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

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03824704
• Other study ID #: CO-338-097
• Status: Terminated
• Phase: Phase 2
• Start date: August 23, 2019
• Est. completion date: August 24, 2020

Study information

• Verified date: June 2023
• Source: zr Pharma & GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Endometrioid
• Carcinoma, Ovarian Epithelial
• Endometrioid Adenocarcinoma
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• High Grade Serous Carcinoma
• Primary Peritoneal Carcinoma

Intervention

Drug:
• Rucaparib
Oral rucaparib will be administered twice daily
• Nivolumab
IV nivolumab will be administered once every 4 weeks

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
zr Pharma & GmbH	Bristol-Myers Squibb, Foundation Medicine

Country where clinical trial is conducted

United States, 

Outcome

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