Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination With Ipilimumab vs Ipilimumab Alone in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma (CheckMate 069)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01927419
First received: August 20, 2013
Last updated: October 13, 2014
Last verified: September 2014
  Purpose

The primary purpose of this study is to compare the objective response rate (ORR) as determined by investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in subjects with unresectable or metastatic melanoma


Condition Intervention Phase
Unresectable or Metastatic Melanoma
Biological: Nivolumab
Biological: Ipilimumab
Biological: Placebo matching with Nivolumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Randomized, Double Blinded, Study of Nivolumab (BMS-936558) in Combination With Ipilimumab vs Ipilimumab Alone in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Objective response rate (ORR) as assessed by the investigator [ Time Frame: Until disease progression is documented (expected to be no more than 5 years) ] [ Designated as safety issue: No ]
    The ORR is defined as the # of subjects with a best overall response (BOR) of complete response (CR) or Partial Response (PR) divided by the number of randomized BRAF wild type (WT) subjects


Secondary Outcome Measures:
  • Investigator assessed progression free survival (PFS) in BRAF WT subjects [ Time Frame: Until disease progression is documented (expected to be no more than 5 years) ] [ Designated as safety issue: No ]
    The PFS is defined as the time between the date of randomization and the first date of documented progression, as assessed by the investigator, or death due to any cause, whichever occurs first

  • ORR and PFS in BRAF mutant subjects [ Time Frame: Until disease progression is documented (expected to be no more than 5 years) ] [ Designated as safety issue: No ]
  • Mean changes from baseline in the EORTC-QLQ-C30 global health status/QoL composite scale [ Time Frame: Every 6 weeks for the first 6 months ] [ Designated as safety issue: No ]

    EORTC-QLQ-C30 = European Organisation for Research and Treatment of Care

    QoL = Quality of life



Estimated Enrollment: 150
Study Start Date: August 2013
Estimated Study Completion Date: April 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Nivolumab + Ipilimumab and Nivolumab

Part I:

Nivolumab 1 mg/kg solution and Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses (4 Cycles)

Part II:

Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression due to toxicity, withdrawal of consent or the study ends

Biological: Nivolumab
Other Name: BMS-936558
Biological: Ipilimumab
Experimental: Arm B: Nivolumab-placebo + Ipilimumab and Nivolumab-placebo

Part I:

Placebo matching with Nivolumab 0 mg/kg solution and Ipilimumab 3 mg/kg solution intravenously every 3 weeks for 4 doses (4 Cycles)

Part II:

Placebo matching with Nivolumab 0 mg/kg solution intravenously every 2 weeks until documented disease progression due to toxicity, withdrawal of consent or the study ends

After documented disease progression, subjects in Arm B will have the option to either start Nivolumab monotherapy on-study (3 mg/kg solution intravenously every 2 weeks) or proceed to follow-up phase of the protocol

Biological: Ipilimumab Biological: Placebo matching with Nivolumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system
  • No prior systemic anticancer therapy for unresectable or metastatic melanoma. Note that prior adjuvant or neoadjuvant melanoma therapy is permitted if it was completed at least 6 weeks prior to date of first dose, and all related adverse events have either returned to baseline or stabilized
  • Tumor tissue obtained in the metastatic setting or from an unresectable site must be provided for biomarker analyses. In order to be randomized, tumor tissue should be received by the central laboratory. Biopsy should be excisional, incisional punch or core needle. Fine needle aspirates or other cytology samples are insufficient
  • Known BRAF V600 mutation status as determined by an FDA approval test. Subjects with either V600 wild-type or V600 mutation-positive melanoma are eligible

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (>10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
  • Ocular melanoma
  • Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01927419

  Show 19 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01927419     History of Changes
Other Study ID Numbers: CA209-069, 2013-002018-11
Study First Received: August 20, 2013
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration
France: Ministry of Health

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 21, 2014