Trial Outcomes & Findings for A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES) (NCT NCT03824704)
NCT ID: NCT03824704
Last Updated: 2023-06-12
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
From enrollment until disease progression (up to approximately 2 years)
Results posted on
2023-06-12
Participant Flow
1 subject was recruited from 1 site in the United States. The Sponsor then discontinued the study due to low accrual.
Participant milestones
| Measure |
Cohort A: Ovarian Cancer Cohort
Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.
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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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1
|
Reasons for withdrawal
| Measure |
Cohort A: Ovarian Cancer Cohort
Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.
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|---|---|
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Overall Study
Study Terminated by Sponsor
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1
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Baseline Characteristics
A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
Baseline characteristics by cohort
| Measure |
Cohort A: Ovarian Cancer Cohort
n=1 Participants
Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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1 Participants
n=5 Participants
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Sex: Female, Male
Female
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1 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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1 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
White
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1 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From enrollment until disease progression (up to approximately 2 years)Population: This study was discontinued by the sponsor so no data is available for this outcome measure.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From enrollment to primary completion of study (up to approximately 2 years)Population: This study was discontinued by the sponsor so no data is available for this outcome measure.
Change in expression of the immune marker PD-L1 pre and post-rucaparib treatment; Cohort A2 only
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.Population: This study was discontinued by the sponsor so no data is available for this outcome measure.
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)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization until disease progression (up to approximately 2 years)Population: This study was discontinued by the sponsor so no data is available for this outcome measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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 yearsPopulation: This study was discontinued by the sponsor so no data is available for this outcome measure.
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.
Outcome measures
Outcome data not reported
Adverse Events
Cohort A: Ovarian Cancer Cohort
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: Ovarian Cancer Cohort
n=1 participants at risk
Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.
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Blood and lymphatic system disorders
Anaemia
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100.0%
1/1 • Number of events 1 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Other adverse events
| Measure |
Cohort A: Ovarian Cancer Cohort
n=1 participants at risk
Patients received combination therapy, including oral rucaparib 600mg administered twice daily starting on Cycle 1 Day 1 and intravenous (IV) nivolumab 480mg administered on Day 1 of every 4-week cycle, starting on Cycle 2 Day 1.
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|---|---|
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Endocrine disorders
Adrenal insufficiency
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100.0%
1/1 • Number of events 1 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Gastrointestinal disorders
Nausea
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100.0%
1/1 • Number of events 1 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Gastrointestinal disorders
Diarrhoea
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100.0%
1/1 • Number of events 4 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Gastrointestinal disorders
Constipation
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100.0%
1/1 • Number of events 4 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Gastrointestinal disorders
Dsypepsia
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100.0%
1/1 • Number of events 1 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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General disorders
Fatigue
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100.0%
1/1 • Number of events 5 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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General disorders
Chest pain
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100.0%
1/1 • Number of events 1 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Investigations
Blood creatinine increased
|
100.0%
1/1 • Number of events 1 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Metabolism and nutrition disorders
Hyperglycaemia
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100.0%
1/1 • Number of events 1 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Musculoskeletal and connective tissue disorders
Back pain
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100.0%
1/1 • Number of events 1 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Nervous system disorders
Tremor
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100.0%
1/1 • Number of events 1 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Nervous system disorders
Dizziness
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100.0%
1/1 • Number of events 2 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Nervous system disorders
Cognitive disorder
|
100.0%
1/1 • Number of events 1 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 2 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Nervous system disorders
Hypoaesthesia
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100.0%
1/1 • Number of events 1 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Psychiatric disorders
Insomnia
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100.0%
1/1 • Number of events 2 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Psychiatric disorders
Panic attack
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100.0%
1/1 • Number of events 3 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Renal and urinary disorders
Chronic kidney disease
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100.0%
1/1 • Number of events 2 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
100.0%
1/1 • Number of events 1 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Skin and subcutaneous tissue disorders
Hair texture abnormal
|
100.0%
1/1 • Number of events 1 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Vascular disorders
Hot flush
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100.0%
1/1 • Number of events 1 • Adverse events were reported from the time informed consent was obtained until 28 days after last dose of study drug.
If a subject experiences the same preferred term (system organ class) multiple times, then the subject will be counted only once for that preferred term (system organ class).
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Additional Information
Medical Information Department
Clovis Oncology, Inc.
Phone: +1 415 409 7220
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
- Publication restrictions are in place
Restriction type: OTHER