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PD-L1 Inhibitor

Durvalumab + Trametinib for Cancer of the Digestive Organs

Phase 2
Waitlist Available
Led By Michael Overman, MD
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 from baseline to 2 years
Awards & highlights

Study Summary

This trial is looking to see if a combo of 2 drugs can help control microsatellite stable colorectal cancer, as well as studying the safety of the drugs.

Eligible Conditions
  • Cancer of the Digestive Organs
  • Colorectal Cancer
  • Colon Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immune-related Best Overall Response Rate.
Secondary outcome measures
Disease Control Rate
Overall Survival
Progression Free Survival as Determined by irRC

Trial Design

1Treatment groups
Experimental Treatment
Group I: Durvalumab + TrametinibExperimental Treatment2 Interventions
Participants take Trametinib tablets by mouth every day. Trametinib taken alone for the first 7 days of the study then participants begin receiving it in combination with Durvalumab. Participants receive Durvalumab by vein every 4 weeks. Each cycle is 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Trametinib
2014
Completed Phase 2
~1550

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,367 Total Patients Enrolled
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,721,006 Total Patients Enrolled
MedImmune LLCIndustry Sponsor
347 Previous Clinical Trials
793,880 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
Study of Durvalumab (MEDI4736) (Anti-PD-L1) and Trametinib (MEKi) in MSS Metastatic Colon Cancer
2018. "Study of Durvalumab (MEDI4736) (Anti-PD-L1) and Trametinib (MEKi) in MSS Metastatic Colon Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03428126.
~4 spots leftby Apr 2025
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