Trial Outcomes & Findings for Pevonedistat and Pembrolizumab for the Treatment of dMMR/MSI-H Metastatic or Locally Advanced Unresectable Solid Tumor (NCT NCT04800627)
NCT ID: NCT04800627
Last Updated: 2022-12-27
Results Overview
TERMINATED
PHASE1/PHASE2
2 participants
21 days
2022-12-27
Participant Flow
Company stopped development of the drug and shut down the entire program with pevonedistat. Takeda had a negative phase III of the agent in liquid tumors and thus shut the program. It was not due to any toxicity, but lack of path for FDA indication.
Participant milestones
| Measure |
Treatment (Pevonedistat, Pembrolizumab)
Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pevonedistat and Pembrolizumab for the Treatment of dMMR/MSI-H Metastatic or Locally Advanced Unresectable Solid Tumor
Baseline characteristics by cohort
| Measure |
Treatment (Pevonedistat, Pembrolizumab)
n=2 Participants
Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5, and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: No data collected due to early termination of the protocol.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: No data collected due to early termination of the protocol.
Will be assessed by immune modified Response Evaluation Criteria in Solid Tumors (iRECIST) version (v) 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: No data collected due to early termination of the protocol.
Will analyze the pharmacodynamics impact of pevonedistat by evaluating changes in protein misfolding between pre-treatment and on-treatment tumor biopsies.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: No data collected due to early termination of the protocol.
Will be assessed by iRECIST v1.1. Will be estimated using the method of Kaplan and Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: No data collected due to early termination of the protocol.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: No data collected due to early termination of the protocol.
Will be estimated using the method of Kaplan and Meier.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: No data collected due to early termination of the protocol.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Pevonedistat, Pembrolizumab)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michael Overman,MD- Assoc VP, CN Research, SVP, Cancer NW Clin & Acad Dev
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place