Clinical trial NCT02990611: Observational Study of Nivolumab Monotherapy or in Combination With Ipilimumab in Participants With Advanced Melanoma and in Participants With Adjuvant Nivolumab Therapy
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-12-13
Enrollment: 1087
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival (OS) of nivolumab/ipilimumab combination therapy
timeFrame: 5 years
measure: Relapse free survival (RFS) of adjuvant nivolumab therapy
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival (OS) of nivolumab monotherapy
timeFrame: 5 years
measure: Overall survival (OS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy, according to other subgroups of interest
timeFrame: 5 years
measure: Progression-free survival (PFS) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy
timeFrame: 5 years
measure: Overall response rate (ORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy
timeFrame: 5 years
measure: Best overall response (BOR) of nivolumab monotherapy and of nivolumab/ipilimumab combination therapy
timeFrame: 5 years
measure: Best overall response rate (BORR) of nivolumab monotherapy or nivolumab/ipilimumab combination therapy
timeFrame: 5 years
measure: Duration of response of monotherapy and combination therapy
timeFrame: Up to 5 years
measure: Distribution of sociodemographic characteristics: Age
timeFrame: 5 years
measure: Distribution of sociodemographic characteristics: Gender
timeFrame: 5 years
measure: Distribution of sociodemographic characteristics: BMI
timeFrame: 5 years
measure: Distribution of clinical characteristics: Initial diagnosis of melanoma
timeFrame: 5 years
measure: Distribution of clinical characteristics: Diagnosis of advanced melanoma
timeFrame: 5 years
measure: 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)
timeFrame: 5 years
measure: Distribution of clinical characteristics: Surgery of complete tumor resection and no evidence of disease
timeFrame: 5 years
measure: Distribution of clinical characteristics: Clinical code and staging melanoma subtypes
timeFrame: 5 years
measure: Distribution of clinical characteristics: Comorbidities
timeFrame: 5 years
measure: Distribution of clinical characteristics: Diagnostic procedures
timeFrame: 5 years
measure: Distribution of clinical characteristics: Mutation status
timeFrame: 5 years
measure: Distribution of clinical characteristics: Performance status as measured by Eastern Cancer Oncology Group (ECOG) scale
timeFrame: 5 years
measure: Distribution of clinical characteristics: Medical history
timeFrame: 5 years
measure: Distribution of clinical characteristics: Concomitant medication
timeFrame: 5 years
measure: Distribution of clinical characteristics: History of cancer
timeFrame: 5 years
measure: Distribution of clinical characteristics: Previous enrollment in an interventional study randomized controlled trials (RCTS)
timeFrame: 5 years
measure: Distribution of treatment patterns: Type of treatment previously received
timeFrame: 5 years
measure: Distribution of treatment patterns: Stage of melanoma
timeFrame: 5 years
measure: Distribution of treatment patterns: Current treatment details
timeFrame: 5 years
measure: European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ C-30)
timeFrame: 5 years
measure: Incidence of adverse events (AEs)
timeFrame: 5 years
measure: Severity of adverse events (AEs)
timeFrame: 5 years
measure: Distribution of management of adverse events (AEs)
timeFrame: 5 years
measure: Overall survival (OS) of adjuvant therapy
timeFrame: 5 years
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: