Clinical Trials /

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

NCT04788043

Description:

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

Related Conditions:
  • Hodgkin Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: IRB-56995
  • SECONDARY ID: LYMHD0019
  • NCT ID: NCT04788043

Conditions

  • Hodgkin Lymphoma
  • Classic Hodgkin Lymphoma
  • Relapsed Classical Hodgkin Lymphoma
  • Refractory Classic Hodgkin Lymphoma

Interventions

DrugSynonymsArms
MagrolimabHu5F9-G4, ONO-7913, anti-CD47 monoclonal antibody Hu5F9-G4Magrolimab (Hu5F9 G4) and pembrolizumab
PembrolizumabKeytruda, MK-3475, SCH 900475, anti-PD-1 monoclonal antibody MK-3475Magrolimab (Hu5F9 G4) and pembrolizumab

Purpose

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)
    

Trial Arms

NameTypeDescriptionInterventions
Magrolimab (Hu5F9 G4) and pembrolizumabExperimentalAll 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).
  • Magrolimab
  • Pembrolizumab

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 ≥ 9.0 g/dL

          -  Absolute neutrophil count ≥ 1,000 cells/μL

          -  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 antibodies targeting PD 1, PD L1, CD47, or Signal regulatory
             protein α (SIRPα)

          -  Prior allogeneic hematopoietic cell transplantation

          -  Systemic autoimmune disorder on chronic immunosuppression (defined as ≥ 10 mg of
             prednisone daily)

          -  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

          -  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

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Complete Response (CR)
Time Frame:2 years
Safety Issue:
Description: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").

Secondary Outcome Measures

Measure:Magrolimab related Adverse Events
Time Frame:4 months
Safety Issue:
Description:Magrolimab safety and tolerability will be assessed on the basis of magrolimab related adverse events occurring within 4 cycles of treatment (4 months). The outcome will be reported as the number of magrolimab related adverse events judged mild (Grade 1), moderate (Grade 2), severe (Grade 3), life threatening (Grade 4), or fatal (Grade 5), numbers without dispersion.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Stanford University

Last Updated

March 9, 2021