Status:
ACTIVE_NOT_RECRUITING
Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hodgkin Lymphoma
Classic Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2027
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04788043
Start Date
June 21 2022
End Date
October 1 2027
Last Update
April 2 2025
Active Locations (2)
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1
Stanford University
Stanford, California, United States, 94304
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215