Dabrafenib + Trametinib + PDR001 In Colorectal Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03668431
Phase
PHASE2
Status
Unknown

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dabrafenib — DRUG
    Dabrafenib will be taken twice a day for 28 consecutive days .
  • Trametinib — DRUG
    Trametinib will be taken once a day for 28 consecutive days
  • PDR001 — DRUG
    PDR001 will be administered IV every 28 days

Study Details

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

Key Dates

Start date
Oct 15, 2018
Status verified
Jun 2022
Primary completion
Sep 1, 2022
Completion
Dec 1, 2022

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PDR001, Dabrafenib, Trametinib
    Patients who fulfill eligibility criteria will be entered into the trial to receive PDR001, Dabrafenib, Trametinib. Treatment will be administered on an outpatient basis. After the screening procedures confirm participation in the research study: * Dabrafenib will be taken twice a day for 28 consecutive days * Trametinib will be taken once a day for 28 consecutive days * PDR001 will be administered IV every 28 days.

Primary Outcome Measure

Overall Response Rate [ Time Frame: From the start of the treatment until disease progression/recurrence, up to approximately 5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstititeBostonMassachusetts02215
Marios Giannakis, MD
[email protected]
617-632-3000
Marios Giannakis, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hosital Cancer CenterBostonMassachusetts02114
Ryan Corcoran, MD
617-724-4000
Ryan Corcoran, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institite· Boston, MAMassachusetts General Hosital Cancer Center· Boston, MA

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