Testing Whether the Combination of Two Immunotherapy Drugs Have Activity in Recurrent or Persistent Clear Cell Ovarian Cancer
NCT03602586 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2024-07-26
Summary
This phase II trial studies how well pembrolizumab and epacadostat work in treating patients with ovarian clear cell carcinoma that has come back (recurrent), remains despite treatment (persistent), or is growing, spreading, or getting worse (progressive). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and epacadostat may work better compared to usual treatment (surgery, radiation, or cytotoxic chemotherapy) in treating patients with ovarian clear cell carcinoma.
Conditions
- Malignant Ovarian Clear Cell Tumor
- Recurrent Ovarian Carcinoma
Interventions
- DRUG
-
Epacadostat
Given PO
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
-
NRG Oncology
collaborator OTHER -
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Lilian T Gien · NRG Oncology
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-21
- Primary Completion
- 2021-02-01
- Completion
- 2024-03-27
- FDA Drug
- Yes
Countries
- United States
- Puerto Rico
Study Locations
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