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

Melanoma Clinical Trial

Official title:

Phase IIIb, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Previously Untreated Unresectable or Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905266
• Other study ID #: CA209-742
• Secondary ID: 2016-001941-26
• Status: Completed
• Phase: Phase 3
• Start date: October 27, 2016
• Est. completion date: October 25, 2019

Study information

• Verified date: November 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 25, 2019
• Est. primary completion date: October 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• Nivolumab
-Specified dose on specified days
• Ipilimumab
-Specified dose on specified days

Locations

Country	Name	City	State
Australia	Greenslopes Private Hospital	Greenslopes	Queensland
Australia	Cabrini Hospital	Malvern	Victoria
Australia	Melanoma Institute Australia	North Sydney	New South Wales
France	Local Institution	Lyon Cedex 08
France	Hopital De La Timone	Marseille Cedex 5
France	Local Institution	Nantes Cedex 1
France	Hopital Saint Louis	Paris
France	Local Institution	Paris Cedex 14
France	Hopital Trousseau - Chru Tours	Tours
Italy	Istituto Nazionale Per La Ricerca Sul Cancro - Oncologia Med	Genova
Italy	Istituto Scientifico Romagnolo Per Lo Studio E Cura Tumori	Meldola (FC)
Italy	Istituto Europeo Di Oncologia	Milan
Italy	Azienda Ospedaliera Citta della Salute e della Scienza	Torino
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Australia,  France,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
Secondary	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.	Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
Secondary	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	Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
Secondary	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	From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months)
Secondary	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	From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months)
Secondary	Geometric Mean Concentration of Ipilimumab at End of Infusion (EOI)		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.
Secondary	Geometric Mean Concentration of Nivolumab at End of Infusion (EOI)		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
Secondary	Geometric Mean Trough Concentration of Ipilimumab		From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks.
Secondary	Geometric Mean Trough Concentration of Nivolumab		From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks.
Secondary	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.	Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression (approximately 20 months)
Secondary	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.	From the date of randomization to the first date of documented progression (approximately 26 months)

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