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Protocol # 18-144

Status

Recruiting

Description

This research study is studying a combination of drugs as a possible treatment for metastatic colorectal cancer characterized by BRAF V600E mutation. The names of the study drugs involved in this study are: - Dabrafenib - Trametinib - PDR001

Condition

  • Metastatic Colorectal Cancer

Interventions

  • Dabrafenib
  • Trametinib
  • PDR001

Phase

Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Overall Response Rate
  • Number of participants with grade 3, 4 and 5 adverse events

Secondary Outcome:

  • Progression Free Survival
  • Disease Control Rate
  • Duration of Response
  • Overall Survival
  • Mechanisms of response and resistance to dabrafenib, trametinib, and PDR001

Enrollment

25

Study Start Date

October 15, 2018

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Massachusetts General Hospital

Source

Massachusetts General Hospital

Official title

A Phase 2 Study of Dabrafenib and Trametinib in Combination With PDR001 in Patients With BRAFV600E Metastatic Colorectal Cancer

Clinicaltrials.gov Identifier

NCT03668431

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.