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Nivolumab for Skin Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byTakami Sato, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well nivolumab works in treating patients with stage IIB-IIC melanoma that can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread.

Research Team

Takami Sato, MD, PhD

Principal Investigator

Sidney Kimmel Cancer Center at Thomas Jefferson University

Eligibility Criteria

This trial is for patients with stage IIB-IIC melanoma that can be surgically removed. They must have no metastatic disease, acceptable blood counts and organ function, and a good performance status (able to carry out daily activities). HIV-positive individuals may join if they meet certain criteria. Women who can bear children need a negative pregnancy test and must use birth control. Participants cannot have had certain prior treatments or live vaccines recently, nor active hepatitis or autoimmune diseases.

Inclusion Criteria

You can participate if you have HIV, but you need to meet certain requirements.

My sentinel lymph node biopsy was negative or the attempt to perform one failed.

Therapy must be initiated within specified timeframes

See 8 more

Exclusion Criteria

I have not taken certain specified drugs or antibodies.

Treatment with any investigational agent within 14 days of first administration of study treatment is not permitted

I have not had any other cancer types, with certain exceptions.

See 6 more

Treatment Details

Interventions

Nivolumab (Checkpoint Inhibitor)

Trial OverviewThe study is testing Nivolumab's effectiveness on early-stage melanoma suitable for surgery. Nivolumab is an antibody that might stop cancer cells from growing by interfering with their signals. The trial will see if this treatment prevents the spread of cancer after the tumor has been surgically removed.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (nivolumab)Experimental Treatment1 Intervention

Patients receive nivolumab IV over at least 30 minutes on day 1. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Cancer Center at Thomas Jefferson University

Lead Sponsor

Trials

164

Recruited

10,900+

Dr. Andrew Chapman

Sidney Kimmel Cancer Center at Thomas Jefferson University

Chief Executive Officer since 2022

Bachelor's degree from the University of Pennsylvania; D.O. from the University of Health Sciences College of Osteopathic Medicine in Kansas City, Missouri