A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Bristol-Myers Squibb387 enrolled

Overview

The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

387

Conditions

Melanoma

Interventions

Nivolumab 3 mg/kg IVBIOLOGICAL

Followed by Nivolumab monotherapy

Ipilimumab 1 mg/kg IVBIOLOGICAL

Followed by Nivolumab monotherapy

Nivolumab 1 mg/kg IVBIOLOGICAL

Ipilimumab 3 mg/kg IV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subject must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma \[per American Joint Committee on Cancer (AJCC) staging system\] that is unresectable or metastatic * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma Exclusion Criteria: * Subjects with active brain metastases or leptomeningeal metastases * Subjects with ocular melanoma * Subjects with active, known or suspected autoimmune disease Other protocol defined inclusion/exclusion criteria could apply

Locations (57)

Outcomes

Primary Outcomes

The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs)

The percentage of participants who experienced at least 1 AE of Grade 3 or higher, judged to be related to study drug by the investigator, and with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment. AE grade was defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria.

Time frame: From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 months)

Secondary Outcomes

Objective Response Rate (ORR)

The percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). BOR is defined as the best response, as determined by the investigator, recorded between the date of randomization and the date of progression per RECIST 1.1 or the date of subsequent anticancer therapy, whichever occurred first. For subjects without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment. Tumor assessments are scheduled at Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Time frame: From date of randomization to date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 5 years)

Overall Survival (OS)

The time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date. OS will be followed continuously while participants are on the study drug and every 3 months via in-person or phone contact after participants discontinue the study drug. Based on Kaplan-Meier Estimates.

Data from ClinicalTrials.gov

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Nivolumab 6 mg/kg IVBIOLOGICAL

A dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to \~ 480mg.

University Of Colorado Cancer Center

Aurora, Colorado, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Allina Health

Fridley, Minnesota, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

University Of Virginia Health System

Charlottesville, Virginia, United States

...and 47 more locations

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up tp approximately 5 years)

Progression Free Survival (PFS)

The time between the date of randomization and the first date of documented progression, determined by the investigator, or death due to any cause, whichever occurs first. Participants who die without a reported progression will be considered to have progressed on the date of their death. Those who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants without on study tumor assessments and who did not die will be censored on their date of randomization. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy. Based on Kaplan-Meier Estimates. Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Time frame: From randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 5 years)

Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale

Health Related Quality of Life (HRQoL) was assessed using the EORTC QLQ-C30 questionnaire. The Physical Functioning Scale sub-scale item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores indicate a higher level of symptoms; lower scores indicating lesser burden and improved symptoms or quality of life. A clinically meaningful change in score may be regarded as 10 points.