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A Trial of Hu5F9-G4 With Avelumab in Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03558139
Recruitment Status : Active, not recruiting
First Posted : June 15, 2018
Last Update Posted : July 2, 2020
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This is an open label, multicenter, Phase 1b trial investigating the combination of Hu5F9 G4 and avelumab in patients with solid tumors and ovarian cancer.

Condition or disease Intervention/treatment Phase
Solid Tumor Ovarian Cancer Drug: Hu5F9-G4 Drug: Avelumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Trial of Hu5F9-G4 in Combination With Avelumab in Solid Tumor Patients and Checkpoint Inhibitor Naïve Ovarian Cancer Patients Who Progress Within 6 Months of Prior Platinum Chemotherapy
Actual Study Start Date : May 24, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Avelumab

Arm Intervention/treatment
Experimental: Treatment
Combination of Hu5F9-G4 and avelumab.
Drug: Hu5F9-G4

Drug: Avelumab

Primary Outcome Measures :
  1. Dose-Limiting Toxicities [ Time Frame: 35-Days ]
    Number of participants with dose-limiting toxicities and treatment-related adverse events as assessed by CTCAE v4.03.

  2. Objective Response Rate [ Time Frame: 8 Weeks ]
    Evaulate anti-tumor activity based on RECIST v1.1, irRECIST, and Gynecologic Cancer Intergroup (GCIG) response criteria.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Safety Run-in: Pathologically confirmed advanced solid tumors.
  • Ovarian Cancer Expansion: Histologically or cytologically confirmed, epithelial ovarian, fallopian tube, or peritoneal cancer.
  • Ovarian Cancer Expansion: Checkpoint inhibitor naïve patients.
  • Ovarian Cancer Expansion: 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 tisse to evaulate PD-L1 expression.

Exclusion Criteria:

  • Patients with symptomatic or untreated central nervous system (CNS) metastases.
  • Prior treatment with CD47 or SIRPα targeting agents.
  • Known active or chronic hepatitis B or C infection or human immunodeficiency virus (HIV).
  • RBC 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03558139

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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Michigan
START Midwest
Grand Rapids, Michigan, United States, 49546
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Gilead Sciences
Merck KGaA, Darmstadt, Germany
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Responsible Party: Gilead Sciences Identifier: NCT03558139    
Other Study ID Numbers: 5F9006
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Antineoplastic Agents