Clinical trial NCT04146324: An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in Australia
Official title: A Prospective Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma in Australia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: Adjuvant
nivolumab
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-10-31
Enrollment: 150
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: Adults whose melanoma had spread to the lymph nodes or other parts of the body and was surgically removed, and who are receiving post-surgery treatment with nivolumab to decrease the risk of cancer coming back.

Brief summary: This study is designed to estimate the effectiveness of nivolumab when given to participants after removing their cancer with surgery, over a 5-year follow-up, in real-world conditions in Australia.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Adults with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete surgical removal and have no evidence of disease
* Decision to treat with adjuvant nivolumab therapy has already been taken
* Ability to provide written informed consent to participate in the study

Exclusion Criteria:

* Adults with a current diagnosis of persisting advanced melanoma
* Adults currently enrolled in an interventional clinical trial for his/her melanoma treatment

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Percentage of Participants with Relapse-Free Survival (RFS)
timeFrame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Secondary outcomes:
measure: Percentage of Participants with Distant Metastasis-Free Survival (DMFS)
timeFrame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
measure: Overall Survival (OS)
timeFrame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
measure: Description of sociodemographic profile of participants
timeFrame: At treatment initiation with adjuvant nivolumab therapy
measure: Description of clinical characteristics of participants
timeFrame: At treatment initiation with adjuvant nivolumab therapy
measure: Prior medical history of participants
timeFrame: At treatment initiation with adjuvant nivolumab therapy
measure: Description of nivolumab pattern of use
timeFrame: At treatment initiation with adjuvant nivolumab therapy
measure: Health-related quality of life (HRQOL) of participants as assessed by European Quality of Life Five Dimensional Scale (EuroQOL-5D/EQ-5D)
timeFrame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
measure: HRQOL of participants as assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ C-30)
timeFrame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
measure: HRQOL of participants as assessed by Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire
timeFrame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
measure: Participants' socioeconomic status as assessed by their highest education level
timeFrame: At treatment initiation with adjuvant nivolumab therapy
measure: Description of care received as assessed by Healthcare Resource Utlization
timeFrame: During, and up to 5 years post discontinuation of nivolumab use
measure: Number of participants experiencing immune-related Adverse Events (AEs)
timeFrame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
measure: Number of participants experiencing non-immune-related AEs
timeFrame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy
Other outcomes:
Locations:
city: Garran
country: Australia
facility: Local Institution
state: Australian Capital Territory
city: Birtinya
country: Australia
facility: Local Institution
state: Queensland
city: Cairns
country: Australia
facility: Local Institution
state: Queensland
city: Greenslopes
country: Australia
facility: Local Institution
state: Queensland
city: Herston
country: Australia
facility: Local Institution
state: Queensland
city: Woolloongabba
country: Australia
facility: Local Institution
state: Queensland
city: Woodville South
country: Australia
facility: Local Institution - 0006
state: South Australia
city: Box Hill
country: Australia
facility: Local Institution
state: Victoria
city: Malvern
country: Australia
facility: Local Institution
state: Victoria
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: