Epithelial Ovarian CancerPhase 2NCT03824704
A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
A Phase 2 study testing Rucaparib and Nivolumab in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by pharmaand GmbH at 5 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- What is being tested?
- Rucaparib and Nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 5 sitesUnited States
- Study dates
- 23 Aug 2019to 24 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Vermont Medical Center
Burlington, Vermont, 05041
Community Cancer Institute
Clovis, California, 93611
Women's Cancer Care
Covington, Louisiana, 70433
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Memorial Health University Medical Center
Savannah, Georgia, 31404
About this study
Official title: A Phase 2, Open-label Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
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
- Conditions
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, High Grade Serous Carcinoma, Endometrioid Adenocarcinoma
- Being tested
- Rucaparib, Nivolumab
- Keywords
- PARP, PARPi, PARP inhibitor, ARIES, Opdivo, Rucaparib, Nivolumab, PD-1, BRCA, LOH, CO-338, Immunotherapy, BMS-936558, Clovis, Clovis Oncology, Rubraca
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Carcinoma, Endometrioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RucaparibDrug
Also called Rubraca, CO-338
Oral rucaparib will be administered twice daily
NivolumabDrug
Also called Opdivo, BMS-936558
IV nivolumab will be administered once every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Ovarian Cancer Cohort | Experimental | Oral rucaparib and Intravenous (IV) nivolumab (combination therapy)
* Cohort A1
* Cohort A2 Receives: Drug: Rucaparib; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until disease progression (up to approximately 2 years)
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
Measured: From enrollment to primary completion of study (up to approximately 2 years)
Secondary outcomes (3)
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)
Measured: 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.
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.
Measured: From randomization until disease progression (up to approximately 2 years)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start23 Aug 2019
- Primary completion24 Aug 2020
- Study completion24 Aug 2020
Why it stopped: Sponsor made a business decision to discontinue the study due to low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- pharmaand GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb, Foundation Medicine
- Responsible party
- Sponsor
- Investigators
- Kathleen N Moore, MD, Principal investigator, Lead Investigator for Ovarian Cohort A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824704
- Sponsor's protocol ID
- CO-338-097
- Status last verified
- Jun 2023
- First submitted
- 21 Jan 2019
- Last updated
- 12 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
- ClinicalTrials.gov ID
- NCT03824704
- Acronym / sponsor ID
- CO-338-097
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor made a business decision to discontinue the study due to low accrual.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- pharmaand GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb, Foundation Medicine
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 24 Aug 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 15 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Ovarian Cancer Cohort | Experimental | Drug: Rucaparib, Drug: NivolumabOral rucaparib and Intravenous (IV) nivolumab (combination therapy) * Cohort A1 * Cohort A2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RucaparibAlso: Rubraca, CO-338Oral rucaparib will be administered twice daily | Drug | Cohort A: Ovarian Cancer Cohort |
| NivolumabAlso: Opdivo, BMS-936558IV nivolumab will be administered once every 4 weeks | Drug | Cohort A: Ovarian Cancer Cohort |
Primary outcome
Objective Response Rate (ORR) by RECIST v1.1 as Assessed by the Investigator
Time frame: From enrollment until disease progression (up to approximately 2 years)
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
Time frame: From enrollment to primary completion of study (up to approximately 2 years)
Change in expression of the immune marker PD-L1 pre and post-rucaparib treatment; Cohort A2 only
3 secondary outcomes
ORR by RECIST v1.1 and Gynecological Cancer InterGroup (GCIG) Cancer Antigen 125 (CA-125 Criteria)
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.
Progression-free Survival (PFS)
Time frame: From randomization until disease progression (up to approximately 2 years)
Duration of Response (DOR)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen N Moore, MD principal investigator
Lead Investigator for Ovarian Cohort A
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rucaparib and Nivolumab in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by pharmaand GmbH at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) by RECIST v1.1 as Assessed by the Investigator (time frame: From enrollment until disease progression (up to approximately 2 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.