Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma

NCT ID: NCT04788043

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-21
• Study Completion Date: 2027-10-31

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)

Conditions

Hodgkin Lymphoma; Classic Hodgkin Lymphoma; Relapsed Classical Hodgkin Lymphoma; Refractory Classic Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Magrolimab (Hu5F9 G4) and pembrolizumab

All subjects will have a baseline PET CT and excisional or core needle biopsy within 1 month of study enrollment and baseline electrocardiogram and laboratory studies within 1 week of study enrollment. All subjects will receive treatment with magrolimab and pembrolizumab according to the dosing schedule. Magrolimab IV given on cycle 1, 2 and 3. Pembrolizumab 200 mg IV given on Cycle 1, 2 and 3. Patients may continue to receive treatment on the study for a maximum of 24 months or until progression of disease, unacceptable toxicity, or bridge to stem cell transplantation (SCT).

Group Type: EXPERIMENTAL

Magrolimab

Intervention Type: DRUG

45 mg/kg with dose escalation starting at 1 mg/kg IV Infusion

Pembrolizumab

Intervention Type: DRUG

200 mg IV infusion

PET/CT

Intervention Type: PROCEDURE

Scan

Interventions

Magrolimab

45 mg/kg with dose escalation starting at 1 mg/kg IV Infusion

Intervention Type: DRUG

Pembrolizumab

200 mg IV infusion

Intervention Type: DRUG

PET/CT

Scan

Intervention Type: PROCEDURE

Other Intervention Names

Hu5F9-G4; ONO-7913; anti-CD47 monoclonal antibody Hu5F9-G4; Keytruda; MK-3475; SCH 900475; anti-PD-1 monoclonal antibody MK-3475; Positron Emission Tomography - Computed Tomography (PET/CT)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ranjana H Advani, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford Universiy

Locations

Stanford University

Stanford, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

LYMHD0019

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2022-05298

Identifier Type: REGISTRY

Identifier Source: secondary_id

IRB-56995

Identifier Type: -

Identifier Source: org_study_id