IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Overview

About this study

The purpose of this study is for IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.

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:

- Participants must be HLA-A*02:01-positive

- Participants must have histologically confirmed Stage IV or unresectable Stage III
melanoma

- Archived or fresh tumor tissue sample that must be confirmed as adequate

- Participants must have measurable disease per RECIST 1.1

- Participant must have BRAF V600 mutation status determined

- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status
score of 0 or 1

- Male and female participants of childbearing potential who are sexually active with a
non-sterilized partner must agree to use highly effective methods of birth control
from the study screening date until 5 months after the final dose of study
intervention

Exclusion Criteria:

- Participants with a history of a malignant disease other than those being treated in
this study

- Participants with untreated, active, or symptomatic central nervous system (CNS)
metastases or carcinomatous meningitis

- Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients

- Participants with clinically significant pulmonary disease or impaired lung function

- Participants with clinically significant cardiac disease or impaired cardiac function

- Participants with active autoimmune disease requiring immunosuppressive treatment

- Participants with any medical condition that is poorly controlled or that would, in
the Investigator's or Sponsor's judgment, adversely impact the participant's
participation in the clinical study due to safety concerns, compliance with clinical
study procedures, or interpretation of study results

- Participants who received prior systemic anticancer therapy for unresectable or
metastatic melanoma

- Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or
anti-LAG-3

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/28/23. Questions regarding updates should be directed to the study team contact.

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

Ruqin Chen, M.D., M.B.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

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

International patient clinical studies questions