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NCT03602586 · ClinicalTrials.gov registry record · Phase 2

Testing Whether the Combination of Two Immunotherapy Drugs Have Activity in Recurrent or Persistent Clear Cell Ovarian Cancer

A Phase 2 study of Recurrent Ovarian Carcinoma and Malignant Ovarian Clear Cell Tumor, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
14
Enrollment target
20
Study locations

NCT03602586: Completed Phase 2 study of Recurrent Ovarian Carcinoma and Malignant Ovarian Clear Cell Tumor, sponsored by National Cancer Institute (NCI).

NCT03602586 is a Phase 2 study of Recurrent Ovarian Carcinoma and Malignant Ovarian Clear Cell Tumor that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 124-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (89% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03602586, a Phase 2 study of Recurrent Ovarian Carcinoma and Malignant Ovarian Clear Cell Tumor, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
14 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 criteria. Exact 95% confidence limits, accounting for interim analysis, will be provided in the final report. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=20% decrease in the sum of the longest diameter of target lesions and a 5 mm absolute increase; Overall Resp

Interventions

  • BIOLOGICAL Pembrolizumab
  • DRUG Epacadostat

Study Locations (20)

Alaska

  • Anchorage Associates in Radiation Medicine - Anchorage
  • Anchorage Radiation Therapy Center - Anchorage
  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Oncology and Hematology LLC - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage

Colorado

  • Rocky Mountain Cancer Centers-Aurora - Aurora
  • The Medical Center of Aurora - Aurora
  • Boulder Community Hospital - Boulder
  • Rocky Mountain Cancer Centers-Boulder - Boulder
  • Penrose-Saint Francis Healthcare - Colorado Springs
  • Rocky Mountain Cancer Centers-Penrose - Colorado Springs
  • National Jewish Health-Main Campus - Denver
  • The Women's Imaging Center - Denver

Arkansas

  • CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
  • University of Arkansas for Medical Sciences - Little Rock

California

  • PCR Oncology - Arroyo Grande
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2018-12-21
Est. Completion 2024-03-27
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT03602586 record still lists

NCT03602586 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 124-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (89% lower).

The record links to 2 conditions, with Recurrent Ovarian Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT03602586 names 20 study sites across 4 states, led by Alaska, Colorado, Arkansas.

Frequently Asked Questions

What is clinical trial NCT03602586 about?

NCT03602586 is a clinical study titled "Testing Whether the Combination of Two Immunotherapy Drugs Have Activity in Recurrent or Persistent Clear Cell Ovarian Cancer". 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, s...

What is the current status of trial NCT03602586?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2018-12-21. Estimated completion is 2024-03-27.

What conditions does trial NCT03602586 study?

This clinical trial studies the following conditions: Recurrent Ovarian Carcinoma, Malignant Ovarian Clear Cell Tumor.

What interventions are being tested in trial NCT03602586?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Epacadostat (DRUG).

Who is sponsoring clinical trial NCT03602586?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03602586 being conducted?

This trial has 20 study locations across Alaska, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Recurrent Ovarian Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03602586's enrollment target sits among peer trials

14 35th of 39 higher than 5 of 39 other Recurrent Ovarian Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Recurrent Ovarian Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03602586, the US trial registry maintained by the National Library of Medicine. NCT03602586 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.