Trial Outcomes & Findings for Phase Ib of L-NMMA and Pembrolizumab (NCT NCT03236935)
NCT ID: NCT03236935
Last Updated: 2026-04-09
Results Overview
Assess the MTD of L-NMMA in combination with pembrolizumab
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
18 weeks
Results posted on
2026-04-09
Participant Flow
The first patient was enrolled and started treatment on 8/27/2018. The last patient was enrolled and started treatment on 11/15/2021.
12 patients met eligibility criteria, consented, and were enrolled onto the study.
Participant milestones
| Measure |
L-NMMA Dose Level -1, 12.5 mg/kg
Cohort -1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 12.5 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor
Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 0 (Starting Dose), 15.0 mg/kg
Cohort 0: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 15.0 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor
Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 1, 20 mg/kg
Cohort 1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor
Pembrolizumab: PD-1 inhibitor
|
|---|---|---|---|
|
Overall Study
STARTED
|
0
|
5
|
7
|
|
Overall Study
COMPLETED
|
0
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
4
|
Reasons for withdrawal
| Measure |
L-NMMA Dose Level -1, 12.5 mg/kg
Cohort -1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 12.5 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor
Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 0 (Starting Dose), 15.0 mg/kg
Cohort 0: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 15.0 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor
Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 1, 20 mg/kg
Cohort 1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor
Pembrolizumab: PD-1 inhibitor
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
1
|
|
Overall Study
Unavailability of LNMMA
|
0
|
0
|
2
|
Baseline Characteristics
Phase Ib of L-NMMA and Pembrolizumab
Baseline characteristics by cohort
| Measure |
L-NMMA Dose Level -1, 12.5 mg/kg
Cohort -1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 12.5 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 0 (Starting Dose), 15.0 mg/kg
n=5 Participants
Cohort 0: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 15.0 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 1, 20 mg/kg
n=7 Participants
Cohort 1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=36 Participants
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=36 Participants
|
4 Participants
n=78 Participants
|
3 Participants
n=23 Participants
|
7 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=36 Participants
|
1 Participants
n=78 Participants
|
4 Participants
n=23 Participants
|
5 Participants
n=23 Participants
|
|
Age, Continuous
|
—
|
62 years
n=78 Participants
|
66 years
n=23 Participants
|
64 years
n=23 Participants
|
|
Sex: Female, Male
Female
|
—
|
1 Participants
n=78 Participants
|
2 Participants
n=23 Participants
|
3 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
—
|
4 Participants
n=78 Participants
|
5 Participants
n=23 Participants
|
9 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
5 Participants
n=78 Participants
|
7 Participants
n=23 Participants
|
12 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
1 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
1 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
1 Participants
n=78 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
—
|
3 Participants
n=78 Participants
|
6 Participants
n=23 Participants
|
9 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=78 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
—
|
5 Participants
n=78 Participants
|
7 Participants
n=23 Participants
|
12 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: 18 weeksAssess the MTD of L-NMMA in combination with pembrolizumab
Outcome measures
| Measure |
L-NMMA Plus Pembrolizumab
n=12 Participants
L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. The dose levels of L-NMMA are as follows: Dose Level -1, 12.5 mg/kg; Dose Level 0 (starting dose), 15.0 mg/kg; and Dose Level 1, 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor
Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 0 (Starting Dose), 15.0 mg/kg
Cohort 0: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 15.0 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 1, 20 mg/kg
Cohort 1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
20 mg/kg
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: There were no patients on dose level -1, which is why the number of participants analyzed is 0. The reason the overall number of participants stated in participant flow is because each row analyzes all participants, instead of participants being split up between each row.
Describe the DLTs and other adverse events associated with the combination of L-NMMA and pembrolizumab, as assessed by the Common Terminology Criteria for Adverse Events V4.03. Patients with any AE is capturing any patient that has had an adverse event on the trial. Patients with grade 3 AE, is capturing the number of patients that were hospitalized due to an adverse event. Patients with grade 4 AE, is capturing the number of patients that experienced a life threataning Adverse event on the trial. Patients with at least 1 DLT is capturing how many patients experienced at least one Dose Limiting Toxicity on the trial. Lower numbers in each row is the better outcome.
Outcome measures
| Measure |
L-NMMA Plus Pembrolizumab
L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. The dose levels of L-NMMA are as follows: Dose Level -1, 12.5 mg/kg; Dose Level 0 (starting dose), 15.0 mg/kg; and Dose Level 1, 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor
Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 0 (Starting Dose), 15.0 mg/kg
n=5 Participants
Cohort 0: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 15.0 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 1, 20 mg/kg
n=7 Participants
Cohort 1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
|---|---|---|---|
|
Dose-limiting Toxicities (DLTs) and Other Adverse Events
Number of Patients with AE of any grade
|
—
|
3 Participants
|
6 Participants
|
|
Dose-limiting Toxicities (DLTs) and Other Adverse Events
Number of Patients with AE of grade 3
|
—
|
1 Participants
|
3 Participants
|
|
Dose-limiting Toxicities (DLTs) and Other Adverse Events
Number of Patients with AE of grade 4
|
—
|
0 Participants
|
0 Participants
|
|
Dose-limiting Toxicities (DLTs) and Other Adverse Events
Number of Patients that experienced at least 1 DLT
|
—
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 18 weeksDetermine the RP2D of L-NMMA in combination with pembrolizumab based on the occurrence of DLTs and MTD determination
Outcome measures
| Measure |
L-NMMA Plus Pembrolizumab
n=12 Participants
L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. The dose levels of L-NMMA are as follows: Dose Level -1, 12.5 mg/kg; Dose Level 0 (starting dose), 15.0 mg/kg; and Dose Level 1, 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor
Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 0 (Starting Dose), 15.0 mg/kg
Cohort 0: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 15.0 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 1, 20 mg/kg
Cohort 1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
|---|---|---|---|
|
Recommended Phase 2 Dose (RP2D) of L-NMMA in Combination With Pembrolizumab
|
20 mg/kg
|
—
|
—
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: There were no patients on dose level -1, which is why the number of participants analyzed is 0.
Assess the antitumor activity of L-NMMA in combination with pembrolizumab, as assessed by the RECIST 1.1
Outcome measures
| Measure |
L-NMMA Plus Pembrolizumab
L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. The dose levels of L-NMMA are as follows: Dose Level -1, 12.5 mg/kg; Dose Level 0 (starting dose), 15.0 mg/kg; and Dose Level 1, 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor
Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 0 (Starting Dose), 15.0 mg/kg
n=5 Participants
Cohort 0: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 15.0 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 1, 20 mg/kg
n=6 Participants
Cohort 1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
|---|---|---|---|
|
Antitumor Activity
Complete Response
|
—
|
1 Participants
|
1 Participants
|
|
Antitumor Activity
Partial Response
|
—
|
1 Participants
|
1 Participants
|
|
Antitumor Activity
Stable Disease
|
—
|
0 Participants
|
3 Participants
|
|
Antitumor Activity
Progressive Disease
|
—
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: Only participants on Dose level 1 were assessed for PK assessments.
Measure plasma concentrations of L-NMMA when combined with pembrolizumab over time
Outcome measures
| Measure |
L-NMMA Plus Pembrolizumab
L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. The dose levels of L-NMMA are as follows: Dose Level -1, 12.5 mg/kg; Dose Level 0 (starting dose), 15.0 mg/kg; and Dose Level 1, 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor
Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 0 (Starting Dose), 15.0 mg/kg
Cohort 0: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 15.0 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 1, 20 mg/kg
n=3 Participants
Cohort 1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
|---|---|---|---|
|
Plasma Concentrations of L-NMMA When Combined With Pembrolizumab
Baseline
|
—
|
—
|
7.083 uM
Standard Deviation 4.767
|
|
Plasma Concentrations of L-NMMA When Combined With Pembrolizumab
End of Treatment
|
—
|
—
|
4.104 uM
Standard Deviation 1.886
|
Adverse Events
L-NMMA Dose Level -1, 12.5 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
L-NMMA Dose Level 0 (Starting Dose), 15.0 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
L-NMMA Dose Level 1, 20 mg/kg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
L-NMMA Dose Level -1, 12.5 mg/kg
Cohort -1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 12.5 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 0 (Starting Dose), 15.0 mg/kg
n=5 participants at risk
Cohort 0: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 15.0 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 1, 20 mg/kg
n=7 participants at risk
Cohort 1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
|---|---|---|---|
|
General disorders
Fever
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
20.0%
1/5 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/7 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Vascular disorders
Thromboembolic Event
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/5 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/5 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
Other adverse events
| Measure |
L-NMMA Dose Level -1, 12.5 mg/kg
Cohort -1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 12.5 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 0 (Starting Dose), 15.0 mg/kg
n=5 participants at risk
Cohort 0: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 15.0 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
L-NMMA Dose Level 1, 20 mg/kg
n=7 participants at risk
Cohort 1: L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. L-NMMA Dose will be 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
L-NMMA: pan-nitric oxide synthase inhibitor Pembrolizumab: PD-1 inhibitor
|
|---|---|---|---|
|
General disorders
Fatigue
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
60.0%
3/5 • Number of events 3 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Blood and lymphatic system disorders
Anemia
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/5 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Gastrointestinal disorders
Abdominal Pain
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
20.0%
1/5 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/7 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Gastrointestinal disorders
Constipation
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
20.0%
1/5 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
General disorders
Chills
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/5 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
General disorders
Fever
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/5 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Infections and infestations
Mucosal Infection
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
20.0%
1/5 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/7 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Infections and infestations
Papulopustular Rash
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/5 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/5 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 3 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/5 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/5 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
40.0%
2/5 • Number of events 2 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/7 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/5 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
20.0%
1/5 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/7 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Nervous system disorders
Headache
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
20.0%
1/5 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/7 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/5 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Vascular disorders
Thromboembolic Event
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/5 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Injury, poisoning and procedural complications
Left knee laceration due to chainsaw injury
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
20.0%
1/5 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/7 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/5 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
14.3%
1/7 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
20.0%
1/5 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/7 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
20.0%
1/5 • Number of events 1 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/7 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
|
Vascular disorders
Hypertension
|
—
0/0 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
0.00%
0/5 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
28.6%
2/7 • Number of events 4 • Per protocol, Adverse events were collected from time of informed consent through cessation of treatment, which is up to 21 weeks for Screening procedures and 6 cycles of treatment.
The dose was not de-escalated to Dose level -1, no patients were on that arm/dose/cohort
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place