A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma

Bristol-Myers Squibb106 enrolled

Overview

This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Melanoma

Interventions

NivolumabBIOLOGICAL

-Specified dose on specified days

IpilimumabBIOLOGICAL

-Specified dose on specified days

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: * Males and Females, ages 15 years ≥ of age (Except where local regulations and/or institutional policies do not allow for subjects \< 18 years of age to participate) * Subjects must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma that is unresectable or metastatic * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Subjects have 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 (16)

Melanoma Institute Australia

North Sydney, New South Wales, Australia

Greenslopes Private Hospital

Greenslopes, Queensland, Australia

Cabrini Hospital

Malvern, Victoria, Australia

Outcomes

Primary Outcomes

Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ)

This outcome describes the percentage of participants experiencing at least 1 AE in the MedDRA Anaphylactic Reaction broad scope SMQ. Such AEs include any acute systemic reaction characterized by a large list of terms, including (but not limited to) pruritus, urticaria, flushing, hypotension, respiratory distress, and vascular insufficiency. It also includes other signs and symptoms such as asthma, choking sensation, coughing, sneezing, and difficulty breathing due to laryngeal spasm and/or bronchospasm. Less frequent clinical presentations are also captured and include hyperventilation, sensation of foreign body, and ocular edema.

Time frame: Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)

Secondary Outcomes

Percentage of Participants Affected by AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ

This outcome describes the percentage of participants experiencing at least 1 AE in the MedDRA Anaphylactic Reaction narrow scope SMQ. The narrow scope SMQ is composed of a large list of terms, including (but not limited to) anaphylactic shock and reaction, shock and shock symptoms, and circulatory collapse, among the others.

Time frame: Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)

Percentage of Participants Affected by Hypersensitivity/Infusion Reaction Select AEs

This outcome describes the percentage of participants experiencing at least 1 AE in the Hypersensitivity/Infusion select AEs category. The select AEs consist of a list of preferred terms defined by the Sponsor and represent AEs with a potential immune-mediated etiology. The following 5 MedDRA preferred terms are included in the hypersensitivity/infusion reaction select AE category: Anaphylactic Reaction, Anaphylactic Shock, Bronchospasm, Hypersensitivity, and Infusion Related Reaction

Time frame: Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)

Data from ClinicalTrials.gov

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Local Institution

Lyon, France

Hopital De La Timone

Marseille, France

Local Institution

Nantes, France

Hopital Saint Louis

Paris, France

Local Institution

Paris, France

Hopital Trousseau - Chru Tours

Tours, France

Istituto Nazionale Per La Ricerca Sul Cancro - Oncologia Med

Genova, Italy

...and 6 more locations

Percentage of Participants Affected by All Causality Grade 3 - 5 AEs

This outcome describes the percentage of participants who experienced at least 1 AE of Grade 3 or higher defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria

Time frame: From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months)

Percentage of Participants Affected by Drug-related Grade 3 - 5 AEs

This outcome describes the percentage of participants who experienced at least 1 Drug-related AE of Grade 3 or higher defined using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria

Time frame: From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months)

Geometric Mean Concentration of Ipilimumab at End of Infusion (EOI)

Time frame: From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported.

Geometric Mean Concentration of Nivolumab at End of Infusion (EOI)

Time frame: From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported

Geometric Mean Trough Concentration of Ipilimumab

Time frame: From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks.

Geometric Mean Trough Concentration of Nivolumab

Time frame: From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks.

Objective Response Rate (ORR)

The ORR is defined as the proportion of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). The BOR is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of subsequent anti-cancer therapy, whichever occurs first.

Time frame: Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression (approximately 20 months)

Progression Free Survival (PFS)

PFS is defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first.

Time frame: From the date of randomization to the first date of documented progression (approximately 26 months)