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

NCT04788043 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: IRB-56995LYMHD0019NCI-2022-05298
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR)

  Each participant's response to treatment will be assessed per the Lugano criteria. The criteria are: * Complete Response (CR): Complete disappearance of all lesions, evidence, and effects of disease * Partial Response (PR): ≥50% decrease in SPD of the 6 largest lesions with no increase in the size of the other nodes; splenic / hepatic nodules regress ≥50%, and with no new sites of disease * Stable disease (SD): less than PR. * Progressive disease (PD): sum of the product of dimensions (SPD) of lesions increased ≥50% from smallest value The outcome will be reported as the number of participants with a CR after 4 and 8 cycles of treatment (4 and 8 months), and if CR is achieved anytime within 2 years ("overall").

  2 years

Secondary Outcomes (1)

• Magrolimab related Adverse Events

  4 months

Other Outcomes (1)

• Overall Response (OR)

  8 months

Study Arms (1)

Magrolimab (Hu5F9 G4) and pembrolizumab

EXPERIMENTAL

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).

Drug: Magrolimab; Drug: Pembrolizumab; Procedure: PET/CT

Interventions

Magrolimab DRUG

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

Also known as: Hu5F9-G4, ONO-7913, anti-CD47 monoclonal antibody Hu5F9-G4

Magrolimab (Hu5F9 G4) and pembrolizumab

Pembrolizumab DRUG

200 mg IV infusion

Also known as: Keytruda, MK-3475, SCH 900475, anti-PD-1 monoclonal antibody MK-3475

Magrolimab (Hu5F9 G4) and pembrolizumab

PET/CT PROCEDURE

Scan

Also known as: Positron Emission Tomography - Computed Tomography (PET/CT)

Magrolimab (Hu5F9 G4) and pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Stanford University

Stanford, California, 94304, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

magrolimab; pembrolizumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ranjana H Advani, MD

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 9, 2021
• Study Start: June 21, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)