Nivolumab + Immunotherapy for Melanoma

Recruiting at 1 trial location

Overseen By Cecily Piteo

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Unresectable brain lesions, Autoimmune disease, Active infection, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 2

Duration: 1 week

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.

Research Team

Peter Forsyth, MD

Principal Investigator

Moffitt Cancer Center

Yolanda Pina, MD

Principal Investigator

Moffitt Cancer Center

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of Nivolumab with either Ipilimumab or Relatlimab prior to surgery for tumor resection

1 week

1 visit (in-person)

Surgery

Participants undergo standard of care surgery for tumor resection 7-10 days after receiving the study drug

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment and surgery

15 months

Treatment Details

Interventions

• Ipilimumab
• Nivolumab
• Nivolumab + Relatlimab
• Standard of Care Craniotomy

Trial Overview 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.

Participant Groups

Group I: Pre-Surgery Nivolumab + Relatlimab(Opdualag) Experimental Treatment 2 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 + Ipilimumab Experimental Treatment 3 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:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Approved in European Union as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania