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Protocol No. EA6141
Principal Investigator Albertini, Mark
Age Group Adult
Sponsor Type National
Title Randomized Phase II/III Study of Nivolumab plus Ipilimumab plus Sargramostim versus Nivolumab plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma
Objective The purpose of this research study is to compare any good and bad effects of giving ipilimumab, nivolumab, and GM-CSF (Sargramostim) at the same time compared to just ipilimumab and nivolumab together. We would also like to find out what effects, good and bad, that this combination of drugs may have on your cancer.
Treatment GM-CSF is a protein that your body normally produces to signal to your body to make white blood cells. White blood cells are very important in the body's defense system as they help identify and destroy foreign invaders, such as bacteria, viruses, and cells that don't belong, such as cancer cells. Injections of GM-CSF increase your body's production of white blood cells and also help enhance the function of the white blood cells. This research study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.
Description A computer will by chance assign you to treatment groups in the research study. This is called randomization.This research study has two study groups, Arm A and Arm B. Arm A will receive the study drugs nivolumab, ipilimumab, and GM-CSF. You will receive the study drugs ipilimumab and nivolumab at cycles 1, 2, 3, and 4, where each cycle equals 21 days for a total of four infusions. You will be instructed on how GM-CSF should be prepared, how it should be injected, and how often it should be injected. If your disease remains stable or continues to improve, you may receive additional doses of nivolumab every 3 weeks after the last dose you received at cycle 4. If you are in Arm B you will receive the study drugs ipilimumab and nivolumab at cycles 1, 2, 3, and 4, where each cycle equals 21 days for a total of four infusions. If your disease remains stable or continues to improve, you may receive additional doses of nivolumab every 3 weeks after the last dose you received at cycle 4.
- All patients must be ≥ 18 years of age
- Patients must have unresectable stage III or stage IV melanoma
- Patients must have known BRAF mutational status of tumor; Wild-type (WT) or mutated, prior to randomization
- Patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive.
- Patients may have had prior systemic therapy in the adjuvant setting (e.g. interferon, BRAF, or MEK agents). Patients may have had prior anti-CTLA-4 in the adjuvant setting, if at least one year from last dose of treatment has passed prior to beginning treatment. Patients may not have had any prior PD-1/PD-L1 agent in the adjuvant setting
- Patients must have measurable disease
- Patients may have had prior anti-CTLA-4 in the adjuvant setting, if at least one year from last dose of treatment has passed prior to beginning treatment
- Patients may not have had any prior ipilimumab and/or anti-PD-1/PD-L1 agent in the metastatic setting
- Patients must have discontinued chemotherapy, immunotherapy or other investigational agents used in the adjuvant setting ≥ 4 weeks prior to randomization
- Patients are ineligible if they have any currently active CNS metastases
- Patients with HIV infection are ineligible
- Patients with evidence of active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection are not eligible
- Patients must not have autoimmune disorders or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids
- Patients must not have a history of inflammatory bowel disease or diverticulitis
- Women must not be pregnant or breast-feeding
Applicable Disease Sites Melanoma/Skin cancer
Therapies Involved Immunotherapy
Drugs Involved BMS-936558 (Nivolumab); Nivolumab; Opdivo (Nivolumab); Yervoy (ipilimumab); gm-csf (sargramostim); ipilimumab; leukine (sargramostim); prokine (sargramostim); sargramostim
Status Not Open