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NCT02953457 · ClinicalTrials.gov registry record · Phase 2
Olaparib, Durvalumab, and Tremelimumab in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube or Primary Peritoneal Cancer With BRCA1 or BRCA2 Mutation
A Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT02953457: Completed Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by Roswell Park Cancer Institute.
NCT02953457 is a Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 40 participants, below the 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (67% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02953457, a Phase 2 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of olaparib when give together with durvalumab and tremelimumab and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer with BRCA1 or BRCA2 genetic mutation that has come back or has not responded to treatment. Drugs, such as olaparib, may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and kill tumors cells with BRCA1 or BRCA2 mutation. Monoclonal antibodies, such as durvalumab and tremelimumab, may help stimulate the immune system in different ways to attack and stop tumor cells from growing. Giving olaparib with durvalumab and tremelimumab may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.
Primary Outcome
The maximum tolerated dose is defined as the highest dose studied, for which the observed incidence of DLT is less than 33%. Number of Participants with Dose-limiting Toxicities (DLTs) in Phase I and Phase II will be reported.
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- OTHER Laboratory Biomarker Analysis
- DRUG Olaparib
- BIOLOGICAL Tremelimumab
Study Locations (2)
New York
- Roswell Park Cancer Institute - Buffalo
- The Feinstein Institute for Medical Research/Lennox Hill Hospital - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-06-29 |
| Est. Completion | 2024-08-15 |
| Phase | Phase 2 |
What the finished NCT02953457 record still lists
NCT02953457 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (67% lower).
The record links to 6 conditions, with Recurrent Ovarian Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Durvalumab is the first listed.
NCT02953457 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02953457 about?
NCT02953457 is a clinical study titled "Olaparib, Durvalumab, and Tremelimumab in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube or Primary Peritoneal Cancer With BRCA1 or BRCA2 Mutation". This phase I/II trial studies the side effects and best dose of olaparib when give together with durvalumab and tremelimumab and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer with BRCA1 or BRCA2 genetic mutation that has come back or has no...
What is the current status of trial NCT02953457?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2017-06-29. Estimated completion is 2024-08-15.
What conditions does trial NCT02953457 study?
This clinical trial studies the following conditions: Recurrent Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Primary Peritoneal Carcinoma, Ovarian Serous Adenocarcinoma, BRCA1 Gene Mutation.
What interventions are being tested in trial NCT02953457?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Olaparib (DRUG), Tremelimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02953457?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02953457 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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 NCT02953457's enrollment target sits among peer trials
40 20th of 39 higher than 17 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.
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