Fianlimab + Cemiplimab for Melanoma

Overseen By Chao Family Comprehensive Cancer Center University of California, Irvine

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, Irvine

Must be taking: Antiretrovirals

Must not be taking: Immunosuppressants, Antibiotics

Disqualifiers: Visceral metastases, Brain metastases, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a phase II, open label clinical trial determining efficacy of Fianlimab in combination with Cemiplimab in subjects with Melanoma. These are subjects who will have surgery to remove their cancer.

Who Is on the Research Team?

Warren Chow, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Women of childbearing potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment.

Life expectancy of at least 12 weeks.

Females of childbearing potential and males must be willing and able to use a highly effective method of contraception to avoid pregnancy for the duration of the study and for at least 6 months after the last dose of study treatment. Acceptable means of contraception are listed in the fianlimab institutional brochure.

Exclusion Criteria

Participants must not have any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study treatment administration, impair the ability of the participant to receive protocol therapy, or interfere with the interpretation of study results.

I have been diagnosed with acral, ocular, or mucosal melanoma.

Known hypersensitivity to the active substances or to any of the excipients.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive neoadjuvant Fianlimab in combination with Cemiplimab every 3 weeks

9-24 weeks

3-8 visits (in-person)

Surgery

Participants undergo surgery to remove their cancer

Adjuvant Treatment

Participants receive adjuvant Fianlimab in combination with Cemiplimab every 3 weeks

9-39 weeks

3-13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 months

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab
• Fianlimab

How Is the Trial Designed?

Group I: 8 doses of neoadjuvant Fianlimab in combination with Cemiplimab Experimental Treatment 2 Interventions

8 doses of neoadjuvant 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks, followed by Surgery and then 8 doses of 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks

Group II: 6 doses of neoadjuvant Fianlimab in combination with Cemiplimab Experimental Treatment 2 Interventions

6 doses of neoadjuvant 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks, followed by Surgery and then 10 doses of 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks

Group III: 3 doses of neoadjuvant of Fianlimab in combination with Cemiplimab Experimental Treatment 2 Interventions

3 doses of neoadjuvant 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks, followed by Surgery and then 13 doses of 1600 mg Fianlimab in combination with 350 mg Cemiplimab every 3 weeks

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

UC Cancer Consortium

Collaborator