protocol specified anticancer pharmacotherapy, 
surgery, or radiotherapy) for treatment of malignant tumor. 
23. Has a life expectancy of less than 3 months and/or has rapidly progressing disease (eg, 
tumor bleeding, uncontrolled tumor pain) in the opinion of the treating Investigator. 
24. Pregnant or breast-feeding or expecting to conceive or donate eggs within the projected 
duration of the study, from the time of consent until at least 150 days after the last dose of 
study treatment for women. 
Investigational Study Drug, Dosage, and Mode of Administration: 
Subjects assigned to Arm A will receive CMP-001 10 mg weekly for 7 doses (W1D1 to W7D1), 
after which CMP-001 10 mg IT will be administered every 3 weeks (Q3W) until a reason for 
treatment discontinuation is reached. A prophylaxis regimen is required before each dose of CMP- 
001. The first dose of CMP-001 may be administered subcutaneously (SC) or by IT injection at the 
discretion of the Investigator; all subsequent doses are planned to be administered by IT injection. 
The initial 7 CMP-001 weekly dose schedule must be completed before starting the Q3W CMP- 
001 dosing schedule. 
Subjects in Arm A and Arm B will receive nivolumab 360 mg IV over 30 minutes at W1D1 and 
Q3W thereafter until the subject satisfies a condition for study treatment discontinuation. Please 
refer to the nivolumab Investigator’s Brochure. 
On visits where CMP-001 and nivolumab are both administered, CMP-001 should always be 
administered before nivolumab. 
Duration of Treatment: 
Subjects will receive study treatment until they reach a reason for treatment or study 
discontinuation (Section 4.5 and Section 4.6). Subjects may continue study treatment beyond 
disease progression based upon Investigator judgement of potential benefit. 
If a subject achieves and maintains a confirmed CR or iCR by Investigator assessment, IT or SC 
injections of CMP-001 or the combination of CMP-001 and nivolumab may be discontinued at the 
Investigator’s discretion once the subject meets both of the following criteria: 
• 
Subject has been treated for at least 48 weeks (the maximum duration of study 
treatment is 2 years) 
• 
Subject has received at least 3 doses of assigned treatment beyond the date of the 
initial CR/iCR 
Subjects who discontinue study treatment should complete the end of treatment visit and 100-day 
safety follow-up. Subjects who are post-treatment but have not met criteria for study 
discontinuation should remain on study for post-treatment follow-up and long-term survival 
                                        VV-RIM-00384192-1.0 Approved - 11 Dec 2024 GMT-5:00

Protocol CMP-001-011 
Checkmate Pharmaceuticals, Inc. 
Amendment 1 (Version 2.0) 04 February 202111  
Confidential 
 
 
 
follow-up and receive study evaluations for efficacy according to the Schedule of Assessments 
(Table 1). 
Subjects who permanently discontinue (for >12 weeks) CMP-001 or nivolumab may not be re- 
treated with the discontinued study treatment in this study. When nivolumab is permanently 
discontinued due to an immune related AE, CMP-001 must also be permanently discontinued. 
Criteria for Evaluation: 
Efficacy: 
Disease status will be assessed by computed tomography or magnetic resonance imaging and other 
appropriate measures according to the Schedule of Assessments (Table 1). Calipers and 
photographs containing a ruler may be used to facilitate measurement of superficial cutaneous 
tumors. Objective responses will be assessed by BICR and the Investigator according to RECIST 
v1.1. Subjects who continue study treatment beyond PD according to RECIST v1.1 will be 
assessed by the Investigator according to iRECIST. Other endpoints in Phase 3 include PFS, DCR, 
and DOR. 
Safety: 
Safety and tolerability will be assessed by evaluating the following: 
• 
Treatment-emergent adverse events, which will be evaluated and assigned a grade 
using CTCAE v5.0 
• 
Vital signs (oral temperature, respiratory rate, pulse, and systolic and diastolic blood 
pressure), and physical examination (including weight and body mass index) 
• 
Clinical laboratory assessments (chemistry, hematology, urinalysis, coagulation, and 
thyroid function tests) 
• 
12-lead electrocardiograms (ECGs) 
Statistical Methods: 
Sample Size: 
A total of 450 subjects will be randomized in this Phase 2/3 study. 
In the Phase 2 portion of the study, a total of 140 subjects will be randomized in a 1:1 ratio to the 
2 treatment arms to receive CMP-001 in combination with nivolumab or nivolumab monotherapy. 
The sample size is calculated to compare the ORR between the 2 treatment arms. A sample size of 
140 provides 80% power to detect an absolute treatment difference of 25% with 2-sided alpha level 
of 0.05, assuming that the ORR in CMP-001 in combination with nivolumab is 65% and the ORR 
in nivolumab monotherapy is 40%. 
If the treatment effect on ORR at end of the Phase 2 portion of the study is statistically significant 
at a 2-sided alpha level of 0.05, an additional 310 subjects may be randomized in a 1:1 ratio to 
receive CMP-001 in combination with nivolumab or nivolumab monotherapy. In combination with 
the 140 subjects randomized in Phase 2, this will make up the Phase 3 study population of 
450 subjects. 
The overall study sample size (n=450) is calculated to compare the PFS between the 2 treatment 
arms at an alpha level of 0.05 (2-sided). The final PFS analysis will be performed when at least 
331 BICR PFS events have been observed across the 2 treatment arms. With 331 PFS events, the 
study has 90% power to demonstrate treatment effect in PFS at 0.05 alpha level (2-sided) when the 
true hazard ratio (HR) is 0.70. The smallest treatment effect that can be detected statistically 
significant in this study is HR 0.805. 
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Amendment 1 (Version 2.0) 04 February 202112  
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Statistical Analysis Methods: 
Study analysis sets for safety and efficacy will include: 
• 
Intent-to-Treat Analysis Set: all subjects who are randomized 
• 
Safety Analysis Set: all subjects who receive at least 1 dose of study treatment 
• 
Per Protocol Analysis Set: all subjects who are randomized and are without major 
protocol deviations 
• 
Pharmacodynamic Analysis Set: all subjects who receive at least 1 dose of CMP-001 
and have at least 1 measurable sample at Baseline and at least 1 evaluable biomarker 
sample after CMP-001 administration 
The Phase 2 analysis sets apply to subjects who were randomized or treated in the Phase 2 portion. 
The Phase 3 analysis sets apply to all subjects who were randomized or treated in both Phase 2 and 
Phase 3 portions. 
The Phase 2 primary endpoint, ORR, will be analyzed using a 2-sided Cochran-Mantel-Haenszel 
test stratified by stage and PD-L1 expression to compare the 2 treatment arms. Associated odds 
ratio and 95% CI will also be calculated. Additionally, ORR and the 95% exact CIs will be 
calculated using the Clopper-Pearson method for each of the 2 treatment arms. The secondary 
endpoint DCR and the 95% Clopper-Pearson CIs will be summarized as well. 
The Phase 3 primary endpoint, PFS, will be analyzed using a 2-sided log-rank test stratified by 
stage and PD-L1 expression to compare the 2 treatment arms. Subject data from the Phase 2 and 
Phase 3 portions will be combined to create the full study sample for all Phase 3 analyses. HRs and 
corresponding 2-sided 95% CIs will be estimated using a Cox proportional hazards model, with 
treatment arm as a single covariate, stratified by the above factors. PFS curves, PFS medians with 
95% CIs, and PFS rates at 6 and 12 months with 95% CIs will be estimated using Kaplan-Meier 
methodology. The secondary endpoints OS and DOR will be analyzed using the same approach as 
PFS. 
Safety data, including vital signs, ECGs, laboratory test results, physical examinations, and AEs, 
will be summarized by assessment time points, as appropriate. Change from Baseline will be 
included in summary tables for laboratory, ECG, and vital sign parameters. 
 
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Protocol CMP-001-011 
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13 
Table 1: 
Schedule of Assessments 
 
Procedure or 
Assessment 
Screening 
(Day -30 
to Day -1) 
W1D1 
W2D1 
W3D1 
W4D1 
W5D1 
W6D1 
W6D2 
W7D1 
Q3W 
(W10, 
W13, 
etc) 
End of 
Treatment 
(EOT)a 
100-Day 
Follow-up 
(100DFU)b 
Post- 
treatment 
Follow-up 
(PTFU)c 
(Q3mo) 
Long-Term 
Survival 
Follow-up 
(LTSFU)d 
(Q3mo) 
Visit Windows 
N/A 
N/A 
±2 d 
±2 d 
±2 d 
±2d 
±2 d 
N/A 
±2 d 
±3 d 
+7 d 
+7 d 
± 2 weeks 
± 4 weeks 
CMP-001 Injection 
(Dose Number)e 
1 
SC/IT 
2 
3 
4 
5 
6 
7 
8+ 
Nivolumab Dosing 
(Dose Number)f 
1 
2 
3 
4+ 
Informed Consent 
X 
Eligibility Criteria 
Assessment 
X 
Demographics 
X 
Medical History 
X 
Melanoma History 
X 
Prior Cancer 
Treatment 
X 
Physical 
Examinationg 
X 
X 
X 
X 
X 
X 
Vital Signsh 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
ECOG Performance 
Status 
X 
X 
X 
X 
X 
X 
Adverse Event 
Monitoringi 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant 
Medicationsj 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-Lead ECGk 
X 
X 
X 
X 
X 
Clinical Laboratory 
Tests (hematology, 
serum chemistry, 
urinalysis)l 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Coagulation Testsl 
X 
X 
X 
X 
Thyroid Function 
Testsl 
X 
X 
X 
X 
X 
 
 
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Protocol CMP-001-011 
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14 
Table 1: 
Schedule of Assessments (Continued) 
Procedure or 
Assessment 
Screening 
(Day -30 
to Day -1) 
W1D1 
W2D1 
W3D1 
W4D1 
W5D1 
W6D1 
W6D2 
W7D1 
Q3W 
(W10, 
W13, 
etc) 
End of 
Treatment 
(EOT)a 
100-Day 
Follow-up 
(100DFU)b 
Post- 
treatment 
Follow-up 
(PTFU)e 
(Q3mo) 
Long-Term 
Survival 
Follow-up 
(LTSFU)f 
(Q3mo) 
Visit Windows 
N/A 
N/A 
±2 d 
±2 d 
±2 d 
±2 d 
±2 d 
N/A 
±2 d 
±3 d 
+7 d 
+7 d 
± 2 weeks 
± 4 weeks 
CMP-001 Injection 
(Dose Number)e 
1 
SC/IT 
2 
3 
4 
5 
6 
7 
8+ 
Nivolumab Dosing 
(Dose Number)f 
1 
2 
3 
4+ 
Autoimmune 
Laboratory Panell 
X 
X 
X 
Pregnancy Test and 
Follicle Stimulating 
Hormonel 
X 
X 
X 
X 
X 
X 
Exploratory 
Biomarker 
Samplingm 
X 
X 
X 
X 
X 
Tumor Biopsy (PD- 
L1 status)n 
X 
X 
Disease Assessment 
(radiographic 
imaging)o 
Disease Assessment 
(CNS Imaging)o 
Disease Assessment 
(photographic 
imaging)o 
100-Day Follow-up 
(Office or Phone 
Call) 
X 
Long-Term Survival 
Follow Up Phone 
Call 
X 
Abbreviations: 100DFU = 100-day follow-up; AE= adverse event; CNS = central nervous system; CR = complete response; CT = computed tomography; D/d = day; ECG = electrocardiogram; ECOG = Eastern 
Cooperative Oncology Group; EOT = End Of Treatment; FSH = follicle stimulating hormone; iRECIST = immunotherapy Response Evaluation Criteria in Solid Tumors; iCR = immune complete response; INR = 
international normalized ratio; iPR = immune partial response; IT = intratumoral; LTSFU = Long-Term Survival Follow-up; MRI = magnetic resonance imaging; N/A = not applicable; PD-L1 = programmed cell 
death protein ligand 1; PET = positron emission tomography; PR = partial response; PT = prothrombin time; PTFU = Post-treatment Follow-up; PTT = partial thromboplastin time; RECIST = Response Evaluation 
Criteria in Solid Tumors; Q3mo = every 3 months; Q3W = every 3 weeks; Q6W = every 6 weeks; SC = subcutaneous; SAE = serious adverse event; W = week; WOCBP = women of child bearing potential. 
 
 
 
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15 
a. End of Treatment assessments to be performed within 7 days following subject discontinuation from the last study treatment (either CMP-001 or nivolumab). Removal of a subject from CMP-001 treatment is 
defined as the time in which the Investigator decides to discontinue study treatment. If a subject has CMP-001 dosing withheld for more than 3 consecutive doses for any reason during the Q3W dosing period, 
resumption of treatment must be discussed with the Medical Monitor, otherwise, the subject will be discontinued from study treatment and will have all EOT assessments performed. 
b. The 100DFU is a safety follow-up visit that may be conducted at the study site or via phone. This visit should occur 100 days (+7) after the EOT. 
c. Post-treatment Follow-up (PTFU) will be conducted every 3 months (± 2 weeks) for all subjects who discontinue study treatment but have not met criteria for study discontinuation. These subjects should remain on 
study and receive disease assessments every 3 months, until discontinuation. 
d. Long-Term Survival Follow-up (LTSFU) will be conducted every 3 months (± 4 weeks) after the EOT visit or the last disease assessment date in PTFU and may occur via phone. 
e. CMP-001 dosing will begin on W1D1. Weekly dosing: A window of ±2 days is permitted for CMP-001 dosing from W2D1 to W7D1. The first dose of CMP-001 may be administered SC or IT, at the discretion of 
the Investigator; all subsequent doses are planned to be administered IT until no injectable lesions remain. Subjects must complete all 7 weekly CMP-001 doses before moving to the Q3W dosing schedule. Q3W 
dosing (W10D1+): A window of ±3 days is permitted for CMP-001 dosing from W10D1 throughout the trial. When nivolumab is permanently discontinued due to an immune related AE, CMP-001 must also be 
permanently discontinued. Refer to Section 5.3 for Treatment Compliance. 
f. Nivolumab dosing will begin on W1D1 and continue Q3W throughout the study for a maximum of 2 years. For subjects in Arm A, when CMP-001 injection and nivolumab dosing fall on the same day, CMP-001 
injection will be given before nivolumab dosing. Refer to Section 5.1.1 for Nivolumab Dosing. 
g. A full physical examination (PE) will be conducted at Screening and EOT. If the Screening full PE is performed >72 hours before the W1D1 visit, then a brief (symptom directed) PE must be performed within 
72 hours before the first injection of CMP-001. Brief PEs focused on areas of disease or AEs must be performed at the W1D1, W3D1, W7D1 CMP-001 injection visits, at every CMP-001 injection visit thereafter, 
and at any other time as clinically indicated. Height will be obtained at Screening only and weight will be obtained at all PE assessments. 
h. Vital signs include measurement of blood pressure (systolic and diastolic blood pressure), respiratory rate, heart rate, and body temperature. Blood pressure and heart rate should be taken in the seated position 
following ≥3 minutes of rest. For subjects in Arm A, for the first 6 CMP-001 dosing visits (W1D1 to W6D1), vital signs must be collected prior to the CMP-001 injection and at 30-minute (±15 minutes) intervals for 
4 hours after CMP-001 injection. Starting at W7D1, observation periods may be reduced to a minimum of 1 hour following CMP-001 injection at the Investigator’s discretion based on the AE profile of the 
individual subject. When vital signs are scheduled at the same time as collection of a blood sample, the vital sign measurements should be obtained before the scheduled phlebotomy. If a study visit occurs where 
only nivolumab is administered, vital signs must be collected before the start of the nivolumab infusion. 
i. AEs will be assessed continually from the time of informed consent through 100 days after the last dose of study treatment or until an alternative cancer treatment is initiated, whichever occurs first, for all subjects. 
Subjects who discontinue CMP-001 but remain on treatment with nivolumab will continue to have AEs collected according to this schedule until 100 days after the last dose of nivolumab. 
j. Concomitant medications will be assessed continually from 30 days before the first dose of study treatment through 100 days after the last dose of study treatment or until an alternative cancer treatment is initiated, 
whichever occurs first. Treatment medications for AEs related to study treatment that occur more than 100 days after the last dose of study treatment will be collected. 
k. 12-lead ECGs will be obtained at Screening, before the W1D1, W3D1, and W7D1 CMP-001 injections, and at EOT. ECG parameters will include heart rate and PR, QRS, QT, and QT corrected for heart rate (using 
Fridericia’s formula) intervals. ECGs will be performed after the subject has been resting in supine or semi-supine position for at least 5 minutes. When an ECG is scheduled at the same time as a blood sampling, the 
ECG reading should be obtained before the scheduled blood sampling. 
l. Clinical laboratory assessments may be performed up to 72 hours before the study treatment administration. When clinical laboratory assessments are done the same day as study treatment administration, vital signs 
should be performed prior to collection of clinical laboratory tests; an extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24- 
hour window. Refer to Section 7.1.12 for Clinical Laboratory Assessments. 
Note: For WOCBP a serum pregnancy test should be done at Screening. Serum or urine pregnancy tests should be done prior to the first CMP-001 injection on W1D1, W4D1, W7D1, Q3W thereafter, and EOT. 
An FSH test is required at screening to confirm menopause (FSH level >40 mIU/mL) in women <55 years of age (Section 4.3.1). Refer to Section 7.1.13 for Pregnancy Testing. 
Note: Coagulation samples (PT, INR, and PTT) to be collected and results reviewed prior to the W1D1 CMP-001 injection visit and prior to every CMP-001 injection beginning at W7D1 and continuing Q3W 
thereafter. 
m. Exploratory biomarker blood samples are to be collected at the following time points during the Phase 2 portion of the study only: W1D1 within 2 hours before CMP-001 injection; W5D1 (same day as tumor 
biopsy) before CMP-001 injection; W6D1 within 2 hours before CMP-001 injection, 4 hours (± 30 minutes) after CMP-001 injection, and 24 hours (± 4 hours) after CMP-001 injection (W6D2); and W7D1 within 2 
hours before CMP-001 injection. Refer to Section 7.3.1 Collection of Blood for Translational Biomarker Analyses. 
n. Fresh tumor biopsy samples are mandatory, if safe and medically feasible, at Screening (before W1D1) and W5D1 (±1 week) prior to CMP-001 IT injection. If the Investigator believes it is unsafe to perform a 
biopsy, the subject may be considered eligible after discussion with the Medical Monitor if tissue and/or prior assessments are available to determine PD-L1 expression. Archival tumor biopsy samples should also 
be collected during Screening, if available. Refer to Section 7.3.2 for Tumor Biopsies. 
o. Disease Assessment methods include radiographic (contrast-enhanced CT alone or in combination with PET or MRI), photographic, and CNS imaging by contrast-enhanced CT or MRI (per site local standards). The 
same modality used at Screening must be used throughout the study. Disease assessments will be performed predose beginning at W10D1 (-7 days) and repeated every 6 weeks (-7 days) (eg, W16D1, W22D1, etc). 
A response (CR, PR, iCR or iPR [per RECIST v1.1 or iRECIST]) will be confirmed with follow-up disease assessments performed at least 4 weeks after the date of initial response. Disease assessments will 
continue every 6 weeks after the confirmatory scans. All scans should be performed at least 2 weeks after a previous CMP-001 IT injection to prevent injection-related pseudoprogression. Disease assessments will 
be performed every 12 weeks for subjects continuing on study more than 1 year. Refer to Section 7.2 for Disease Assessments. 
p. Baseline CNS imaging by contrast-enhanced CT or MRI must be provided at Screening; on-study CNS imaging is required only if symptoms or history of CNS disease is present at Baseline. 
 
 
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Checkmate Pharmaceuticals, Inc. 
Amendment 1 (Version 2.0) 04 February 202116  
Confidential 
 
 
TABLE OF CONTENTS 
SYNOPSIS ................................................................................................................... 5 
TABLE OF CONTENTS ............................................................................................ 16 
LIST OF TABLES ...................................................................................................... 22 
LIST OF FIGURES ..................................................................................................... 23 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ............................. 24 
1. 
INTRODUCTION ................................................................................... 28 
1.1. 
Background .............................................................................................. 28 
1.2. 
CMP-001 .................................................................................................. 28 
1.2.1. 
Previous Clinical Studies With CMP-001................................................ 29 
1.3. 
Nivolumab ................................................................................................ 30 
1.3.1. 
Nivolumab Mechanism of Action ............................................................ 30 
1.3.2. 
Nivolumab Clinical Activity .................................................................... 30 
1.3.3. 
Benefit/Risk Assessment .......................................................................... 30 
1.4. 
Study Rationale ........................................................................................ 31 
1.4.1. 
Rationale for Combining a TLR9 Agonist with an PD-1 Blocking 
Antibody .................................................................................................. 31 
1.4.2. 
Rationale for Intratumoral Administration of TLR9 Agonists ................ 31 
1.4.3. 
Rationale for CMP-001 Dose and Schedule ............................................ 32 
1.4.4. 
Rationale for Nivolumab Dose and Schedule .......................................... 32 
1.4.5. 
Rationale for Open Label Randomized, Controlled Trial ........................ 32 
2. 
STUDY OBJECTIVES AND ENDPOINTS ........................................... 33 
2.1. 
Phase 2 Study Objectives ......................................................................... 33 
2.1.1. 
Phase 2 Primary Objective ....................................................................... 33 
2.1.2. 
Phase 2 Secondary Objective ................................................................... 33 
2.2. 
Phase 3 Study Objectives ......................................................................... 33 
2.2.1. 
Phase 3 Primary Objective ....................................................................... 33 
2.2.2. 
Phase 3 Secondary Objectives ................................................................. 33 
2.2.3. 
Phase 3 Exploratory Objectives ............................................................... 33 
2.3. 
Phase 2 Study Endpoints .......................................................................... 33 
2.3.1. 
Phase 2 Primary Endpoint ........................................................................ 33 
2.3.2. 
Phase 2 Secondary Endpoints .................................................................. 34 
2.4. 
Phase 3 Study Endpoints .......................................................................... 34 
2.4.1. 
Phase 3 Primary Endpoint ........................................................................ 34 
2.4.2. 
Phase 3 Secondary Endpoints .................................................................. 34 
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2.4.3. 
Phase 3 Exploratory Endpoints ................................................................ 34 
3. 
INVESTIGATIONAL PLAN .................................................................. 35 
3.1. 
Overall Study Design ............................................................................... 35 
3.2. 
Duration of Treatment with Nivolumab ................................................... 36 
3.3. 
Blinded Independent Central Review Committee .................................... 37 
3.4. 
Independent Data Monitoring Committee ............................................... 37 
4. 
SELECTION AND WITHDRAWAL OF SUBJECTS ........................... 38 
4.1. 
Inclusion Criteria...................................................................................... 38 
4.2. 
Exclusion Criteria .................................................................................... 39 
4.3. 
Women of Childbearing Potential ............................................................ 40 
4.3.1. 
Women of Non-Childbearing Potential ................................................... 41 
4.3.2. 
Acceptable Methods of Contraception ..................................................... 41 
4.4. 
Prohibited Concomitant Medications ....................................................... 41 
4.5. 
Treatment Discontinuation ....................................................................... 42 
4.6. 
Study Discontinuation .............................................................................. 43 
4.7. 
End of Clinical Trial ................................................................................ 43 
5. 
TREATMENT OF SUBJECTS ............................................................... 44 
5.1. 
Administration of Study Treatment ......................................................... 44 
5.1.1. 
Nivolumab ................................................................................................ 44 
5.1.1.1. 
Nivolumab Dose Selection ....................................................................... 44 
5.1.1.2. 
Clinical Pharmacology Summary ............................................................ 45 
5.1.2. 
CMP-001 .................................................................................................. 46 
5.1.2.1. 
Prophylaxis Prior to CMP-001 Injection .................................................. 47 
5.1.2.2. 
Observation Following CMP-001 Dosing ............................................... 47 
5.1.2.3. 
CMP-001 Injections ................................................................................. 47 
5.1.3. 
Dose Modifications and Management of CMP-001 Associated Adverse 
Events ....................................................................................................... 48 
5.1.3.1. 
Injection Site Reactions ........................................................................... 48 
5.1.3.2. 
Management of Adverse Events Associated with CMP-001 ................... 49 
5.1.4. 
Dose Modifications and Management of Adverse Events Associated with 
Nivolumab ................................................................................................ 49 
5.1.4.1. 
Criteria to Resume Nivolumab Treatment ............................................... 54 
5.1.4.2. 
Treatment of Nivolumab-Related Infusion Reactions ............................. 55 
5.1.4.3. 
Nivolumab Treatment Beyond Disease Progression ................................ 56 
5.1.5. 
Subject Randomization and Stratification ................................................ 56 
5.1.6. 
Blinding and Unblinding Process ............................................................ 56 
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5.2. 
Prior and Concomitant Medications......................................................... 57 
5.3. 
Treatment Compliance ............................................................................. 57 
6. 
STUDY TREATMENT MATERIALS AND MANAGEMENT ............ 58 
6.1. 
Study Treatments ..................................................................................... 58 
6.2. 
Study Drug Labeling and Packaging ....................................................... 58 
6.3. 
Study Drug Handling, Storage, Accountability ....................................... 58 
6.4. 
Study Drug Dispensing ............................................................................ 59 
7. 
STUDY ASSESSMENTS AND PROCEDURES ................................... 60 
7.1. 
Procedures and Assessments .................................................................... 60 
7.1.1. 
Informed Consent ..................................................................................... 60 
7.1.2. 
Eligibility Criteria .................................................................................... 60 
7.1.3. 
Demographics .......................................................................................... 60 
7.1.4. 
Medical History ....................................................................................... 60 
7.1.5. 
Melanoma History ................................................................................... 60 
7.1.6. 
Prior Cancer Treatments .......................................................................... 60 
7.1.7. 
Medication History .................................................................................. 61 
7.1.8. 
Physical Examination ............................................................................... 61 
7.1.9. 
Vital Signs ................................................................................................ 61 
7.1.10. 
Eastern Cooperative Oncology Group Performance Status ..................... 61 
7.1.11. 
Electrocardiogram .................................................................................... 61 
7.1.12. 
Clinical Laboratory Assessments ............................................................. 62 
7.1.13. 
Pregnancy Testing .................................................................................... 63 
7.2. 
Disease Assessments ................................................................................ 64 
7.2.1. 
Radiographic Imaging .............................................................................. 64 
7.2.2. 
Photographic Imaging .............................................................................. 64 
7.2.2.1. 
Central Nervous System Imaging ............................................................ 64 
7.2.3. 
On-Treatment Disease Assessment .......................................................... 64 
7.2.3.1. 
Disease Assessment Beyond Progressive Disease ................................... 65 
7.2.3.2. 
Confirmation of Response ....................................................................... 65 
7.3. 
Translational Assessments ....................................................................... 65 
7.3.1. 
Collection of Blood for Translational Biomarker Analyses .................... 65 
7.3.2. 
Collection of Tumor Biopsies for PD-L1 Staining and Translational 
Analyses ................................................................................................... 65 
7.4. 
Safety Assessments .................................................................................. 66 
7.4.1. 
Adverse Events ........................................................................................ 67 
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Checkmate Pharmaceuticals, Inc. 
Amendment 1 (Version 2.0) 04 February 202119  
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7.5. 
100-Day Follow-up Contact..................................................................... 67 
7.6. 
Post-treatment Follow-up ......................................................................... 67 
7.7. 
Long-Term Survival Follow-up ............................................................... 67 
8. 
SAFETY DATA COLLECTION, RECORDING, AND REPORTING. 69 
8.1. 
Adverse Events ........................................................................................ 69 
8.1.1. 
Definition of an Adverse Event................................................................ 69 
8.1.2. 
Definition of a Serious Adverse Event ..................................................... 69 
8.1.3. 
Definition of a Treatment-Emergent Adverse Event ............................... 70 
8.1.4. 
Definition of a Pretreatment Adverse Event ............................................ 71 
8.2. 
Evaluation of Adverse Events and Serious Adverse Events .................... 71 
8.2.1. 
Adverse Event Severity/Grade ................................................................. 71 
8.2.2. 
Relationship to Study Treatment .............................................................. 71 
8.2.3. 
Classification of Adverse Event Outcome ............................................... 72 
8.2.4. 
Action Taken Related to Study Treatment Administration Regarding the 
Adverse Event .......................................................................................... 73 
8.3. 
Procedures for Recording and Reporting Adverse Events ...................... 73 
8.3.1. 
Reporting Serious Adverse Events .......................................................... 74 
8.3.2. 
Reporting Pregnancies ............................................................................. 75 
8.3.3. 
Reporting Serious Adverse Events to Institutional Review Boards and 
Regulatory Authorities ............................................................................. 75 
8.3.4. 
Follow-up of Adverse Events/Serious Adverse Events ........................... 76 
9. 
STATISTICAL METHODS .................................................................... 77 
9.1. 
Sample Size Calculation .......................................................................... 77 
9.2. 
Multiplicity ............................................................................................... 77 
9.3. 
Analysis Sets ............................................................................................ 78 
9.3.1. 
Intent-to-Treat Analysis Set ..................................................................... 78 
9.3.2. 
Safety Analysis Set .................................................................................. 78 
9.3.3. 
Per Protocol Analysis Set ......................................................................... 78 
9.3.4. 
Pharmacodynamic Analysis Set ............................................................... 78 
9.4. 
Background Characteristics...................................................................... 78 
9.4.1. 
Disposition ............................................................................................... 78 
9.4.2. 
Demographics and Other Baseline Characteristics .................................. 78 
9.4.3. 
ECOG Performance Status ....................................................................... 78 
9.4.4. 
Melanoma History ................................................................................... 78 
9.4.5. 
Prior Cancer Treatments .......................................................................... 79 
9.4.6. 
Medical and Surgical History .................................................................. 79 
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9.4.7. 
Protocol Deviations .................................................................................. 79 
9.4.8. 
Prior and Concomitant Medications......................................................... 79 
9.5. 
Study Treatment Exposure and Compliance ............................................ 79 
9.6. 
Efficacy Analyses .................................................................................... 79 
9.6.1. 
Confirmed Objective Response Rate ....................................................... 80 
9.6.2. 
Progression-Free Survival ........................................................................ 81 
9.6.3. 
Overall Survival ....................................................................................... 81 
9.6.4. 
Disease Control Rate ................................................................................ 81 
9.6.5. 
Duration of Response ............................................................................... 81 
9.6.6. 
 ................................... 82 
9.6.7. 
Post-Progression Disease Response ......................................................... 82 
9.6.8. 
................................................................ 82 
9.7. 
Safety Analyses ........................................................................................ 82 
9.7.1. 
Adverse Events ........................................................................................ 82 
9.7.2. 
Clinical Laboratory Assessments ............................................................. 82 
9.7.3. 
Vital Signs ................................................................................................ 83 
9.7.4. 
Physical Examinations ............................................................................. 83 
9.7.5. 
Electrocardiograms ................................................................................... 83 
9.8. 
Pharmacodynamic Analyses .................................................................... 83 
9.9. 
Exploratory Tumor Biopsy Analyses ....................................................... 83 
9.10. 
Appropriateness of Measures ................................................................... 83 
9.10.1. 
Blinded Independent Central Review ...................................................... 83 
9.11. 
In-House Blinding .................................................................................... 84 
10. 
QUALITY CONTROL AND QUALITY ASSURANCE ....................... 85 
10.1. 
Study Monitoring ..................................................................................... 85 
10.2. 
Case Report Forms ................................................................................... 85 
11. 
QUALITY CONTROL AND QUALITY ASSURANCE ....................... 86 
11.1. 
Data Quality Assurance ........................................................................... 86 
11.2. 
Quality Assurance Audits ........................................................................ 86 
11.3. 
Audits and Inspections by Regulatory Authorities .................................. 86 
11.4. 
Retention of Records ................................................................................ 86 
12. 
ETHICS.................................................................................................... 87 
12.1. 
Ethics Review .......................................................................................... 87 
12.2. 
Ethical Conduct of the Study ................................................................... 87 
12.3. 
Written Informed Consent ....................................................................... 87 
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13. 
PUBLICATION POLICY........................................................................ 89 
14. 
LIST OF REFERENCES ......................................................................... 90 
15. 
APPENDICES ......................................................................................... 93 
APPENDIX A. ECOG PERFORMANCE STATUS ............................................... 94 
APPENDIX B. APPROXIMATE MAXIMUM AMOUNT OF BLOOD DRAWN 
FOR ONE YEAR OF STUDY PARTICIPATION ................................. 95 
APPENDIX C. COMMON TERMINOLOGY CRITERIA FOR ADVERSE 
EVENTS (CTCAE) VERSION 5.0 ......................................................... 96 
APPENDIX D. RESPONSE EVALUATION CRITERIA IN SOLID TUMORS 
(RECIST) VERSION 1.1 ......................................................................... 97 
APPENDIX E. IMMUNOTHERAPY RESPONSE EVALUATION CRITERIA IN 
SOLID TUMORS (IRECIST)................................................................ 102 
APPENDIX F. 
 
 106 
APPENDIX G. CMP-001 INJECTION GUIDELINE ........................................... 114 
APPENDIX H. NIVOLUMAB SAFETY ALGORITHM ..................................... 117 
APPENDIX I. COUNTRY SPECIFIC REQUIREMENTS FOR HIV 
TESTING/EXCLUSION ....................................................................... 126 
APPENDIX J. WOMEN OF CHILDBEARING POTENTIAL DEFINITION AND 
METHODS OF CONTRACEPTION .................................................... 127 
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LIST OF TABLES 
Table 1: 
Schedule of Assessments ......................................................................... 13 
Table 2: 
Dose Modifications and Management of Adverse Events Associated with 
Nivolumab ................................................................................................ 50 
Table 3: 
Clinical Laboratory Assessments ............................................................. 63 
Table 4: 
Criteria for Determination of Serious Adverse Events ............................ 70 
Table 5: 
CTCAE Adverse Event Grades ............................................................... 71 
Table 6: 
Classification for Adverse Event Causality ............................................. 72 
Table 7: 
Classifications for Adverse Event Outcomes ........................................... 72 
Table 8: 
Classifications for Actions Taken Related to Study Treatment 
Administration Regarding an Adverse Event .......................................... 73 
Table 9: 
Response for Lesion Category ............................................................... 110 
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Checkmate Pharmaceuticals, Inc. 
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Confidential 
 
 
LIST OF FIGURES 
Figure 1: 
CMP-001-011 Study Schema .................................................................. 36 
Figure 2: 
Suggested Prophylaxis and Treatment for Symptoms Associated with 
CMP-001 .................................................................................................. 49 
Figure 3: 
Go/No-Go Decision Tree Based on End of Phase 2 Efficacy .................. 80 
Figure 4: 
Method for CMP-001 Intratumoral Injection ......................................... 114 
Figure 5: 
Preferred Sites of Subcutaneous Injection ............................................. 116 
                                        VV-RIM-00384192-1.0 Approved - 11 Dec 2024 GMT-5:00

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Checkmate Pharmaceuticals, Inc. 
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Confidential 
 
 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
Abbreviation or Specialist Term 
Explanation 
ADL 
activities of daily living 
AE 
adverse event 
AJCC 
American Joint Committee on Cancer 
AST 
aspartate aminotransferase 
ATC 
Anatomical Therapeutic Chemical 
BICR 
Blinded Independent Central Review 
BOR 
best overall response 
Cavg28 
average serum concentration at Day 28 
CD 
cluster of differentiation 
CFR 
Code of Federal Regulations 
cHL 
classical Hodgkin lymphoma 
CL 
clearance 
CLss 
steady state clearance 
Cmin28 
trough serum concentration at Day 28 
CNS 
central nervous system 
CpG 
cytosine linked to a guanine by a phosphate bond 
CR 
complete response 
CRA 
Clinical Research Associate 
CRC 
colorectal cancer 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTL 
cytotoxic T lymphocyte 
CTLA-4 
cytotoxic T-lymphocyte-associated protein 4 
CV 
coefficient of variation 
CXCL10 
C-X-C motif chemokine 10 
DCR 
disease control rate 
DOR 
duration of response 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EDC 
electronic data capture 
eGFR 
estimated glomerular filtration rate 
EOT 
end of treatment 
ER 
exposure response 
                                        VV-RIM-00384192-1.0 Approved - 11 Dec 2024 GMT-5:00

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Checkmate Pharmaceuticals, Inc. 
Amendment 1 (Version 2.0) 04 February 202125  
Confidential 
 
 
 
Abbreviation or Specialist Term 
Explanation 
FDA 
Food and Drug Administration 
FSH 
follicle stimulating hormone 
GCP 
Good Clinical Practice 
HCC 
hepatocellular carcinoma 
HR 
hazard ratio 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonisation 
iCR 
immune complete response 
ID 
identification 
IDMC 
Independent Data Monitoring Committee 
iDOR 
immune duration of response 
IEC 
Independent Ethics Committee 
IFN 
interferon 
IMAE 
immune-mediated adverse event 
INR 
international normalized ratio 
iORR 
immune objective response rate 
iPFS 
immune progression-free survival 
iPR 
immune partial response 
IRB 
Institutional Review Board 
iRECIST 
immunotherapy Response Evaluation Criteria in Solid 
Tumors 
iSD 
immune stable disease 
IT 
intratumoral(ly) 
itRECIST 
intratumoral Response Evaluation Criteria in Solid 
Tumors 
ITT 
Intent-to-Treat 
iUPD 
immune unconfirmed progressive disease 
IV 
intravenous 
IWRS 
Interactive Web Response System 
LTSFU 
long-term survival follow-up 
MedDRA 
Medical Dictionary for Regulatory Activities 
MEK 
mitogen-activated protein kinase 
MRI 
magnetic resonance imaging 
NCI 
National Cancer Institute 
NSCLC 
non-small cell lung cancer 
ODN 
oligodeoxynucleotide 
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Abbreviation or Specialist Term 
Explanation 
ORR 
objective response rate 
OS 
overall survival 
PD 
progressive disease 
PD-1 
programmed cell death protein 1 
pDC 
plasmacytoid dendritic cell 
PD-L1 
programmed death-ligand 1 
PET 
positron emission tomography 
PFS 
progression-free survival 
PK 
pharmacokinetics 
PPK 
population pharmacokinetics 
PR 
partial response 
PS20 
polysorbate 20 
PT 
prothrombin time 
PTFU 
Post-treatment Follow-up 
PTT 
partial thromboplastin time 
Q2W 
every 2 weeks 
Q3W 
every 3 weeks 
Q4W 
every 4 weeks 
Qb 
Qbeta 
QTc 
QT corrected 
RCC 
renal cell carcinoma 
RECIST 
Response Evaluation Criteria in Solid Tumors 
RVT 
residual viable tumor 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SC 
subcutaneous (ly) 
SCCHN 
squamous cell carcinoma of the head and neck 
SD 
stable disease 
SOC 
system organ class 
SOP 
standard operating procedure 
TB 
total bilirubin 
TEAE 
treatment-emergent adverse event 
TLR9 
toll-like receptor 9 
ULN 
upper limit of normal 
USPI 
United States Prescribing Information 
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Abbreviation or Specialist Term 
Explanation 
VLP 
virus-like particle 
WNL 
within normal limits 
 
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1. 
INTRODUCTION 
1.1. 
Background 
Melanoma remains the most common cause of skin cancer death in the United States, Europe, 
and Australia. Despite an evolving understanding of the molecular aberrations and clinical 
factors that impact outcomes as well as improvements in the therapeutic paradigm, including 
immunotherapy, metastatic melanoma remains essentially incurable in view of the limited 
efficacy and the toxicity of the currently available agents. Over the past 10 years, newly 
approved treatment options with programmed cell death protein 1 (PD-1) blocking antibodies 
have improved survival outcomes in patients with melanoma, including patients with 
previously treated unresectable melanoma or treatment-naïve advanced melanoma. Treatment 
with a single-agent PD-1 blocking antibody resulted in objective response rates (ORR) of 
34% to 40%, median progression-free survival (PFS) ranging from 4.1 to 6.9 months, and 
long-term (5-year) survival rates up to 45% (KEYTRUDA® United States Prescribing 
Information [USPI]; OPDIVO® USPI; Larkin-2019). When combined with a cytotoxic 
T-lymphocyte-associated protein 4 (CTLA-4) inhibitor, PD-1 blocking antibody had an ORR 
of 50%, median PFS of 11.5 months, and long-term survival rate of 52% (OPDIVO® USPI; 
Larkin-2019). Despite the improved outcomes with PD-1 blocking antibodies, more than 
55% of patients do not respond to single-agent nivolumab or pembrolizumab and half do not 
respond to combination therapy with a CTLA-4 inhibitor. Therefore, there remains a critical 
need for innovative anticancer therapy in this condition. 
There are several preferred Category 1 regimens (based upon high-level evidence and 
National Comprehensive Cancer Network consensus) available for the first-line treatment of 
patients with unresectable Stage III/IV melanoma, including PD-1 blockade monotherapy or, 
if a BRAF V600-activating mutation is present, a combination of agents targeted at BRAF 
and mitogen-activated protein kinase (MEK) (NCCN-2020). In certain circumstances, 
nivolumab combined with ipilimumab may be another option. 
1.2. 
CMP-001 
CMP-001 is a toll-like receptor 9 (TLR9) agonist composed of 
 
, a cytosine linked to a guanine by a phosphate bond (CpG) 
oligodeoxynucleotide (ODN). The VLP is composed of a capsid protein derived from 
bacteriophage Qbeta. G10 is an ODN that contains CpG and poly-G tails that allow it to form 
G-quadruplexes. Once administered to a patient, an antidrug antibody response to the VLP 
(anti-Qbeta antibodies) develops. Antibody-coated 
 is taken up by cells through Fc 
receptors into the endosome. In plasmacytoid dendritic cells (pDCs), antibody-coated 
 
is taken up via FcRIIA into endosomes where the G10 is released and activates TLR9 
(Lemke-Miltner-2020). 
Toll-like receptor 9 is found in pDCs and B cells, but Type A CpG compounds have little 
effect on B cells. Plasmacytoid dendritic cells primarily reside in blood but can also be found 
in tumors and lymph nodes. Inactivated tumor-infiltrating pDCs contribute to tumor growth 
and are associated with an adverse prognosis in patients with cancer (Lombardi-2015; 
Demoulin-2013). Activation and maturation of pDCs through TLR9 agonism induces Type I 
interferons (IFNs), which in turn mediate the release of IFN-inducible chemokines such as 
C-X-C motif chemokine 9 and C-X-C motif chemokine 10 (CXCL10) (Swiecki-2015). 
Activated pDCs also take up tumor specific antigens for presentation to T cells and other 
immune cells, facilitating the development of an antigen-specific, antitumor T-cell response. 
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Together, the Type I IFNs, IFN-inducible chemokines, and antigen presentation promote the 
activation and differentiation of cluster of differentiation (CD) 8+ T cells into cytotoxic 
T lymphocytes (CTLs) capable of circulating throughout the body and attacking distant tumor 
cells. Therefore, administration of intratumoral (IT) CMP-001 is hypothesized to change the 
pDC functional phenotype from tumor promoting to one that promotes an antigen-specific, 
antitumor CD8+ T cell response. 
1.2.1. 
Previous Clinical Studies With CMP-001 
The safety and efficacy data demonstrating the clinical benefit of CMP-001 IT in 
combination with pembrolizumab intravenous (IV) in patients with melanoma refractory to 
PD-1 blockade were obtained in an ongoing clinical study, Study CMP-001-001 
(Milhem -2020). In the 98 subjects treated with pembrolizumab according to the 
KEYTRUDA® (pembrolizumab) United States Prescribing Information (KEYTRUDA® 
USPI) in combination with CMP-001 10 mg IT every week for 7 weeks and every 3 weeks 
(Q3W) thereafter, the objective response rate (ORR) was 27.6% (27/98; 95% confidence 
interval [CI] 19.0%, 37.6%), including patients with responses after initial progressive 
disease and the best ORR by RECIST v1.1 was 23.5% (23/98; 95% CI: 15.5%, 33.1%), 
including 7 complete responses and 16 partial responses. This ORR is substantially higher 
than the 7.7% response rate observed in the 6 of 78 patients who received treatment beyond 
progression with pembrolizumab in the Keynote-002 study (Ahmed-2020). The clinical 
benefit of this combination treatment includes durable CRs and PRs in injected and 
non-injected target lesions and non-target lesions of the skin, lymph nodes, and viscera. The 
Kaplan-Meier estimate for median duration of response (DOR) for both RECIST v1.1 
responders and RECIST v1.1 responders plus post-progressive disease responders was 
19.9 months (95% CI: 6 months, 19.9 months). Most treatment related adverse events 
(TRAEs) were Grade 1 or 2 and included flu-like symptoms, including chills, fever, fatigue, 
nausea, vomiting, and headache, and injection site pain. The most common treatment-related 
Grade 3 or 4 adverse events were hypotension (6.3%) and hypertension (5.0%). No Grade 5 
treatment-related adverse events were reported. Additional information is provided in the 
CMP-001 Investigator’s Brochure (IB). 
Preliminary safety and efficacy data from an ongoing Phase 2 Investigator Sponsored Trial of 
CMP-001 IT in combination with nivolumab in subjects with high-risk resectable melanoma 
(Study HCC 17-169) demonstrated clinical activity and a tolerable safety profile 
(Davar -2020). Pathological responses, defined as ≤ 50% residual viable tumor (RVT), were 
reported in 70% of subjects 21/30) and included pathological complete response (pCR), 
defined as 0% RVT, in 50% (15/30) of subjects, pathological major response (pMR), defined 
as 1% to 10% RVT, in 10% (3/30) of subjects, and pathological partial response (pPR), 
defined as 11% to 50% RVT, in 10% (3/30) of subjects. In the 31 subjects evaluable for 
safety, CMP-001 in combination with nivolumab was generally well tolerated with an acute 
toxicity profile consisting predominantly of Grade 1 or 2 TRAEs. The only treatment-related 
Grade 3 adverse event in more than 1 subject was hypertension (n = 3, 9.7%). No Grade 4/5 
TRAEs were reported. There were no dose limiting toxicities or delays in surgery related to 
neoadjuvant treatment. One-year regression free survival was 89% in patients with major 
pathological response (pCR and pMR) and 90% in patients with any pathological response 
(pCR, pMR, and pPR). 
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1.3. 
Nivolumab 
1.3.1. 
Nivolumab Mechanism of Action 
Nivolumab (also referred to as BMS-936558, MDX1106, or ONO-4538) is a human 
monoclonal antibody (HuMAb; immunoglobulin G4-S228P) that targets the PD-1 cluster of 
differentiation 279 cell surface membrane receptor. PD-1 is a negative regulatory molecule 
expressed by activated T and B lymphocytes (Schadendorf 2017). Binding of PD-1 to its 
ligands, programmed death–ligands 1 (PD-L1) and 2 (PD-L2), results in the down-regulation 
of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes 
immune responses and antigen-specific T-cell responses to both foreign antigens as well as 
self-antigens. Nivolumab is expressed in Chinese hamster ovary cells and is produced using 
standard mammalian cell cultivation and chromatographic purification technologies. The 
clinical study product is a sterile solution for parenteral administration. 
Nivolumab is approved for the treatment of several types of cancer in multiple regions 
including the US (Dec-2014), the European Union (EU, Jun-2015), and Japan (Jul-2014). 
1.3.2. 
Nivolumab Clinical Activity 
Nivolumab has demonstrated durable responses exceeding 6 months as monotherapy in 
several tumor types, including non-small cell lung cancer (NSCLC), melanoma, renal cell 
carcinoma (RCC), classical Hodgkin lymphoma (cHL), small cell lung cancer, gastric cancer, 
squamous cell carcinoma of the head and neck (SCCHN), urothelial cancer, hepatocellular 
carcinoma (HCC), and colorectal cancer (CRC). In confirmatory trials, nivolumab as 
monotherapy demonstrated a statistically significant improvement in OS as compared with 
the current standard of care in patients with advanced or metastatic NSCLC, unresectable or 
metastatic melanoma, advanced RCC, or SCCHN. Details of the clinical activity in these 
various malignancies are provided in the nivolumab Investigator’s Brochure. 
1.3.3. 
Benefit/Risk Assessment 
Extensive details on the safety profile of nivolumab are available in the nivolumab 
Investigator’s Brochure and will not be repeated herein. 
Overall, the safety profile of nivolumab monotherapy is manageable and generally consistent 
across completed and ongoing clinical trials with no maximum tolerated dose reached at any 
dose tested up to 10 mg/kg. Most AEs were low-grade (Grade 1 to 2) with relatively few 
related high-grade (Grade 3 to 4) AEs. There was no pattern in the incidence, severity, or 
causality of AEs with respect to nivolumab dose level. 
A pattern of immune-related AEs has been defined, for which management algorithms have 
been developed; these are provided in Appendix H. Most high-grade events were manageable 
with the use of corticosteroids or hormone replacement therapy (endocrinopathies) as 
instructed in these algorithms. 
Additional details on the safety profile of nivolumab, including results from other clinical 
studies, are also available in the nivolumab Investigator’s Brochure. 
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1.4. 
Study Rationale 
1.4.1. 
Rationale for Combining a TLR9 Agonist with an PD-1 Blocking Antibody 
PD-1 blockade is an effective and important therapy for the treatment of melanoma, however, 
more than 60% of patients do not respond to monotherapy treatment with a PD-1 blocking 
antibody. PD-1 negatively regulates T cell function when it interacts with its ligand PD-L1, 
which is commonly expressed on tumors (Chen-2013). A major mechanism of resistance to 
PD-1 blockade is the absence of activated effector T cells in the tumor. Therefore, 
TLR9-mediated T cell activation and trafficking to tumor has the potential to improve the 
response to PD-1 blockade, particularly in non-inflamed tumors. 
In prior clinical trials, TLR9 agonism resulted in strong induction of CTL responses; 
however, very few objective responses were observed and the T cell responses were not 
sustained, especially within tumors (Appay-2006). This may be because TLR9-mediated 
T cell activation induces PD-1 expression on activated T cells (Fourcade-2014). TLR9 
agonists are capable of inducing tumor-specific CD8+ T cells in cancer subjects, but the 
expression of PD-1 on these T cells blocks their function. Therefore, PD-1 blockade may 
facilitate and sustain the TLR9-mediated activation of tumor-specific T cells. 
Several nonclinical and clinical reports support the hypothesis that TLR9 agonism may 
enhance the antitumor response of melanoma to PD-1 blockade. The ex vivo addition of a 
PD-1–blocking antibody to CD8+ T cells from melanoma subjects who had been treated with 
a TLR9 agonist significantly increased the T cell function for cytokine secretion 
(Fourcade-2014), providing a rationale for the use of the combination of TLR9 agonists and 
PD-1–blocking antibodies in cancer therapy. 
Several TLR9 agonists have shown antitumor efficacy in mouse tumor models in 
combination with PD-1 blockade. In mice with MB49 bladder cancer, a CpG-B ODN in 
combination with anti-CTLA-4 or anti-PD-1 increased survival, and PD-1 blockade plus CpG 
treatment was superior to either agent alone. CpG plus anti-CTLA-4 or anti-PD-1 increased 
the numbers of circulating tumor-specific, CD107a-expressing CD8+ T cells as well as 
activated (CD25+FoxP3-) CD4 splenocytes. Furthermore, regulatory T cells were decreased 
in the tumor area of treated animals after anti-CTLA-4 or anti-PD-1 plus CpG therapy 
(Mangsbo-2010). Additionally, mice treated with a CpG-B TLR9 agonist in combination 
with PD-1 blockade in an ovarian cancer model also had improved survival 
(Duraiswamy-2013). Mechanistic studies in the PD-L1 resistant mouse tumor models, 
including CT26 and MC38 colon carcinoma and TSA mammary adenocarcinoma, 
demonstrated that IT injection of a CpG-C ODN reversed resistance to PD-1 blockade by 
inducing the infiltration of activated CD8+ T cells expressing IFN gamma (Wang-2016). 
Finally, injection of CMP-001 IT in a mouse A20 lymphoma model reduced the growth of 
both injected and noninjected tumors and improved survival, and these antitumor effects were 
enhanced by combination with systemic anti-PD-1 therapy (Lemke-Miltner-2020). The VLP 
appeared to contribute to the antitumor efficacy of CpG-A therapy, since a reduced antitumor 
effect was observed if the CpG-A TLR9 agonist was administered without the VLP. 
1.4.2. 
Rationale for Intratumoral Administration of TLR9 Agonists 
CMP-001 is intended to activate pDCs via TLR9 agonism, which causes the pDCs to release 
Type I IFN and take up and present tumor antigens to T cells, culminating in the generation 
of an antigen-specific, antitumor T cell response. Administration of CMP-001 IT is intended 
to activate pDCs, and subsequently T cells, within the tumor and tumor-draining lymph nodes 
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where tumor-specific antigen is most likely to exist. Systemic administration of TLR9 
agonists is expected to result in uptake by the liver, spleen, and reticuloendothelial system, 
which may lead to suboptimal activation of pDCs in tumor and tumor-draining lymph nodes. 
Intratumoral administration of CMP-001 is expected to activate resting pDCs, thereby 
overcoming their tumor-promoting phenotype and ultimately inducing an antitumor CD8+ 
T cell response in the tumor microenvironment. In preclinical models, IT dosing of TLR9 
agonists was more effective than distant subcutaneous (SC) dosing, and induced regression 
not only in the directly injected tumor lesion, but also distant metastases (Heckelsmiller- 
2002; Shirota-2012). 
1.4.3. 
Rationale for CMP-001 Dose and Schedule 
In the dose escalation phase of Study CMP-001-001, CMP-001 IT was evaluated at doses of 
1 to 10 mg IT using 2 different dosing schedules and with preparations containing 2 different 
concentrations of the excipient polysorbate 20 (PS20) (0.01% and 0.00167%) in combination 
with pembrolizumab IV in subjects with PD-1 refractory melanoma. The safety profile was 
similar and manageable at all CMP-001 doses of 1 to 10 mg. Antitumor activity, including 
durable complete and partial responses, with a predictable/manageable safety profile was 
observed in 23% of subjects who initiated treatment with the proposed dose and schedule for 
this study: CMP-001 10 mg (PS20 0.01%) IT QW for 7 doses, followed by administration 
Q3W in combination with pembrolizumab 200 mg IV Q3W. This dose and schedule were 
selected for further development. 
Further details can be found in the CMP-001 Investigator’s Brochure. 
1.4.4. 
Rationale for Nivolumab Dose and Schedule 
The rationale for administering nivolumab Q3W is to align with the schedule of CMP-001 
evaluated in Study CMP-001-001. Population PK analyses have shown that the PK of 
nivolumab is linear, with proportional exposures over a dose range of 0.1 to 10 mg/kg. The 
benefit-risk profiles of nivolumab 240 mg every 2 weeks (Q2W), 360 mg Q3W, and 480 mg 
every 4 weeks (Q4W) are predicted to be comparable to 3 mg/kg Q2W. This is further 
discussed in Section 5.1.1.1. 
1.4.5. 
Rationale for Open Label Randomized, Controlled Trial 
A randomized, controlled trial comparing CMP-001 in combination with nivolumab versus 
nivolumab monotherapy was designed to address the contribution of CMP-001 to the 
combination of CMP-001 with PD-1 blockade. Confirmed ORR assessed by Blinded 
Independent Central Review (BICR) using RECIST v1.1 is the Phase 2 primary endpoint to 
provide an early assessment of benefit and risk, without compromising the Phase 3 primary 
endpoint of PFS, prior to enrolling the larger Phase 3 population. The rationale for an open- 
label study is based on the fact that a blinded study would require subjects assigned to 
placebo to unnecessarily receive the pretreatment prophylaxis, have a sham procedure 
performed, and potentially prolong the time in the clinic to receive the additional study 
treatment. These risks were perceived to outweigh the benefits to the rigor of the study and 
the lack of placebo control is not expected to impact the veracity of the results. 
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2. 
STUDY OBJECTIVES AND ENDPOINTS 
2.1. 
Phase 2 Study Objectives 
2.1.1. 
Phase 2 Primary Objective 
The primary objective of the Phase 2 portion of the study is to determine confirmed ORR for 
treatment with first-line CMP-001 in combination with nivolumab versus nivolumab 
monotherapy in subjects with unresectable or metastatic melanoma. 
2.1.2. 
Phase 2 Secondary Objective 
The secondary objective of the Phase 2 portion of the study is to evaluate the safety and 
tolerability of first-line CMP-001 in combination with nivolumab versus nivolumab 
monotherapy in subjects with unresectable or metastatic melanoma. 
2.2. 
Phase 3 Study Objectives 
2.2.1. 
Phase 3 Primary Objective 
The primary objective of the Phase 3 portion of the study is to evaluate PFS for subjects 
receiving first-line CMP-001 in combination with nivolumab versus nivolumab monotherapy 
for unresectable or metastatic melanoma. 
2.2.2. 
Phase 3 Secondary Objectives 
The secondary objectives of the Phase 3 portion of the study are to: 
• Evaluate the safety and tolerability of first-line CMP-001 in combination with 
nivolumab versus nivolumab monotherapy in subjects with unresectable or 
metastatic melanoma 
• Evaluate the efficacy of first-line CMP-001 in combination with nivolumab versus 
nivolumab monotherapy in subjects with unresectable or metastatic melanoma 
2.2.3. 
Phase 3 Exploratory Objectives 
The exploratory objectives of the Phase 3 portion of the study are to: 
 
 
 
 
 
 
 
2.3. 
Phase 2 Study Endpoints 
2.3.1. 
Phase 2 Primary Endpoint 
The primary endpoint in the Phase 2 portion of the study is the ORR defined as the 
proportion of subjects with a confirmed objective response of CR or PR based on Response 
Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as determined by BICR. 
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2.3.2. 
Phase 2 Secondary Endpoints 
The secondary endpoint in the Phase 2 portion of the study is AEs, SAEs, and AEs leading to 
discontinuation or death and severity of AEs as assessed by the National Cancer Institute 
(NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. 
2.4. 
Phase 3 Study Endpoints 
2.4.1. 
Phase 3 Primary Endpoint 
The primary endpoint in the Phase 3 portion of the study is PFS defined as the time from the 
date of randomization to first date of documented progressive disease based on RECIST v1.1 
by BICR or death from any cause, whichever occurs first. 
2.4.2. 
Phase 3 Secondary Endpoints 
The secondary endpoints in the Phase 3 portion of the study are: 
• AEs, SAEs, and AEs leading to discontinuation or death and severity of AEs as 
assessed by NCI CTCAE v5.0 
• OS, defined as the time from the date of randomization until death from any 
cause. 
• Confirmed ORR, defined as the proportion of subjects with a confirmed objective 
response of CR or PR based on RECIST v1.1 as determined by BICR 
• DOR, defined as the time from date of first documented response (CR or PR) to 
date of documented progressive disease, based on RECIST v1.1 as determined by 
BICR 
• Disease control rate (DCR), defined as the proportion of subjects who have a 
confirmed best response of CR or PR, or stable disease (SD) lasting at least 
4 months, based on RECIST v1.1 as determined by BICR 
• Treatment response in noninjected target lesions based on RECIST v1.1 by 
Investigator 
• PFS, ORR, DOR, and DCR based on RECIST v1.1 and immune PFS (iPFS), 
immune DOR (iDOR), and immune ORR (iORR) based on immunotherapy 
RECIST (iRECIST) as determined by Investigator assessment 
2.4.3. 
Phase 3 Exploratory Endpoints 
The exploratory endpoints in the Phase 3 portion of the study are: 
 
 
 
 
• Change from Baseline in blood concentrations of CXCL10 after treatment with 
CMP-001 
• Baseline, and change from Baseline, in tumor or blood measurements of 
biomarkers related to TLR9 (data from Phase 2 portion of the study) 
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3. 
INVESTIGATIONAL PLAN 
3.1. 
Overall Study Design 
This is a randomized, open-label, active-control study of first-line CMP-001 administered by 
intratumoral (IT) injection in combination with intravenous (IV) nivolumab versus nivolumab 
monotherapy in subjects with Stage III or IV unresectable or metastatic melanoma who have 
not been previously treated with a programmed cell death protein 1 (PD-1) blocking antibody 
for metastatic disease. Subjects will be randomized in a 1:1 manner to Arm A to receive 
CMP-001 IT in combination with nivolumab IV or Arm B to receive nivolumab monotherapy 
according to the Schedule of Assessments (Table 1) and Section 5.1. 
The study will follow a Phase 2/3 design. Eligible subjects will be enrolled in the Phase 2 
portion of the study; enrollment into the Phase 3 portion of the study will not proceed until 
the primary endpoint of Phase 2 is evaluated. 
The Phase 2 primary endpoint of ORR per RECIST v1.1 as determined by BICR will be 
assessed approximately 30 weeks after the last subject is randomized into the Phase 2 portion 
of the study. If the primary endpoint of Phase 2 is met, subjects enrolled in the Phase 2 
portion of the study will continue to receive study treatment (in Arm A or Arm B) in the 
Phase 3 portion of the study, and enrollment will proceed in Phase 3. If the Phase 2 primary 
endpoint is not met, subjects enrolled in Phase 2 may remain in the study and continue to 
receive study treatment until a reason for treatment discontinuation is reached but no further 
subjects will be enrolled. An Independent Data Monitoring Committee (IDMC) will review 
safety and efficacy data throughout the study. 
Disease assessments by computed tomography (CT) or magnetic resonance imaging (MRI) 
and other appropriate measures will be performed beginning predose at Week 10 Day 1 
(W10D1) (-7 days) and will be repeated every 6 weeks (eg, W16D1). Responses (CR, PR, 
iCR, or immune PR [iPR]) will be confirmed by a follow-up disease assessment performed at 
least 4 weeks after the initial response date. Disease assessments will continue every 6 weeks 
while the subject is on treatment. Disease assessments will be conducted every 12 weeks for 
subjects on study after 1 year. All scans should be performed at least 2 weeks after the 
previous CMP-001 IT injection to prevent injection-related pseudoprogression. Imaging 
should not be delayed for delays in treatment. 
Subjects may continue to receive study treatment beyond progressive disease (PD) according 
to RECIST v1.1 and will be evaluated by the Investigator according to iRECIST. Subjects 
with PD per RECIST v1.1 as determined by Investigator assessment should remain on 
treatment per Investigator discretion and have a follow-up scan performed at least 4 weeks 
after the initial date of PD to confirm progression per RECIST v1.1. 
Subjects who discontinue study treatment should complete an end of treatment (EOT) visit 
and 100-day safety follow-up contact, which should occur 100 days (+7) after EOT or until 
an alternative cancer treatment is initiated, whichever occurs first. Subjects who are post- 
treatment but have not met criteria for study discontinuation should remain on study for post- 
treatment follow-up (PTFU) and long-term survival follow-up (LTSFU) and receive study 
evaluations for efficacy according to the Schedule of Assessments (Table 1). 
At the end of the treatment period (2 years), the Sponsor will not continue to provide supplied 
study treatment to subjects/investigators unless the Sponsor chooses to extend the study. The 
Investigator should ensure that the subjects receive appropriate standard of care to treat the 
condition under study. 
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The study design for is summarized in Figure 1. 
Figure 1: 
CMP-001-011 Study Schema 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: 100DFU = 100-Day Follow-up; EOT = End of Treatment; LTSFU = Long-Term Survival Follow-up; IT = 
intratumoral; IV = intravenous; PTFU = Post-treatment Follow-up; Q3W = every 3 weeks; Q6W = every 6 weeks; Q12W 
= every 12 weeks; QW = weekly; W1D1 = Week 1 Day 1; W10D1 = Week 10 Day 1. 
a The first CMP-001 dose (W1D1) may be administered subcutaneously or by IT injection at the discretion of the 
Investigator. 
 
 
 
3.2. 
Duration of Treatment with Nivolumab 
The optimal duration of immunotherapy is an important question and continues to be 
investigated. Clinical trials across different tumors types in the nivolumab and ipilimumab 
development program indicate that most of the responses occur early, with a median time to 
response of 2 to 4 months, and emerging data suggest that benefit can be maintained in the 
absence of continued treatment. A retrospective pooled analysis of 2 melanoma studies 
suggest the majority of patients who discontinue nivolumab and/or ipilimumab for toxicity 
maintain disease control in the absence of further treatment (Schadendorf-2017). 
Furthermore, a limited duration of ipilimumab, including only 4 induction doses, resulted in 
long-term survival in patients with metastatic melanoma, with a sustained plateau in survival 
starting around 2 years after the start of treatment (Schadendorf-2015). 
Accumulating data suggest that 2 years of treatment with a PD-1 checkpoint inhibitor may be 
sufficient for long-term benefit. CA209003, a dose-escalation cohort expansion trial 
evaluating the safety and clinical activity of nivolumab in patients with previously treated 
advanced solid tumors (including 129 subjects with NSCLC), specified a maximum treatment 
duration of 2 years. Among 16 subjects with NSCLC who discontinued nivolumab after 
completing 2 years of treatment, 12 subjects were alive >5 years and remained progression- 
free without any subsequent therapy. In the CA209003 NSCLC cohort, the OS curve begins 
to plateau after 2 years, with an OS rate of 25% at 2 years and 18% at 3 years 
(Brahmer-2017). These survival outcomes are similar to Phase 3 studies in previously treated 
NSCLC, in which nivolumab treatment was continued until progression or unacceptable 
toxicity (2-year OS rates of 23% and 29%, and 3-year OS rates of 16% and 18% for 
squamous and non-squamous NSCLC, respectively) (Felip-2017). 
Taken together, these data suggest that treatment beyond 2 years is unlikely to confer 
additional clinically meaningful benefit and that the risk of progression after discontinuing 
treatment at 2 years is low. 
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In contrast, a shorter duration of nivolumab of only 1 year was associated with increased risk 
of progression in previously treated patients with NSCLC, suggesting that treatment beyond 
1 year is likely needed. In CA209153, patients with previously treated advanced NSCLC who 
completed 1 year of nivolumab therapy were randomized to either continue or stop treatment, 
with the option of retreatment upon progression. Among 163 patients still on treatment at 
1 year and without progression, those who were randomized to continue nivolumab had 
significant improvement in (PFS compared to those who were randomized to stop treatment, 
with median PFS (post-randomization) not reached vs 10.3 months, respectively; hazard ratio 
(HR) = 0.42 (95% CI: 0.25, 0.71). With a median follow-up of 14.9 months post- 
randomization, there also was a trend for patients on continued treatment to live longer (OS 
HR = 0.63 [95% CI: 0.33, 1.20]). Of note, the PFS curves in both groups plateau 
approximately 1 year after randomization (ie, 2 years after treatment initiation), suggesting 
that there may be minimal benefit in extending treatment beyond a total of 2 years 
(Spigel-2017). 
Collectively, these data suggest that there is minimal if any benefit derived from continuing 
immune-oncology treatment beyond 2 years in advanced tumors. Even though 
immunotherapy is well tolerated, subjects will be at risk for additional toxicity with longer 
term treatment. Therefore, in this study, treatment will be given for a maximum of 2 years 
from the start of study treatment. 
3.3. 
Blinded Independent Central Review Committee 
On-treatment disease assessments (MRI, CT scans, and photographic images) will be 
assessed by a BICR committee using RECIST v1.1 (see Section 7.2.). Further details are 
provided in the BICR charter. 
3.4. 
Independent Data Monitoring Committee 
An external IDMC will review interim safety and efficacy data during the study. The IDMC 
will make recommendations to the Sponsor throughout the study to ensure subject safety. 
Members of the IDMC must not be involved with the study in any other way and must have 
no competing interest that could affect their roles with respect to the study. 
The IDMC will have a finalized charter before their first meeting. Details regarding the roles 
and responsibilities of IDMC members, meeting facilitation, and proper documentation of 
IDMC reports will be provided in the charter. 
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4. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
4.1. 
Inclusion Criteria 
Subjects enrolled in the study must meet all of the following inclusion criteria to be eligible. 
1. Histologically or cytologically confirmed unresectable Stage III or Stage IV 
melanoma per American Joint Committee on Cancer (AJCC) Cancer Staging Manual 
Eighth Edition. 
2. Measurable disease, as defined by RECIST v1.1 and all of the following: 
a. At least 1 accessible lesion amenable to repeated IT injection 
b. One or more measurable lesions at least 1 cm in diameter that are not intended for 
CMP-001 injection and can be followed as target lesions per RECIST v1.1 
3. Able to provide tissue from a core or excisional/incisional biopsy (fine needle aspirate 
is not sufficient). A newly obtained biopsy (within 90 days before the first dose of 
study treatment) is mandatory, but an archival sample is acceptable if no intervening 
therapy for melanoma/cancer was received. 
Note: For tissue sampling details, please refer to the Laboratory Manual. 
4. Adequate organ function based on most recent laboratory values within 3 weeks 
before the first dose of study treatment on W1D1: 
a. Bone marrow function: 
− neutrophil count ≥1500/mm3 
− platelet count ≥100 000/mm3 
− hemoglobin concentration ≥9 g/dL 
− white blood cell ≥2000/mm3 
b. Liver function: 
− total bilirubin ≤ 1.5 × the upper limit of normal (ULN) with the following 
exception: subjects with Gilbert Disease total serum bilirubin ≤3 × ULN 
− aspartate aminotransferase (AST) and alanine aminotransferase ≤3 × ULN 
c. Lactate dehydrogenase ≤2 × ULN 
d. Renal function: estimated (Cockcroft-Gault) or measured creatinine 
clearance ≥30 mL/min 
e. Coagulation 
− International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN, 
unless subject is receiving anticoagulant therapy, as long as PT or partial 
thromboplastin time (PTT) is within therapeutic range of intended use of 
anticoagulants 
− Activated partial thromboplastin time or ≤1.5 × ULN, unless subject is 
receiving anticoagulant therapy, as long as PT or PTT is within therapeutic 
range of intended use of anticoagulants 
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5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 at 
Screening. 
6. Age ≥18 years at time of consent. 
7. Capable of understanding and complying with protocol requirements. 
8. Women of childbearing potential must have negative serum pregnancy test prior to 
dosing at W1D1 and be willing to use an adequate method of contraception 
(Section 4.3.2) from the time of consent until at least 150 days after the last dose of 
study treatment. 
9. Able and willing to provide written informed consent and to follow study instructions. 
Subjects unable to provide written informed consent on their own behalf will not be 
eligible for the study. 
4.2. 
Exclusion Criteria 
Subjects presenting with any of the following will not qualify for entry into the study: 
1. Uveal, acral, or mucosal melanoma. 
2. Received prior systemic treatment for melanoma in the unresectable or metastatic 
setting. Prior adjuvant therapy is acceptable if the treatment course (of approximately 
1 year duration) was completed and there was no recurrence within 6 months of the 
last dose of adjuvant treatment. 
3. Received prior therapy with CMP-001. 
4. Requires systemic pharmacologic doses of corticosteroids greater than the equivalent 
of 10 mg/day prednisone within 30 days before the first dose of study treatment on 
W1D1. 
a. Subjects who are currently receiving steroids at a prednisone-equivalent dose of 
≤10 mg/day do not need to discontinue steroids prior to enrollment. 
b. Replacement doses, topical, ophthalmologic, and inhalational steroids are 
permitted. 
5. History of CTCAE v5.0 Grade 4 immune-related AE due to adjuvant CTLA-4 or 
PD-1 blocking antibody. 
6. Not fully recovered from AEs (to Grade 1 or less [per CTCAE v5.0], with the 
exception of persistent alopecia, adrenal insufficiency, and hypothyroidism) due to 
prior treatment. 
7. Active pneumonitis, history of pneumonitis that required steroids, or history of 
interstitial lung disease. 
8. Severe uncontrolled cardiac disease within 6 months of Screening, including but not 
limited to poorly controlled hypertension, unstable angina, myocardial infarction, 
congestive heart failure (New York Heart Association Class II or greater), pericarditis 
within the previous 6 months, cerebrovascular accident, and implanted or continuous 
use of a pacemaker or defibrillator. 
9. Known history of immunodeficiency. 
10. Known additional malignancy that has progressed or required active treatment within 
the past 3 years. Exceptions include basal cell carcinoma of the skin, squamous cell 
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carcinoma of the skin that has undergone potentially curative therapy, curatively 
treated localized prostate cancer with prostate-specific antigen level below 4.0 ng/mL, 
in situ cervical cancer on biopsy or a squamous intraepithelial lesion on Papanicolaou 
smear, thyroid cancer (except anaplastic), and adjuvant hormonal therapy for breast 
cancer > 3 years from curative-intent surgical resection. 
11. Active autoimmune disease that has required systemic treatment in past 2 years; 
replacement therapy is not considered a form of systemic treatment. 
12. Untreated, symptomatic, or enlarging central nervous system (CNS) metastases or 
carcinomatous meningitis (including leptomeningeal metastases from solid tumors). 
13. Prior allogenic tissue/solid organ transplant. 
14. Known or suspected active infection with severe acute respiratory syndrome 
coronavirus 2 virus (SARS-CoV-2). 
15. Active infection requiring systemic therapy. 
16. Known or suspected infection with HIV, hepatitis B virus, or hepatitis C virus; testing 
is not required unless suspected. 
17. Received a live/attenuated virus vaccination within 30 days prior to the first dose of 
study treatment on W1D1. 
18. Received blood products (including platelets or red blood cells) or colony stimulating 
factors (including granulocyte colony stimulating factor, granulocyte/macrophage 
colony stimulating factor, or recombinant erythropoietin) within 30 days prior to the 
start of Screening. 
19. History of permanent discontinuation of nivolumab due to infusion reactions. 
20. Any concurrent uncontrolled illness, including mental illness or substance abuse, 
which in the opinion of the Investigator, would make the subject unable to cooperate 
or participate in the trial. 
21. Participation in another clinical study of an investigational anticancer therapy or 
device within 30 days before the first dose of study treatment on W1D1. 
Note: Participation in the follow-up phase (receiving no study treatment) of a prior 
study is allowed. 
22. Requires prohibited treatment (ie, non-protocol specified anticancer pharmacotherapy, 
surgery, or conventional radiotherapy) for treatment of malignant tumor. 
23. Has a life expectancy of less than 3 months and/or has rapidly progressing disease 
(eg, tumor bleeding, uncontrolled tumor pain) in the opinion of the treating 
Investigator. 
24. Pregnant or breast-feeding or expecting to conceive or donate eggs within the 
projected duration of the study, from the time of consent until at least 150 days after 
the last dose of study treatment for women. 
4.3. 
Women of Childbearing Potential 
A woman of childbearing potential is considered fertile following menarche and until 
becoming postmenopausal unless permanently sterile (Section 4.3.1). If fertility is unclear 
and a menstrual cycle cannot be confirmed before the first dose of study treatment (W1D1), 
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subject should be considered of childbearing potential and applicable pregnancy tests 
completed. 
4.3.1. 
Women of Non-Childbearing Potential 
Female subjects must meet 1 of the following criteria to be considered of non-childbearing 
potential: 
• Have undergone hysterectomy or bilateral salpingectomy/oophorectomy or 
bilateral tubal occlusion/ligation at least 1 month before Informed Consent. 
• Are medically confirmed to be post-menopausal. A postmenopausal state is 
defined as 12 months of amenorrhea before W1D1 in a woman over age 45 years 
in the absence of other biological or physiological causes. 
In addition, females under the age of 55 years must have a serum follicle 
stimulating hormone, (FSH) level > 40 mIU/mL on 2 measurements done 
2 months apart to confirm menopause. 
4.3.2. 
Acceptable Methods of Contraception 
Heterosexually active female subjects of childbearing potential must agree to use a highly 
effective method of contraception for the duration of the study and at least 150 days after the 
last dose of study treatment. Women should not donate eggs during this period. 
Highly effective methods of contraception are those that, alone or in combination, result in a 
failure rate of <1% per year when used consistently and correctly (ie, perfect use) and 
include: 
• Established use of oral, injected, or implanted hormonal methods of contraception 
• Correctly placed intrauterine device or intrauterine system 
• Sexual abstinence 
• Vasectomized partner 
4.4. 
Prohibited Concomitant Medications 
The following medications are prohibited during the study (unless utilized to treat a drug- 
related AE): 
• Immunosuppressive agents. 
• Any concurrent systemic anti-neoplastic therapy (ie, chemotherapy, hormonal 
therapy, immunotherapy, or standard or investigational agents for treatment of 
unresectable or metastatic melanoma). 
• Any non-palliative radiation therapy. 
• Any complementary medications (eg, herbal supplements or traditional Chinese 
medicines) intended to treat the disease under study. 
• Any live/attenuated vaccine (eg, varicella, zoster, yellow fever, rotavirus, oral 
polio, and measles, mumps, rubella [MMR]) during treatment and until 100 days 
post last dose. 
• Concurrent anticancer therapy with agents other than the combination drug 
therapy (CMP-001 or nivolumab) is not allowed at any time during the study. 
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• Chloroquine, hydroxychloroquine, and quinacrine, as these agents are known to 
have significant TLR9 antagonism. 
• Systemic pharmacologic doses of corticosteroids greater than the equivalent of 
10 mg/day prednisone are not permitted at the time of study enrollment with the 
following exceptions: 
− Allowed for subjects with a history of adrenal insufficiency. Consultation with 
the Medical Monitor is required prior to enrollment of subjects with a history 
of adrenal insufficiency; 
− Allowed for the management of immune-mediated toxicities; 
− Allowed for palliation of pain, brain metastases, or other disorders if subjects 
remain on study based on Investigator’s judgement after consultation with 
Medical Monitor. 
• Medications intended solely for supportive care (ie, antiemetics, analgesics, 
megestrol acetate for anorexia) are allowed. 
Palliative radiotherapy or palliative surgery (ie, for pain, bleeding, spinal cord compression, 
brain metastasis, new or impending pathologic fracture, superior vena-cava syndrome, or 
obstruction) may be allowed after Medical Monitor consultation to ascertain whether clinical 
progression has occurred. If the lesion(s) targeted for palliation are target lesions, then the 
anatomic site requiring palliation must be assessed for disease status. 
Given the potential for injection site reactions and flu-like symptoms, vaccination with a viral 
vector or mRNA vaccine should not be performed within 48 hours of CMP-001 injection. 
4.5. 
Treatment Discontinuation 
Treatment discontinuation is defined as any subject who stops receiving study treatment and 
does not restart within 12 weeks. Subjects who permanently discontinue (for >12 weeks) 
CMP-001 or nivolumab may not be re-treated with the discontinued study treatment in this 
study. When nivolumab is permanently discontinued due to an immune related AE, CMP-001 
must also be permanently discontinued. 
Treatment with study treatment should continue until one of the following occurs: 
• Unacceptable AE that precludes further study treatment 
• 2 years of study treatment 
• PD per RECIST v1.1; continuation of treatment through suspected 
pseudoprogression is permitted at the Investigator’s discretion until confirmed 
PD per iRECIST 
• Upon request of the Sponsor or regulatory agency 
• Clinical disease progression in the opinion of the Investigator 
• If medically necessary in the opinion of the Investigator 
• Subject withdraws consent for study treatment 
• Subject has received study treatment for 2 years 
• Subject becomes pregnant or begins breastfeeding 
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• Subject is lost to follow-up 
• Death 
• End of Clinical Trial 
If a subject achieves and maintains a confirmed CR or iCR by Investigator assessment, IT or 
SC injections of CMP-001 or the combination of CMP-001 and nivolumab may be 
discontinued at the Investigator’s discretion once the subject meets both of the following 
criteria: 
• Subject has been treated for at least 48 weeks (the maximum duration of study 
treatment is 2 years) 
• Subject has received at least 3 doses of assigned treatment beyond the date of the 
initial CR/iCR 
Subjects with PD per RECIST v1.1 as determined by Investigator assessment should remain 
on treatment and have a follow-up scan performed at least 4 weeks after the initial date of PD 
to confirm progression per RECIST v1.1 by BICR. 
Subjects who discontinue study treatment should complete an EOT visit and 100-day safety 
follow-up contact, which should occur 100 days (+7) after the EOT or until an alternative 
cancer treatment is initiated, whichever occurs first (Table 1). Subjects who discontinue study 
treatment for reasons other than disease progression (either per RECIST v1.1 or iRECIST by 
Investigator assessment) should remain on study for PTFU (Section 7.6) and receive disease 
assessments according to the Schedule of Assessments (Table 1). 
4.6. 
Study Discontinuation 
Subjects may withdraw from the study at any time without penalty or loss of future medical 
care or any other benefits to which they are otherwise entitled. Subjects will be withdrawn 
from the study for any of the following reasons: 
• Subject withdraws consent for the study 
• Subject lost to follow-up 
• Death 
• End of Clinical Trial 
Subjects who withdraw consent from overall study participation (not only study treatment) 
will not have the EOT visit, safety follow-up visits, or further evaluations performed. 
4.7. 
End of Clinical Trial 
The End of Clinical Trial is defined as the last visit for the last subject on the trial. 
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5. 
TREATMENT OF SUBJECTS 
5.1. 
Administration of Study Treatment 
5.1.1. 
Nivolumab 
Subjects will receive CMP-001 10 mg IT injection followed by nivolumab 360 mg IV (Arm 
A) or nivolumab 360 IV monotherapy (Arm B) at W1D1 and Q3W thereafter until the 
subject satisfies a condition for study treatment discontinuation. Nivolumab should be 
administered to the subject according to the nivolumab Investigator’s Brochure. Nivolumab 
should be administered until the subject satisfies a condition for study treatment 
discontinuation (Section 4.5.). On visits where both study treatments are administered, 
nivolumab should be administered after CMP-001. There is no specified waiting period 
between the end of CMP-001 administration and the initiation of nivolumab infusion. 
Subjects should receive nivolumab at a dose of 360 mg as a 30-minute infusion each 
treatment cycle until progression, unacceptable toxicity, withdrawal of consent, or the study 
ends, whichever occurs first. 
There will be no dose escalations or reductions of nivolumab allowed. Subjects may be dosed 
no less than 19 days from the previous dose. 
Subjects should be carefully monitored for infusion reactions during nivolumab 
administration. If an acute infusion reaction is noted, subjects should be managed according 
to Section 5.1.4. 
Doses of study treatment(s) may be interrupted, delayed, or discontinued depending on how 
well the subject tolerates the treatment. Dosing visits are not skipped, only delayed. 
The assessment for discontinuation of nivolumab should be made separately from the 
assessment made for discontinuation of CMP-001. If discontinuation criteria are met for 
CMP-001 but not for nivolumab, treatment with nivolumab may continue if CMP-001 is 
discontinued. 
Please refer to the nivolumab Investigator’s Brochure and/or Pharmacy Manual for further 
details regarding storage, preparation, and administration of nivolumab. 
Care must be taken to assure sterility of the prepared solution as the product does not contain 
any antimicrobial preservative or bacteriostatic agent. 
5.1.1.1. 
Nivolumab Dose Selection 
The nivolumab dose of 360 mg Q3W was selected based on clinical data and modeling and 
simulation approaches using population pharmacokinetics (PPK) and exposure-response (ER) 
analyses of data from studies in multiple tumor types (melanoma, NSCLC, and RCC) where 
body weight normalized dosing (mg/kg) was used. 
Nivolumab pharmacokinetics (PK) have been extensively studied in multiple tumor types, 
including melanoma, NSCLC, RCC, cHL, SCCHN, CRC, and urothelial carcinoma and has 
been safely administered at doses up to 10 mg/kg Q2W. Nivolumab monotherapy was 
originally approved as a body-weight based dose of 3 mg/kg Q2W and was updated to 
240 mg Q2W or 480 mg Q4W in multiple indications nivolumab Investigator’s Brochure. 
Nivolumab 360 mg Q3W is also under evaluation in monotherapy and in combination 
therapy studies. Less frequent 360 mg Q3W and 480 mg Q4W dosing regimens can reduce 
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the burden to subjects of frequent, lengthy IV treatments and allow combination of 
nivolumab with other agents using alternative dosing regimens. 
The benefit-risk profiles of nivolumab 240 mg Q2W, 360 mg Q3W, and 480 mg Q4W are 
predicted to be comparable to 3 mg/kg Q2W. This assessment is based on a comprehensive 
characterization of nivolumab PK, safety, efficacy, and ER relationships across indications. 
Population PK (PPK) analyses have shown that the PK of nivolumab is linear with 
proportional exposures over a dose range of 0.1 to 10 mg/kg; no clinically meaningful 
differences in PK across ethnicities and tumor types were observed. Using the PPK model, 
the exposures following administration of several dosing regimens of nivolumab 
administered as a flat dose were simulated, including 240 mg Q2W, 360 mg Q3W, and 
480 mg Q4W. The simulated average serum concentration at steady state following 
administration of nivolumab 360 mg Q3W and 480 mg Q4W are predicted to be similar to 
those following administration of nivolumab 240 mg Q2W and nivolumab 3 mg/kg Q2W 
administered to subjects over a wide body weight range (34-180 kg) across tumor types. 
Nivolumab ER relationships for efficacy and safety were evaluated for IV nivolumab 
administered as monotherapy at the dose range of 1 mg/kg Q2W to 10 mg/kg Q2W. 
Generally a flat ER relationship was observed over this dose range in melanoma, RCC, and 
NSCLC subjects between nivolumab exposure and clinical endpoints such as the hazard of 
death, probability of overall response, AE leading to discontinuation or death, Grade 3 or 
higher AEs, and/or Grade 2 or higher immune-mediated AEs. Therefore, 3 mg/kg IV Q2W 
was approved in melanoma, RCC, and NSCLC and was also studied and approved in other 
indications. For NSCLC, there was a trend of additional benefit (especially in ORR) at 
3 mg/kg IV Q2W when compared to 1 mg/kg IV Q2W, which had a small sample size. 
Therefore, a flat ER relationship could only be confirmed from 3 mg/kg IV Q2W to 10 mg/kg 
IV Q2W for NSCLC. Flat doses of 240 mg IV Q2W nivolumab, 360 mg IV Q3W nivolumab, 
and 480 mg IV Q4W nivolumab have been incorporated in monotherapy and combination 
oncology studies, and the 240 mg IV Q2W and 480 mg IV Q4W nivolumab dose regimens 
are now approved in multiple indications. Every 4 week (Q4W) dosing regimens can reduce 
the burden to subjects of frequent, lengthy IV treatments and allow combination of 
nivolumab with other agents using alternative dosing regimens. 
Extensive ER analyses using multiple PK measures (maximum serum concentration in 
Cycle 1, average serum concentration at Day 28 [Cavg28], and trough serum concentration at 
Day 28 [Cmin28]) and efficacy and safety endpoints indicated that the efficacy of the flat-dose 
480 mg IV regimen is similar to that of 3 mg/kg IV Q2W. In ER efficacy analyses for OS and 
ORR conducted in melanoma, RCC, and NSCLC using Cavg28 as the driver of efficacy, 
probabilities of achieving a response and survival probabilities at 1 year and 2 years for 
480 mg IV Q4W were similar to that of 3 mg/kg IV Q2W. 
Similar analyses conducted in different tumor types using the Cmin28 as the worst-case 
scenario for the potential loss of efficacy also showed benefit risk profiles of 480 mg IV 
Q4W were comparable to 3 mg/kg IV Q2W. 
5.1.1.2. 
Clinical Pharmacology Summary 
Nivolumab PK was assessed using a PPK approach for both single-agent nivolumab and 
nivolumab with ipilimumab. 
Nivolumab as a single agent: The PK of single-agent nivolumab was studied in patients over 
a dose range of 0.1 to 20 mg/kg administered as a single dose or as multiple doses of 
nivolumab as a 60-minute IV infusion Q2W or Q3W. Nivolumab clearance (CL) decreases 
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over time, with a mean maximal reduction (% coefficient of variation [CV%]) from Baseline 
values of 24.5% (47.6%) resulting in a geometric mean steady-state clearance (CLss) (CV%) 
of 8.2 mL/h (53.9%) in patients with metastatic tumors; the decrease in CLss is not considered 
clinically relevant. Nivolumab clearance does not decrease over time in patients with 
completely resected melanoma, as the geometric mean population clearance is 24% lower in 
this patient population compared with patients with metastatic melanoma at steady state. The 
geometric mean volume of distribution at steady state (CV%) is 6.8 L (27.3%), and geometric 
mean elimination half-life (CV%) is 25 days (77.5%). Steady-state concentrations of 
nivolumab were reached by 12 weeks when administered at 3 mg/kg every 2 weeks, and 
systemic accumulation was 3.7-fold. The exposure to nivolumab increased in a dose 
proportional manner over the dose range of 0.1 to 10 mg/kg administered Q2W. The 
predicted exposure (average serum concentration and maximum serum concentration) of 
nivolumab after a 30-minute infusion is comparable to that observed with a 60-minute 
infusion. 
Specific Populations: The PPK analysis suggested that the following factors had no clinically 
important effect on the CL of nivolumab: age (29 to 87 years), weight (35 to 160 kg), gender, 
race, Baseline lactate dehydrogenase PD-L1 expression, solid tumor type, tumor size, renal 
impairment, and mild hepatic impairment. 
Renal Impairment: The effect of renal impairment on the CL of nivolumab was evaluated by 
a PPK analysis in patients with mild (estimated glomerular filtration rate [eGFR] 60 to 
89 mL/min/1.73 m2), moderate (eGFR 30 to 59 mL/min/1.73 m2), or severe (eGFR 15 to 
29 mL/min/1.73 m2) renal impairment. No clinically important differences in the clearance of 
nivolumab were found between patients with renal impairment and patients with normal renal 
function. 
Hepatic Impairment: The effect of hepatic impairment on the CL of nivolumab was evaluated 
by population PK analyses in patients with HCC and in patients with other tumors with mild 
hepatic impairment (total bilirubin [TB] ≤ ULN and AST > ULN or TB > 1 to 1.5 × ULN and 
any AST) and in HCC patients with moderate hepatic impairment (TB > 1.5 to 3 × ULN and 
any AST). No clinically important differences in the clearance of nivolumab were found 
between patients with mild/moderate hepatic impairment. 
Details on the clinical pharmacology aspects of nivolumab can be found in the nivolumab 
Investigator’s Brochure. 
5.1.2. 
CMP-001 
Subjects randomized to Arm A will receive CMP-001 10 mg weekly for 7 doses (W1D1 to 
W7D1), after which CMP-001 will be administered by IT injection Q3W (W10D1, W13D1, 
etc.). The first dose of CMP-001 may be administered SC or by IT injection, at the discretion 
of the Investigator; all subsequent doses are planned to be administered IT. The initial 
7 CMP-001 weekly dose schedule must be completed before starting the Q3W CMP-001 
dosing schedule. 
On visits where both CMP-001 and nivolumab are administered, CMP-001 should always be 
administered before nivolumab. There is no waiting period between the end of CMP-001 
administration and the initiation of nivolumab infusion. 
CMP-001 should be administered until a reason for treatment discontinuation is reached 
(Section 4.5). 
See Section 5.1.3 for dose modifications for CMP-001. 
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5.1.2.1. 
Prophylaxis Prior to CMP-001 Injection 
To prevent or reduce the severity of symptoms associated with CMP-001 administration, 
prophylaxis is required. Institutional regimens for prophylaxis related to cytokine release may 
be followed but only after discussion with the Medical Monitor; otherwise, the recommended 
regimen should be completed prior to initiation of CMP-001 injections: 
• Intravenous fluids (eg, approximately 500 to 1000 cc IV normal saline; the 
volume is at the Investigator's discretion) 
• Antipyretics (eg, acetaminophen 1000 mg and a non-steroidal anti-inflammatory 
agent such as indomethacin 50 mg or ibuprofen 600 to 800 mg) 
• Antiemetics (eg, oral ondansetron 8 mg) 
• Antihistamine (eg, oral diphenhydramine 50 mg, with or without an 
H2-antagonist) 
• Recommended: hydrocortisone 25 mg at the Investigator’s discretion. Subjects 
with adrenal insufficiency should be treated with stress dose steroids as described 
in Section 5.1.2.1.1. 
Maintenance IV fluids should be continued after the CMP-001 injection during the 
observation period for continued fluid administration to minimize the risk for hypotension. 
Antipyretics and antiemetics may be repeated at the Investigator’s discretion. There is no 
waiting period between the end of prophylaxis and the start of the CMP-001 injection. All 
treatments given prophylactically before and after CMP-001 dosing must be recorded for 
each visit. 
5.1.2.1.1. Prophylaxis for Subjects with a History of Adrenal Insufficiency 
Subjects with a history of adrenal insufficiency are at increased risk for moderate to severe 
AEs, such as hypotension, which may occur within 1 to 4 hours after CMP-001 injection but 
may also occur outside this window. These subjects must receive stress dose steroids (eg, 
50 mg to 100 mg hydrocortisone or equivalent orally every 8 hours) before and for 24 to 
48 hours after each CMP-001 injection. 
5.1.2.2. 
Observation Following CMP-001 Dosing 
Subjects must be observed for at least 4 hours following each of the first 6 CMP-001 
injections (W1D1 to W6D1). Beginning with the seventh CMP-001 injection (W7D1), the 
observation period may be reduced to a minimum of 1 hour following CMP-001 injection at 
the Investigator’s discretion based on the AE profile of the individual subject. 
5.1.2.3. 
CMP-001 Injections 
5.1.2.3.1. Injectable Tumor Selection 
Eligible subjects must have at least 1 accessible lesion amenable to repeated IT injection. 
Cutaneous, SC, and/or nodal tumors that are visible, palpable, or detectable by ultrasound 
guidance are acceptable for IT injection. Tumors should be at least 0.5 cm in longest diameter 
and need not be the largest lesion. The preferred tumor for IT injection is an accessible lesion 
that is most rapidly progressing in the judgment of the Investigator. 
When more than 1 tumor is amenable to IT injection, the Investigator may inject up to 
3 tumors per CMP-001 treatment visit. The total dose of CMP-001 may be divided across the 
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tumors at the Investigator’s discretion, and the volume injected into each tumor must be 
recorded. The same tumor(s) should be injected each week during therapy, if possible. If an 
injected tumor is clearly decreasing in size and another accessible non-injected tumor is not, 
then the Investigator may divide the CMP-001 dose between the 2 tumors or switch from 
injecting the regressing tumor to injecting the non-responding (or growing) tumor. However, 
there should always be at least 1 target lesion measuring 1 cm or more in diameter that will 
not be injected for each subject. These lesions not intended for injection may be located in 
any metastatic site. 
Subjects with metastatic disease who have regression of all injectable lesions, or who have an 
injection site reaction that precludes injection of the tumor, should receive CMP-001 SC near 
an original tumor (peritumoral) or in the area of the draining lymph nodes (see Appendix G). 
5.1.2.3.2. Method of CMP-001 Administration 
Topical or local anesthesia may be used at the Investigator’s discretion. 
Syringe size is at the discretion of the Investigator or qualified designated staff for 
administering the CMP-001 study drug according to institutional guidelines or standard 
operating procedures (SOPs). For methods of CMP-001 administration, see Appendix G. 
5.1.3. 
Dose Modifications and Management of CMP-001 Associated Adverse Events 
Based on earlier studies of CMP-001, CMP-001–associated adverse events such as injection 
site reactions and flu-like symptoms may occur within hours following CMP-001 injection. 
Guidance for the observation period following CMP-001 injection is provided in 
Section 5.1.2.2. CMP-001 is a TLR9 agonist designed to activate pDCs, which secrete IFN 
and activate other immune cells to produce IFN-associated T helper cell Type 1-promoting 
cytokines and chemokines. Therefore, it is expected that the AE profile associated with 
CMP-001 injection may be similar to that observed after systemic administration of IFNs. 
These AEs may be observed with any injection and could occur outside of the observation 
window following an injection. More information can be found in the CMP-001 
Investigator’s Brochure. 
The CMP-001 dose should remain unchanged during the study, unless deemed medically 
necessary by the Investigator after discussion with the Medical Monitor. 
If a planned dose cannot be administered on schedule due to a CMP-001 related toxicity, the 
injection should be delayed until the toxicity has improved or resolved. When nivolumab 
dosing is held or delayed, CMP-001 dosing must also be held or delayed. If a subject has 
CMP-001 dosing withheld for more than 3 consecutive doses for any reason during the Q3W 
dosing period, resumption of treatment must be discussed with the Medical Monitor, 
otherwise, the subject will be discontinued from study treatment and will have all EOT 
assessments performed. 
If a planned nivolumab dosing is delayed, the CMP-001 dosing may also be delayed. 
5.1.3.1. 
Injection Site Reactions 
Injection site inflammation is expected following the second and subsequent injections of 
CMP-001. If subjects develop inflammation at the injection site, this may be managed using 
cold compresses and medications for pain and inflammation, such as acetaminophen or 
non-steroidal anti-inflammatory agents. If, in the Investigator’s opinion, a tumor cannot be 
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injected due to injection site reaction or pain, refer to Section 5.1.2.3.1 on changing the site of 
injection. 
5.1.3.2. 
Management of Adverse Events Associated with CMP-001 
CMP-001 has been associated with a variety of flu-like symptoms and hypotension. 
These symptoms could include fever, nausea, vomiting, chills, rigors, or hypotension. 
Additionally, symptoms such as headache, tachycardia, rash, and hypoxia may also occur. 
Symptoms should be expected within 1 to 4 hours following the injection but may also occur 
outside this window. Required prophylaxis is outlined in Section 5.1.2.1 to prevent or 
minimize the severity of these symptoms. If hypotension is unresponsive to IV fluids, stress 
dose steroids should be administered. The following algorithm (Figure 2) is provided as 
guidance for the treatment of symptoms associated with CMP-001. 
For subjects who experience a Grade 3 or higher symptom deemed related to CMP-001, 
prophylaxis with stress dose steroids (prednisone 25 mg or equivalent at the Investigator’s 
discretion) is recommended for subsequent CMP-001 doses. 
Figure 2: 
Suggested Prophylaxis and Treatment for Symptoms Associated with 
CMP-001 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: IV = intravenously; NSAID = nonsteroidal anti-inflammatory drug; po/PO= orally; Q4-6H = 
every 4-6 hours. 
 
 
5.1.4. 
Dose Modifications and Management of Adverse Events Associated with 
Nivolumab 
Nivolumab has been associated with a variety of AEs. The current nivolumab Investigator’s 
Brochure should be consulted for treatment guidance on dose modifications. 
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If a planned nivolumab dosing is delayed, the CMP-001 dosing may also be delayed. When 
nivolumab is permanently discontinued because of an immune-related AE, CMP-001 must 
also be permanently discontinued. 
A pattern of immune-related AEs has been defined for nivolumab, for which management 
algorithms have been developed; these are provided in Appendix H. Most high-grade events 
were manageable with the use of corticosteroids or hormone replacement therapy 
(endocrinopathies) as instructed in these algorithms. 
Nivolumab administration should be delayed or discontinued as specified in Table 2. 
Table 2: 
Dose Modifications and Management of Adverse Events Associated with 
Nivolumab 
 
Drug-Related 
Adverse Event 
Severitya 
Action Taken 
Clarifications, Exceptions, and 
Resume Criteria 
Colitis or diarrhea 
Grade 2 
Delay doseb 
Dosing may resume when AE 
resolves to Baseline. 
Grade 3 
Delay doseb 
when 
administered 
as a single 
agent 
Dosing may resume when AE 
resolves to Baseline. 
Grade 4 
Permanently 
discontinue 
Serum Creatinine 
Increased 
Grade 2 or 3 
Delay doseb 
Dosing may resume when AE 
resolves to Grade ≤ 1 or Baseline 
value. 
Grade 4 
Permanently 
discontinue 
Pneumonitis 
Grade 2 
Delay doseb 
Dosing may resume after 
pneumonitis resolves to Grade ≤ 1 
or Baseline value. 
Grade 3 or 4 
Permanently 
discontinue 
Aspartate 
aminotransferase 
(AST), alanine 
aminotransferase 
(ALT), or total 
bilirubin (T.bili) 
increasedc 
AST or ALT > 3x 
and ≤ 5x upper limit 
of normal (ULN) or 
T.Bili >1.5 x and 
≤ 3 x ULN, 
regardless of 
Baseline value 
Delay doseb 
Dosing may resume when 
laboratory values return to 
Baseline. 
AST or ALT > 5 x 
ULN or T. bili >3 x 
ULN, regardless of 
Baseline value 
Delay doseb or 
permanently 
discontinue 
(see 
clarification) 
In most cases of AST or ALT > 5 x 
ULN, study treatment will be 
permanently discontinued. If the 
Investigator determines a possible 
favorable benefit/risk ratio that 
warrants continuation of study 
treatment, a discussion between the 
Investigator and the Medical 
Monitor/ designee must occur and 
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Drug-Related 
Adverse Event 
Severitya 
Action Taken 
Clarifications, Exceptions, and 
Resume Criteria 
approval from Medical Monitor 
prior to resuming therapy. 
Adrenal 
Insufficiency 
Grade 2 adrenal 
insufficiency 
Delay doseb 
Dosing may resume after 
adequately controlled with 
hormone replacement. 
Grade 3 or 4 adrenal 
insufficiency or 
adrenal crisis 
Delay doseb or 
permanently 
discontinue 
Mandatory discussion with and 
approval from the Medical Monitor 
needed prior to resuming therapy. 
If adrenal insufficiency resolves or 
is adequately controlled with 
physiologic hormone replacement, 
participant may not require 
discontinuation of study drug. 
Hyperglycemia 
Grade 2 or 3 
(Hyperglycemia 
requiring initiation 
or change in daily 
management) 
Delay doseb 
Dosing may resume if 
hyperglycemia resolves to Grade 
≤ 1 or Baseline value, or is 
adequately controlled with glucose- 
controlling agents. 
Grade 4 
Permanently 
discontinue 
Mandatory discussion with and 
approval from the Medical Monitor 
needed prior to resuming therapy. 
If hyperglycemia resolves, or is 
adequately controlled with glucose- 
controlling agents, participant may 
not require discontinuation of study 
drug. 
Hypophysitis/ 
Hypopituitarism 
Symptomatic Grade 
1 to 3 that is also 
associated with 
corresponding 
abnormal lab and/or 
pituitary scan 
Delay doseb 
Dosing may resume if 
endocrinopathy resolves to be 
asymptomatic, or is adequately 
controlled with only physiologic 
hormone replacement. 
Grade 4 
Delay doseb or 
permanently 
discontinue 
Mandatory discussion with and 
approval from the Medical Monitor 
needed prior to resuming therapy. 
If endocrinopathy resolves or is 
adequately controlled with 
physiologic hormone replacement, 
participant may not require 
discontinuation of study drug. 
Hyperthyroidism or 
Hypothyroidism 
Grade 2 or 3 
Delay doseb 
Dosing may resume if 
endocrinopathy resolves to be 
asymptomatic, or is adequately 
controlled with only physiologic 
hormone replacement or other 
medical management. 
Grade 4 
Delay doseb or 
permanently 
discontinue 
Mandatory discussion with and 
approval from the Medical Monitor 
needed prior to resuming therapy. 
If endocrinopathy resolves or is 
adequately controlled with 
physiologic hormone replacement 
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Drug-Related 
Adverse Event 
Severitya 
Action Taken 
Clarifications, Exceptions, and 
Resume Criteria 
or other medical management, 
participant may not require 
discontinuation of study drug. 
Rash 
Grade 2 rash 
covering > 30% 
body surface area or 
Grade 3 rash or 
suspected SJS, TEN, 
or DRESS 
Delay doseb 
Dosing may resume when rash 
reduces to ≤ 10% body surface 
area. Dosing may resume if SJS, 
TEN, or DRESS is ruled out and 
rash reduces to is ≤ 10% body 
surface area. 
Grade 4 rash or 
confirmed SJS, 
TEN, or DRESS 
Permanently 
discontinue 
Guillain-Barre 
Syndrome (GBS) 
Any Grade 
Permanently 
discontinue 
Myasthenia Gravis 
(MG) 
Any Grade 
Permanently 
discontinue 
Encephalitis 
Any Grade 
encephalitis 
Delay doseb 
After workup for differential 
diagnosis, (ie, infection, tumor- 
related), if encephalitis is not drug 
related, then dosing may resume 
when AE resolves. 
Any Grade drug- 
related encephalitis 
Permanently 
discontinue 
Myelitis 
Any Grade myelitis 
Delay doseb 
After workup for differential 
diagnosis, (ie, infection, tumor- 
related), if myelitis is not drug 
related, then dosing may resume 
when AE resolves. 
Any Grade drug- 
related myelitis 
Permanently 
discontinue 
Neurological (other 
than GBS, MG, 
encephalitis, or 
myelitis) 
Grade 2 
Delay doseb 
Dosing may resume when AE 
resolves to Baseline. 
Grade 3 or 4 
Permanently 
discontinue 
Myocarditis 
Symptoms induced 
from mild to 
moderate activity or 
exertion 
Delay doseb 
Dosing may resume after 
myocarditis has resolved. 
Severe or life 
threatening, with 
symptoms at rest or 
with minimal 
activity or exertion, 
and/or where 
intervention 
indicated. 
Permanently 
discontinue 
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Drug-Related 
Adverse Event 
Severitya 
Action Taken 
Clarifications, Exceptions, and 
Resume Criteria 
Pancreatitis: 
Amylase or Lipase 
increased 
Grade 3 with 
symptoms 
Delay doseb 
Note: Grade 3 increased amylase or 
lipase without signs or symptoms 
of pancreatitis does not require 
dose delay. Dosing may resume 
when subject becomes 
asymptomatic. 
Grade 4 
Permanently 
discontinue 
Uveitis 
Grade 2 uveitis 
Delay doseb 
Dosing may resume if uveitis 
responds to topical therapy (eye 
drops) and after uveitis resolves to 
Grade ≤ 1 or Baseline. If subject 
requires oral steroids for uveitis, 
then permanently discontinue study 
drug. 
Grade 3 or 4 uveitis 
Permanently 
discontinue 
Other drug-related 
AE (not listed 
above) 
Grade 2 non-skin 
AE, except fatigue 
Delay doseb 
Dosing may resume when AE 
resolves to Grade ≤ 1 or Baseline 
value. 
Grade 3 AE - First 
occurrence lasting 
≤ 7 days 
Delay doseb 
Dosing may resume when AE 
resolves to Grade ≤ 1 or Baseline 
value. 
Grade 3 AE- First 
occurrence lasting 
> 7 days 
Permanently 
discontinue 
Recurrence of Grade 
3 AE of any 
duration 
Permanently 
discontinue 
Grade 4 or Life- 
threatening adverse 
reaction 
Permanently 
discontinue 
Other drug-related 
laboratory 
abnormality (not 
listed above) 
Grade 3 
Delay doseb 
Exceptions: 
No delay required for: Grade 3 
lymphopenia 
Permanent Discontinuation for: 
Grade 3 thrombocytopenia > 7 days 
or associated with bleeding. 
Grade 4 
Permanently 
discontinue 
Exceptions: The following events 
do not require discontinuation of 
study drug: 
• Grade 4 neutropenia ≤ 7 days 
• Grade 4 lymphopenia or 
leukopenia 
• Grade 4 isolated electrolyte 
imbalances/abnormalities that are 
not associated with clinical 
sequelae and are responding to 
supplementation/appropriate 
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Drug-Related 
Adverse Event 
Severitya 
Action Taken 
Clarifications, Exceptions, and 
Resume Criteria 
management within 72 hours of 
their onset. 
Hypersensitivity 
reaction or infusion 
reaction (manifested 
by fever, chills, 
rigors, headache, 
rash, pruritus, 
arthralgia, 
hypotension, 
hypertension, 
bronchospasm, or 
other allergic-like 
reactions) 
Grade 3 or 4 
Permanently 
discontinue 
Refer to Section 5.1.4.2. on 
Treatment of Related Infusion 
Reactions. 
Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; DRESS = drug reaction with 
eosinophilia and systemic symptoms; SJS = Stevens-Johnson syndrome; TEN = toxic epidermal necrolysis; ULN = upper 
limit of normal. 
a Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. 
b Resume treatment when adverse reaction improves to Grade 0 or 1. 
c Resume treatment when AST/ALT returns to Baseline. 
 
 
Nivolumab dosing should also be delayed for any AE, laboratory abnormality, or intercurrent 
illness which, in the judgment of the Investigator, warrants delaying the dose of study 
medication. 
Any event that leads to delay in dosing lasting > 12 weeks from the previous dose requires 
discontinuation, with the following exceptions: 
• Dosing delays to allow for prolonged steroid tapers to manage drug-related AEs 
are allowed. 
• Dosing delays lasting > 12 weeks from the previous dose that occur for non-drug- 
related reasons may be allowed if approved by the Medical Monitor (or designee). 
Subjects who require delay of nivolumab should be re-evaluated weekly or more frequently if 
clinically indicated and resume nivolumab dosing when re-treatment criteria are met (see 
Section 5.1.4.1). Tumor assessments should continue as per protocol even if dosing is 
delayed. 
A pattern of immune-related AEs has been defined, for which management algorithms have 
been developed; these are provided in Appendix H. Most high-grade events were manageable 
with the use of corticosteroids or hormone replacement therapy (endocrinopathies) as 
instructed in these algorithms. 
5.1.4.1. 
Criteria to Resume Nivolumab Treatment 
Please see Table 2 for guidance on resuming treatment. 
Tumor assessments should continue as per protocol even if dosing is delayed. Periodic study 
visits to assess safety and laboratory studies should also continue every 6 weeks or more 
frequently if clinically indicated during such dosing delays. 
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5.1.4.2. 
Treatment of Nivolumab-Related Infusion Reactions 
Since nivolumab contains only human immunoglobulin protein sequences, it is unlikely to be 
immunogenic and induce infusion or hypersensitivity reactions. However, if such a reaction 
were to occur, it might manifest with fever, chills, rigors, headache, rash, pruritus, arthralgias, 
hypotension, hypertension, bronchospasm, or other allergic-like reactions. Any Grade 3 or 4 
infusion reaction should be reported within 24 hours to the study Medical Monitor/designee 
and reported as an SAE if it meets the criteria. Infusion reactions should be graded according 
to NCI CTCAE v5.0 guidelines. 
Treatment recommendations are provided below and may be modified based on local 
treatment standards and guidelines, as appropriate: 
For Grade 1 symptoms (mild reaction; infusion interruption not indicated; intervention not 
indicated): 
• Remain at bedside and monitor subject until recovery from symptoms. The 
following prophylactic premedications are recommended for future infusions: 
diphenhydramine 50 mg (or equivalent) and/or acetaminophen/paracetamol 325 to 
1000 mg at least 30 minutes before additional nivolumab administrations. 
For Grade 2 symptoms (Therapy or infusion interruption indicated but responds promptly to 
symptomatic treatment [eg, antihistamines, nonsteroidal anti-inflammatory drugs, narcotics, 
IV fluids]; prophylactic medications indicated for ≤24 hours): 
• Stop the study drug infusion, begin an IV infusion of normal saline, and treat the 
subject with diphenhydramine 50 mg IV (or equivalent) and/or 
acetaminophen/paracetamol 325 to 1000 mg; remain at bedside and monitor 
subject until resolution of symptoms. Corticosteroid and/or bronchodilator therapy 
may also be administered as appropriate. If the infusion is interrupted, then restart 
the infusion at 50% of the original infusion rate when symptoms resolve; if no 
further complications ensue after 30 minutes, the rate may be increased to 100% 
of the original infusion rate. Monitor subject closely. If symptoms recur, then no 
further study medication will be administered at that visit. 
• For future infusions, the following prophylactic premedications are recommended: 
− diphenhydramine 50 mg (or equivalent) and/or acetaminophen/paracetamol 
325 to 1000 mg should be administered at least 30 minutes before nivolumab 
infusion. If necessary, corticosteroids (up to 25 mg of hydrocortisone or 
equivalent) may be used. 
For Grade 3 or 4 symptoms (severe reaction, Grade 3: Prolonged [eg, not rapidly 
responsive to symptomatic medication and/or brief interruption of infusion]; recurrence of 
symptoms following initial improvement; hospitalization indicated for clinical sequelae. 
Grade 4: Life-threatening consequences; urgent intervention indicated): 
• Immediately discontinue infusion of study drug. Begin an IV infusion of normal 
saline and treat the subject as follows: Recommend bronchodilators, epinephrine 
0.2 to 1 mg of a 1:1000 solution for SC administration or 0.1 to 0.25 mg of a 
1:10,000 solution injected slowly for IV administration, and/or diphenhydramine 
50 mg IV with methylprednisolone 100 mg IV (or equivalent), as needed. Subject 
should be monitored until the Investigator is comfortable that the symptoms will 
not recur. Study drug will be permanently discontinued. Investigators should 
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follow their institutional guidelines for the treatment of anaphylaxis. Remain at 
bedside and monitor subject until recovery of the symptoms. 
In case of late-occurring hypersensitivity symptoms (eg, appearance of a localized or 
generalized pruritus within 1 week after treatment), symptomatic treatment may be given (eg, 
oral antihistamine or corticosteroids). 
5.1.4.3. 
Nivolumab Treatment Beyond Disease Progression 
Reasons for treatment discontinuation are described in Section 4.5. These include 
discontinuation for progressive disease per RECIST v1.1 and clinical disease progression in 
the opinion of the Investigator. 
Accumulating evidence indicates a minority of subjects treated with immunotherapy may 
derive clinical benefit despite initial evidence of PD (Spigel-2017). 
Subjects treated with nivolumab will be permitted to continue nivolumab treatment beyond 
initial RECIST v1.1-defined PD assessed by the Investigator up to a maximum of 24 months 
from date of first dose as long as they meet the following criteria: 
• Investigator-assessed clinical benefit 
• Tolerance of study treatment 
• Stable performance status 
5.1.5. 
Subject Randomization and Stratification 
Subjects who complete Screening procedures and meet inclusion/exclusion criteria will be 
randomized in a 1:1 ratio to Arm A (CMP-001 in combination with nivolumab) or Arm B 
(nivolumab monotherapy) using an Interactive Web Response System (IWRS) and stratified 
by the following factors: 
• TNM Stage AJCC Cancer Staging Manual Eighth Edition (M0/M1a/M1b versus 
M1c/M1d) 
• Tumor PD-L1 expression (≥ 5% versus < 5%) 
During the Screening process, subject-specific values will be recorded for each of the 
2 stratification variables. Based on the entered values, the subject will be assigned to a 
treatment group according to a preprogrammed randomization schedule, which is designed to 
balance the 2 treatment groups by each variable to the extent possible. 
Subjects will be assigned a unique Subject identification (ID) number by the IWRS at 
randomization. This number will be recorded on the subject’s electronic case report from 
(eCRF) pages and used to identify the subject throughout the study. Once a subject number is 
assigned, it cannot be reassigned to any other subject. 
Details of the IWRS randomization and stratification process will be provided in the Trial 
Supply Management Manual. 
5.1.6. 
Blinding and Unblinding Process 
This is an open-label study. 
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5.2. 
Prior and Concomitant Medications 
IMPORTANT: Please refer to Section 5.1.2.1 for required prophylaxis prior to CMP-001 
administration. Prophylaxis administered before and after CMP-001 dosing will be collected 
for each visit. 
Please refer to Section 4.4 for prohibited treatments. 
Concomitant medications will be assessed continually from 30 days before the first dose of 
study treatment (W1D1) through 100 days after the last dose of study treatment or until an 
alternative cancer treatment is initiated, whichever occurs first. Treatment medications for 
AEs related to study treatment that occur more than 100 days after the last dose of study 
treatment or until an alternative cancer treatment is initiated, whichever occurs first, will be 
collected. Subjects who discontinue CMP-001 but remain on treatment with nivolumab will 
continue to have concomitant medications/treatments collected according the Schedule of 
Assessments (Table 1). 
In addition, at each LTSFU contact, an inquiry will be made regarding the start of any new 
cancer treatments since the date of the last contact. Prior cancer treatments will be 
documented on a separate eCRF. 
5.3. 
Treatment Compliance 
CMP-001 injections must be performed by qualified, trained site personnel. Any deviations in 
planned dosing will be documented in the source documents, verified by the Clinical 
Research Associate (CRA), and recorded as a protocol deviation as appropriate. Nivolumab 
will be administered by trained site personnel at the clinic site according to the dosing 
instructions provided in the nivolumab Investigator’s Brochure and in the Pharmacy Manual. 
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6. 
STUDY TREATMENT MATERIALS AND MANAGEMENT 
6.1. 
Study Treatments 
Nivolumab is a Food and Drug Administration (FDA) approved drug product for the 
treatment of several types of cancer in multiple regions including the United States 
(Dec-2014), the European Union (Jun-2015), and Japan (Jul-2014). The physical 
characteristics of nivolumab are found in the nivolumab Investigator’s Brochure. 
CMP-001 is an investigational study drug and will be provided by the Sponsor. CMP-001 is 
provided as a 5 mg/mL solution in a single-use vial. Each single use vial will contain either 
1.0 mL extractable volume, for a 5 mg dose of CMP-001, or 2.0 mL extractable volume, for a 
10 mg dose of CMP-001. The physical characteristics and other details about CMP-001 study 
drug are found in the CMP-001 Investigator’s Brochure and the Pharmacy Manual. 
At the end of the treatment period, study treatment will no longer be provided to 
subjects/Investigators unless the Sponsor chooses to extend the study. The Investigator 
should ensure that the subject receives appropriate standard of care to treat the condition 
under study. 
6.2. 
Study Drug Labeling and Packaging 
Details of the study drug labeling and packaging are provided in the Pharmacy Manual. The 
study drug vials will be labeled with the following information: 
• The protocol number 
• The kit number 
• Number of vials per kit (carton only) 
• The batch number of the drug 
• The drug name, concentration, and nominal volume per vial 
• The recommended storage conditions of the drug 
• Cautionary statement to keep away from children 
• Cautionary statement indicating that the drug is for investigational use only 
• The name and address of the Sponsor 
6.3. 
Study Drug Handling, Storage, Accountability 
All study drug vials will be transported, received, stored, and handled in accordance with the 
carton and vial labels and instructions provided to the site and relevant personnel. The site’s 
SOPs and applicable regulations will be followed. 
Appropriate storage and transportation conditions will be maintained for study drug vials 
from the point of manufacture up to delivery. All shipments of study drug vials will include a 
temperature monitoring device that records required storage conditions for the vials at regular 
intervals for the entire time the shipment is in transit. 
Upon receipt by the site, the designated site personnel will examine the shipment and 
temperature monitoring devices to verify the study drug vials were received in acceptable 
condition. Vials received in acceptable condition should be stored at the specified 
temperature (2°C to 8°C) in a locked area accessible only to designated site personnel until 
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dispensed. Dispensed study drug vials will be stored in a limited access area under 
appropriate environmental conditions as defined in the Pharmacy Manual. Vials not received 
in acceptable condition should be immediately quarantined at the appropriate temperature 
(2°C to 8°C), and the site personnel must immediately notify the IQVIA Biotech CRA. Such 
study drug vials may not be used until IQVIA Biotech representatives (eg, IQVIA Biotech 
CRA) has conveyed a determination about these specific study drug vials. 
The designated site personnel will be responsible for maintaining accurate records of the 
quantity and dates of all study drug supplies received, dispensed, and returned, in accordance 
with applicable regulations and the site’s SOPs. The quantity of study drug lost, destroyed, or 
otherwise unaccounted for must also be accounted for and documented. 
All original study drug vials, whether empty or containing study drug, will be kept at the site. 
Study drug vials are single-use only; therefore, contents of partially used study drug vials 
may not be combined or dispensed again, even to the same subject, nor relabeled or 
reassigned for use by other subjects. Unused study drug vials will be available for verification 
by the study monitor. Once dispensed, used study drug vials will be stored in a limited access 
area under appropriate environmental conditions. 
At each investigational site closeout visit and end of clinical trial, a final study drug vial 
accountability review and reconciliation must be completed by the Sponsor or its 
representatives and any discrepancies must be investigated, and their resolution documented. 
All study drug vials will be destroyed at the investigational site as per institutional SOPs after 
site closeout has been completed or if approved by the Sponsor or its representative as 
required by the site (ie, space limitations, policy) once drug accountability is conducted by 
the IQVIA Biotech CRA. A copy of the site destruction SOP must be maintained on file and 
available for the IQVIA Biotech CRA. If unable to destroy on site, please inform the IQVIA 
Biotech CRA. 
Details of the study drug storage and handling are provided in the Pharmacy Manual. 
6.4. 
Study Drug Dispensing 
CMP-001 will be dispensed, prepared, and administered according to the Pharmacy Manual 
and site SOPs. Details regarding the preparation and administration of the CMP-001 is 
outlined in the Pharmacy Manual. Only eligible subjects participating in the study may 
receive CMP-001. CMP-001 study drug is dedicated to each study and is labeled specifically 
for each CMP-001 study. Only authorized and qualified site staff may dispense, prepare, or 
administer CMP-001. 
Nivolumab will be dispensed, prepared, and administered according to the Pharmacy Manual, 
and site SOPs. 
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7. 
STUDY ASSESSMENTS AND PROCEDURES 
7.1. 
Procedures and Assessments 
Assessments to be performed at Screening and throughout the study are specified in the 
Schedule of Assessments (Table 1). 
7.1.1. 
Informed Consent 
Subjects must sign a written informed consent form (ICF) prior to the initiation of any study 
procedures and thereafter if there are any ICF changes. Subjects will be given a signed copy 
of the ICF to take home. Subjects unable to provide written informed consent on their own 
behalf will not be eligible for the study. 
7.1.2. 
Eligibility Criteria 
Subjects must meet all inclusion and exclusion criteria to be eligible for the study. Refer to 
Section 4. 
7.1.3. 
Demographics 
Demographic data will be collected during Screening. Demographic data will include date of 
birth, sex, ethnicity and race (ie, white, black or African American, Asian, American 
Indian/Alaskan Native, Native Hawaiian/other Pacific Islander, or other). 
7.1.4. 
Medical History 
At Screening, a general medical history will be obtained, including chronic conditions and 
comorbidities, relevant acute conditions or infections, surgical procedures unrelated to 
melanoma, and any reported conditions affecting major body systems during the 10 years 
prior to Screening. 
7.1.5. 
Melanoma History 
Eligible subjects must have been diagnosed with histopathologically or cytologically 
confirmed Stage III or IV metastatic malignant or unresectable melanoma. Subjects with 
uveal, acral, or mucosal melanoma are not eligible. 
At Screening, a detailed melanoma history will be obtained, including date of initial 
diagnosis, AJCC melanoma cancer staging at diagnosis, and BRAF mutation status including 
treatment with a kinase inhibitor targeted for BRAF mutation (with or without a MEK 
inhibitor). BRAF mutation status must be assessed with an FDA-approved test. Sites should 
refer to the Eighth Edition AJCC Cancer Staging Manual (AJCC-2017) for cancer staging. 
PD-L1 status from prior biopsies, if available, will be recorded in the electronic data capture 
(EDC). 
7.1.6. 
Prior Cancer Treatments 
Details regarding all prior cancer treatments, including drug generic name, dose (if available), 
route of administration, start date, end date, best response, and last response to prior therapy, 
will be documented on a separate page in the EDC. Data on prior surgical procedures related 
to melanoma will also be captured in the EDC. 
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7.1.7. 
Medication History 
All medications (see Section 5.2) administered to the subject from 30 days prior to first dose 
of study treatment (W1D1) until 100 days after discontinuation of both CMP-001 and 
nivolumab will be recorded in the EDC. Treatment medications for AEs related to study 
treatment that occur more than 100 days after the last dose of study treatment will also be 
collected. Documentation for each medication will include the generic name of the 
medication, total daily dose, route of administration, dates of administration, and indication 
for use. Combination drugs must be listed separately by each component study treatment and 
dose. Prior cancer treatment will be recorded separately. 
7.1.8. 
Physical Examination 
Physical examinations, including height and weight, will be conducted as specified in the 
Schedule of Assessments (Table 1). A full physical examination will be conducted at 
Screening and EOT. If the Screening full physical examination is performed >72 hours prior 
to the W1D1 visit, then a brief (symptom directed) physical examination must be performed 
within 72 hours prior to the first injection of CMP-001. Brief physical examinations focused 
on areas of disease or AEs may be performed at any clinically indicated time but must be 
obtained before the first, third, and seventh weekly CMP-001 injections (W1D1, W3D1, 
W7D1) and at each CMP-001 injection visit thereafter. Height will be obtained at Screening 
only and weight will be obtained at all physical examination assessments. 
7.1.9. 
Vital Signs 
Vital signs will be conducted as specified in the Schedule of Assessments (Table 1). Vital 
signs include measurement of blood pressure (systolic and diastolic blood pressure), 
respiratory rate, heart rate, and body temperature. Blood pressure and heart rate should be 
taken in the seated position following ≥3 minutes of rest. When vital signs are scheduled at 
the same time as collection of a blood sample, the vital sign measurements should be 
obtained before the scheduled phlebotomy. If a study visit occurs where only nivolumab is 
administered, vital signs must be collected before the start of the nivolumab infusion. If an 
indwelling cannula is being used to obtain blood, blood pressure should be measured in the 
arm opposite to the cannula placement. 
7.1.10. 
Eastern Cooperative Oncology Group Performance Status 
At Screening, the ECOG performance status (Appendix A) will be assessed and must be 
either 0 or 1 for the subject to be eligible. The ECOG performance status will be assessed as 
specified in the Schedule of Assessments (Table 1). 
7.1.11. 
Electrocardiogram 
A single standard, 12-lead electrocardiogram (ECG) will be obtained as specified in the 
Schedule of Assessments (Table 1). Assessed ECG parameters will include heart rate and PR, 
QRS, QT, and QT corrected for heart rate (QTc) intervals. QT will be corrected using 
Fridericia’s (QTcF) formula. ECGs will be performed after the subject has been resting in 
supine or semi-supine position for at least 5 minutes. When an ECG is scheduled at the same 
time as a blood sampling, the ECG reading should be obtained before the scheduled blood 
sampling. The ECG results will be interpreted at the site by a medically qualified person. If 
indicated, the ECG must be evaluated by a cardiologist or qualified internist. 
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7.1.12. 
Clinical Laboratory Assessments 
Clinical laboratory tests will be performed as specified in the Schedule of Assessments 
(Table 1). Additional tests may be performed as clinically indicated. 
Clinical laboratory parameters (Table 3) to be obtained include: 
• Hematology, chemistry, and urinalysis assessments 
• Coagulation (PTT, PT, and INR) assessments 
• Thyroid function tests (thyroid stimulating hormone, triiodothyronine, and free 
thyroxine ) for clinical signs and symptoms of thyroid disorder 
• Autoimmune panel 
A central laboratory will be used for clinical laboratory safety assessments; local laboratories 
may be used for eligibility and treatment decisions. The central laboratory will provide 
collection supplies and perform analysis of clinical laboratory evaluations. Specimens will be 
appropriately processed, and laboratory reports will be provided to the Investigator. A 
summary of the number and volume of laboratory specimens collected at each study visit is 
provided in Appendix B. 
The Investigator is responsible for reviewing local and central laboratory results and 
assessing all out-of-range findings as either clinically significant or non-clinically significant. 
Clinically significant laboratory results should be recorded as medical history if prior to 
CMP-001 dosing at W1D1 or as AEs following CMP-001 dosing at W1D1 in the eCRF. 
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Table 3: 
Clinical Laboratory Assessments 
 
Hematology 
Serum Chemistry 
Urinalysis 
Other Laboratory 
Tests 
Red blood cells (RBCs) 
White blood cells 
(WBCs) 
Differential WBC count 
Total leukocyte count, 
including differential 
Hemoglobin 
Hematocrit 
Platelets 
Alanine 
aminotransferase 
Albumin 
Alkaline phosphatase 
Amylase 
Aspartate 
aminotransferase 
Bilirubin 
Blood urea nitrogen or 
serum urea 
Calcium 
Chloride 
Creatinine 
Glucose 
Lactate dehydrogenase 
Lipase 
Phosphorous 
Potassium 
Sodium 
Total protein 
Blood 
Glucose 
Nitrites 
pH 
Protein 
Specific gravity 
WBCs 
Microscopic battery: 
RBCs, WBCs, 
epithelial cells, casts 
(only if significant 
positive findings on 
urinalysis) 
Coagulation: 
Partial thromboplastin 
time 
Prothrombin time 
International 
normalized ratio 
Thyroid Function 
Studies: 
TSH, T3, free T4 (at 
Screening) 
TSH, with reflexive 
T3 and free T4 if TSH 
is abnormal (on 
treatment) 
Autoimmune 
laboratory panel: 
Anti-doubled stranded 
DNA, antinuclear 
antibody, 
antineutrophil 
cytoplasmic antibody, 
rheumatoid factor, and 
antibodies to 
ribonucleoprotein 
HIV 
Hepatitis B and C 
Abbreviations: RBC = red blood cell; T3 = triiodothyronine; T4 = thyroxine; TSH = thyroid stimulating 
hormone; WBC = white blood cell. 
Note: Refer to the Laboratory Manual for additional information. 
 
7.1.13. 
Pregnancy Testing 
Pregnancy testing will be performed on women of childbearing potential at the time points 
specified in the Schedule of Assessments (Table 1). A central serum pregnancy test is 
required during Screening. Women of childbearing potential must have a negative serum or 
urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic 
gonadotropin) prior to dosing at W1D1 as specified in Table 1. Urine pregnancy testing will 
be completed for time points after Screening. If a urine pregnancy test is positive at any time 
point, the test must be confirmed with a serum sample. If a serum pregnancy test is required 
based on a positive urine pregnancy test, serum test results must be confirmed as negative 
prior to enrollment or subsequent treatment of the subject. 
If the serum test confirms the subject is pregnant, they must have the EOT visit and the 
pregnancy must be reported. 
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7.2. 
Disease Assessments 
Disease assessments (radiographic, photographic, and CNS imaging) will be collected 
according to the Schedule of Assessments (Table 1). 
Acceptable assessment methods, definition of measurable disease, and selection of target and 
non-target lesions will be defined by RECIST v1.1 (see Appendix D). 
All disease assessments will be evaluated by BICR according to RECIST v1.1, and by 
Investigator according to RECIST v1.1 (see Appendix D), iRECIST (see Appendix E), and 
 
All scans should be performed at least 2 weeks after a previous CMP-001 IT injection to 
prevent an injection-related pseudoprogression. 
All radiographic and photographic images should be uploaded into the imaging portal within 
1 week of completion to enable BICR (see imaging guideline). 
7.2.1. 
Radiographic Imaging 
Contrast-enhanced CT and MRI are the preferred radiographic imaging modalities for disease 
assessment. Contrast-enhanced CT imaging is required when contraindications are not 
present. Contrast-enhanced CT assessments may be combined with positron emission 
tomography (PET) as long as disease status can be thoroughly assessed. Ultrasound imaging 
 
Any additional imaging that may demonstrate tumor response or progression (including scans 
performed at unscheduled time points and/or at an outside institution) should be collected for 
RECIST v1.1 tumor assessment and submitted for BICR. 
7.2.2. 
Photographic Imaging 
Digital photographic images of CMP-001 target and non-target skin lesions, including caliper 
measurements of superficial cutaneous lesions, will be obtained per the time points specified 
in the Schedule of Assessments (Table 1). Photos should be taken with a digital camera of 
adequate resolution according to the imaging guideline. To clearly capture the morphology of 
the tumor, both the skin lesion and the surrounding tissue must be included in the field of 
view. Each lesion should be clearly labeled with a unique identifier which must be used 
throughout the trial. A metric ruler must also be included in the photograph field of view as a 
size reference. 
If a CR is observed, sites should continue to obtain confirmation photographs according to 
the Schedule of Assessments (Table 1). 
Refer to the Imaging Guideline for further guidance. 
7.2.2.1. 
Central Nervous System Imaging 
Baseline brain imaging by contrast-enhanced CT or MRI (per site local standards) must be 
provided at Screening. Subsequent brain imaging is only required for subjects with current or 
prior history of brain metastases or clinical signs or symptoms of CNS disease. The same 
modality of brain imaging should be utilized throughout the study for an individual subject. 
7.2.3. 
On-Treatment Disease Assessment 
On-treatment disease assessments will be collected per the time points specified in the 
Schedule of Assessments (Table 1). 
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The volume and inflammation from an IT injection of CMP-001 may cause a tumor to 
transiently enlarge leading to an inaccurate assessment. All scans should be performed 
predose and at least 2 weeks after a previous CMP-001 IT injection to prevent 
injection-related pseudoprogression. 
7.2.3.1. 
Disease Assessment Beyond Progressive Disease 
Subjects with PD per RECIST v1.1 as determined by Investigator assessment should remain 
on treatment per Investigator discretion and have a follow-up scan performed at least 4 weeks 
after the initial date of PD to confirm progression per RECIST v1.1. Subjects who receive 
study treatment beyond PD per RECIST v1.1 will have subsequent disease assessments 
evaluated using iRECIST by the Investigator. Disease assessments should continue according 
to the Schedule of Assessments (Table 1). 
7.2.3.2. 
Confirmation of Response 
Subjects with a CR or PR per RECIST v1.1 or iCR or iPR per iRECIST as determined by 
Investigator assessment must have a confirmatory assessment at least 4 weeks after the initial 
response. All scans should be performed at least 2 weeks after the previous CMP-001 
injection to prevent injection-related pseudoprogression. 
Once confirmed, subsequent assessments should continue according to the Schedule of 
Assessments (Table 1). 
7.3. 
Translational Assessments 
7.3.1. 
Collection of Blood for Translational Biomarker Analyses 
Blood samples, including serum and/or plasma, will be collected for exploratory assessments 
during the Phase 2 portion of the study as specified in the Schedule of Assessments (Table 1). 
The procedures for sample collection, processing, storage, and shipment are provided in the 
Laboratory Manual. Blood samples will be tested to determine concentration of CXCL10 
before and during treatment with CMP-001 to evaluate association with the observed clinical 
responses to study treatment. Samples may be used for additional exploratory analysis of 
biomarkers thought to play a role in melanoma, cancer immunotherapy, or TLR9, including 
but not limited to concentration of serum/plasma analytes. These findings may be analyzed 
for association with observed clinical responses to the combination of CMP-001 and 
nivolumab and subsequent exploration of factors associated with response or resistance to 
CMP-001 in combination with nivolumab. These samples may be also used for research to 
develop methods, assays, prognostics, and/or companion diagnostics related to TLR9 
agonism and cancer immunotherapy. 
7.3.2. 
Collection of Tumor Biopsies for PD-L1 Staining and Translational Analyses 
Determination of PD-L1 expression is required to confirm subject eligibility. 
Fresh tumor biopsy samples are mandatory, if safe and medically feasible, as specified in the 
Schedule of Assessments (Table 1). If in the Investigator's opinion it is unsafe to perform a 
new biopsy, archival material must be used for analysis of PD-L1 expression. The decision 
and rationale to forego biopsy samples at Screening or during the treatment period should be 
clearly documented. Archival tumor biopsy samples should also be collected during 
Screening, if available. 
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Tumor biopsies will be used to assess PD-L1 expression and may be used to analyze tumor 
immune cell infiltrates, such as CD3+CD8+ T cells. Biopsies may be used for additional 
exploratory analysis of biomarkers thought to play a role in melanoma, cancer 
immunotherapy, or TLR9, including but not limited to RNA analyses to monitor gene 
expression and DNA analyses to identify mutations associated with cancer. These findings 
may be analyzed for association with observed clinical response, resistance, and/or AEs to 
the combination of CMP-001 and nivolumab. 
Additional tumor biopsies may be collected during the study at the discretion of the 
Investigator. 
7.4. 
Safety Assessments 
Safety will be assessed on an ongoing basis throughout this study. All safety assessments and 
AEs will be recorded on the appropriate eCRF and reported to the Sponsor or its 
representatives (as applicable). All AEs/SAEs will be assessed continually from the time of 
informed consent through 100 days after the last dose of study treatment (both CMP-001 and 
nivolumab) or until an alternative cancer treatment is initiated, whichever occurs first, for all 
subjects. All other medical occurrences (non-adverse events) that begin before the start of 
study treatment should be recorded on the Medical History/Current Medical Conditions 
section of the eCRF, not the AE section. All AEs reported on or after the date that study 
treatment was first administered (W1D1), will be recorded on the eCRF and will be 
considered treatment-emergent adverse events (TEAEs). All TEAEs, defined as an AE that 
started or worsened in severity on or after the date that study treatment was first administered 
(W1D1), will be graded according to CTCAE v5.0 (Appendix C) and coded using Medical 
Dictionary for Regulatory Activities (MedDRA). Worsening TEAEs (ie, increase to higher 
severity/grade) should be recorded as new AEs. Ongoing AEs with a decrease in 
severity/grade do not need to be captured as new AEs. Subjects who discontinue CMP-001 
but remain on treatment with nivolumab will continue to have AEs collected according to this 
schedule until 100 days after the last dose of nivolumab or until an alternative cancer 
treatment is initiated, whichever occurs first. 
Abnormal vital sign measurements, clinical laboratory test results, and/or physical 
examination findings deemed clinically significant by the Investigator may be repeated, until 
the value returns to Baseline, within normal limits (WNL), or reaches a clinically stable 
endpoint, as determined by the Investigator. Any post-Baseline abnormal findings that are 
considered clinically significant by the Investigator will be recorded on the AE page of the 
eCRF. The Investigator is responsible for reviewing all clinical laboratory results. 
Additional measures, including non-study required laboratory tests, should be performed as 
clinically indicated or to comply with local regulations. Laboratory toxicities (eg, suspected 
drug-induced liver enzyme evaluations) will be monitored during the follow-up phase via on- 
site/local laboratories until all study treatment-related toxicities resolve, return to Baseline, or 
are deemed irreversible. 
If a subject shows cardiac- or pulmonary-related signs (hypoxia, abnormal heart rate, or 
changes from Baseline) or symptoms (eg, dyspnea, cough, chest pain, fatigue, palpitations), 
the subject should be immediately evaluated to rule out cardiac or pulmonary toxicity. 
Some of the assessments referred to in this section may not be captured as data in the eCRF. 
They are intended to be used as safety monitoring by the treating physician. Additional 
testing or assessments may be performed as clinically necessary or where required by 
institutional or local regulations. 
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Any incidental findings of potential clinical relevance that are not directly associated with the 
objectives of the protocol should be evaluated and handled by the Study Investigator as per 
standard medical/clinical judgment. 
7.4.1. 
Adverse Events 
AEs will be assessed continually from the time that the informed consent is signed through 
100 days after the last dose of study treatment (both CMP-001 and nivolumab) or until an 
alternative cancer treatment is initiated, whichever occurs first, for all subjects. Subjects who 
discontinue CMP-001 but remain on treatment with nivolumab will continue to have AEs 
collected according to this schedule until 100 days after the last dose of nivolumab or until an 
alternative cancer treatment is initiated, whichever occurs first. All AEs from the time that the 
informed consent is signed will be captured on the eCRF. 
Treatment-related SAEs starting more than 100 days after the last dose of study treatment 
will be recorded on the AE eCRF. 
Immune-mediated AEs (IMAEs) are AEs consistent with an immune-mediated mechanism or 
immune-mediated component for which noninflammatory etiologies (eg, infection or tumor 
progression) have been ruled out. IMAEs can include events with an alternate etiology which 
were exacerbated by the induction of autoimmunity. Information supporting the assessment 
will be collected on the subject’s case report form. 
See Section 8.3 for a full description of the collection and reporting of AEs during this study. 
7.5. 
100-Day Follow-up Contact 
The 100-Day Follow-up contact is a safety follow up that may be conducted in the study 
clinic or via phone and should occur 100 days (+7) after the EOT or until an alternative 
cancer treatment is initiated, whichever occurs first. The subject should be questioned for any 
new AEs, resolution of prior AEs, and use of concomitant medications, including other 
cancer treatments. No other safety assessments are required unless the Investigator identifies 
a new safety concern that requires further follow-up. 
7.6. 
Post-treatment Follow-up 
Subjects who discontinue study treatment and transition into PTFU will continue to have 
disease assessments collected per the time points specified in the Schedule of Assessments 
(Table 1). Post-treatment follow-up disease assessments will continue until disease 
progression, initiation of another cancer treatment, death, loss to follow-up, withdrawal of 
consent, or End of Clinical Trial. 
7.7. 
Long-Term Survival Follow-up 
Subjects who discontinue study treatment and PTFU will be contacted by the site according 
to the Schedule of Assessments (Table 1) for LTSFU, which will continue until death, 
withdrawal of consent, lost to follow-up, or End of Clinical Trial. 
OS is a key endpoint of this study. Post-study follow-up is of critical importance and is 
essential to preserving subject safety and the integrity of the study. Subjects who discontinue 
study treatment must continue to be followed for collection of outcome and/or survival 
follow-up data as required until death or the conclusion of the study. 
The Sponsor may request that survival data be collected on all treated subjects outside of the 
protocol-defined window (Schedule of Assessments, Table 1). At the time of this request, 
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each subject will be contacted to determine their survival status unless the subject has 
withdrawn consent for all contacts or is lost to follow-up. 
 
 
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8. 
SAFETY DATA COLLECTION, RECORDING, AND 
REPORTING 
8.1. 
Adverse Events 
8.1.1. 
Definition of an Adverse Event 
An AE is an untoward or medical occurrence associated with the use of study treatment 
(active or placebo drug, biologic, or device) in clinical investigation subjects, which does not 
necessarily have a causal relationship with the study treatment. An AE can therefore be any 
unfavorable and unintended symptom, sign, disease, condition, or test abnormality whether or 
not considered related to study treatment (Appendix C). Adverse events that do not meet the 
definition for an SAE are considered non-SAEs. 
Adverse events should be recorded upon first occurrence and followed until resolution. A 
persistent AE is continuous and does not resolve between Q3W dosing visits. The AE is 
documented only once unless the grade becomes more severe. If the grade becomes more 
severe, the AE must be reported again with the new grade. Any recurrent AE should be 
reported as new AE. 
Adverse events include: 
• Changes in health status described by the subject or signs observed by the 
Investigator or medical staff. 
• Test abnormalities (eg, laboratory tests) that result in an alteration in medical care 
(diagnostic or therapeutic) and/or are considered clinically significant by the 
Investigator. 
Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism 
or immune-mediated component for which non-inflammatory etiologies (eg, infection or 
tumor progression) have been ruled out. IMAEs can include events with an alternate etiology, 
which were exacerbated by the induction of autoimmunity. Information supporting the 
assessment will be collected on the subject’s eCRF. 
Every AE must be assessed by the Investigator with regard to whether it is considered 
immune-mediated. For events that are potentially immune-mediated, additional information 
will be collected on the subject’s eCRF. 
Disease progression and associated hospitalization, are not considered AEs or SAEs in this 
study. 
Abnormalities present at Baseline will be recorded as medical history and will only be 
considered AEs if they reoccur after resolution or worsen during the study. 
8.1.2. 
Definition of a Serious Adverse Event 
An SAE is any AE that fulfills 1 of the criteria outlined in Table 4. 
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Table 4: 
Criteria for Determination of Serious Adverse Events 
 
Death 
An adverse event (AE) that results in death. 
Note: In this study, deaths due to disease progression are not to be 
reported as serious adverse events (SAEs). 
Life-threatening AE 
An AE that places the subject, in the view of the Investigator, at 
immediate risk of death from the AE as it occurred (ie, does not include 
an AE that had it occurred in a more severe form, might have caused 
death). 
Required or prolonged 
inpatient 
hospitalizationa 
An AE that results in an initial inpatient hospitalization or prolongs an 
existing hospitalization of the subject. If a subject is hospitalized as part 
of the clinical use of the study treatment, a period of normal 
hospitalization will be outlined in the protocol or by the judgment of the 
Investigator. Hospitalizations longer than this period will be prolonged 
hospitalizations. 
Persistent or 
significant 
disability/incapacity 
An AE that results in a substantial disruption of a subject’s ability to 
conduct normal life functions. 
Congenital 
anomaly/birth defect 
A congenital anomaly/birth defect that occurs in the offspring of a subject 
exposed to the study treatment. 
Important medical 
event 
An AE which may not result in death, be life-threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate 
medical judgment, the event may jeopardize the subject and may require 
medical or surgical intervention to prevent one of the outcomes listed 
above, in the opinion of the Investigator. 
Abbreviations: AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events; SAE = serious adverse 
event; W1D1 = Week 1 Day 1. 
a. Planned hospital admissions or surgical procedures for elective procedures or an illness or disease that existed before the 
time of consent will not be captured as SAEs. If there was a change in medical condition it may be an SAE. 
Appendix C: CTCAE v5.0 
 
 
Examples of “important medical events” include allergic bronchospasm requiring intensive 
treatment in an emergency room or at home, blood dyscrasias or convulsions that do not 
result in inpatient hospitalization, or the development of drug dependency or drug abuse. 
Medical and scientific judgment should be exercised in deciding whether expedited reporting 
is appropriate in other situations, such as with important medical events described above. 
Events that meet SAE criteria must be recorded and reported regardless of expectedness or 
assessed association with study treatment. 
Hospitalization due solely to the progression of underlying melanoma should NOT be 
reported as an SAE. 
8.1.3. 
Definition of a Treatment-Emergent Adverse Event 
A TEAE is defined as an AE that started or worsened in severity on or after the date that 
study treatment was first administered (W1D1) until 100 days after the last dose of study 
treatment or until an alternative cancer treatment is initiated, whichever occurs first. 
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8.1.4. 
Definition of a Pretreatment Adverse Event 
Pretreatment AEs are AEs that are related to study procedures that occur from the time of 
informed consent to the first dose of study treatment (W1D1). 
8.2. 
Evaluation of Adverse Events and Serious Adverse Events 
The Investigator or designee is responsible for making an assessment as to the severity 
(CTCAE v5.0 Grade), causality/relationship to CMP-001 and to nivolumab separately, and 
outcome of AEs and SAEs (as defined in Section 8.2.3). Every attempt should be made to 
provide the causality/relationship at the time at the time of reporting the SAE. In addition, the 
Investigator or designee must report any actions taken as a result of an AE or SAE separately 
for CMP-001 and nivolumab. 
8.2.1. 
Adverse Event Severity/Grade 
For each recorded AE or SAE, the Investigator or designee must provide an assessment of 
severity/grade using the CTCAE v5.0 (Appendix C). 
Note that severity is not the same as “seriousness” (defined in Table 4). Seriousness (not 
severity) serves as a guide for defining regulatory reporting obligations. 
Worsening of an ongoing TEAE (ie, an increase to higher grade) should be recorded as a new 
AE. Ongoing AEs that decrease in severity/grade should not be captured as new AEs. 
Table 5: 
CTCAE Adverse Event Grades 
 
Classification 
Definition 
Grade 1 
Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated 
Grade 2 
Moderate; minimal, local, or non-invasive intervention indicated; limiting 
age-appropriate instrumental activities of daily living 
Grade 3 
Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limited 
self-care activities of daily living 
Grade 4 
Life-threatening consequences: urgent intervention indicated 
Grade 5 
Death related to adverse event 
Appendix C: CTCAE v5.0 
 
8.2.2. 
Relationship to Study Treatment 
For each AE or SAE, the Investigator will determine whether there is a reasonable possibility 
demonstrated by evidence that suggests a causal relationship between the study treatment and 
each AE according to the categories provided in Table 6 (See Appendix C). Attribution of 
AEs will be determined for each of the individual components (CMP-001 and nivolumab) of 
the study treatment. The Investigator may change their opinion of causality in light of follow- 
up information; if this occurs, the Investigator must amend the AE or SAE information in the 
EDC and on the paper SAE form accordingly. 
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Table 6: 
Classification for Adverse Event Causality 
 
Classification 
Definition 
Unrelated 
There is no suspicion of a causal relationship between exposure to the study 
treatment regimen and the adverse event (AE); another cause of the AE has 
been identified, no temporal association with study treatment has been 
identified, or the study treatment cannot be implicated 
Possibly related 
There is some evidence supporting the possibility of a causal relationship 
between study treatment regimen exposure and the AE; an alternative 
explanation (ie, concomitant drug or concomitant disease) is inconclusive, 
the temporal association with study treatment is reasonable, and the causal 
relationship cannot be excluded 
Probably related 
An AE that has a timely relationship to the administrative of the 
investigational drug regimen and follows a known pattern of response, but 
for which a potential alternative cause may be present 
Definitely related 
There is strong evidence that there is a causal relationship between study 
treatment regimen and the AE; the AE cannot be reasonably explained by an 
alternate explanation (ie, concomitant drug or concomitant disease) and the 
temporal association with study treatment is suggestive of a causal 
relationship 
Note: CMP-001 and nivolumab must be assessed separately. An AE is considered related to treatment if the 
attribution is “possibly related”, “probably related”, or “definitely related.” 
Appendix C: CTCAE v5.0 
 
Every AE must be assessed by the Investigator with regard to whether it is considered 
immune-mediated. For events that are potentially immune-mediated, additional information 
will be collected on the subject’s eCRF. 
8.2.3. 
Classification of Adverse Event Outcome 
Adverse event outcome describes the status of the AE at the last observation. The 
Investigator will document the outcomes of each AE using the categories provided in 
Table 7. 
Table 7: 
Classifications for Adverse Event Outcomes 
 
Classification 
Definition 
Fatal 
Termination of life as a result of an adverse event (AE) 
Not recovered/not resolved 
Subject has not recuperated, or the AE has not improved 
Recovered/resolved 
Subject has recuperated, the AE resolved, or returned to 
Baseline status / stabilized 
Recovered/resolved with sequelae 
Adverse event has resolved, but the subject has been left 
with symptoms or pathology 
Unknown 
Not known, not observed, not recorded, or refused 
Appendix C: CTCAE v5.0 
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8.2.4. 
Action Taken Related to Study Treatment Administration Regarding the 
Adverse Event 
The Investigator will provide the action taken regarding study treatment separately for 
CMP-001 and nivolumab in response to the AE. Refer to Section 5.1.3 and Section 5.1.4 for 
allowed dose modifications of CMP-001 and nivolumab, respectively. Classification for each 
of the potential actions taken are provided in Table 8. 
Table 8: 
Classifications for Actions Taken Related to Study Treatment 
Administration Regarding an Adverse Event 
 
Classification 
Definition 
No change 
No change in administration of study treatment 
Study treatment delayed 
Temporary delay in administration of the study treatment 
Study treatment withheld 
One or more planned doses of study treatment completely withheld 
(skipped) 
Study treatment dose 
reduced 
Study treatment dose reduced from the previous dose levela 
Study treatment permanently 
withdrawn 
Administration of the study treatment terminated (no further dosing) 
Not applicable 
Determination of a value is not relevant in the current context 
a. The CMP-001 dose should remain unchanged during the study, unless deemed medically necessary by the 
Investigator after discussion with the Medical Monitor; dose reductions of nivolumab are not allowed. 
 
8.3. 
Procedures for Recording and Reporting Adverse Events 
The Investigator is required to report to the Sponsor or its representatives all AEs that occur 
during the clinical study (Title 21 Code of Federal Regulations [CFR] Part 312.64[b] and 
International Council for Harmonisation [ICH] E6 entitled “Guideline to Good Clinical 
Practice”). At each study visit, subjects will be evaluated for new AEs and the status of 
existing AEs. All AEs/SAEs will be captured from the time of ICF and recorded on the eCRF 
as AEs. All other medical occurrences (non-adverse events) that begin before start of study 
treatment should be recorded on the Medical History/Current Medical Conditions section of 
the eCRF, not the AE section. All AEs reported on or after the date that study treatment was 
first administered (W1D1), will be recorded on the eCRF and will be considered TEAEs. 
Treatment-emergent adverse events observed until 100 days after the last dose of study 
treatment (both CMP-001 and nivolumab) or until an alternative cancer treatment is initiated, 
whichever occurs first, are to be recorded on the AE page of the eCRF. 
The date, time of onset, resolution, determination of seriousness, severity, action taken, 
outcome and relationship to CMP-001 and nivolumab will be recorded for all AEs. AEs 
starting more than 100 days after the last dose of study treatment should not be recorded on 
the AE eCRF unless they are serious and considered to be related to study treatment. 
All AEs and SAEs experienced by a subject will be recorded on the appropriate eCRF. In 
addition, for all SAEs a paper SAE Report Form will be completed and submitted to IQVIA 
Biotech Safety preferably via email to: Safety-Inbox.Biotech@IQVIA.com or by fax to 
+1 866 761-1274 as back up within 24 hours of awareness. Information including a detailed 
description of the event; date and time (24-hour clock) of event onset and resolution; 
determination of seriousness, severity, corrective treatment, outcome, relationship to the 
individual components (CMP-001 and nivolumab) of the study treatment; and action taken 
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regarding the study treatment will be recorded. Vital signs, laboratory results, and other 
safety assessments noted in Section 7.1 will be recorded as AEs if they are determined to be 
clinically significant findings in the opinion of the Investigator. When possible, a diagnosis 
should be recorded as an AE rather than symptoms or isolated laboratory abnormalities 
related to the diagnosis. A medical or surgical procedure is not an AE; rather the condition 
leading to the procedure should be recorded as the AE. If the condition is not known, the 
procedure must be recorded as an AE instead. Similarly, death is not an AE, but is rather the 
outcome of the AE(s) that resulted in death. If the AE(s) leading to death are not known, then 
death must be reported as an AE. 
8.3.1. 
Reporting Serious Adverse Events 
All SAEs and associated source documents must be reported in written or typed English via 
completion of the eCRF AE page and accompanying paper SAE Report Form to IQVIA 
Biotech Safety (following the same reporting process outlined in Section 8.3 within 24 hours 
of first knowledge of the event regardless of relationship to the study procedures or individual 
study treatments. The paper SAE Report Form should be used to record pertinent 
information, regarding the SAE. The Investigator is requested to supply as much detailed 
information as possible regarding the event at the time of the initial report. 
SAEs will be collected from the time of informed consent until 100 days after the last dose of 
study treatment or until an alternative cancer treatment is initiated, whichever occurs first. 
Any SAE considered to have at least possible relationship to the study treatment and 
discovered by the Investigator at any time period after EOT should be reported throughout 
the study period. 
If at any time after the subject has completed participation in the study, the Investigator or 
study staff becomes aware of an SAE that occurred during the study reporting period that 
they believe is possibly, probably, or definitely related to either study treatment (see Section 
8.2.2), then the event and any known details must be reported promptly to the Sponsor or its 
representatives. The following reporting instructions must be followed. 
At minimum, the Investigator will be asked to provide the following information: 
• For the initial SAE notification, the Investigator must provide, at a minimum, 
basic information such as the protocol number, subject’s year of birth or age at 
onset, subject ID number, period of study treatment intake, event term, nature of 
the event, detailed description of the event, seriousness criteria, causality of the 
event to CMP-001 and nivolumab separately, and severity. 
• In addition, the initial SAE information entered on the eCRF and paper SAE 
Report Form should include all pertinent known information about the SAE and 
the affected subject, such as the following: subject sex; description of the AE 
including reason for assessment as serious, and individual study treatment 
information including doses, dates of dosing, and action taken with individual 
study treatments. 
Follow-up information must be entered or uploaded into the eCRF system and paper SAE 
Report Form and sent to IQVIA Biotech Safety (following the same reporting process 
outlined in Section 8.3.1) within 24 hours of the Investigator’s first knowledge of the new 
information. Follow-up SAE reports may describe the evolution of the reported events and 
any new assessment of their outcome and/or relationship to individual study treatments. 
Supporting documentation may be solicited from the site even if the SAE occurred at another 
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institution. Such documentation may include copies of relevant subject/hospital records, and 
pathology or autopsy reports. For subject deaths, the cause of death is to be recorded as the 
SAE term. A death certificate and an autopsy report, if performed, should be submitted. 
The Sponsor representative contact information is available for SAE reporting on a 24-hour 
basis and is reviewed during normal business hours. A paper SAE Report Form should be 
completed and submitted to IQVIA Biotech Safety within 24 hours of awareness. 
8.3.2. 
Reporting Pregnancies 
Female subjects or the partners of male subjects who become pregnant within 1 year of their 
last dose of study treatment will be instructed to notify the Investigator immediately. 
If the Investigator learns of a report of pregnancy at any time after the W1D1 visit, the 
Investigator must complete and submit a paper Pregnancy Report Form and report the 
pregnancy to the IQVIA Biotech Safety within 24 hours of awareness (following the same 
reporting process outlined in Section 8.3). 
The Investigator will inform the subject that the Sponsor or its representatives is required to 
gather information regarding the course and outcome of a pregnancy that has occurred after 
exposure to a study treatment. The progress of the pregnancy must be followed until the 
outcome of the pregnancy is known (ie, delivery, elective termination, or spontaneous 
abortion). If the pregnancy results in the birth of a child, additional follow-up information 
may be requested. 
The Investigator will be asked to obtain follow-up information no later than 2 months after 
the gestational period to obtain maternal/fetal/neonatal outcome and any other relevant 
information. 
Follow-up information may be requested at additional time points. All study-related contacts 
involving a known pregnancy should include pregnancy status assessment until pregnancy 
outcome is known. 
Please note that pregnancy in and of itself is not an AE or an SAE. Pregnancy should not be 
entered into the eCRF as an AE unless the Investigator suspects an interaction between the 
study treatment and the contraceptive method. Additionally, all information received will be 
assessed for any AEs and SAEs and processed per study guidelines. If the subject is 
discontinued because of pregnancy, pregnancy will be documented as the reason for study 
discontinuation. Spontaneous abortions and stillbirths will be reported as SAEs. 
8.3.3. 
Reporting Serious Adverse Events to Institutional Review Boards and 
Regulatory Authorities 
Investigators will follow up on expedited safety reports (unexpected SAEs that are 
determined to be associated with the use of study treatment) from the Sponsor or its 
representatives. The Investigator is responsible for fulfilling applicable local reporting 
requirements to their Institutional Review Board (IRB). Investigators must forward copies of 
the IRB notification to the Sponsor or its representatives. 
In the United States, the Sponsor will be responsible for notifying the FDA of any serious 
unexpected suspected adverse reaction that is determined to be associated with the use of 
study treatment. The Sponsor’s assessment of attribution and expectedness will determine 
regulatory reporting. 
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8.3.4. 
Follow-up of Adverse Events/Serious Adverse Events 
All AEs and SAEs documented at a previous visit that are designated as not 
recovered/resolved will be reviewed by the Investigator at subsequent visits. 
All AEs will be followed until resolution of AE, completion of the subject’s study 
participation, or study termination, whichever occurs first. 
Serious AEs and AEs resulting in discontinuation will be followed until 1 of the following 
occurs: 
• The event resolves. 
• The event stabilizes. 
• The event returns to a Baseline value if a Baseline value is available. 
• The event can be attributed to agents other than the study treatment or to factors 
unrelated to study conduct. 
• The Investigator and Medical Monitor agree that follow-up is no longer necessary. 
Follow-up reports from the Investigator must be provided via completion of the eCRF AE 
page and accompanying paper SAE page within 24 hours of the Investigator’s first 
knowledge of the new information. Additional information (ie, hospital records, laboratory, 
or other diagnostic test results) should be provided if requested and/or indicated. In addition, 
for SAEs the follow-up information should be added using the same form on which the initial 
SAE was reported. It should be completed and submitted to IQVIA Biotech Safety via email: 
Safety-Inbox.Biotech@IQVIA.com 
Rules for AE/SAE follow-up apply to all subjects, including those who withdraw consent 
prior to study completion (to the extent allowed). The Investigator will ensure that follow-up 
includes further investigations to elucidate the nature and/or causality of the AE/SAE. These 
investigations must be consistent with appropriate medical management and subject consent. 
Investigators are not obligated to actively seek AEs or SAEs in former study subjects that 
occur pursuant to the follow-up period. However, if the Investigator or designee learns of any 
AE or SAE at any time after a subject has been discharged from the study and the event is 
considered as reasonably related to the study treatment, the Investigator will notify the 
Sponsor. 
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9. 
STATISTICAL METHODS 
Categorical variables will be summarized as the number and percentage of subjects within 
each category (with a category for missing data, if applicable). Continuous variables will be 
presented as number (n), mean, median, standard deviation, and range (minimum and 
maximum). 
Data from all investigational sites will be pooled in the analyses. 
A detailed statistical analysis plan (SAP) will be finalized before database lock and will 
document the analysis methods, data handling procedures, and other statistical analysis 
issues. Statistical analyses will be performed using SAS® software version 9.4 or higher. 
9.1. 
Sample Size Calculation 
This study will randomize a total of 450 subjects in the Phase 2 and Phase 3 portions of the 
study. Subjects who have provided written informed consent at the time the enrollment goal 
in either phase is reached may complete Screening and be randomized if they meet all 
eligibility criteria, at the discretion of the Sponsor or its representatives. 
Phase 2 Sample Size 
A total of 140 subjects will be randomized in a 1:1 ratio to receive either CMP-001 in 
combination with nivolumab (Arm A) or nivolumab monotherapy (Arm B). A sample size of 
140 subjects provides 80% power to detect an absolute treatment difference of 25% with a 
2-sided alpha level of 0.05, assuming that the ORR in Arm A is 65% and the ORR in Arm B 
is 40%. The sample size calculation is performed in PASS-2020 for testing 2 independent 
proportions using the continuity corrected Z-test with pooled variance. 
Phase 2/3 Sample Size 
If there is a statistically significant treatment difference at a 2-sided alpha level of 0.05 for the 
ORR at the end of Phase 2, an additional 310 subjects will be randomized in a 1:1 ratio to 
receive either CMP-001 in combination with nivolumab (Arm A) or nivolumab monotherapy 
(Arm B). Combined with the 140 subjects enrolled in Phase 2, this will make up the overall 
Phase 3 study population sample size of 450 subjects. 
The Phase 3 sample size of 450 subjects is calculated to compare the PFS by BICR between 
the 2 treatment arms at an alpha level of 0.05 (2-sided). The final PFS analysis will be 
performed when at least 331 PFS events have been observed across the 2 treatment arms (PD 
by BICR review or death from any cause). With 331 PFS events, the study has 90% power to 
demonstrate a treatment effect in PFS at a 0.05 alpha level (2-sided) when the true HR is 
0.70. The smallest treatment effect that can be detected statistically significant in this study is 
HR 0.805. The sample size calculation is performed in PASS-2020. 
9.2. 
Multiplicity 
In order to preserve the family-wise type I error rate of 5% (2-sided), the gatekeeping strategy 
will be applied. 
The 5% (2-sided) alpha is allocated to ORR primary analysis at end of Phase 2. If the 
treatment effect on ORR at end of Phase 2 is statistically significant at a 2-sided alpha level 
of 0.05, then enrollment in Phase 3 may be triggered. The 5% (2-sided) alpha will be recycled 
to the Phase 3 primary analysis of PFS. The detailed testing hierarchy including the 
secondary endpoints will be pre-specified in the SAP. The overall type I error rate for this 
study will be strictly controlled at 5% (2-sided). 
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9.3. 
Analysis Sets 
The main analysis sets are defined in this section. The Phase 2 analysis sets apply to subjects 
who are randomized or treated in the Phase 2 portion of the study. The Phase 3 analysis sets 
apply to all subjects who are randomized or treated in both the Phase 2 portion and Phase 3 
portion of the study. Additional analysis sets may be defined in the SAP. 
9.3.1. 
Intent-to-Treat Analysis Set 
The Intent-to-Treat (ITT) Analysis Set is defined as all subjects who are randomized. 
9.3.2. 
Safety Analysis Set 
The Safety Analysis Set is defined as all subjects who receive at least 1 dose of study 
treatment. 
9.3.3. 
Per Protocol Analysis Set 
The Per Protocol Analysis Set is defined as all subjects who are randomized and are without 
major protocol deviations. 
9.3.4. 
Pharmacodynamic Analysis Set 
The Pharmacodynamic Analysis Set is defined as all subjects who receive at least 1 dose of 
CMP-001 and have at least 1 measurable sample at Baseline and at least 1 evaluable 
biomarker sample after CMP-001 administration. 
9.4. 
Background Characteristics 
9.4.1. 
Disposition 
The number and percentage of subjects who screen fail, are randomized in the study, are 
treated in the study, discontinue study treatment, and who discontinue the study will be 
summarized by treatment arm. The primary reason for treatment and study discontinuation 
will also be summarized. 
Subject disposition will be presented in a by-subject data listing. 
9.4.2. 
Demographics and Other Baseline Characteristics 
Demographics and other Baseline characteristics (age, sex, race, ethnicity, body weight, 
height, and body mass index) will be summarized by treatment arm using descriptive 
statistics for the ITT Analysis Set and listed by subject. 
9.4.3. 
ECOG Performance Status 
ECOG data will be presented in a by-subject data listing. Change from Baseline in ECOG 
Performance Status will be summarized by treatment arm for the ITT Analysis Set. 
9.4.4. 
Melanoma History 
Melanoma history (time since initial diagnosis, tumor stage, nodal status, and metastatic 
disease status at time of initial diagnosis), and PD-L1 status will be summarized by treatment 
arm using descriptive statistics for the ITT Analysis Set and listed by subject. 
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9.4.5. 
Prior Cancer Treatments 
All prior melanoma treatments will be captured in the EDC separately from other prior 
medications. A summary of the number of prior lines of cancer therapy will be generated for 
the ITT Analysis Set by treatment arm. 
9.4.6. 
Medical and Surgical History 
Medical and surgical history will be listed by subject. Medical history will be coded using 
MedDRA. 
9.4.7. 
Protocol Deviations 
All protocol deviations will be captured electronically and presented in a by-subject data 
listing. All deviations will be reviewed on an ongoing basis and classified as major or minor. 
9.4.8. 
Prior and Concomitant Medications 
Prior medications are those taken within 30 days of the first dose of study treatment and 
discontinued before the first dose of study treatment. 
Concomitant medications will be assessed continually from 30 days before the first dose of 
study treatment (W1D1) through 100 days after the last dose of study treatment (both CMP- 
001 and nivolumab) or until an alternative cancer treatment is initiated, whichever occurs 
first. Treatment medications for AEs related to study treatment that occur more than 100 days 
after the last dose of study treatment will be collected. 
Medications will be coded using the World Health Organization drug dictionary and 
summarized by treatment arm according to the Anatomical Therapeutic Chemical (ATC) 
class and preferred term for each dose group for the Safety Analysis Set. Subjects will be 
counted only once for a given concomitant medication for each ATC class and preferred term 
in the summary tables. 
Concomitant medications will be presented in a by-subject data listing. 
9.5. 
Study Treatment Exposure and Compliance 
The number of CMP-001 and nivolumab doses received by each subject will be summarized 
descriptively by treatment arm for the Safety Analysis Set. The duration of each treatment, 
dose intensity, and relative dose intensity will also be summarized. 
CMP-001 dosing, including date and time of each dose, route of administration, dose 
administered, location of each injection, and the volume injected into each tumor at each 
dosing visit will be presented in a by-subject data listing. 
Nivolumab dosing, including date, time, and dose administered, will be presented in a 
by-subject data listing. 
9.6. 
Efficacy Analyses 
The efficacy analyses will be based on the ITT Analysis Set and may also be performed for 
the Per-Protocol Analysis Set if deemed appropriate. Phase 3 efficacy analyses will be 
performed based on the results of the end of Phase 2 primary endpoint results, as described in 
Figure 3. 
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Figure 3: 
Go/No-Go Decision Tree Based on End of Phase 2 Efficacy 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abbreviations: IDMC = Independent Data Monitoring Committee; ORR = objective response rate; PFS = 
progression-free survival. 
 
9.6.1. 
Confirmed Objective Response Rate 
The primary efficacy endpoint for the Phase 2 portion of the study is the confirmed ORR 
based on RECIST v1.1 as determined by BICR. 
The confirmed ORR is defined as the proportion of subjects in the analysis set who have 
confirmed best overall response (BOR) as CR or PR. The confirmed ORR will be calculated 
as the number of subjects with a confirmed CR or PR divided by the number of subjects in 
the analysis population [ORR = (confirmed CR + confirmed PR)/# subjects] in each 
treatment group for the ITT Analysis Set. 
ORR will be analyzed using a 2-sided Cochran-Mantel-Haenszel test stratified by stage and 
PD-L1 expression to compare the 2 treatment arms. Associated odds ratio and 95% CI will 
also be calculated. Additionally, ORR and the 95% exact CIs will be calculated using the 
Clopper-Pearson method for each of the 2 treatment arms. The secondary endpoint DCR and 
the 95% Clopper-Pearson CIs will be summarized as well. 
The BOR is defined as the best response designation based on RECIST v1.1 as determined by 
BICR. Subjects who discontinue due to death due to disease progression, or disease 
progression, prior to having a post-Baseline tumor assessment will be classified as having a 
best response of PD. Subjects who discontinue prior to having a post-Baseline scan for other 
reasons will be counted as non-responders in the ITT analyses. 
Objective response rate based on RECIST v1.1 as determined by BICR will be evaluated as a 
secondary endpoint in the Phase 3 portion of the study. Objective response rate per RECIST 
v1.1 and iORR per iRECIST by Investigator assessment will also be summarized. 
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9.6.2. 
Progression-Free Survival 
The primary endpoint in the Phase 3 portion of the study, PFS, will be analyzed using a 
2-sided log-rank test stratified by stage and PD-L1 expression to compare the 2 treatment 
arms. All subjects enrolled in the Phase 3 portion of the study (including subjects also treated 
in Phase 2) will be included in this analysis. HRs and corresponding 2-sided 95% CIs will be 
estimated using a Cox proportional hazards model, with treatment arm as a single covariate, 
stratified by the above factors. PFS curves, PFS medians with 95% CIs, and PFS rates at 6 
and 12 months with 95% CIs will be estimated using Kaplan-Meier methodology. 
PFS is defined as the time from date of randomization to the date of documented progressive 
disease based on RECIST v1.1 by BICR or death from any cause, whichever occurs first 
(FDA-2018). Subjects who are alive and progression-free at the time of analyses will be 
censored in the analyses. Additional censoring rules may be defined in the SAP. 
Analysis of PFS and iPFS based on RECIST v1.1 and iRECIST determined by Investigator 
assessment will also be performed. 
9.6.3. 
Overall Survival 
Overall survival will be calculated from the date of randomization to death from any cause 
(FDA-2018). Subjects who are alive at the time of analyses will be censored at the time of 
last study contact. Median OS will be calculated using the Kaplan-Meier method for each 
treatment arm OS will be analyzed using the same approach as PFS. 
9.6.4. 
Disease Control Rate 
The confirmed disease control rate is defined as the proportion of subjects in each treatment 
arm in the analysis set who have a confirmed best response of CR or PR, or SD lasting at 
least 4 months. Per RECIST v1.1, CR or PR must be confirmed by a confirmatory assessment 
performed at least 4 weeks after the initial response. In the case of stable disease, 
measurements must have met the SD criteria at least once after study entry at a minimum 
interval of 6 weeks. Disease control rate (DCR) will be analyzed in a similar manner as ORR. 
9.6.5. 
Duration of Response 
Duration of response (DOR) will be based on RECIST v1.1 as determined by BICR and 
calculated for responders. 
The DOR will be measured from the time at which criteria are first met for CR or PR 
(whichever is first recorded) until the first date that recurrence or PD is objectively 
documented (taking as reference for PD the smallest measurements recorded on study). The 
duration of overall CR is measured from the time measurement criteria are first met for CR 
until the first date that recurrent disease is objectively documented. Censoring details will be 
described in the SAP, including handling of subjects who continue to be followed for PTFU 
disease assessments. 
Duration of response (DOR) and iDOR will also be determined by Investigator assessment 
per RECIST and iRECIST. 
Duration of response (DOR) will be analyzed using the same approach as PFS. 
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9.6.7. 
Post-Progression Disease Response 
Post-progression disease assessments of tumor response based on iRECIST by Investigator 
assessment will be summarized for each treatment arm. 
 
 
 
 
 
 
 
 
9.7. 
Safety Analyses 
The assessment of safety will be based on the following assessments: AEs, clinical laboratory 
tests, vital sign measurements, ECGs, and physical examinations. 
9.7.1. 
Adverse Events 
Treatment-emergent AEs (TEAEs) will be coded using MedDRA and data will be 
summarized by treatment arm for the Safety Analysis Set. The number and percent of 
subjects reporting each TEAE will be summarized, as well as the number of TEAEs. A 
subject with 2 or more TEAEs within the same level of summarization (ie, system organ class 
[SOC] or preferred term) will be counted only once in that level using the most severe event 
or most related (for the relationship to study treatment tables). 
Additional summary tables will be generated for Grade 3 or higher TEAEs, TEAEs 
considered related to treatment (possibly, probably, or definitely), TEAEs by maximum grade 
and relationship, TEAEs resulting in death, SAEs, related SAEs, and TEAEs leading to 
treatment discontinuation. 
A by-subject AE data listing, including verbatim term, SOC, preferred term, treatment, grade, 
outcome, and relationship to treatment for CMP-001 and nivolumab, will be generated. 
Separate listings will also be generated for Grade ≥3TEAEs , TEAEs considered related to 
study treatment (possibly, probably, or definitely), TEAEs resulting in death, SAEs, and 
TEAEs leading to treatment discontinuation. 
9.7.2. 
Clinical Laboratory Assessments 
Safety central laboratory data will be summarized by treatment arm using descriptive 
statistics (mean, standard deviation, median, minimum, and maximum), and presented for 
each time point, including change from Baseline, for the Safety Analysis Set. Shift from 
Baseline tables will also be created. The categories in the shift tables will be WNL, Low, and 
High. WNL and Normal will be used when appropriate for urinalysis parameters. Clinically 
significant post-Baseline laboratory values will be reported as AEs. By-subject data listings 
of all central laboratory data will be generated and all values outside the normal range will be 
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flagged as High or Low. Listings of all clinically significant post-Baseline laboratory values 
from local and central laboratory assessments will be presented in the data listings. 
Local laboratory data will be used for subject management including safety reporting and 
dose selection. 
9.7.3. 
Vital Signs 
Vital signs will be summarized by treatment arm using descriptive statistics (mean, standard 
deviation, median, minimum, and maximum) and presented for each time point, including 
change from Baseline, for the Safety Analysis Set. Clinically significant post-Baseline vital 
sign findings will be reported as AEs. A by-subject data listing of all vital sign data will be 
generated. 
9.7.4. 
Physical Examinations 
Information on the physical examinations will be listed by subject. Clinically significant post- 
Baseline physical examination findings will be reported as AEs. 
9.7.5. 
Electrocardiograms 
Heart rate, PR interval, QRS interval, QT interval, and QTcF interval will be summarized 
using descriptive statistics (mean, standard deviation, median, minimum, and maximum) and 
presented for each time point, including change from Baseline, by treatment arm for the 
Safety Analysis Set. Clinically significant post-Baseline ECG findings will be reported as 
AEs. A by-subject data listing of all ECG data will be generated. 
9.8. 
Pharmacodynamic Analyses 
Concentrations of CXCL10 and other biomarkers will be summarized by treatment arm using 
descriptive statistics for all time points for the Pharmacodynamic Analysis Set. 
9.9. 
Exploratory Tumor Biopsy Analyses 
Tumor biopsy obtained at Baseline and specified time points during the study may be 
analyzed for protein, RNA, DNA, or other biomarkers related to TLR9, immune checkpoints, 
and potential markers of resistance or response to immunotherapy for the Pharmacodynamic 
Analysis Set. 
9.10. 
Appropriateness of Measures 
The safety assessments in this protocol (ie, physical examination, vital signs, hematology, 
serum chemistry, urinalysis, coagulation, thyroid function, AEs, and concomitant 
medications) are widely used and generally recognized as reliable, accurate, and relevant for 
a late phase oncology study. The safety assessments are adequate to protect the subjects’ 
safety. 
9.10.1. 
Blinded Independent Central Review 
Blinded Independent Central Review will be used for the primary efficacy assessments of 
tumor response. The BICR charter will be finalized before the first BICR assessment. 
Blinded Independent Central Review Committee responsibilities include confirmation of 
disease progression prior to study entry. 
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9.11. 
In-House Blinding 
Although this study is being conducted as an open-label study, in order to ensure data 
integrity, the Sponsor analysis and reporting team will be blinded to subject treatment 
assignments. 
 
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10. 
QUALITY CONTROL AND QUALITY ASSURANCE 
10.1. 
Study Monitoring 
Before an investigational site can enter a subject into the study, a representative of the 
Sponsor will determine the adequacy of the clinical facilities and discuss with the 
Investigator(s) and other site personnel their responsibilities with regard to protocol 
adherence, and the responsibilities of the Sponsor or its representatives. This will be 
documented in a Clinical Study Agreement between the Sponsor and the Investigator. 
During the study, a monitor from Sponsor or its representatives will have regular contacts 
with the investigational site, for the following: 
• Provide information and support to the Investigator(s) 
• Confirm that the facilities remain acceptable 
• Confirm that the study team is adhering to the protocol, that data are being accurately 
recorded in the eCRFs, and the study treatment is being properly maintained and 
accountability records are current 
• Perform source data verification with access to all original clinical records for each 
subject 
Additional details regarding monitoring procedures and responsibilities are provided in the 
Clinical Monitoring Plan. 
10.2. 
Case Report Forms 
Electronic Case Report Forms will be used in this study. An eCRF is required and should be 
completed for each screened (ie, subject who has signed an ICF) and enrolled subject. The 
completed eCRFs are the sole property of Checkmate Pharmaceuticals, Inc. and should not be 
made available in any form to third parties without written permission from Checkmate 
Pharmaceuticals, Inc. Limited data will be collected for Screen Failures. 
The Investigator has ultimate responsibility for the collection and reporting of all clinical, 
safety, and laboratory data entered on the eCRFs and any other data collection forms (source 
documents) and ensuring that they are accurate, authentic/original, attributable, complete, 
consistent, legible, timely (contemporaneous), enduring, and available when required. The 
eCRFs must be electronically signed by the Investigator to attest that the data contained on 
the eCRF is true. Any corrections to entries made in the source documents must be dated, 
initialed, and explained (if necessary) and should not obscure the original entry. 
In most cases, the source documents are the hospital’s or physician’s subject chart. In these 
cases, data collected on the eCRFs must match the data in those charts. 
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11. 
QUALITY CONTROL AND QUALITY ASSURANCE 
11.1. 
Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data. Such steps will include the 
selection of qualified Investigators and appropriate sites, review of protocol procedures with 
Investigators and associated personnel before study start, and periodic site monitoring visits 
by the Sponsor or its representatives. Before study initiation, Investigators and site personnel 
will receive specific training with regards to study procedures and systems as required. 
Training will include use of clinical laboratory kits and central laboratory operations. 
Data management representatives will be available to provide assistance to study center 
personnel regarding entering subject data. The Sponsor or its representatives will review data 
contained within eCRFs for accuracy and completeness during remote and/or on-site 
monitoring visits and after entry into the database. Identified discrepancies will be queried 
and resolved with the Investigator (or designee) as indicated. 
11.2. 
Quality Assurance Audits 
To ensure compliance with Good Clinical Practice (GCP) and all applicable regulatory 
requirements, the Sponsor or its representatives may also conduct a quality assurance audit. 
The purpose of a Sponsor audit or inspection is to systematically and independently examine 
all study-related activities and documents to determine whether these activities were 
conducted, and data were recorded, analyzed, and accurately reported according to the 
protocol, GCP guidelines of the ICH, and any applicable regulatory requirements. 
11.3. 
Audits and Inspections by Regulatory Authorities 
A regulatory authority or an IRB may visit the site to perform audits or inspections. The 
Investigator should contact the Sponsor immediately if contacted by a regulatory agency 
about an inspection. 
11.4. 
Retention of Records 
The Investigator must maintain all documentation relating to the study for a period of 2 years 
after a marketing application is approved for the test article, or if not approved, or if no 
application is to be filed, 2 years following the discontinuance of the test article for 
investigation (21 CFR 312.6I). If it becomes necessary for the Sponsor or a Regulatory 
Authority to review any documentation relating to the study, the Investigator must permit 
access to such records. 
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12. 
ETHICS 
12.1. 
Ethics Review 
The final study protocol, including the final version of the Informed Consent Form, must be 
approved or given a favorable opinion in writing by an IRB or Independent Ethics Committee 
(IEC) as appropriate. The Investigator must submit written approval to the Sponsor or its 
representatives before he or she can enroll any subject into the study. Initial IRB approval and 
all materials approved by the IRB for this study, including the ICF and recruitment materials, 
must be maintained by the Investigator and made available for inspection. 
The Principal Investigator is responsible for informing the IRB or IEC of any amendment to 
the protocol in accordance with local requirements. No changes will be made in the study 
without IRB approval, except when required to eliminate apparent immediate hazards to 
human subjects. In addition, the IRB or IEC must approve all advertising used to recruit 
subjects for the study. The protocol must be reapproved by the IRB or IEC upon receipt of 
amendments and annually, as local regulations require. 
The Principal Investigator is also responsible for providing the IRB with reports of any 
reportable serious adverse drug reactions from any other study conducted with CMP-001 
study treatment. The Sponsor or its representatives will provide this information to the 
Principal Investigator. 
Progress reports and notifications of serious adverse drug reactions will be provided to the 
IRB or IEC according to local regulations and guidelines. 
Notification of the End of Clinical Trial will be sent to the IRB within 90 days after 
completion of follow-up for the last subject or per local regulations and guidelines. 
In the event the study is ended prematurely, the IRB will be notified within 15 days or per 
local regulations and guidelines, including the reasons for the premature termination. 
The Clinical Study Report will be sent to the sites and IRB where appropriate per local 
regulations and guidance, within 1 year after the End of Clinical Trial. 
12.2. 
Ethical Conduct of the Study 
This study will be conducted in compliance with the protocol and in accordance with current 
US FDA regulations. This study is also designed to comply with ICH E6 Guideline for GCP 
(CPMP/ICH/135/95), the European Union Clinical Trials Directive 2001/20/EC, as well as 
the ethical principles that have their origin in the Declaration of Helsinki, adopted by the 18th 
World Medical Assembly Helsinki, Finland, June 1964 and subsequent amendments. 
12.3. 
Written Informed Consent 
The ICF should be written in accordance with the current revision of the Declaration of 
Helsinki and current ICH and GCP guidelines. The Sponsor or its representatives will provide 
template ICF to the Investigator. The final ICF must be approved by the Sponsor or its 
representatives prior to being reviewed and approved by the IRB. The final IRB approved 
ICF must be provided to the Sponsor or its representatives for regulatory purposes. 
The Investigator will ensure that the subject is given full and adequate oral and written 
information about the nature, purpose, possible risk and benefit of the study. Subjects must 
also be notified that they are free to discontinue from the study at any time. The subject 
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should be given the opportunity to ask questions and allowed time to consider the information 
provided. 
Each subject must provide voluntary written informed consent (and sign other locally 
required documents) according to local requirements after the nature of the study has been 
fully explained. Each subject must sign an ICF before any study-related activities are 
performed and before participation in the study. A copy of the signed ICF must be provided 
to the subject, and the original signed ICF must remain in each subject’s study file and must 
be available for verification by the study monitor at any time. The Investigator will also 
ensure each subject follows the proper re-consenting procedures for all applicable or 
additional versions of the ICF that become effective while they are enrolled in the study. 
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13. 
PUBLICATION POLICY 
All information concerning CMP-001, Sponsor operations, patent application, formulas, 
manufacturing processes, basic scientific data, and formulation information, supplied by the 
Sponsor or its representatives to the Investigator and not previously published, is confidential 
and remains the sole property of the Sponsor. The Investigator agrees to use this information 
only to complete this study and not for other purposes without the Sponsor’s written consent. 
The institution and Investigator understand that the information developed in this study will 
be used by the Sponsor in connection with the continued development of CMP-001, and thus 
may be disclosed as required to other Investigators, government regulatory agencies, or other 
scientific groups. To permit the information derived from this study to be used, the 
Investigator is obligated to provide the Sponsor with all data obtained in the study. 
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14. 
LIST OF REFERENCES 
Ahmed FS, Dercle L, Goldmacher GV, et al. Comparing RECIST 1.1 and iRECIST in 
advanced melanoma patients treated with pembrolizumab in a phase II clinical trial. Eur 
Radiol. 2020 Sep 30; online ahead of print. 
AJCC Cancer Staging Manual (8th edition). Springer International Publishing: American 
Joint Commission on Cancer. 2017. 
Appay V, Jandus C, Voelter V, et al. New generation vaccine induces effective melanoma- 
specific CD8+ T cells in the circulation but not in the tumor site. J Immunol. 
2006;177(3):1670-1678. 
Brahmer J, et al. Five-year follow-up from the CA209-003 study of nivolumab in previously 
treated advanced non-small cell lung cancer: clinical characteristics of long-term survivors. 
Oral presentation presented at: American Association for Cancer Research (AACR) Annual 
Meeting.,; Washington, DC, USA. 2017 April 1-5. 
Chen DS, Mellman I. Oncology meets immunology: the cancer-immunity cycle. Immunity. 
2013;39(1):1-10. 
Common Terminology Criteria for Adverse Events (CTCAE) v5.0; 
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick 
_Reference_5x7.pdf. Publish date Version 5.0 2017 November 27. 
Davar D, Karunamurthy A, Hartman D, et al. Phase II trial of neoadjuvant nivolumab (Nivo) 
and intra-tumoral (IT) CMP-001 in high-risk resectable melanoma (Neo-C-Nivo): final 
results. Presented at: Society for Immunotherapy of Cancer 2020 Virtual Meeting. 2020 
November 10-15. 
Demoulin S, Herfs M, Delvenne P, Hubert P. Tumor microenvironment converts 
plasmacytoid dendritic cells into immunosuppressive/tolerogenic cells: insight into the 
molecular mechanisms. J Leukoc Biol. 2013;93:343-352. 
Duraiswamy J, Freeman GJ, Coukos G. Therapeutic PD-1 pathway blockade augments with 
other modalities of immunotherapy T-cell function to prevent immune decline in ovarian 
cancer. Cancer Res. 2013;73(23):6900-12. 
Food and Drug Administration (FDA). Guidance for Industry: Clinical Trial Endpoints for 
the Approval of Cancer Drugs and Biologics. 2018. Available from: 
https://www.fda.gov/media/71195/download. 
Felip E, et al. Three-year follow-up from Checkmate 017/057: Nivolumab versus docetaxel in 
patients with previously treated advanced non-small lung cancer (NSCLC). Poster discussion 
presentation at the European Society of Medical Oncology Annual Meeting. 2017 Sep 8-12; 
Madrid, Spain. Poster 1301PD 
Fourcade J, Sun Z, Pagliano O, et al. PD-1 and Tim-3 regulate the expansion of tumor 
antigen-specific CD8+ T cells induced by melanoma vaccines. Cancer Res. 2014;74(4):1045- 
55. 
Goldmacher GV, Khilnani AD, Andtbacka RHI, et al. Response Criteria for Intratumoral 
Immunotherapy in Solid Tumors: itRECIST. J Clin Oncol. 2020;38(23):2667-2676. 
Heckelsmiller K, Rall K, Beck S, et al. Peritumoral CpG DNA elicits a coordinated response 
of CD8 T cells and innate effectors to cure established tumors in a murine colon carcinoma 
model. J Immunol. 2002;169:3892–3899. 
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International Council for Harmonisation of Technical Requirements for Pharmaceuticals for 
Human Use (ICH). Integrated Addendum to ICH E6(R1): Guideline for Good Clinical 
Practice E6(R2). Available from: 
https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf 
KEYTRUDA® United States Prescribing Information: Merck & Co., Inc. Available 
from:https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125514s066lbl.pdf. 
Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Five-Year Survival with Combined 
Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2019;381(16):1535- 
1546. 
Lee DW, Gardner R, Porter DL, et al. Current concepts in the diagnosis and management of 
cytokine release syndrome. Blood. 2014;124(2):188-195. 
Lemke-Miltner CD, Blackwell SE, Yin C, et al. Antibody opsonization of a TRL9 agonist- 
containing virus-like particle enhances in situ immunization. J Immunol. 2020;204(5):1386- 
1394. 
Lombardi VC, Khaiboullina SF, Rizvanov AA. Plasmacytoid dendritic cells, a role in 
neoplastic prevention and progression. Eur J Clin Invest. 2015;45 Suppl 1:1-8. 
Milhem M, Zakharia Y, Davar D, et al. Intratumoral injection of CMP-001, a Toll-like 
receptor 9 (TLR9) agonist, in combination with pembrolizumab reversed programmed death 
receptor 1 (PD-1) blockade resistance in advanced melanoma. Presented at: Society for 
Immunotherapy of Cancer 2020 Virtual Meeting. 2020 November 10-15. 
Mangsbo SM, Sandin LC, Anger K, Korman AJ, Loskog A, Tötterman TH. Enhanced tumor 
eradication by combining CTLA-4 or PD-1 blockade with CpG therapy. J Immunother. 
2010;33(3):225-235. 
NCCN Clinical Practice Guidelines in Oncology. National Comprehensive Cancer Network 
(NCCN). Cutaneous Melanoma. Version 1 2020. 
Nivolumab (OPDIVO, BMS-936558) Investigator’s Brochure version 19, dated 29 June 2020 
and Addendum No. 01 to Investigator Brochure Version 19, dated 29 June 2020. Bristol- 
Myers Squibb Company. Princeton, NJ USA. 
Oken M, Creech RH, Tormey DC, et al. Toxicity and response criteria of the eastern 
cooperative oncology group. Am J Clin Oncol. (CCT) 1982; 5:649-655. 
OPDIVOTM Annex I Summary of Product Characteristics. Bristol-Myers Squibb Company. 
2020. 
Power Analysis & Sample Size (PASS) software. Version 20.0.1. NCSS; 2020. 
Schadendorf D, Wolchok, JD, Hodi, FS, et al. Efficacy and Safety Outcomes in Patients With 
Advanced Melanoma Who Discontinued Treatment With Nivolumab and Ipilimumab 
Because of Adverse Events: A Pooled Analysis of Randomized Phase II and III Trials. J Clin 
Oncol. 2017;35(34): 3807-3814. 
Schadendorf D, Hodi FS, Robert C, et al. Pooled Analysis of Long-Term Survival Data from 
Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin 
Oncol. 2015;33(17): 1889-1894. 
Shirota Y, Shirota H, Klinman DM. Intratumoral injection of CpG oligonucleotides induces 
the differentiation and reduces the immunosuppressive activity of myeloid-derived 
suppressor cells. J Immunol. 2012 Feb 15;188(4):1592-1599. 
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Spigel DR, et al. Randomized results of continuous vs 1-year fixed-duration in patients with 
advanced non-small cell lung cancer. Oral presentation at the European Society of Medical 
Oncology Annual Meeting. 2017 Sep 8-12; Madrid, Spain. 
Swiecki M, Colonna M. The multifaceted biology of plasmacytoid dendritic cells. Nat Rev 
Immunol. 2015;15(8):471-485. 
Wang S, Campos J, Gallotta M, Gong M, Crain C, Naik E, et al. Intratumoral injection of a 
CpG oligonucleotide reverts resistance to PD-1 blockade by expanding multifunctional CD8+ 
T cells. Proc Natl Acad Sci U S A. 2016;113(46):E7240-E7249. 
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15. 
APPENDICES 
 
 
 
 
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APPENDIX A.  ECOG PERFORMANCE STATUS 
 
Grade 
Eastern Cooperative Oncology Group (ECOG)a 
0 
Fully active, able to carry on all predisease-performance without restriction. 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out 
work of a light or sedentary nature, eg, light housework, office work. 
2 
Ambulatory and capable of all selfcare but unable to carry out any work 
activities. Up and about more than 50% of waking hours. 
3 
Capable of only limited selfcare, confined to bed or chair more than 50% of 
waking hours. 
4 
Completely disabled. Cannot carry on any selfcare. Totally confined to bed or 
chair. 
5 
Death 
a Oken-1982 
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APPENDIX B. APPROXIMATE MAXIMUM AMOUNT OF BLOOD 
DRAWN FOR ONE YEAR OF STUDY 
PARTICIPATION 
 
Study Phase 
Estimated Blood Volume 
Screening/Baseline 
35 mL 
Weekly Dosing 
(7 doses every week) 
245 mL 
Q3 Week Visits 
(~15 visits over 1 year) 
375 mL 
End of Treatment 
35 mL 
Total Blood Volume Estimate for 1 year of 
study participation 
690 mL 
(approximately 2.9 cups) 
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APPENDIX C. COMMON TERMINOLOGY CRITERIA FOR 
ADVERSE EVENTS (CTCAE) VERSION 5.0 
Common Terminology Criteria for Adverse Events Terms 
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), 
symptom, or disease temporally associated with the use of a medical treatment or procedure 
that may or may not be considered related to the medical treatment or procedure. An AE is a 
term that is a unique representation of a specific event used for medical documentation and 
scientific analyses. Each CTCAE version 5.0 term is a MedDRA Lowest Level Term. 
Definitions 
A brief definition is provided to clarify the meaning of each AE term. A single dash (-) 
indicates a definition is not available. Grade refers to the severity of the AE. The CTCAE 
displays Grade 1 to Grade 5 with unique clinical descriptions of severity for each AE based 
on this general guideline: 
• Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic 
observations only; intervention not indicated. 
• Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting 
age-appropriate instrumental activities of daily living (ADL)*. 
• Grade 3 Severe or medically significant but not immediately life threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting 
selfcare ADL**. 
• Grade 4 Life-threatening consequences; urgent intervention indicated. 
• Grade 5 Death related to AE. 
A Semi-colon indicates “or” within the description of the grade. 
A single dash (-) indicates a grade is not available. Not all Grades are appropriate for all AEs. 
Therefore, some AEs are listed with fewer than 5options for Grade selection. 
Activities of Daily Living (ADL) 
*Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the 
telephone, managing money, etc. 
**Selfcare ADL refer to bathing, dressing and undressing, feeding self, using the toilet, 
taking medications, and not bedridden. 
*Version 5.0 Publish date 27 November 2017 (v5.0: 27 November 2017) 
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick 
_Reference_8.5x11.pdf 
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APPENDIX D. RESPONSE EVALUATION CRITERIA IN SOLID 
TUMORS (RECIST) VERSION 1.1 
Response criteria were adapted from: RECIST Criteria; Version 1.1, 2009 
(http://www.eortc.be/Recist/documents/RECISTGuidelines.pdf). These criteria are provided 
as reference; any discrepancy should be resolved by consulting the original publication. 
Assessment of Overall Tumor Burden and Measurable Disease 
To assess objective response, it is necessary to estimate the overall tumor burden at Baseline 
and use this as a comparator for subsequent measurements. Only subjects with measurable 
disease at Baseline should be included in protocols where objective tumor response is an 
endpoint. Measurable disease is defined by the presence of at least 1 measurable lesion. 
A measurable lesion is defined as one that can be accurately measured in at least 1 dimension 
(longest diameter in the plane of measurement is to be recorded) with a minimum size of: 
• 1 cm by CT scan (CT scan slice thickness no greater than 0.5 cm) 
• 1 cm caliper measurement by clinical examination (lesions which cannot be 
accurately measured with calipers should be recorded as non-measurable) 
• 2 cm by chest x-ray 
Non-measurable lesions are defined as all other lesions, included small lesions (longest 
diameter <1.0 cm or pathological lymph nodes with ≥10 to <1.5 cm short axis) as well as 
truly non-measurable lesions. Lesions considered truly non-measurable include: 
leptomeningeal disease, ascites, pleural or pericardial effusion, inflammatory breast disease, 
lymphangitic involvement of skin or lung, abdominal masses/abdominal organomegaly 
identified by physical examination that is not measurable by reproducible imaging 
techniques. 
Special considerations regarding lesion measurability: 
Bone lesions: 
Bone scan, PET scan, or plain films are not considered adequate imaging techniques to 
measure bone lesions. However, these techniques can be used to confirm the presence or 
disappearance of bone lesions. Lytic bone lesions or mixed lytic-blastic lesions, with 
identifiable soft tissue components, that can be evaluated by cross sectional imaging 
techniques such as contrast-enhanced CT or MRI can be conserved as measurable lesions if 
the soft tissue component meets the definition of measurability described above. Blastic bone 
lesions are non-measurable. 
Cystic lesions: 
Lesions that meet the criteria for radiographically defined simple cysts should not be 
considered as malignant lesions (neither measurable nor non-measurable) since they are, by 
definition, simple cysts. ‘Cystic lesions’ thought to represent cystic metastases can be 
considered as measurable lesions, if they meet the definition of measurability described 
above. However, if non-cystic lesions are present in the same subject, these are preferred for 
selection as target lesions. 
Lesions with prior local treatment: 
Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco- 
regional therapy, are usually not considered measurable unless there has been demonstrated 
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progression in the lesion. 
Baseline Documentation of Target and Non-Target Lesions 
Baseline documentation of tumor sites may include imaging assessment of disease in the 
chest, abdomen, and pelvis. A Baseline CNS image is required for all subjects within 3 
months of Screening. All Baseline tumor measurements must be documented within 4 weeks 
prior to start of therapy. 
Target Lesions 
All measurable lesions up to a maximum of 5 lesions total (and a maximum of 2 lesions per 
organ) representative of all involved organs should be identified as target lesions and will be 
recorded and measured at Baseline (this means in instances where subjects have only 1 or 2 
organ sites involved a maximum of 2 and 4 lesions respectively will be recorded). Target 
lesions should be selected on the basis of their size (lesions with the longest diameter), be 
representative of all involved organs, but in addition should be those that lend themselves to 
reproducible repeated measurements. It may be the case that, on occasion, the largest lesion 
does not lend itself to reproducible measurement in which circumstance the next largest 
lesion that can be measured reproducibility should be selected. A sum of the diameters 
(longest for non-nodal lesions, short axis for nodal lesions) for all target lesions will be 
calculated and reported as the Baseline sum diameters. If lymph nodes are to be included in 
the sum, then as noted above, only the short axis is added into the sum. The Baseline sum 
diameters will be used as reference to further characterize any objective tumor regression in 
the measurable dimension of the disease. 
Non-Target Lesions 
All other lesions (or sites of disease) including pathological lymph nodes should be identified 
as non-target lesions and should also be recorded at Baseline. Measurements are not required, 
and these lesions should be followed as ‘present,’ ‘absent,’ or in rare cases ‘unequivocal 
progression.’ In addition, it is possible to record multiple non-target lesions involving the 
same organ as a single item on the case record form (ie, ‘multiple enlarged pelvic lymph 
nodes’ or ‘multiple liver metastases’). 
Tumor Response Criteria 
Evaluation of Target Lesions 
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes 
(whether target or non-target) must have reduction in short axis to < 1 cm. 
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, 
taking as reference the Baseline sum diameters. 
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, 
taking as reference the smallest sum on study (this includes the Baseline sum if that is the 
smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate 
an absolute increase of at least 0.5 cm (Note: the appearance of 1 or more new lesions is also 
considered progression). 
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to 
qualify for PD, taking as reference the smallest sum diameters while on study. 
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Evaluation of Non-Target Lesions 
Complete Response (CR): Disappearance of all non-target lesions and normalization of tumor 
marker level. All lymph nodes must be non-pathological in size (< 1 cm short axis). 
Non-complete response/Non-progressive disease: Persistence of 1 or more non-target 
lesion(s) and/or maintenance of tumor marker level above the normal limits. 
Progressive Disease (PD): Unequivocal progression of existing non-target lesions. (Note: the 
appearance of 1 or more new lesions is also considered progression). 
Evaluation of Best Overall Response 
The BOR recorded from the start of the study treatment until the End of Clinical Trial taking 
into account any requirement for confirmation. The subject’s BOR assignment will depend 
on the findings of both target and non-target disease and will also take into consideration the 
appearance of new lesions. In non-randomized trials where response is the primary endpoint, 
confirmation of PR or CR is needed to deem either one the ‘BOR.’ 
Determination of Tumor Response 
 
Target Lesions 
Non-Target Lesions 
New Lesions 
Response Assessment 
CR 
CR 
No 
CR 
CR 
Non-CR/Non-PD 
No 
PR 
CR 
Not Evaluated 
No 
PR 
PR 
Non-PD or Not All 
Evaluated 
No 
PR 
SD 
Non-PD or Not All 
Evaluated 
No 
SD 
Not All Evaluated 
Non-PD 
No 
NE 
PD 
Any 
Yes or No 
PD 
Any 
PD 
Yes or No 
PD 
Any 
Any 
Yes 
PD 
CR = complete response, PR = partial response, SD = stable disease, PD = progressive disease, NE = 
inevaluable. 
Note: Subjects with a global deterioration of health status, requiring discontinuation of 
treatment without objective evidence of disease progression at that time, should be reported 
as “symptomatic deterioration.” Every effort should be made to document the objective 
progression, even after discontinuation of treatment. Conditions that may define “early 
progression, early death, and inevaluability” are study-specific and should be clearly defined 
in each protocol (depending on treatment duration and treatment periodicity). In some 
circumstances it may be difficult to distinguish residual disease from normal tissue. When the 
evaluation of CR depends upon this determination, it is recommended that the residual lesion 
be investigated (fine needle aspiration/biopsy) before confirming the CR status. 
Best Overall Response When Confirmation of CR or PR Are Required 
When confirmation of response is required, complete or partial responses may be claimed 
only if the criteria for each are met at a subsequent time point as speciﬁed in the protocol 
(generally 4 weeks later). 
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Confirmation of CR and PR 
Overall Response 
First Time Point 
Overall Response 
Subsequent Time Point 
BEST Overall Response 
CR 
CR 
CR 
CR 
PR 
SD, PD, or PRa 
CR 
SD 
SD provided minimum criteria for SD duration met, otherwise PD 
CR 
PD 
SD provided minimum criteria for SD duration met, otherwise PD 
CR 
NE 
SD provided minimum criteria for SD duration met, otherwise NE 
PR 
CR 
PR 
PR 
PR 
PR 
PR 
SD 
SD 
PR 
PD 
SD provided minimum criteria for SD duration met, otherwise PD 
PR 
NE 
SD provided minimum criteria for SD duration met, otherwise NE 
NE 
NE 
NE 
Abbreviations: CR = complete response; PR = partial response; SD = stable disease; PD = progressive disease; 
NE = inevaluable 
a If a CR is truly met at the first time point, any disease seen at a subsequent time point, even disease meeting 
PR criteria relative to Baseline, makes the disease PD at that time point (because disease must have reappeared 
after CR). Best response would depend on whether minimum duration for SD was met. However, “CR” may 
be claimed when subsequent scans suggest small lesions were likely still present and in fact the subject had 
PR, not CR at the first time point. Under these circumstances, the original CR should be changed to PR and 
the best response PR. 
Guidelines for Evaluation of Measurable Disease 
All measurements should be recorded in metric notation using a ruler or calipers. All 
Baseline evaluations should be performed as close as possible to the treatment start and never 
more than 4 weeks before the beginning of treatment. 
Note: Tumor lesions in a previously irradiated area are not optimally considered measurable 
disease. If the Investigator thinks it appropriate to include them, the conditions under which 
such lesions should be considered must be defined in the protocol. 
The same method of assessment and the same technique should be used to characterize each 
identified and reported lesion at Baseline and during follow-up. Imaging based evaluation 
should always be done rather than clinical examination unless the lesion(s) being followed 
cannot be imaged but are assessable by clinical examination. 
Clinical lesions will only be considered measurable when they are superficial and 1 cm 
diameter as assessed using calipers (ie, skin nodules). For the case of skin lesions, 
documentation by color photography including a ruler to estimate the size of the lesion is 
suggested. 
For chest lesions, chest CT is preferred over chest x-ray, particularly when progression is an 
important endpoint, since CT is more sensitive than x-ray, particularly in identifying new 
lesions. However, lesions on chest x-ray may be considered measurable if they are clearly 
defined and surrounded by aerated lung. 
Cross Sectional Imaging: CT is the best currently available and reproducible method to 
measure lesions selected for response assessment. This guideline has defined measurability of 
lesions on CT scan based on the assumption that CT slice thickness is 0.5 cm or less. When 
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CT scans have slice thickness greater than 0.5 cm, the minimum size for a measurable lesion 
should be twice the slice thickness. MRI is also acceptable in certain situations (ie, for body 
scans). 
Ultrasound is not useful in assessment of lesion size and should not be used as a method of 
measurement. If new lesions are identified by ultrasound in the course of the study, 
confirmation by contrast-enhanced CT or MRI is advised. If there is concern about radiation 
exposure at CT, MRI may be used instead of CT in selected instances. 
Duration of Overall Response 
The duration of overall response is measured from the time measurement criteria are first met 
for CR/PR (whichever is first recorded) until the first date that recurrent or PD is objectively 
documented (taking as reference for PD the smallest measurements recorded on study). The 
duration of overall CR is measured from the time measurement criteria are first met for CR 
until the first date that recurrent disease is objectively documented. 
Duration of Stable Disease 
Stable disease (SD) is measured from the start of the treatment until the criteria for 
progression are met, taking as reference the smallest sum on study (if the Baseline sum is the 
smallest, this is the reference for calculation of PD). 
Time to Disease Progression 
Defined as the time from the date of first day of enrollment to progression as assessed by the 
conventional response criteria, death, or the start of further antitumor therapy. Subjects lost to 
follow-up will be censored at their last known alive date. 
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APPENDIX E. IMMUNOTHERAPY RESPONSE EVALUATION 
CRITERIA IN SOLID TUMORS (IRECIST) 
Response criteria were adapted from: Response Evaluation Criteria in Solid Tumors 
(RECIST) for use in trials testing immunotherapeutics; published in final edited form as: 
Lancet Oncol. 2017 March; 18(3): e143–e152. doi:10.1016/S1470-2045(17)30074-8. These 
criteria are provided as reference; any discrepancy should be resolved by consulting the 
original publication. 
iRECIST 
The basic principles of defining tumor lesions as measurable or non-measurable and 
assessing tumor responses used in iRECIST remain unchanged from RECIST v1.1. The most 
important change is in the introduction of an additional follow-up to confirm or withdraw an 
‘unconfirmed’ tumor progression after initial increase in size. Similar to RECIST v1.1, 
iRECIST is primarily based on the use of contrast-enhanced CT and MRI, while inclusion of 
clinically visible superficial lesions in malignant melanoma is possible as well. 
Baseline Evaluation 
At Baseline, iRECIST is used similarly to RECIST v1.1 to determine the total tumor burden 
by defining target and non-target lesions. For that purpose, a distinction is made between 
measurable and non-measurable lesions (target lesions and non-target lesions). 
Target Lesions 
All measurable solid tumor manifestations with a minimum long axis diameter 
(LAD) ≥10 mm (or at least double slice thickness), nodal lesions with a short axis diameter 
(SAD) ≥15 mm and clinical measurements of superficially localized tumor lesions ≥ 10 mm 
(documented photographically using a tape measure) can be defined as target lesions. 
Of these potential target lesions, analogous to RECIST v1.1, up to 5 lesions per subject, can 
be determined within iRECIST, of which a maximum of 2 lesions per organ can be defined as 
target lesions. Paired organs, such as lung or kidneys, and organ systems, such as the skeletal 
or lymphatic systems, are understood as an organ group for which a maximum of 2 target 
lesions can be defined. The individual quantitative measurement results of the selected target 
lesions are noted and documented as a Baseline target sum. This Baseline sum diameters are 
used as reference to further characterize any objective tumor regression or progression in the 
measurable dimension of the disease. 
Non-Target Lesions 
Non-target lesions are lesions that may not be measured with a sufficient amount of 
reproducibility, eg, solid tumor lesions <10 mm, lymph node metastases with a SAD ranging 
between 10 and 14 mm and tumor manifestations without clear borders like infiltrative organ 
metastases, lymphangitis carcinomatosa, or lesions with highly variable distribution patterns, 
such as malignant pleural and pericardial effusion or ascites. In addition to these non-target 
lesions, all other potential measurable target lesions that have not been selected for the 
category target lesion are also added to the non-target lesion category. 
Several tumor lesions of one organ could be combined into one organ group, such as 
‘multiple lung metastases’ or ‘diffuse liver metastasis.’ Non-target lesions are qualitatively 
documented as ‘present’ and do not require a specific indication of quantitative size or 
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absolute number. This procedure is intended to warrant complete lesion documentation in 
case of uncountable metastases. 
Bone and Cystic Lesions 
According to RECIST v1.1, there are specific recommendations regarding bone lesions, 
cystic lesions, and lesions previously treated with local therapy. First, osteolytic bone lesions 
or mixed lytic-blastic lesions with a measurable soft tissue component ≥10 mm could be 
considered as target lesions. However, osteoblastic bone lesions represent non-target lesions. 
Second, cystic metastatic lesions ≥10 mm could be considered as target lesions. However, if 
non-cystic target lesions are present in the same subject, these should be preferred. Finally, 
lesions with prior local treatment, eg, radiation therapy or biopsy, should usually not be 
considered as target lesions unless there has been demonstrated clear tumor progression 
afterwards. 
Follow-up 
Regular follow-up response assessment every 6 to 12 weeks is recommended for iRECIST. 
During iRECIST follow-up monitoring, in line with RECIST v1.1, all target lesions defined 
at Baseline must be quantitatively remeasured and all non-target lesions must be qualitatively 
re-evaluated. The measurement of the maximum diameter of the target lesion at the new 
follow-up is independent of the previous direction of the measurement within the lesion or 
slice position, but always in identical slice orientation. In case a target lesion is reported as 
too small to measure but still visible, a default value of 5 mm could be used. In the rare case 
if a target lesion splits into 2 separate lesions, the separate measurements of the lesions 
should be added together for the target lesion sum. In case target lesions coalesce and are 
radiologically no longer separable, the maximum longest diameter for the coalesced lesion 
should be provided and the other lesion should be noted with 0 mm. Lymph node metastases 
are handled specifically. Even under a highly effective treatment in most cases they will 
never fully disappear and will only shrink to their physiological size. Lymph nodes are 
considered as tumor free once their SAD is <10 mm, but the measurements should be 
recorded in all subsequent follow-ups in order not to overstate progression in case of a minor 
increase in size, eg, from 9 mm to 11 mm. This means that when lymph node metastases are 
target lesions, the tumor burden will mostly not become ‘zero’ even in the case of a CR. 
Please notice that a target lesion defined at Baseline assessment always remains a target 
lesion, even if it shows a size reduction to less than 10 mm. Similarly, non-target lesions 
yielding a size increase of more than 10 mm at follow-up remains a non-target lesion but 
could qualify for ‘unequivocal progression’ in case of an overall level of substantial 
worsening in non-target disease. 
With regards to the measurable target lesion, the proportional change of the sum of the target 
lesions can be calculated with the formula: Change in (%) = ([∑Follow-up - ∑Baseline/ 
∑Nadir]/ ∑Baseline/ ∑Nadir) * 100. Taking as reference the smallest target sum in the study, 
so called Nadir, which could be the Baseline target sum if that is the smallest sum in the 
study. 
Non-target lesions are assessed qualitatively, ie, visually, as either ‘present,’ ‘disappeared,’ or 
‘unequivocal progression.’ When considering determining an ‘unequivocal progression’ of 
non-target lesions, the total tumor load should always be taken into account in proportion and 
carefully weighed, as this would necessarily imply classification of ‘PD,’ even if all other 
lesions have responded strongly or even completely. In case of doubt, the responsible 
oncologist should be consulted. 
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In contrast to RECIST v1.1, where new tumor lesions are considered qualitatively and 
directly denote ‘PD’ and end of study, within iRECIST, they are differentiated into new 
measurable and non-measurable lesions. Although new tumor lesions within iRECIST will 
also be classified as tumor progression, this progression initially counts as an immune 
unconfirmed progressive disease (iUPD), which should be re-assessed in a dedicated earlier 
follow-up after 4 to 8 weeks. For classification as new measurable or non-measurable tumor 
lesions, criteria applied are the same as for the Baseline examination with a maximum of 5 
measurable new target lesions per subject and 2 per organ, respectively, which are measured 
as a separate group at the time of the first occurrence while the sum product of all new 
measurable target lesions is determined. The new non-measurable lesions are documented 
qualitatively similarly to the non-target lesions at Baseline. Tumor lesions diagnosed for the 
first time in a previously unexamined body region are also classified as ‘new lesions’ in line 
with RECIST v1.1. The rationale behind this procedure is that the extension of imaging to a 
previously unexamined region, which leads to the detection of new tumor lesions, is usually 
triggered by the occurrence of new clinical symptoms. 
In case of a new unclear lesion, eg, because of its small size, this lesion should be preferably 
noted as a ‘finding,’ therapy should be continued, and follow-up evaluation could clarify if it 
represents truly new disease. If repeat examination confirms a new tumor lesion, then 
progression should be declared using the date of the initial scan when the lesion was first 
detected. 
Tumor Response Criteria 
The overall response according to iRECIST results from the combination of changes in target 
lesions and non-target lesions, as well as the possible detection and change of new 
measurable and non-measurable tumor lesions. The objective response in the context of 
immunotherapy (with the prefix ‘i’ for immune-related) is differentiated into: 
• Immune complete response, which describes the complete disappearance of target 
lesions and non-target lesion. All lymph nodes must be non-pathological in size 
(<10 mm in SAD). 
• Immune partial response, which occurs when the tumor load of the target lesion is 
reduced by ≥30% compared to the Baseline, or in the case of complete remission 
of the target lesion, when 1 or more non-target lesion can still be distinguished. 
• Immune stable disease (iSD), which is to be determined if the criteria of iCR or 
iPR are not met and no tumor progression is present. 
In case of a tumor progression, and in order to facilitate differentiation of true tumor 
progression from pseudoprogression in clinically stable subjects, iRECIST proposes to 
determine first: 
• Unconfirmed progressive disease due to an increase in the sum of all target lesions 
by ≥20% (but at least ≥5 mm) compared to the time point with the lowest target 
lesion sum (nadir), or an unequivocal progression of non-target lesions, or by the 
occurrence of new measurable and/or non-measurable tumor lesions. 
• This initially unconfirmed tumor progression might be confirmed by a subsequent 
follow-up where: 
- 
Immune confirmed progressive disease is present if further progress of 
the target sum (≥ 5mm), or any further progress of the non-target lesion, 
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and/or progress of the new measurable and not measurable lesions either 
in number or in size (sum ≥ 5mm). 
In case of iUPD, the follow-up for re-evaluation and diagnosis of potential pseudoprogression 
should be carried out earlier, after 4 to 8 weeks, in contrast to the regularly recommended 
time interval of 6 to 12 weeks. In case tumor progression is not confirmed and target lesions, 
non-target lesions, and new lesions remain unchanged, iUPD status should be kept and 
subsequent follow-up should be performed according to the regular schedule, eg, after 8, 16, 
and 24 weeks. Moreover, if the tumor burden decreases more than 20%, this should be 
considered iSD; if it decreases more than 30%, this should be considered iPR. If tumor 
lesions completely disappear, there is iCR even after iUPD. 
However, in iRECIST it is clearly recommended to carefully consider the continuation of 
immunotherapy at the first stage of iUPD. This decision should be thoroughly discussed with 
both subject and referring physicians and made only in case of subjective stable tumor 
disease or clinically suspected pseudoprogression. New lesions in a potentially curative 
therapy approach could be biopsied in order to enable a more reliable differentiation of rare 
pseudoprogression from more frequent PD and to be able to initiate an early modification of 
the tumor therapy before the subject may no longer tolerate it due to a physical deterioration. 
In the case that a biopsy is not technically feasible or only feasible with a significantly 
increased risk, the confirmation of the less probable delayed therapy response can be 
represented by a follow-up after 4 to 8 weeks in subjectively stable tumor subjects during this 
period. 
According to RECIST v1.1, the RECIST working group did not believe that there was 
sufficient data available to recommend implementation of metabolic and/or functional 
imaging response parameters. An exception is the use of fluorodeoxyglucose PET imaging as 
an adjunct to determination of progression if a positive fluorodeoxyglucose PET at follow-up 
corresponds to a new site of disease confirmed by CT. However, the actual literature does not 
support the non-invasive differentiation of true progression from pseudoprogression by 
PET/CT. 
Evaluation of Best Overall Response 
For iRECIST, the BOR is the best time point response recorded from the start of 
immunotherapy until the end of treatment. Immune UPD will not override a subsequent BOR 
of iSD, iPR, or iCR. 
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APPENDIX G. CMP-001 INJECTION GUIDELINE 
Syringe size is at the discretion of the Investigator or qualified designated staff for 
administering the CMP-001 study drug according to institutional guidelines or SOPs. Refer to 
the current Pharmacy Manual for additional information. 
Method of CMP-001 Administration 
Intratumoral Injection 
Using standard aseptic technique, the needle should be inserted near the tumor periphery 
(Figure 4 left panel) and advanced into the tumor to the desired depth while maintaining 
gentle backward pressure on the syringe plunger to confirm an extravascular location of the 
needle tip. The syringe and needle should be slowly withdrawn to within a few millimeters of 
the skin or tumor surface while maintaining gentle downward pressure on the plunger to 
inject the desired volume of CMP-001 along the needle track (Figure 4 middle panel). 
With the tip of the needle still under the skin, the syringe should be rotated by approximately 
20 o to 40o and the process of insertion and injection during needle withdrawal repeated 
(Figure 4 right panel). Using this process, CMP-001 is injected IT along multiple tracks 
through a single insertion point as far as the radial reach of the needle allows within the 
tumor; 2 insertion points may be used if the tumor is larger than the radial reach of the needle 
or the intended volume cannot be delivered through a single insertion point. If gentle 
injection pressure along 5 needle tracks within the tumor has not succeeded in delivering the 
desired volume, then the remainder of the CMP-001 may be injected peritumorally around 
the same lesion. If the full volume cannot be injected within the tumor, the remaining drug 
volume should be injected into a second accessible tumor, if present; otherwise, the 
remaining volume should be injected SC near an original tumor (peritumoral). 
Figure 4: 
Method for CMP-001 Intratumoral Injection 
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Recommended Intratumoral Injection Volume Based on Lesion Size 
 
Lesion Size (Longest Dimension) 
CMP-001 Injection Volume 
<0.5 cm 
Up to 0.25 mL 
0.5 to 1.5 cm 
Up to 0.5 mL 
1.5 to 2.5 cm 
Up to 1 mL 
>2.5 cm 
2 mL 
Note: If the full 2-mL dose cannot be accommodated within accessible tumor(s), then the remaining volume 
may be injected peritumorally. 
Subcutaneous Injection 
Subcutaneous administration of CMP-001 should only occur when all accessible lesions have 
regressed. CMP-001 SC can be administered within the area of lymphatic drainage 
corresponding to the site of metastatic disease and follow local standards for SC injection. 
In order to maximize the distribution and exposure to CMP-001, the full volume from a 
single dose should be distributed to as many SC sites as is practical. It is recommended that 
equal amounts of drug be injected at each SC site. 
Preferred sites of injection include the following: 
• Location of the primary tumor. 
• Within the area of lymphatic drainage corresponding to the site of metastatic 
disease. For example, in a subject with a muscle or bone metastasis in the lower 
leg, preferred SC injection sites would be in the same leg, with the expectation 
that at least some of the CMP-001 will drain to lymph nodes that also contain 
tumor antigens. Likewise, in a subject with metastases in an upper lobe of the 
lung, a preferred SC injection site would be in the ipsilateral supraclavicular fossa, 
where the injection may activate pDC in the supraclavicular lymph nodes that also 
can drain the upper lung. 
• Unsuitable sites for injection would include, for example, the palm of the hand or 
the sole of the foot. 
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Figure 5: 
Preferred Sites of Subcutaneous Injection 
 
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APPENDIX H. NIVOLUMAB SAFETY ALGORITHM 
These general guidelines constitute guidance to the Investigator and may be supplemented by 
discussions with the Medical Monitor representing the Sponsor. The guidance applies to all 
immuno-oncology agents and regimens. 
A general principle is that differential diagnoses should be diligently evaluated according to 
standard medical practice. Non-inflammatory etiologies should be considered and 
appropriately treated. 
Corticosteroids are a primary therapy for immuno-oncology drug-related adverse events. The 
oral equivalent of the recommended IV doses may be considered for ambulatory subjects 
with low-grade toxicity. The lower bioavailability of oral corticosteroids should be taken into 
account when switching to the equivalent dose of oral corticosteroids. 
Consultation with a medical or surgical specialist, especially prior to an invasive diagnostic 
or therapeutic procedure, is recommended. 
The frequency and severity of the related adverse events covered by these algorithms will 
depend on the immuno-oncology agent or regimen being used. 
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Myocarditis Adverse Event Management Algorithm 
 
 
 
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APPENDIX I. COUNTRY SPECIFIC REQUIREMENTS FOR HIV 
TESTING/EXCLUSION 
Certain countries may require additional parameters for exclusion of HIV positive subjects 
which are local mandated. 
As needed, the following table can be used to identify the changes needed to adapt the 
protocol to suit these local requirements. 
 
Original Language 
Country-Specific Language 
Section 4.1 Exclusion Criterion #16 
TBD 
Section 7.1.12 Clinical Laboratory Assessments, 
Table 3 
TBD 
Table 1, Schedule of Assessments 
TBD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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APPENDIX J. WOMEN OF CHILDBEARING POTENTIAL 
DEFINITION AND METHODS OF CONTRACEPTION 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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COLLECTION OF PREGNANCY INFORMATION 
Guidance for collection of Pregnancy Information and outcome of pregnancy is provided in 
Section 7.1.13 and Section 8.3.2. 
 
 
 
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