Clinical trial NCT04590781: Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer
Official title: A Phase 1b/2 Multiple-Dose Study to Evaluate the Safety and Efficacy of XmAb18087 ± Pembrolizumab in Subjects With Advanced Merkel Cell Carcinoma or Extensive-stage Small Cell Lung Cancer (DUET-1-02) Protocol
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Merkel Cell Carcinoma
Small Cell Lung Cancer
Keywords: MCC
SCLC
Lead sponsor: Xencor, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2020-10-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1b/2, multiple-dose study designed to describe safety and efficacy, and to assess PK and immunogenicity of XmAb18087 monotherapy and in combination with pembrolizumab in participants with metastatic Merkel cell (MCC) or locoregional MCC that has recurred after locoregional therapy with surgery and/or radiation therapy, and mAb18087 monotherapy in participants with extensive-stage small cell lung cancer (SCLC) that has progressed after standard therapies.

This study was terminated by the sponsor. No participants enrolled in Part B.


Eligibility criteria: Inclusion Criteria:

* Able to provide written informed consent
* Adult participants ≥ 18 years
* Disease measurable by RECIST 1.1 criteria using either computed tomography (CT) or magnetic resonance imaging (MRI) scan
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* All participants must have adequate archival tumor sample (slides or archival formalin-fixed paraffin-embedded \[FFPE\] block\[s\] containing tumor that has not been previously irradiated
* Female participants of childbearing potential must agree to use a highly effective method of birth control during and for 4 weeks after completion of study. success), or sexual abstinence
* Fertile male participants must be willing to practice a highly effective method of birth control for the duration of the study and continuing for 4 weeks after the last dose of XmAb18087 or pembrolizumab (when applicable
* Able and willing to complete the entire study according to the study schedule

Additional Inclusion Criteria for Part A and Part B Cohorts:

• Histologically or cytologically confirmed metastatic MCC or locoregional MCC that has recurred following standard locoregional therapy with surgery and/or radiation therapy.

Additional Inclusion Criteria for Part A Cohorts:

• Participants must have progressed on or been ineligible for treatment with anti-PD1 or anti-PDL1 therapy.

Additional Inclusion Criteria for Part B Cohorts:

• Participants must be eligible to receive pembrolizumab as standard of care.

Additional Inclusion Criteria for Part C Cohorts:

• Histologically or cytologically confirmed extensive-stage SCLC that has progressed following standard therapies

Exclusion Criteria:

Additional Exclusion Criteria for Part B Cohorts: XmAb18087 in Combination with Pembrolizumab

* Prior treatment with therapeutics directed at anti-programmed cell death 1 (anti-PD1) or anti-programmed cell death ligand 1 (anti-PDL1)
* Have severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: Day 1 (after dosing) up to end of study (up to 163 days)
measure: Overall Response Rate as Assessed by RECIST 1.1 Criteria
timeFrame: Up to end of study (up to 163 days)
measure: Complete and Partial Response Rate as Assessed by RECIST 1.1 Criteria
timeFrame: Up to end of study (up to 163 days)
Secondary outcomes:
measure: Duration of Response
timeFrame: Up to end of study (up to 163 days)
measure: Progression-free Survival as Assessed by Per RECIST 1.1 Criteria
timeFrame: Up to end of study (up to 163 days)
measure: Overall Survival as Assessed by Per RECIST 1.1 Criteria
timeFrame: Up to end of study (up to 163 days)
measure: Pharmacokinetics: Maximum Observed Serum Concentration
timeFrame: Predose up to end of study (up to 163 days)
measure: Immunogenicity: Number of Participants With Anti-XmAb18087 Antibodies
timeFrame: Up to end of study (up to 163 days)
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Oklahoma City
country: United States
facility: OU Health, Stephenson Cancer Center
state: Oklahoma
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Medical Director, Clinical Development, Xencor
name: Benjamin Thompson, MD, PhD
role: STUDY_DIRECTOR
References: