An Observational Study of Adjuvant (Post-surgery) Therapy With Nivolumab for Resected (Completely Removed) Melanoma in Australia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04146324 |
Recruitment Status :
Recruiting
First Posted : October 31, 2019
Last Update Posted : June 18, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Melanoma | Drug: nivolumab |
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Prospective Observational Study in Patients Receiving Adjuvant Nivolumab Therapy for Resected Melanoma in Australia |
Actual Study Start Date : | October 24, 2019 |
Estimated Primary Completion Date : | July 9, 2025 |
Estimated Study Completion Date : | July 9, 2025 |

Group/Cohort | Intervention/treatment |
---|---|
Adjuvant nivolumab therapy
Participants receiving nivolumab as an adjuvant therapy according to the market authorization in Australia
|
Drug: nivolumab
Administered as adjuvant therapy as per the market authorization in Australia |
- Percentage of Participants with Relapse-Free Survival (RFS) [ Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy ]The time between the date of randomisation and the date of first recurrence, new primary melanoma, or death due to any cause, whichever occurred first.
- Percentage of Participants with Distant Metastasis-Free Survival (DMFS) [ Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy ]
- Overall Survival (OS) [ Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy ]
- Description of sociodemographic profile of participants [ Time Frame: At treatment initiation with adjuvant nivolumab therapy ]
- Description of clinical characteristics of participants [ Time Frame: At treatment initiation with adjuvant nivolumab therapy ]
- Prior medical history of participants [ Time Frame: At treatment initiation with adjuvant nivolumab therapy ]
- Description of nivolumab pattern of use [ Time Frame: At treatment initiation with adjuvant nivolumab therapy ]
- Health-related quality of life (HRQOL) of participants as assessed by European Quality of Life Five Dimensional Scale (EuroQOL-5D/EQ-5D) [ Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy ]
- HRQOL of participants as assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ C-30) [ Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy ]
- HRQOL of participants as assessed by Functional Assessment of Cancer Therapy-Melanoma (FACT-M) questionnaire [ Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy ]
- Participants' socioeconomic status as assessed by their highest education level [ Time Frame: At treatment initiation with adjuvant nivolumab therapy ]
- Description of care received as assessed by Healthcare Resource Utlization [ Time Frame: During, and up to 5 years post discontinuation of nivolumab use ]
- Number of participants experiencing immune-related Adverse Events (AEs) [ Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy ]
- Number of participants experiencing non-immune-related AEs [ Time Frame: Up to 5 years post treatment initiation with adjuvant nivolumab therapy ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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 Inclusion/Exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146324
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, | please email: | Clinical.Trials@bms.com | |
Contact: First line of the email MUST contain NCT # and Site # |
Australia, Australian Capital Territory | |
Local Institution | Not yet recruiting |
Garran, Australian Capital Territory, Australia, 2605 | |
Contact: Site 0004 | |
Australia, Queensland | |
Local Institution | Recruiting |
Birtinya, Queensland, Australia, 4575 | |
Contact: Site 0011 | |
Local Institution | Recruiting |
Cairns, Queensland, Australia, 4870 | |
Contact: Site 0010 | |
Local Institution | Recruiting |
Greenslopes, Queensland, Australia, 4120 | |
Contact: Site 0001 | |
Local Institution | Recruiting |
Herston, Queensland, Australia, 4031 | |
Contact: Site 0008 | |
Local Institution | Recruiting |
Woolloongabba, Queensland, Australia, 4012 | |
Contact: Site 0005 | |
Australia, South Australia | |
Local Institution | Withdrawn |
Adelaide, South Australia, Australia, 5000 | |
Local Institution | Recruiting |
Woodville South, South Australia, Australia, 5001 | |
Contact: Site 0006 | |
Australia, Victoria | |
Local Institution | Recruiting |
Box Hill, Victoria, Australia, 3128 | |
Contact: Site 0002 | |
Local Institution | Recruiting |
Malvern, Victoria, Australia, 3144 | |
Contact: Site 0003 | |
Local Institution | Withdrawn |
Melbourne, Victoria, Australia, 3004 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT04146324 |
Other Study ID Numbers: |
CA209-7CK |
First Posted: | October 31, 2019 Key Record Dates |
Last Update Posted: | June 18, 2020 |
Last Verified: | June 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Adjuvant nivolumab |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Nevi and Melanomas Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents |