A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection


About this study

The purpose of this study is to compare the drug levels of nivolumab administered subcutaneously versus intravenous administration in participants with melanoma following complete resection.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that
is completely surgically resected (free of disease) with negative margins

- Complete resection performed within 12 weeks prior to randomization or treatment

- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

Exclusion Criteria:

- History of uveal or mucosal melanoma

- Untreated/unresected CNS metastases or leptomeningeal metastases

- Active, known or suspected autoimmune disease

- Serious or uncontrolled medical disorder 4 weeks prior to screening

- Concurrent malignancy (present during screening) requiring treatment or history of
prior malignancy active within 2 years prior to randomization or treatment assignment.
Participants with history of prior early stage basal/squamous cell skin cancer or
non-invasive or in situ cancers that have undergone definitive treatment at any time
are eligible

- Prior immunotherapy treatments for any prior malignancies are not permitted

Other protocol-defined inclusion/exclusion criteria apply

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Roxana Dronca, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions