Trial Outcomes & Findings for Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous NSCLC (NCT NCT04925986)
NCT ID: NCT04925986
Last Updated: 2025-04-17
Results Overview
The Objective Response Rate (ORR): The primary endpoint for this study will be ORR as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in the main study population. Presented are counts of participants in the following RECIST categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
up to 267 days
Results posted on
2025-04-17
Participant Flow
Participant milestones
| Measure |
Group 1A: PD-L1 1-49%, Main Study Population
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Group 1B: PD-L1 1-49%, Pembrolizumab run-in Population
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Group 2A: PD-L1 ≥ 50%, Main Study Population
Participants with PD-L1 Tumor Proportion Score (TPS) ≥ 50% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Group 2B: PD-L1 ≥ 50%, Pembrolizumab run-in Population
Participants with PD-L1 Tumor Proportion Score (TPS) ≥ 50% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
3
|
3
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
3
|
Reasons for withdrawal
| Measure |
Group 1A: PD-L1 1-49%, Main Study Population
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Group 1B: PD-L1 1-49%, Pembrolizumab run-in Population
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Group 2A: PD-L1 ≥ 50%, Main Study Population
Participants with PD-L1 Tumor Proportion Score (TPS) ≥ 50% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Group 2B: PD-L1 ≥ 50%, Pembrolizumab run-in Population
Participants with PD-L1 Tumor Proportion Score (TPS) ≥ 50% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
2
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
2
|
Baseline Characteristics
Sitravatinib Plus Pembrolizumab in Patients With Advanced Treatment-Naïve PD-L1+ Non-Squamous NSCLC
Baseline characteristics by cohort
| Measure |
Sitravatinib: Group 1A
n=1 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2A
n=3 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib Group 1B
n=2 Participants
Participants with receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib Group 2B
n=3 Participants
Participants with receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
3 participants
n=4 Participants
|
9 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 267 daysPopulation: Participants available for assessment.
The Objective Response Rate (ORR): The primary endpoint for this study will be ORR as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in the main study population. Presented are counts of participants in the following RECIST categories: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD)
Outcome measures
| Measure |
Sitravatinib: Group 1A
n=1 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2A
n=2 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 1B
n=2 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2B
n=3 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
|---|---|---|---|---|
|
Objective Response Rate (ORR)
Complete Response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Objective Response Rate (ORR)
Partial Response (PR)
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Objective Response Rate (ORR)
Stable Disease (SD)
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Objective Response Rate (ORR)
Progressive Disease (PD)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: until death or date of last contact, up to 2 yearsPopulation: Only patients who met the eligibility criteria were analyzed.
Overall Survival (OS) in the main study populations (ie groups 1A and 2A) is a secondary endpoint for this study. OS in groups 1B and 2B is an exploratory endpoint. Defined as the time from date of treatment start to death due to any cause
Outcome measures
| Measure |
Sitravatinib: Group 1A
n=1 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2A
n=3 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 1B
Participants receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2B
Participants receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
246 days
Due to insufficient number of participants with events, confidence intervals could not be calculated.
|
210 days
Interval 24.0 to
Due to insufficient number of participants with events, upper limit could not be calculated.
|
—
|
—
|
SECONDARY outcome
Timeframe: Until progressive disease, death, or last contact, up to 2 yearsPopulation: Only patients who met the eligibility criteria were analyzed.
Progression Free Survival (PFS) in the main study populations (ie groups 1A and 2A) is a secondary endpoint for this study. PFS in groups 1B and 2B is an exploratory endpoint. Defined as time from first dose to first progressive disease (PD) or death due to any cause in the absence of documented PD.
Outcome measures
| Measure |
Sitravatinib: Group 1A
n=1 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2A
n=3 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 1B
Participants receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2B
Participants receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
246 days
Due to insufficient number of participants with events, confidence intervals could not be calculated.
|
210 days
Interval 24.0 to
Due to insufficient number of participants with events, upper limit could not be calculated.
|
—
|
—
|
SECONDARY outcome
Timeframe: Until progressive disease, death, or last contact, up to 2 yearsPopulation: Data for this outcome was not collected as there were no patients that met criteria for CR or PR.
Duration of Response (DOR) for patients in Group A is a secondary endpoints for this study; DOR for Group B is an exploratory endpoint. Defined as time that measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented or to death due to any cause in the absence of documented PD.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Only patients who met the eligibility criteria were analyzed. For paricipants in Group 2A, 2 had confirmed SD and 1 was unevaluable.
