Trial Outcomes & Findings for A Study of Rucaparib and Nivolumab in People With Leiomyosarcoma (NCT NCT04624178)
NCT ID: NCT04624178
Last Updated: 2026-07-17
Results Overview
as assessed by RECIST 1.1
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
by 24 weeks
Results posted on
2026-07-17
Participant Flow
Participant milestones
| Measure |
Rucaparib in Combination With Nivolumab
One treatment cycle will consist of 28 days. Patients will receive rucaparib at 600 mg, orally, twice daily, continuously for 28 days. They will receive 480mg of nivolumab intravenously on day 1 of every four-week cycle. This is the recommended phase II dose of the combination therapy. Re-staging scans will be performed every 8 weeks.
Treatment will be repeated until the patient develops progressive disease or unacceptable toxicity or for a maximum duration of 26 cycles as long as patients are receiving benefit from treatment, have not had disease progression, met any criteria for study withdrawal and are tolerating therapy.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Rucaparib and Nivolumab in People With Leiomyosarcoma
Baseline characteristics by cohort
| Measure |
Rucaparib in Combination With Nivolumab
n=20 Participants
One treatment cycle will consist of 28 days. Patients will receive rucaparib at 600 mg, orally, twice daily, continuously for 28 days. They will receive 480mg of nivolumab intravenously on day 1 of every four-week cycle. This is the recommended phase II dose of the combination therapy. Re-staging scans will be performed every 8 weeks.
Treatment will be repeated until the patient develops progressive disease or unacceptable toxicity or for a maximum duration of 26 cycles as long as patients are receiving benefit from treatment, have not had disease progression, met any criteria for study withdrawal and are tolerating therapy.
|
|---|---|
|
Age, Continuous
|
58 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: by 24 weeksas assessed by RECIST 1.1
Outcome measures
| Measure |
Rucaparib in Combination With Nivolumab
n=20 Participants
One treatment cycle will consist of 28 days. Patients will receive rucaparib at 600 mg, orally, twice daily, continuously for 28 days. They will receive 480mg of nivolumab intravenously on day 1 of every four-week cycle. This is the recommended phase II dose of the combination therapy. Re-staging scans will be performed every 8 weeks.
Treatment will be repeated until the patient develops progressive disease or unacceptable toxicity or for a maximum duration of 26 cycles as long as patients are receiving benefit from treatment, have not had disease progression, met any criteria for study withdrawal and are tolerating therapy.
|
|---|---|
|
Best Objective Response Rate
|
5 percentage of participants
Interval 0.0 to 25.0
|
SECONDARY outcome
Timeframe: at 24 weeksPFS is defined as the period from start of study treatment until recurrent or progressive of disease (POD) is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death, or date of last study visit involving assessment of disease status.
Outcome measures
| Measure |
Rucaparib in Combination With Nivolumab
n=20 Participants
One treatment cycle will consist of 28 days. Patients will receive rucaparib at 600 mg, orally, twice daily, continuously for 28 days. They will receive 480mg of nivolumab intravenously on day 1 of every four-week cycle. This is the recommended phase II dose of the combination therapy. Re-staging scans will be performed every 8 weeks.
Treatment will be repeated until the patient develops progressive disease or unacceptable toxicity or for a maximum duration of 26 cycles as long as patients are receiving benefit from treatment, have not had disease progression, met any criteria for study withdrawal and are tolerating therapy.
|
|---|---|
|
Progression Free Survival (PFS)
|
7.8 weeks
Interval 6.7 to 15.0
|
Adverse Events
Rucaparib in Combination With Nivolumab
Serious events: 5 serious events
Other events: 19 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Rucaparib in Combination With Nivolumab
n=20 participants at risk
One treatment cycle will consist of 28 days. Patients will receive rucaparib at 600 mg, orally, twice daily, continuously for 28 days. They will receive 480mg of nivolumab intravenously on day 1 of every four-week cycle. This is the recommended phase II dose of the combination therapy. Re-staging scans will be performed every 8 weeks.
Treatment will be repeated until the patient develops progressive disease or unacceptable toxicity or for a maximum duration of 26 cycles as long as patients are receiving benefit from treatment, have not had disease progression, met any criteria for study withdrawal and are tolerating therapy.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
5.0%
1/20 • 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • 24 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
1/20 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • 24 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
2/20 • 24 weeks
|
|
Investigations
Neutrophil count decreased
|
5.0%
1/20 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
1/20 • 24 weeks
|
|
Investigations
White blood cell decreased
|
5.0%
1/20 • 24 weeks
|
Other adverse events
| Measure |
Rucaparib in Combination With Nivolumab
n=20 participants at risk
One treatment cycle will consist of 28 days. Patients will receive rucaparib at 600 mg, orally, twice daily, continuously for 28 days. They will receive 480mg of nivolumab intravenously on day 1 of every four-week cycle. This is the recommended phase II dose of the combination therapy. Re-staging scans will be performed every 8 weeks.
Treatment will be repeated until the patient develops progressive disease or unacceptable toxicity or for a maximum duration of 26 cycles as long as patients are receiving benefit from treatment, have not had disease progression, met any criteria for study withdrawal and are tolerating therapy.
|
|---|---|
|
Endocrine disorders
Hypothyroidism
|
10.0%
2/20 • 24 weeks
|
|
Gastrointestinal disorders
Mucositis oral
|
5.0%
1/20 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
40.0%
8/20 • 24 weeks
|
|
Investigations
Neutrophil count decreased
|
10.0%
2/20 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • 24 weeks
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • 24 weeks
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
5.0%
1/20 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
2/20 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
2/20 • 24 weeks
|
|
Infections and infestations
Thrush
|
5.0%
1/20 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
5/20 • 24 weeks
|
|
Investigations
Weight loss
|
5.0%
1/20 • 24 weeks
|
|
Investigations
White blood cell decreased
|
20.0%
4/20 • 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
2/20 • 24 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
6/20 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • 24 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
5/20 • 24 weeks
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • 24 weeks
|
|
General disorders
Chills
|
5.0%
1/20 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • 24 weeks
|
|
Investigations
Creatinine increased
|
20.0%
4/20 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
35.0%
7/20 • 24 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
2/20 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.0%
1/20 • 24 weeks
|
|
Nervous system disorders
Dysgeusia
|
30.0%
6/20 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
2/20 • 24 weeks
|
|
General disorders
Edema face
|
5.0%
1/20 • 24 weeks
|
|
General disorders
Fatigue
|
45.0%
9/20 • 24 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
2/20 • 24 weeks
|
|
General disorders
Fever
|
10.0%
2/20 • 24 weeks
|
|
General disorders
Flu like symptoms
|
10.0%
2/20 • 24 weeks
|
|
Nervous system disorders
Headache
|
15.0%
3/20 • 24 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
5.0%
1/20 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
1/20 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
4/20 • 24 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • 24 weeks
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
4/20 • 24 weeks
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
4/20 • 24 weeks
|
Additional Information
Dr. Sujana Movva, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-6787
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place