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

Primary Purpose

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Rucaparib

Nivolumab

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring PARP, PARPi, PARP inhibitor, ARIES, Opdivo, Rucaparib, Nivolumab, PD-1, BRCA, LOH, CO-338, Immunotherapy, BMS-936558, Clovis, Clovis Oncology, Rubraca

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Community Cancer Institute
Memorial Health University Medical Center
Women's Cancer Care
Stephenson Cancer Center
University of Vermont Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohort A: Ovarian Cancer Cohort

Arm Description

Oral rucaparib and Intravenous (IV) nivolumab (combination therapy) Cohort A1 Cohort A2

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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)

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.

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.

Full Information

NCT ID

NCT03824704

First Posted

January 21, 2019

Last Updated

June 7, 2023

Sponsor

pharmaand GmbH

Collaborators

Bristol-Myers Squibb, Foundation Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03824704

Brief Title

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

Official Title

A Phase 2, Open-label Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

August 23, 2019 (Actual)

Primary Completion Date

August 24, 2020 (Actual)

Study Completion Date

August 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

pharmaand GmbH

Collaborators

Bristol-Myers Squibb, Foundation Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

PARP, PARPi, PARP inhibitor, ARIES, Opdivo, Rucaparib, Nivolumab, PD-1, BRCA, LOH, CO-338, Immunotherapy, BMS-936558, Clovis, Clovis Oncology, Rubraca

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort A: Ovarian Cancer Cohort

Arm Type

Experimental

Arm Description

Oral rucaparib and Intravenous (IV) nivolumab (combination therapy) Cohort A1 Cohort A2

Intervention Type

Drug

Intervention Name(s)

Rucaparib

Other Intervention Name(s)

Rubraca, CO-338

Intervention Description

Oral rucaparib will be administered twice daily

Intervention Type

Drug

Intervention Name(s)

Nivolumab

Other Intervention Name(s)

Opdivo, BMS-936558

Intervention Description

IV nivolumab will be administered once every 4 weeks

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

The Effect of Rucaparib on the Immune Microenvironment

Description

Change in expression of the immune marker PD-L1 pre and post-rucaparib treatment; Cohort A2 only

Time Frame

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

Secondary Outcome Measure Information:

Title

ORR by RECIST v1.1 and Gynecological Cancer InterGroup (GCIG) Cancer Antigen 125 (CA-125 Criteria)

Description

Time Frame

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.

Title

Progression-free Survival (PFS)

Description

Time Frame

From randomization until disease progression (up to approximately 2 years)

Title

Duration of Response (DOR)

Description

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.

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathleen N Moore, MD

Organizational Affiliation

Lead Investigator for Ovarian Cohort A

Official's Role

Principal Investigator

Facility Information:

Facility Name

Community Cancer Institute

City

Clovis

State/Province

California

ZIP/Postal Code

93611

Country

United States

Facility Name

Memorial Health University Medical Center

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31404

Country

United States

Facility Name

Women's Cancer Care

City

Covington

State/Province

Louisiana

ZIP/Postal Code

70433

Country

United States

Facility Name

Stephenson Cancer Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

University of Vermont Medical Center

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05041

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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