Phase 1 Safety and Tolerability of MEDI4736 in Combination With Dabrafenib and Trametinib or With Trametinib Alone

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
MedImmune LLC
Study ID
NCT02027961
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — BIOLOGICAL
    Intravenous dose of 3 or 10 mg/kg durvalumab.
  • Dabrafenib — DRUG
    Oral dose of 150 mg dabrafenib capsule.
  • Trametinib — DRUG
    Oral dose of 2 mg trametinib tablet.

Study Details

The purpose of this study is to determine the maximum tolerated dose and characterize the safety profile of durvalumab (MEDI4736) in combination with dabrafenib and trametinib or with trametinib alone in participants with metastatic or unresectable melanoma with BRAF-mutation positive or wild-type (WT) BRAF, respectively.

Key Dates

Start date
Dec 20, 2013
Status verified
May 2019
Primary completion
Apr 24, 2018
Completion
Apr 24, 2018

Study Design

Enrollment
68 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A1: Durvalumab (3 mg/kg) + Dabrafenib +Trametinib
    Participants will receive intravenous (IV) dose of 3 milligrams per kilogram (mg/kg) durvalumab every 2 weeks (Q2W) from Day 1 up to 12 months along with oral 150 mg dabrafenib capsule twice daily (BID) and oral 2 mg trametinib tablet once daily (QD) until confirmed disease progression (PD), initiation of alternate cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment. Post-durvalumab treatment period, participants who developed PD and meet the criteria for re-administration, will receive durvalumab 3 mg/kg up to an additional 12 months and continued the treatment of dabrafenib and trametinib.
  • Experimental: Cohort A2: Durvalumab (10 mg/kg) + Dabrafenib +Trametinib
    Participants will receive IV dose of 10 mg/kg durvalumab Q2W from Day 1 up to 12 months along with oral doses of dabrafenib 150 mg capsule BID and trametinib 2 mg tablet QD until confirmed PD, initiation of alternate cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment. Post-durvalumab treatment period, participants who developed PD and meet the criteria for re-administration, will receive durvalumab 10 mg/kg up to an additional 12 months and continued the treatment of dabrafenib and trametinib.
  • Experimental: Cohort B: Durvalumab (10 mg/kg) +Trametinib (Concurrent)
    Participants will receive concurrent doses of IV 10 mg/kg durvalumab Q2W from Day 1 up to 12 months along with oral dose of trametinib 2 mg tablet QD until confirmed PD, initiation of alternate cancer therapy, unacceptable toxicity, withdrawal of consent, or other reasons to discontinue treatment. Post-durvalumab treatment period, participants who developed PD and meet the criteria for re-administration, will receive durvalumab 10 mg/kg up to an additional 12 months and continued the treatment of trametinib.
  • Experimental: Cohort C: Durvalumab (10 mg/kg) +Trametinib (Sequential)
    Participants will receive sequential doses of oral trametinib tablet 2 mg QD from Day 1 to Day 42 and IV durvalumab 10 mg/kg Q2W starting from Day 29 (Week 5) up to 12 months. Post-durvalumab treatment period, participants who developed PD and meet the criteria for re-administration, will receive durvalumab 10 mg/kg up to an additional 12 months.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: From first dose of study drug (Day 1) until the planned 3rd dose of durvalumab (Day 29) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Research SiteScottsdaleArizona85258-
Research SiteLos AngelesCalifornia90095-
Research SiteSan FranciscoCalifornia94115-
Research SiteMiami BeachFlorida33140-
Research SiteChicagoIllinois60611-
Research SiteBostonMassachusetts02114-
Research SiteSt LouisMissouri63110-

Find similar trials in Scottsdale, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Research Site· Scottsdale, AZResearch Site· Los Angeles, CAResearch Site· San Francisco, CAResearch Site· Miami Beach, FLResearch Site· Chicago, ILResearch Site· Boston, MA

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