Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma

Launched by BRISTOL-MYERS SQUIBB · Dec 1, 2009

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Eligibility criteria

• • For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
• Inclusion Criteria:
• • Histologic diagnosis of malignant melanoma (MEL)
• • Measurable unresectable Stage III or IV MEL
• • ECOG performance status score of 0 or 1
• • Life expectancy ≥4 months
• • For those enrolled in amendment 5 and later, tumor tissue (archival or recent acquisition) must be available
• • For Cohorts 1-5, subjects may have been treated with up to 3 prior systemic standard treatments for metastatic melanoma not including any post-incisional adjuvant therapy. Subjects may be treatment naïve. All metastatic melanoma regardless of primary site of disease will be allowed
• • For Cohorts 6-7, subjects may have been treated with up to 3 prior systemic standard treatments for metastatic melanoma; this does not include any post-incisional adjuvant therapy. Specifically, subjects must have received ≥3 doses of Ipilimumab therapy and the last dose having been administered within 4-12 weeks of initiation of study treatment
• Exclusion Criteria:
• • History of severe hypersensitivity reactions to other mAbs
• • Prior malignancy active within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the investigator present a low risk for recurrence
• • Active autoimmune disease or a history of known or suspected autoimmune disease
• • History of recently active diverticulitis or symptomatic peptic ulcer disease and history of adrenal insufficiency
• • Regular narcotic analgesia
• • Active, untreated central nervous system metastasis
• • For subjects enrolled in Cohorts 1-5, prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody
• • For subjects enrolled in Cohorts 6-7, prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CD137 antibodies
• • Any non-oncology vaccine therapy used for prevention of infectious disease
• • Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs
• • Positive tests for human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B, hepatitis C
• • Subjects weighing ≥125 kg are excluded from Cohort 5
• • Subjects in Cohorts 6 and 7 must have received Ipilimumab monotherapy immediately prior to study entry, but must not have received that Ipilimumab as part of a clinical trial
• • Subjects with ocular melanoma are excluded from Cohort 8