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ACTIVE NOT RECRUITING Phase 1

PARP-inhibition and CTLA-4 Blockade in BRCA-deficient Ovarian Cancer

NCT02571725 · View on ClinicalTrials.gov ↗

Study Summary

Of the approximately 21,000 cases of ovarian cancer diagnosed annually in the U.S, ten percent are attributed to hereditary syndromes, most commonly the result of mutations in the breast cancer susceptibility genes 1 or 2 (BRCA1 or BRCA2). Mutation in these genes results in the inability to repair double-stranded breaks in DNA. Treating these tumors with poly(adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitors results in the specific killing of BRCA negative cells by blocking a second DNA-repair mechanism. Treatment of ovarian cancer patients with PARP inhibitors has resulted in improved progression free survival (PFS), but not overall survival (OS). It's not completely understood why this is the case, but some preclinical studies using ovarian cancer models in mice have suggested that combining PARP inhibitors with immune system modulators like T cell checkpoint inhibitors improves long-term survival. Therefore, the purpose of this study is to evaluate the safety and efficacy of a combination of a PARP inhibitor (Olaparib) with a T cell checkpoint inhibitor (the anti-CTLA-4 antibody Tremelimumab) in women with recurrent BRCA mutation-associated ovarian cancer.

Interventions

  • DRUG Olaparib
  • DRUG Tremelimumab

Study Locations (5)

New Mexico

  • Southwest Gynecologic Oncology Associates — Albuquerque
  • University of New Mexico Comprehensive Cancer Center — Albuquerque

Florida

  • Moffitt Cancer Center — Tampa

Ohio

  • The Ohio State University — Columbus

Virginia

  • University of Virginia Cancer Center — Charlottesville

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2016-02-23
Est. Completion 2027-07-15
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02571725

The ClinicalTrials.gov registry entry for NCT02571725 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New Mexico Cancer Research Alliance, which has 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 2 interventions — of which Olaparib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02571725 reports 5 study locations spanning 4 distinct geographic areas — top geographies include New Mexico, Florida, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02571725 about?

NCT02571725 is a clinical study titled "PARP-inhibition and CTLA-4 Blockade in BRCA-deficient Ovarian Cancer". Of the approximately 21,000 cases of ovarian cancer diagnosed annually in the U.S, ten percent are attributed to hereditary syndromes, most commonly the result of mutations in the breast cancer susceptibility genes 1 or 2 (BRCA1 or BRCA2). Mutation in these genes results in the inability to repair d...

What is the current status of trial NCT02571725?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2016-02-23. Estimated completion is 2027-07-15.

What conditions does trial NCT02571725 study?

This clinical trial studies the following conditions: Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02571725?

The interventions under investigation include: Olaparib (DRUG), Tremelimumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02571725?

This trial is sponsored by New Mexico Cancer Research Alliance, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02571725 being conducted?

This trial has 5 study locations across Florida, New Mexico, Ohio, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial