Combination Therapy for Melanoma

Overseen by Sean S. Park, M.D., Ph.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This early phase I trial investigates how well radiation therapy, plasma exchange, and pembrolizumab or nivolumab work in treating patients with melanoma. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Plasma exchange (also known as "plasmapheresis") is a way to "clean" or "flush out" the blood. Immunotherapy with monoclonal antibodies, such as pembrolizumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Plasma exchange may help to improve the effect of standard radiation therapy and immunotherapy treatment on tumor cells of patients with melanoma.

Research Team

Jacob J. Orme, M.D., Ph.D.

Principal Investigator

Mayo Clinic in Rochester

Sean S. Park, M.D., Ph.D.

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for melanoma patients with measurable or non-measurable disease, able to visit the study site for follow-up, and have proper vascular access. Participants must not be pregnant, agree to use contraception if of childbearing potential, provide consent and blood samples for research, have a performance status score of 3 or less (meaning they are capable of self-care), and an sPD-L1 level above 1.7 ng/ml.

Inclusion Criteria

Provide written informed consent

Negative pregnancy test done =< 7 days prior to radiation therapy, for women of childbearing potential only

I can take care of myself but can't do heavy physical work.

Exclusion Criteria

Pregnant or nursing women

I am currently taking biotin supplements.

Your sPD-L1 level is less than 1.7 ng/ml as tested by ELISA.

Treatment Details

Interventions

• Nivolumab (Checkpoint Inhibitor)
• Pembrolizumab (Checkpoint Inhibitor)
• Radiation Therapy (Radiation)
• Therapeutic Exchange Plasma (Biological)

Trial Overview The trial investigates the combination of radiation therapy (high energy x-rays to kill tumor cells), plasma exchange ('flushing out' the blood), and immunotherapy drugs pembrolizumab or nivolumab in treating melanoma. It aims to see how well these treatments work together in attacking cancer cells and limiting their growth.

Participant Groups

Group I: Treatment (radiation therapy, plasma exchange, immunotherapy) Experimental Treatment 8 Interventions

Patients undergo radiation therapy daily on days 1-5 (weekdays). Patients then undergo therapeutic plasma exchange over 1-2 hours on the first session starting on the last day of radiation therapy and the last session ending prior to immunotherapy. Beginning day 5, patients receive pembrolizumab IV or nivolumab IV. Treatment with pembrolizumab continues every 3 weeks or treatment with nivolumab continues every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection throughout the study and SOC CT, PET, and/or MRI scans as clinically indicated during follow-up.

Nivolumab is already approved in Canada, Switzerland for the following indications:

Approved in Canada as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

• Melanoma
• Non-small cell lung cancer
• Renal cell carcinoma
• Hodgkin lymphoma
• Head and neck squamous cell carcinoma
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Gastroesophageal junction cancer
• Esophageal adenocarcinoma

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School