MCS110 With BRAF/MEK Inhibition in Patients With Melanoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03455764
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • MCS110 — DRUG
    MCS110 is a colony-stimulating factor-1 (CSF-1) inhibitor. It is a human monoclonal antibody which binds CSF-1.
  • Dabrafenib — DRUG
    Dabrafenib attack different proteins that promote the growth of cancerous cells
  • Trametinib — DRUG
    Trametinib attack different proteins that promote the growth of cancerous cells

Study Details

This research study is studying a combination of targeted therapies as a possible treatment for advanced melanoma that was found to have a BRAF V600E or BRAF V600K genetic mutation. The interventions involved in this study are: * MCS110 * Dabrafenib * Trametinib

Key Dates

Start date
Sep 10, 2018
Status verified
Jul 2024
Primary completion
Sep 5, 2023
Completion
Sep 5, 2023

Study Design

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

Arms

  • Experimental: MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 1]
    * MCS110 2.5mg/kg will be administered intravenously every 3 weeks. * Dabrafenib 150mg is given orally every 12 hours. * Trametinib 2mg is given orally daily
  • Experimental: MCS110 + Trametinib + Dabrafenib [Phase 2]
    * MCS110 will be administered intravenously every 3 weeks. The Dosage will be determined by the DLT of Phase 1 * Dabrafenib 150mg is given orally every 12 hours. * Trametinib 2mg is given orally daily
  • Experimental: MCS110+ Trametinib + Dabrafenib [Phase I Dose Level -1]
    * MCS110 1.25 mg/kg was administered intravenously every 3 weeks. * Dabrafenib 150mg is given orally every 12 hours. * Trametinib 2mg is given orally daily
  • Experimental: MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 2]
    * MCS110 5mg/kg was administered intravenously every 3 weeks. * Dabrafenib 150mg is given orally every 12 hours. * Trametinib 2mg is given orally daily
  • Experimental: MCS110+ Trametinib + Dabrafenib [Phase I Dose Level 3]
    * MCS110 10mg/kg was administered intravenously every 3 weeks. * Dabrafenib 150mg is given orally every 12 hours. * Trametinib 2mg is given orally daily

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLT) [Phase I] [ Time Frame: Participants were followed up to 21 days. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Boston, MA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Dana Farber Cancer Institute· Boston, MA

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