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PD-1 Inhibitor

Pembrolizumab for Solid Tumors

Phase 1 & 2
Waitlist Available
Led By Michael J Overman
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing pevonedistat + pembrolizumab to see if it is more effective than pembrolizumab alone in treating patients with mismatch repair deficiency (dMMR)/high-frequency microsatellite instability (MSI-H) solid tumors.

Eligible Conditions
  • Solid Tumors
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response (Partial Response [PR] or Complete Response [CR]) (Phase II)
Recommended Phase 2 Dose of Pevonedistat When Combined With Pembrolizumab (Phase I)
Secondary outcome measures
Changes in Protein Misfolding
Duration of Response
Incidence of Adverse Events
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pevonedistat, pembrolizumab)Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Pevonedistat
2021
Completed Phase 2
~290

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,319 Total Patients Enrolled
Michael J OvermanPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
316 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pevonedistat and Pembrolizumab for the Treatment of dMMR/MSI-H Metastatic or Locally Advanced Unresectable Solid Tumor
2021. "Pevonedistat and Pembrolizumab for the Treatment of dMMR/MSI-H Metastatic or Locally Advanced Unresectable Solid Tumor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04800627.
~0 spots leftby Apr 2025
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