Clinical Benefit Rate (CBR) in Group A is a secondary endpoints for this study, while CBR in Group B is an exploratory endpoint. Defined as percent of patients documented to have a confirmed Complete Response (CR), confirmed Partial Response (PR), or Stable Disease (SD) documented on at least 1 on-study assessment and including at least 5 weeks on study
Outcome measures
| Measure |
Sitravatinib: Group 1A
n=1 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2A
n=3 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 1B
Participants receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2B
Participants receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
|---|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
100 percentage of participants
|
66.7 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearsEvaluation of the safety and toxicity profile of the combination of sitravatinib and pembrolizumab in the first-line treatment of patients with non-squamous metastatic NSCLC is a secondary objective in this study. Secondary endpoint is adverse events as per CTCAE v.5. The Safety population is defined as all patients who received any dose of study treatment (i.e., sitravatinib and/or pembrolizumab) and will be used for all safety analyses. Number of participants that experienced at least 1 adverse event.
Outcome measures
| Measure |
Sitravatinib: Group 1A
n=1 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2A
n=3 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 1B
n=2 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2B
n=3 Participants
Participants receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
|---|---|---|---|---|
|
Number of Participants That Experienced at Least 1 Adverse Event
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
Adverse Events
Sitravatinib: Group 1A
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Sitravatinib: Group 2A
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Sitravatinib: Group 1B
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Sitravatinib: Group 2B
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sitravatinib: Group 1A
n=1 participants at risk
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2A
n=3 participants at risk
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 1B
n=2 participants at risk
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2B
n=3 participants at risk
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
100.0%
1/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Nervous system disorders
Subarachnoid bleeding
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
100.0%
2/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Vascular disorders
Thromboembolic event
|
100.0%
1/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
100.0%
1/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
Other adverse events
| Measure |
Sitravatinib: Group 1A
n=1 participants at risk
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2A
n=3 participants at risk
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily, beginning on cycle 1 day 1 (C1D1).
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 1B
n=2 participants at risk
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
Sitravatinib: Group 2B
n=3 participants at risk
Participants with PD-L1 Tumor Proportion Score (TPS) 1-49% receive Pembrolizumab 200mg intravenous (IV) for one dose alone, beginning on cycle 1 day 1 (C1D1). On Cycle 2 Day 1 (C2D1), participants receive Pembrolizumab 200mg intravenous (IV) once every 3 weeks (Q3w) and Sitravatinib 100mg PO (by mouth) daily.
Sitravatinib: Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
Pembrolizumab: All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
Eye disorders
Double vision
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Gastrointestinal disorders
Constipation
|
100.0%
1/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
100.0%
3/3 • Up to 450 days
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Gastrointestinal disorders
Mucositis, oral
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
100.0%
2/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
100.0%
2/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
General disorders
Chest pain
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
General disorders
Chills
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
General disorders
Edema of limbs
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
General disorders
Facial pain
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
General disorders
Fatigue
|
0.00%
0/1 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
100.0%
2/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
General disorders
Gait disturbance
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
General disorders
Pain
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Infections and infestations
Laryngitis
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Infections and infestations
Lung infection
|
0.00%
0/1 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Infections and infestations
Rash
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
100.0%
2/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
Investigations
ALT increased
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
Investigations
AST increased
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
Investigations
Creatinine increased
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Investigations
QTc prolongation
|
100.0%
1/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Investigations
Free T4 increased
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Investigations
Hemoglobin increased
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Investigations
LDH increased
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Investigations
Platelet count decreased
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Investigations
Urine ketone elevated
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Investigations
WBC elevated
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Investigations
Weight loss
|
0.00%
0/1 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
1/1 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
100.0%
1/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Nervous system disorders
Ataxia
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
100.0%
2/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Nervous system disorders
Seizure
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Nervous system disorders
Subarachnoid Bleeding
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Nervous system disorders
Transient Ischemic Attack
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Psychiatric disorders
Confusion
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Psychiatric disorders
Depression
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Renal and urinary disorders
Bactiuria
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
Renal and urinary disorders
Leukocytes in Urine
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Skin and subcutaneous tissue disorders
Alopeica
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Skin and subcutaneous tissue disorders
Eyelashes Loss
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Skin and subcutaneous tissue disorders
Hair Texture Abnormal
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
Skin and subcutaneous tissue disorders
Rash Maculopapular
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
100.0%
2/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Vascular disorders
Hematoma
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
66.7%
2/3 • Up to 450 days
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
0.00%
0/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Vascular disorders
Raynaud's Syndrome
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
|
Vascular disorders
Thromboembolic Event
|
100.0%
1/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
33.3%
1/3 • Up to 450 days
|
|
Vascular disorders
Vasculitis
|
0.00%
0/1 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
50.0%
1/2 • Up to 450 days
|
0.00%
0/3 • Up to 450 days
|
Additional Information
Sarah Goldberg, MD, MPH: Associate Professor of Internal Medicine (Medical Oncology)
Yale School of Medicine
Phone: (203) 200-5864
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place