Trial Outcomes & Findings for Talazoparib and Avelumab in Participants With Metastatic Renal Cell Carcinoma (NCT NCT04068831)
NCT ID: NCT04068831
Last Updated: 2024-12-27
Results Overview
confirmed complete response (iCR) or partial response (iPR) assessed by iRECIST.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
4 months
Results posted on
2024-12-27
Participant Flow
Participant milestones
| Measure |
Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual)
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Talazoparib: 1 mg talazoparib daily
Avelumab: 800 mg avelumab every 2 weeks
|
Talazoparib and Avelumab (FH- or SDH-deficiency)
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Talazoparib: 1 mg talazoparib daily
Avelumab: 800 mg avelumab every 2 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
Reasons for withdrawal
| Measure |
Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual)
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Talazoparib: 1 mg talazoparib daily
Avelumab: 800 mg avelumab every 2 weeks
|
Talazoparib and Avelumab (FH- or SDH-deficiency)
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Talazoparib: 1 mg talazoparib daily
Avelumab: 800 mg avelumab every 2 weeks
|
|---|---|---|
|
Overall Study
Disease Progression
|
10
|
8
|
Baseline Characteristics
Talazoparib and Avelumab in Participants With Metastatic Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual)
n=10 Participants
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Talazoparib: 1 mg talazoparib daily
Avelumab: 800 mg avelumab every 2 weeks
|
Talazoparib and Avelumab (FH- or SDH-deficiency)
n=8 Participants
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Talazoparib: 1 mg talazoparib daily
Avelumab: 800 mg avelumab every 2 weeks
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
40 years
n=7 Participants
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsconfirmed complete response (iCR) or partial response (iPR) assessed by iRECIST.
Outcome measures
| Measure |
Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual)
n=10 Participants
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Talazoparib: 1 mg talazoparib daily
Avelumab: 800 mg avelumab every 2 weeks
|
Talazoparib and Avelumab (FH- or SDH-deficiency)
n=8 Participants
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Talazoparib: 1 mg talazoparib daily
Avelumab: 800 mg avelumab every 2 weeks
|
|---|---|---|
|
the Objective Response Rate (ORR)
Pts with ORR
|
0 Participants
|
0 Participants
|
|
the Objective Response Rate (ORR)
Pts without ORR
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 2 yearsby RECIST v1.1
Outcome measures
| Measure |
Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual)
n=10 Participants
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Talazoparib: 1 mg talazoparib daily
Avelumab: 800 mg avelumab every 2 weeks
|
Talazoparib and Avelumab (FH- or SDH-deficiency)
n=8 Participants
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Talazoparib: 1 mg talazoparib daily
Avelumab: 800 mg avelumab every 2 weeks
|
|---|---|---|
|
Progression-free Survival (PFS)
|
3.5 months
Interval 1.0 to 3.9
|
1.2 months
Interval 0.4 to 2.9
|
Adverse Events
Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 9 deaths
Talazoparib and Avelumab (FH- or SDH-deficiency)
Serious events: 5 serious events
Other events: 8 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual)
n=10 participants at risk
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Talazoparib: 1 mg talazoparib daily
Avelumab: 800 mg avelumab every 2 weeks
|
Talazoparib and Avelumab (FH- or SDH-deficiency)
n=8 participants at risk
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Talazoparib: 1 mg talazoparib daily
Avelumab: 800 mg avelumab every 2 weeks
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
10.0%
1/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
1/10 • 2 years
|
37.5%
3/8 • 2 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
10.0%
1/10 • 2 years
|
0.00%
0/8 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
General disorders
Fatigue
|
0.00%
0/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Investigations
Platelet count decrease
|
0.00%
0/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
General disorders
Chills
|
0.00%
0/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
10.0%
1/10 • 2 years
|
0.00%
0/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • 2 years
|
0.00%
0/8 • 2 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Renal and urinary disorders
Acute Kidney Pain
|
0.00%
0/10 • 2 years
|
12.5%
1/8 • 2 years
|
Other adverse events
| Measure |
Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual)
n=10 participants at risk
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Talazoparib: 1 mg talazoparib daily
Avelumab: 800 mg avelumab every 2 weeks
|
Talazoparib and Avelumab (FH- or SDH-deficiency)
n=8 participants at risk
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Talazoparib: 1 mg talazoparib daily
Avelumab: 800 mg avelumab every 2 weeks
|
|---|---|---|
|
General disorders
Fatigue
|
60.0%
6/10 • 2 years
|
75.0%
6/8 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
30.0%
3/10 • 2 years
|
37.5%
3/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
3/10 • 2 years
|
37.5%
3/8 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • 2 years
|
25.0%
2/8 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • 2 years
|
37.5%
3/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • 2 years
|
25.0%
2/8 • 2 years
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • 2 years
|
25.0%
2/8 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • 2 years
|
25.0%
2/8 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain
|
20.0%
2/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Investigations
Creatinine increased
|
20.0%
2/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo popular
|
20.0%
2/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Investigations
Platelet count decrease
|
10.0%
1/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/10 • 2 years
|
12.5%
1/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
10.0%
1/10 • 2 years
|
0.00%
0/8 • 2 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
10.0%
1/10 • 2 years
|
0.00%
0/8 • 2 years
|
|
Cardiac disorders
Heart failure
|
10.0%
1/10 • 2 years
|
0.00%
0/8 • 2 years
|
|
Investigations
Neutrophil count decreased
|
10.0%
1/10 • 2 years
|
0.00%
0/8 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • 2 years
|
0.00%
0/8 • 2 years
|
|
Vascular disorders
Thromboembolic event
|
10.0%
1/10 • 2 years
|
0.00%
0/8 • 2 years
|
Additional Information
Dr. Ritesh Kotecha, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-422-4791
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place