Study of the Anti-PD-1 Antibody Nivolumab in Combination With Dabrafenib and/or Trametinib

Sponsor
University of Pittsburgh
Study ID
NCT02357732
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study evaluates nivolumab in combination drug treatments involving 1) nivolumab and dabrafenib 2) nivolumab and trametinib and 3) nivolumab, dabrafenib and trametinib in patients with BRAF or NRAS-mutated metastatic melanoma.

Key Dates

Start date
Aug 31, 2015
Status verified
Dec 2015
Primary completion
Aug 31, 2015
Completion
Aug 31, 2015

Study Design

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

Arms

  • Experimental: Nivolumab and Dabrafenib Combination (doublets)
    Level -1, Nivolumab 1mg/kg IV every 2 weeks (q2 weeks); Dabrafenib 100mg by mouth (PO) twice a day(BID) every day (QD); Level 1, Nivolumab 1mg/kg IV q2 weeks; Dabrafenib 150mg PO BID QD; Level 2, Nivolumab 3mg/kg IV q2 weeks; Dabrafenib 150mg PO BID QD;
  • Experimental: Nivolumab and Trametinib Combination (doublets)
    Level -1, Nivolumab 1mg/kg IV q2 weeks; Trametinib 1mg PO QD; Level 1, Nivolumab 1mg/kg IV q2 weeks; Trametinib 2mg PO QD; Level 2, Nivolumab 3mg/kg IV q2 weeks; Trametinib 2mg PO QD;
  • Experimental: Nivolumab, Dabrafenib and Trametinib Combination (triplet)
    Level -1, Nivolumab 1mg/kg IV q2 weeks; Dabrafenib 150mg PO BID; Trametinib 1mg PO QD; Level 1, Nivolumab 1mg/kg IV q2 weeks; Dabrafenib 150mg PO BID; Trametinib 2mg PO QD; Level 2, Nivolumab 3mg/kg IV q2 weeks; Dabrafenib 150mg PO BID; Trametinib 2mg PO QD;

Primary Outcome Measure

To determine the Maximally Tolerated Dose and/or Recommended Phase II Dose (RP2D) of nivolumab in combination with dabrafenib and/or trametinib in patients with BRAF- or NRAS-mutated metastatic melanoma [ Time Frame: The first four weeks of dosing ]

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