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


Malignant Melanoma

Trial Phase

Phase 1

Trial Purpose and Description

Trial Purpose

The purpose of this study is to determine the safety and tolerability of treatment with BMS-936558 (MDX-1106) in combination with Ipilimumab (BMS-734016) when given at the same time or as a sequenced regimen in subjects with unresectable Stage III or Stage IV malignant melanoma (MEL)

Participation Guidelines

18 Years - N/A

Eligibility Criteria

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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
Bristol-Myers Squibb
Ono Pharma USA Inc
December 2009
Last Updated:
July 9, 2014
Study HIC#:

Clinicaltrials.gov ID: NCT01024231