Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma

Metastatic Melanoma Clinical Trial

— CheckMate 069  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927419
• Other study ID #: CA209-069
• Secondary ID: 2013-002018-11
• Status: Completed
• Phase: Phase 2
• Start date: August 23, 2013
• Est. completion date: February 26, 2021

Study information

• Verified date: February 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: February 26, 2021
• Est. primary completion date: July 24, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Key Inclusion Criteria:

• Eastern Cooperative Oncology Group performance status of 0 or 1

• Histologically confirmed unresectable Stage III or Stage IV melanoma

• 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 and sent to 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-approved test. Patients with either V600 wild-type or V600 mutation-positive melanoma are eligible.

Key Exclusion Criteria:

• Active brain metastases or leptomeningeal metastases. Patients with treated brain metastases are eligible if there is no evidence of progression on magnetic resonance imaging scan for at least 8 weeks after completion of treatment 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

• Patients with active, known, or suspected autoimmune disease. Those 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.

Related Conditions & MeSH terms

• Melanoma
• Metastatic Melanoma
• Unresectable Melanoma

Intervention

Drug:
• Nivolumab

• Ipilimumab

• Placebo
Matching nivolumab

Locations

Country	Name	City	State
France	Hopital Larrey	Toulouse
France	Institut Gustave Roussy	Villejuif
United States	University Of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The Christ Hospital	Cincinnati	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	St. Luke's Hospital	Easton	Pennsylvania
United States	GHS Cancer Institute	Greenville	South Carolina
United States	Comprehensive Cancer Centers Of Nevada	Las Vegas	Nevada
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University Of Louisville Medical Center, Inc., Dba	Louisville	Kentucky
United States	University Of Wisconsin Paul P Carbone Comprehensive Ca Ctr	Madison	Wisconsin
United States	Memorial Sloan Kettering Nassau	New York	New York
United States	NYU Clinical Cancer Center	New York	New York
United States	Orlando Health Inc	Orlando	Florida
United States	Oregon Health & Science University	Portland	Oregon
United States	Washington University School Of Medicine	Saint Louis	Missouri
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	San Francisco Oncology Associates	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) - BRAF Wild-type (WT) Participants	Objective Response Rate is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR), assessed by the investigator by using RECIST 1.1 criteria.; CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm).; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.	From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months)
Secondary	Progression-Free Survival (PFS) - BRAF Wild-type (WT) Participants	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. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or died were censored on the date of their last evaluable tumor assessment.; PFS values are based on Kaplan-Meier Estimates.	From randomization to progression or death (up to approximately 88 months)
Secondary	Objective Response Rate (ORR) - BRAF Mutant Participants	Objective Response Rate is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR), assessed by the investigator by using RECIST 1.1 criteria.; CR=all target and nontarget lesions have disappeared. Lymph nodes selected must have returned to normal size (<10 mm).; PR=at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.	From 12 weeks after Randomization, assessed every 6 weeks up to Week 49 of study treatment and then every 12 weeks until disease progression (up to approximately 76 months)
Secondary	Progression-Free Survival (PFS) - BRAF Mutant Participants	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. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or died were censored on the date of their last evaluable tumor assessment.; PFS values are based on Kaplan-Meier Estimates.	From randomization to progression or death (up to approximately 88 months)
Secondary	Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Overall Quality of Life (QOL) C30 Score	The EORTC QLQ-C30 version 3 is a questionnaire developed to assess the QOL of cancer patients. The questionnaire is a 30-item tool, and it comprises 6 functional subscales (physical functioning, role functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as 9 symptom subscales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).; Scores for each subscale range from 0 to 100. For the 6 functional subscales, a higher score represents a better level of functioning/health status. For the 9 symptom subscales, a lower score represents a better outcome (low level of symptomatology).; Scores for the 15 subscales are presented individually.	From Baseline (prior to start of study treatment) to Week 25 after first dose

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form