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Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer

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ClinicalTrials.gov Identifier: NCT03572478
Recruitment Status : Terminated (The study was terminated due to lack of efficacy.)
First Posted : June 28, 2018
Results First Posted : February 12, 2021
Last Update Posted : March 9, 2021
Sponsor:
Collaborators:
Bristol-Myers Squibb
Clovis Oncology, Inc.
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Prostate Cancer
Endometrial Cancer
Interventions Drug: Rucaparib
Drug: Nivolumab
Enrollment 12
Recruitment Details  
Pre-assignment Details The study was terminated due to lack of efficacy such that participants were enrolled only in phase 1 cohort (single arm).
Arm/Group Title Combination Therapy (Phase 1 Cohort)
Hide Arm/Group Description

Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.

Participants will receive rucaparib plus nivolumab in 4 week cycles.

Rucaparib: 600 mg taken by mouth twice daily.

Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.

Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Combination Therapy (Phase 1 Cohort)
Hide Arm/Group Description

Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.

Participants will receive rucaparib plus nivolumab in 4 week cycles.

Rucaparib: 600 mg taken by mouth twice daily.

Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.

Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
72
(60 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
1
   8.3%
Male
11
  91.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
  25.0%
White
9
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Dose Limiting Toxicities (DLT) (Phase 1)
Hide Description Dose limiting toxicities (DLT) is measured by patients with grade 3 or 4 toxicity within 4 weeks of starting leading to discontinuation of rucaparib for at least 1 week
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients were not evaluable for DLT due to rapidly progressive disease.
Arm/Group Title Combination Therapy (Phase 1 Cohort)
Hide Arm/Group Description:

Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.

Participants will receive rucaparib plus nivolumab in 4 week cycles.

Rucaparib: 600 mg taken by mouth twice daily.

Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: percentage of participants
50
2.Primary Outcome
Title Frequency of Patients With T Cell Inflammation in the Tumor Compared Between Treatment Arms (Phase 2)
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled in Phase 2 cohort.
Arm/Group Title Combination Therapy (Phase 1 Cohort)
Hide Arm/Group Description:

Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.

Participants will receive rucaparib plus nivolumab in 4 week cycles.

Rucaparib: 600 mg taken by mouth twice daily.

Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Time to Disease Progression in Prostate Cancer Patients (Phase 2)
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled in Phase 2 cohort.
Arm/Group Title Combination Therapy (Phase 1 Cohort)
Hide Arm/Group Description:

Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.

Participants will receive rucaparib plus nivolumab in 4 week cycles.

Rucaparib: 600 mg taken by mouth twice daily.

Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Time to Disease Progression in Endometrial Cancer Patients (Phase 2)
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled in Phase 2 cohort.
Arm/Group Title Combination Therapy (Phase 1 Cohort)
Hide Arm/Group Description:

Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.

Participants will receive rucaparib plus nivolumab in 4 week cycles.

Rucaparib: 600 mg taken by mouth twice daily.

Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Response Rate in Prostate Cancer Patients (Phase 2)
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled in Phase 2 cohort.
Arm/Group Title Combination Therapy (Phase 1 Cohort)
Hide Arm/Group Description:

Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.

Participants will receive rucaparib plus nivolumab in 4 week cycles.

Rucaparib: 600 mg taken by mouth twice daily.

Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Response Rate in Endometrial Cancer Patients (Phase 2)
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled in Phase 2 cohort.
Arm/Group Title Combination Therapy (Phase 1 Cohort)
Hide Arm/Group Description:

Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.

Participants will receive rucaparib plus nivolumab in 4 week cycles.

Rucaparib: 600 mg taken by mouth twice daily.

Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Changes in Number of T Cells in Tumor Samples Compared Between Treatment Arms (Phase 2)
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled in Phase 2 cohort.
Arm/Group Title Combination Therapy (Phase 1 Cohort)
Hide Arm/Group Description:

Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.

Participants will receive rucaparib plus nivolumab in 4 week cycles.

Rucaparib: 600 mg taken by mouth twice daily.

Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Correlation of Change in T Cells in Tumor Samples and PTEN Mutation Status (Phase 2)
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled in Phase 2 cohort.
Arm/Group Title Combination Therapy (Phase 1 Cohort)
Hide Arm/Group Description:

Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.

Participants will receive rucaparib plus nivolumab in 4 week cycles.

Rucaparib: 600 mg taken by mouth twice daily.

Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data were collected up to 28 days after the end of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Combination Therapy (Phase 1 Cohort)
Hide Arm/Group Description

Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.

Participants will receive rucaparib plus nivolumab in 4 week cycles.

Rucaparib: 600 mg taken by mouth twice daily.

Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.

All-Cause Mortality
Combination Therapy (Phase 1 Cohort)
Affected / at Risk (%)
Total   7/12 (58.33%) 
Hide Serious Adverse Events
Combination Therapy (Phase 1 Cohort)
Affected / at Risk (%)
Total   4/12 (33.33%) 
Blood and lymphatic system disorders   
anemia   1/12 (8.33%) 
Gastrointestinal disorders   
Abdominal pain   1/12 (8.33%) 
nausea   1/12 (8.33%) 
vomiting   1/12 (8.33%) 
diarrhea   1/12 (8.33%) 
General disorders   
death   1/12 (8.33%) 
Metabolism and nutrition disorders   
anorexia   1/12 (8.33%) 
Nervous system disorders   
neoplasms benign, malignant and unspecified   1/12 (8.33%) 
Renal and urinary disorders   
acute kidney injury   1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Hypoxia   1/12 (8.33%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Combination Therapy (Phase 1 Cohort)
Affected / at Risk (%)
Total   12/12 (100.00%) 
Blood and lymphatic system disorders   
Anemia   8/12 (66.67%) 
Gastrointestinal disorders   
Abdominal pain   1/12 (8.33%) 
Constipation   1/12 (8.33%) 
Diarrhea   1/12 (8.33%) 
Dyspepsia   1/12 (8.33%) 
Esophageal obstruction   1/12 (8.33%) 
Nausea   7/12 (58.33%) 
Vomiting   2/12 (16.67%) 
General disorders   
Edema limbs   2/12 (16.67%) 
Fatigue   7/12 (58.33%) 
Pain   2/12 (16.67%) 
Investigations   
Alanine aminotransferase increased   8/12 (66.67%) 
Alkaline phosphatase increased   5/12 (41.67%) 
Aspartate aminotransferase increased   8/12 (66.67%) 
Creatinine increased   2/12 (16.67%) 
Lymphocyte count decreased   4/12 (33.33%) 
Lymphocyte count increased   1/12 (8.33%) 
Neutrophil count decreased   2/12 (16.67%) 
Platelet count decreased   5/12 (41.67%) 
Weight loss   4/12 (33.33%) 
White blood cell decreased   1/12 (8.33%) 
Metabolism and nutrition disorders   
Anorexia   9/12 (75.00%) 
Hyperglycemia   1/12 (8.33%) 
Hyperkalemia   1/12 (8.33%) 
Musculoskeletal and connective tissue disorders   
Arthralgia   2/12 (16.67%) 
Generalized muscle weakness   2/12 (16.67%) 
Pain in extremity   1/12 (8.33%) 
Nervous system disorders   
Dizziness   1/12 (8.33%) 
Dysgeusia   2/12 (16.67%) 
Peripheral sensory neuropathy   1/12 (8.33%) 
Renal and urinary disorders   
Acute kidney injury   1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders   
Cough   1/12 (8.33%) 
Dyspnea   1/12 (8.33%) 
Hypoxia   1/12 (8.33%) 
Skin and subcutaneous tissue disorders   
Pruritus   1/12 (8.33%) 
Rash maculo-papular   1/12 (8.33%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Walter STadler
Organization: University of Chicago
Phone: 773-702-4150
EMail: wstadler@medicine.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03572478    
Other Study ID Numbers: IRB18-0154
First Submitted: June 19, 2018
First Posted: June 28, 2018
Results First Submitted: January 26, 2021
Results First Posted: February 12, 2021
Last Update Posted: March 9, 2021