Fallopian Tube Cancer Clinical Trial
Official title:
A Phase 2, Open-label Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
Verified date | June 2023 |
Source | zr Pharma & GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 1 |
Est. completion date | August 24, 2020 |
Est. primary completion date | August 24, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Vermont Medical Center | Burlington | Vermont |
United States | Community Cancer Institute | Clovis | California |
United States | Women's Cancer Care | Covington | Louisiana |
United States | Stephenson Cancer Center | Oklahoma City | Oklahoma |
United States | Memorial Health University Medical Center | Savannah | Georgia |
Lead Sponsor | Collaborator |
---|---|
zr Pharma & GmbH | Bristol-Myers Squibb, Foundation Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate (ORR) by RECIST v1.1 as Assessed by the Investigator | Objective response rate (ORR) is defined as the percentage of patients with a best confirmed response of complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the investigator. | From enrollment until disease progression (up to approximately 2 years) | |
Primary | The Effect of Rucaparib on the Immune Microenvironment | Change in expression of the immune marker PD-L1 pre and post-rucaparib treatment; Cohort A2 only | From enrollment to primary completion of study (up to approximately 2 years) | |
Secondary | ORR by RECIST v1.1 and Gynecological Cancer InterGroup (GCIG) Cancer Antigen 125 (CA-125 Criteria) | Objective Response Rate (ORR) is defined as the percentage of patients with a best confirmed response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by the investigator or a confirmed response per Gynecological Cancer InterGroup (GCIG) cancer antigen 125 (CA-125 criteria) | For patients with measurable disease, every 8 weeks after the start of combination treatment for 3 years, then every 24 weeks thereafter until disease progression or up to 25 months. Study data collection expected to last for 2 years. | |
Secondary | Progression-free Survival (PFS) | Progression-Free Survival (PFS) is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first. | From randomization until disease progression (up to approximately 2 years) | |
Secondary | Duration of Response (DOR) | Duration of response (DOR) for any confirmed RECIST CR or PR measured from the date of the first response until the first date that progressive disease (PD) is documented. | For patients with measurable disease, every 12 weeks after the start of combination treatment for 3 years, then every 24 weeks thereafter until disease progression. Study data collection expected to last for 2 years |
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