A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04007588
Phase
PHASE2
Status
Withdrawn

Conditions

  • Melanoma Stage III
  • Melanoma Stage IV

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab is a types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer
  • BMS-986205 — DRUG
    BMS-986205 is a types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. BMS-986205 work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer
  • Ipilimumab — DRUG
    Ipilimumab is a types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Ipilimumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer

Study Details

This research study is studying different immunotherapy regimens as a possible treatment for stage III or IV resectable melanoma.

Key Dates

Start date
Sep 6, 2019
Status verified
Feb 2020
Primary completion
Dec 19, 2019
Completion
Dec 19, 2019

Study Design

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

Arms

  • Experimental: Nivolumab+BMS-986205
    * Nivolumab will be administered intravenously Day 1 of each 28 day cycle. * BMS-986205 will be administered orally on a daily basis
  • Experimental: Nivolumab
    -Nivolumab will be administered intravenously Day 1 of each 28 day cycle.
  • Experimental: Nivolumab+Ipilimumab
    * Nivolumab will be administered intravenously Day 1 of each 28 day cycle. * Ipilimumab will be administered intravenously every 6 weeks

Primary Outcome Measure

Major Pathologic Response Rate [ Time Frame: 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

Related Studies