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

Trial Purpose and Description

Trial Purpose

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Participation Guidelines

Eligibility Criteria

For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.

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

Sponsor:

Bristol-Myers Squibb

Medarex

Ono Pharma USA Inc

Dates:

January 2009

Last Updated:

June 6, 2013

Study HIC#:

0908005564

Clinicaltrials.gov ID: NCT01024231