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J1764-A Phase 1/2a Study of BMS-986205 Administered in Combination with Nivolumab (BMS-936558, anti-PD-1 Monoclonal Antibody) and in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors
Protocol Number:
Phase I/II
William Sharfman
Johns Hopkins Kimmel Cancer Center in Baltimore
This research is being conducted to determine the activity against cancer of BMS-986205 (oral pill) in combination with nivolumab vs. nivolumab as a single therapy for some subpopulations of melanoma.Nivolumab is approved by the FDA for the use in metastatic melanoma. BMS-986205 is not FDA approved for metastatic melanoma and it is being used in this study as an investigation agent to evaluate if BMS-986205 when given together with Nivolumab will have a better response against cancer. The types of Melanoma patients treated on this study will be:1.Immunotherapy treatment naïve 2.BRAF + and BRAF –, have received BRAF therapy and have Not received BRAF therapy3.Melanoma patients having received PD-1 agent as most recent therapy4.Melanoma patients having received PD-1 and CTLA-4 agents as most recent therapy
Hopkins is only enrolling patients in the Melanoma cohort.Must be able to swallow pills or capsules. No active spread to brain and if brain spread – must have been treated greater than 4 weeks prior to start of study with MRI confirmation of stability. No systemic use of steroids greater than 10mg of prednisone per day. No prior cancer within 3 years except those with local spread that have been deemed cured such as basal cell carcinoma. No autoimmune diseases. No prior therapies with vaccines, checkpoint inhibitors (unless specified above), or drugs specifically targeting the regulatory T cell. No Hepatitis B, Hepatitis C, HIV positive, or AIDS diagnosis. Not currently pregnant.All subjects must have a good performance status, tumors available to be biopsied, and good organ functioning as determined by lab work.
The 1st cohort will received nivolumab 1 x per month IV and BMS-986205 dailyThe 2nd cohort will receive nivolumab 1 x per month IV
Last Update
08/07/2020 05:02 AM