Trial Search Results

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

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Merck Sharp & Dohme LLC

Stanford Investigator(s):

Intervention(s):

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

Phase:

Phase 2

Eligibility


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 6 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mariel Rojas
Recruiting