Clinical trial NCT04788043: Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma
Official title: A Phase 2 Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hodgkin Lymphoma
Classic Hodgkin Lymphoma
Relapsed Classical Hodgkin Lymphoma
Refractory Classic Hodgkin Lymphoma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2021-03-09
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the safety and efficacy of magrolimab in combination with pembrolizumab in patients with Hodgkin lymphoma.

Detailed description: Primary Objectives:

- To assess the complete remission (CR) rate of magrolimab in combination with pembrolizumab in adult subjects with relapsed or refractory cHL

Secondary Objectives:

* To assess the safety and tolerability of magrolimab in combination with pembrolizumab in adult subjects with relapsed or refractory cHL
* To assess the overall response rate (ORR)

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Biopsy proven relapsed or refractory cHL
* Prior treatment with at least two systemic therapies
* Metabolically active measurable disease by PET imaging per the 2014 Lugano criteria
* Hemoglobin ≥ 9.5 g/dL
* Absolute neutrophil count ≥ 1,000 cells/μL without G-CSF support within 3 weeks prior to enrollment
* Platelet count ≥ 75,000 cells/μL
* Creatinine clearance \> 40 mL/min per the Cockroft-Gault formula
* Total bilirubin \< 1.5 x upper limit of normal (ULN) (or \< 3.0 x ULN and primarily unconjugated in subjects with a history of Gilbert's syndrome)
* Negative urine or serum pregnancy test within 30 days of enrollment and within 72 hours before the first administration of magrolimab for women of childbearing potential
* Women of childbearing potential must be willing to use at least 1 highly effective method of contraception during the study and continue for 4 months after the last dose of magrolimab
* Male subjects who are sexually active with a woman of childbearing potential and who have not had vasectomies must be willing to use a barrier method of contraception during the study and for 4 months after the last dose of magrolimab
* Ability to understand and the willingness to sign the written IRB approved informed consent document
* Must be willing and able to comply with the clinic visits and procedures outlined in the study protocol

Exclusion Criteria:

* Prior treatment with a PD-1 inhibitor within 3 months prior to enrollment
* Prior treatment with antibodies targeting CD47 or SIRPα2
* Prior allogeneic hematopoietic cell transplantation
* Systemic autoimmune disorder on chronic immunosuppression (defined as ≥ 10 mg of prednisone daily)
* RBC transfusion dependence, defined as requiring more than 2 units of RBCs during the 4-week period prior to screening
* History of hemolytic anemia, autoimmune thrombocytopenia, or Evan's syndrome within the last 3 months
* Second malignancy not in complete remission for at least 1 year, excluding fully resected non melanoma skin cancer or localized prostate cancer
* Women who are pregnant or breast feeding
* HIV or hepatitis B or C infection with active viral replication by PCR
* Second malignancy not in complete remission for at least 1 year, excluding fully resected non-melanoma skin cancer or localized prostate cancer
* Active cardiac disease including unstable angina, decompensated congestive heart failure, or severe uncontrolled conduction abnormalities
* History of non-infectious pneumonitis requiring corticosteroids or current pneumonitis
* Significant medical conditions, as assessed by the investigators and IND holder, that would substantially increase the risk benefit ratio of participating in the study
* History of psychiatric illness or substance abuse likely to interfere with ability to comply with protocol requirements
* Received a live or live attenuated vaccine within 30 days before the first dose of study intervention
* Received any anti-cancer therapy within 2 weeks prior to the first dose of study intervention

Primary outcomes:
measure: Complete Response (CR)
timeFrame: 2 years
Secondary outcomes:
measure: Magrolimab related Adverse Events
timeFrame: 4 months
Other outcomes:
measure: Overall Response (OR)
timeFrame: 8 months
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Stanford Universiy
name: Ranjana H Advani, MD
role: PRINCIPAL_INVESTIGATOR
References: