Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab Therapy

NCT02990611 | Completed

• 1 other identifier: CA209-654
• Study Type: observational
• Target: 1,087
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to describe the safety and effectiveness of nivolumab treatment, either in monotherapy or in combination with ipilimumab, overall and according to various subgroups of interest, in participants with advanced melanoma and in participants with adjuvant nivolumab therapy.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

• Overall survival (OS) of nivolumab/ipilimumab combination therapy

  5 years

• Relapse free survival (RFS) of adjuvant nivolumab therapy

  5 years

Secondary Outcomes (31)

• Overall survival (OS) of nivolumab monotherapy

  5 years

• Overall survival (OS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy, according to other subgroups of interest

  5 years

• Progression-free survival (PFS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy

  5 years

• Overall response rate (ORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy

  5 years

• Best overall response (BOR) of nivolumab monotherapy and of nivolumab/ipilimumab combination therapy

  5 years

Study Arms (3)

Cohort 1: Nivolumab/Ipilimumab combination therapy

Participants who start a new systemic therapy with nivolumab/ipilimumab combination therapy for the first time

Cohort 2: Nivolumab monotherapy

Participants who start a new systemic therapy with nivolumab monotherapy for the first time

Cohort 3: Nivolumab adjuvant therapy

Participants who start adjuvant treatment with nivolumab after complete surgical tumor resection and no evidence of disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult participants who are at least 18 years of age of the time of treatment decision with a primary diagnosis of advanced melanoma (histologically confirmed Stage III \[unresectable\] or Stage IV skin, ocular, or mucosal melanoma) and whose physician has already decided to initiate a treatment with nivolumab or nivolumab/ipilimumab for the first time for the treatment of melanoma, according to the label approved in Germany. Participants with a current primary diagnosis of a cancer other than advanced melanoma, participants currently included in an interventional clinical trial, or participants who have already received nivolumab in a prior line of therapy (for monotherapy arm) will all be excluded from this study. Adult participants in the adjuvant nivolumab treatment cohort will be enrolled after complete surgical resection and no evidence of disease after the treating physician has decided to initiate an adjuvant therapy with nivolumab according to the label approved in Germany.

You may qualify if:

• For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
• Advanced melanoma (Stage III/Stage IV)
• Histologically confirmed diagnosis
• Treatment decision for nivolumab monotherapy or nivolumab/ipilimumab combination therapy has already been taken
• For Cohort 3: (Recruitment ended by 08/31/2020)
• Primary diagnosis of advanced melanoma after complete surgical tumor resection and no evidence of disease
• Treatment decision for adjuvant nivolumab therapy has already been taken

You may not qualify if:

• For Cohort 1 and 2: (Recruitment ended by 02/20/2020)
• Current primary diagnosis of a cancer other than advanced melanoma, that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
• Previous treatment with nivolumab, for nivolumab monotherapy cohort only
• Current active participation in an interventional clinical trial
• For Cohort 3: (Recruitment ended by 08/31/2020)
• Current diagnosis of persisting advanced melanoma or a cancer other than advanced melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
• Current active participation in an interventional clinical trial

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Essen, 45147, Germany

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 13, 2016
• Study Start: December 6, 2016
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

DE (1)