Nivolumab + Immunotherapy for Melanoma

Recruiting at 1 trial location
CP
Overseen ByCecily Piteo
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Peter Forsyth | Moffitt

Peter Forsyth, MD

Principal Investigator

Moffitt Cancer Center

YP

Yolanda Pina, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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.
See 18 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
See 28 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Pre-Surgery Nivolumab + Relatlimab(Opdualag)Experimental Treatment2 Interventions
Group II: Pre-Surgery Nivolumab + IpilimumabExperimental Treatment3 Interventions

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

🇺🇸
Approved in United States as Yervoy for:
🇪🇺
Approved in European Union as Yervoy for:

Find a Clinic Near You

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 profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

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

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