Nivolumab + Immunotherapy for Melanoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byYolanda Pina, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this pilot study is to determine the safety and feasibility of giving a single dose of Nivolumab with Ipilimumab or Relatlimab in participants with brain metastases from melanoma who can undergo surgery for removal of their brain metastases 7- 10 days after receiving the study drug.

Eligibility Criteria

This trial is for adults with melanoma brain metastases who can have surgery to remove these metastases. They must not have had immunotherapy in the last 6 months, be willing to provide samples for research, and meet certain health criteria including organ function and performance status. Women of childbearing potential must use contraception.

Inclusion Criteria

I need surgery for brain metastases but it's not an emergency.

I have had brain radiation therapy before.

I can have surgery 7-10 days after starting treatment.

+19 more

Exclusion Criteria

I have another cancer that is getting worse or needs treatment.

I don't have any health issues that could affect the trial's results.

Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the trial

+28 more

Participant Groups

The study tests the safety of a single dose of Nivolumab combined with either Ipilimumab or Relatlimab given before surgical removal of brain tumors from melanoma patients. The drugs are administered 7-10 days prior to scheduled craniotomy.

2Treatment groups

Experimental Treatment

Group I: Pre-Surgery Nivolumab + Relatlimab(Opdualag)Experimental Treatment2 Interventions

Patients will be given one dose of Opdualag (Nivolumab 480 mg IV + Relatlimab160 mg IV), prior to standard of care surgery for tumor resection.

Group II: Pre-Surgery Nivolumab + IpilimumabExperimental Treatment3 Interventions

Patients will be given one dose of Nivolumab (1mg/kg IV) and Ipilimumab (3mg/kg IV) prior to standard of care surgery for tumor resection.

Ipilimumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Yervoy for: