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A Phase 1b, Open-label, Multicenter, Multidose, Dose-escalation Study of BMS-936558 (MDX-1106) in Combination With Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Malignant Melanoma

Thank you

Trial Information

A Phase 1b, Open-label, Multicenter, Multidose, Dose-escalation Study of BMS-936558 (MDX-1106) in Combination With Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety assessments will be based on adverse event reports and the results of clinical laboratory tests, immune safety tests, physical examinations, vital sign measurements, ECOG performance status, and ECG evaluations

Outcome Description:

Eastern Cooperative Oncology Group (ECOG), electrocardiogram (ECG)

Outcome Time Frame:

Up to 12 weeks after the last dose of the last study drug dose (approximately up to 5.5 years)

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA209-004

NCT ID:

NCT01024231

Start Date:

January 2009

Completion Date:

August 2014

Related Keywords:

  • Malignant Melanoma
  • Melanoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Local InstitutionDuncansville, Pennsylvania  
Yale University School Of MedicineNew Haven, Connecticut  06520
Georgetown University Med CtrWashington, District of Columbia  20007