Ovarian Cancer Clinical Trial

Study of Magrolimab (Hu5F9-G4) in Combination With Avelumab in Solid Tumor Participants and Checkpoint-Inhibitor-Naive Ovarian Cancer Participants Who Progress Within 6 Months of Prior Platinum Chemotherapy

Summary

The primary objectives of this study are to investigate the safety and tolerability of magrolimab in combination with avelumab in participants with advanced solid tumors and to confirm the safety and tolerability of this combination and evaluate the anti-tumor activity based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Eisenhauer 2009) in participants with checkpoint inhibitor-naive ovarian cancer, fallopian tube cancer, and primary peritoneal carcinoma who have previously progressed within 1-6 months of receiving platinum chemotherapy.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Safety Run-in Cohort: Pathologically confirmed advanced solid tumors.

Ovarian Cancer Expansion Cohort: Histologically or cytologically confirmed, epithelial ovarian, fallopian tube, or peritoneal cancer.

Checkpoint inhibitor naive participants.
Willing to consent to 1 mandatory pre-treatment and 1 on-treatment tumor biopsy.
Adequate performance status. Adequate hematological, liver, and kidney functions.
Availability of pre-treatment tumor tissue to evaluate programmed cell death-ligand 1(PD-L1) expression.

Key Exclusion Criteria:

Individuals with symptomatic or untreated central nervous system (CNS) metastases.
Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha (SIRPα) targeting agents.
Known active or chronic hepatitis B or C infection or human immunodeficiency virus (HIV).
Red blood cell transfusion dependence.
Prior organ transplantation requiring immunosuppression or active autoimmune disease.
Significant medical diseases and/or history of uncontrolled intercurrent illness or other serious medical condition.
Pregnancy or active breast feeding.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

34

Study ID:

NCT03558139

Recruitment Status:

Completed

Sponsor:

Gilead Sciences

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There are 6 Locations for this study

See Locations Near You

University of Chicago
Chicago Illinois, 60637, United States
START Midwest
Grand Rapids Michigan, 49546, United States
Oklahoma University Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75235, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio Texas, 78229, United States
University of Washington
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

34

Study ID:

NCT03558139

Recruitment Status:

Completed

Sponsor:


Gilead Sciences

How clear is this clinincal trial information?

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