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

Melanoma Clinical Trial

— NICO  

Official title:

A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) Monotherapy or in Combination With Ipilimumab in Patients With Advanced (Unresectable or Metastatic) Melanoma and in Patients With Adjuvant Nivolumab Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02990611
• Other study ID #: CA209-654
• Status: Active, not recruiting
• Start date: December 6, 2016
• Est. completion date: August 31, 2025

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1087
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria apply

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
Germany	Local Institution	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS) of nivolumab/ipilimumab combination therapy		5 years
Primary	Relapse free survival (RFS) of adjuvant nivolumab therapy		5 years
Secondary	Overall survival (OS) of nivolumab monotherapy		5 years
Secondary	Overall survival (OS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy, according to other subgroups of interest		5 years
Secondary	Progression-free survival (PFS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy		5 years
Secondary	Overall response rate (ORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy		5 years
Secondary	Best overall response (BOR) of nivolumab monotherapy and of nivolumab/ipilimumab combination therapy		5 years
Secondary	Best overall response rate (BORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy		5 years
Secondary	Duration of response of monotherapy and combination therapy		Up to 5 years
Secondary	Distribution of sociodemographic characteristics: Age		5 years
Secondary	Distribution of sociodemographic characteristics: Gender		5 years
Secondary	Distribution of sociodemographic characteristics: BMI		5 years
Secondary	Distribution of clinical characteristics: Initial diagnosis of melanoma		5 years
Secondary	Distribution of clinical characteristics: Diagnosis of advanced melanoma		5 years
Secondary	Distribution of clinical characteristics: Duration of disease from date of initial melanoma diagnosis to initial treatment in study, or date of study entry (if untreated)		5 years
Secondary	Distribution of clinical characteristics: Surgery of complete tumor resection and no evidence of disease		5 years
Secondary	Distribution of clinical characteristics: Clinical code and staging melanoma subtypes		5 years
Secondary	Distribution of clinical characteristics: Comorbidities		5 years
Secondary	Distribution of clinical characteristics: Diagnostic procedures		5 years
Secondary	Distribution of clinical characteristics: Mutation status		5 years
Secondary	Distribution of clinical characteristics: Performance status as measured by Eastern Cancer Oncology Group (ECOG) scale		5 years
Secondary	Distribution of clinical characteristics: Medical history		5 years
Secondary	Distribution of clinical characteristics: Concomitant medication		5 years
Secondary	Distribution of clinical characteristics: History of cancer		5 years
Secondary	Distribution of clinical characteristics: Previous enrollment in an interventional study randomized controlled trials (RCTS)		5 years
Secondary	Distribution of treatment patterns: Type of treatment previously received		5 years
Secondary	Distribution of treatment patterns: Stage of melanoma		5 years
Secondary	Distribution of treatment patterns: Current treatment details		5 years
Secondary	European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ C-30)		5 years
Secondary	Incidence of adverse events (AEs)		5 years
Secondary	Severity of adverse events (AEs)		5 years
Secondary	Distribution of management of adverse events (AEs)		5 years
Secondary	Overall survival (OS) of adjuvant therapy		5 years

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls