TerminatedPhase 2

A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)

Stopped: Sponsor made a business decision to discontinue the study due to low accrual.

United States1 participantsStarted 2019-08-23

Plain-language summary

This is an open label Phase 2, 2-stage, 2-cohort study to evaluate rucaparib in combination with nivolumab in patients with high-grade serous or endometroid ovarian cancer. Patients entering the following cohorts must have BRCA mutational status confirmed by a central lab: * Cohort A1: No BRCA mutation in tumor; high level of LOH (loss of heterozygosity) * Cohort A2: BRCA mutation in tumor

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

General Inclusion Criteria: * ≥ 18 years of age * Adequate organ function * Life expectancy ≥ 16 weeks * Women of childbearing potential must have a negative serum pregnancy test * High-grade serous or endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer * Received 1 or 2 prior regimens, including ≥ 1 prior platinum-based therapy and have platinum-sensitive disease * Relapsed/progressive disease (confirmed by radiologic assessment) * Willing and able to have a biopsy of tumor at screening and after 4 weeks of treatment. * Measurable disease (RECIST v1.1)- Cohort A1 only * ECOG performance status of 0 to 1 General Exclusion Criteria * Active second malignancy * Central nervous system brain metastases * Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis. * Active, known or suspected autoimmune disease (eg, autoimmune hepatitis). * Condition requiring systemic treatment with either corticosteroids * Prior treatment with a PARP inhibitor or immune checkpoint inhibitor. * Non-epithelial tumors (pure sarcomas) or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors. Mixed Mullerian tumors/carcinosarcomas are allowed.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objective Response Rate (ORR) by RECIST v1.1 as Assessed by the Investigator

Timeframe: From enrollment until disease progression (up to approximately 2 years)

The Effect of Rucaparib on the Immune Microenvironment

Timeframe: From enrollment to primary completion of study (up to approximately 2 years)

Trial details

NCT IDNCT03824704

Sponsorpharmaand GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-08-24

Results submitted2021-05-19

View on ClinicalTrials.gov More Epithelial Ovarian Cancer trials