Nivolumab + Ipilimumab for Melanoma

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Abramson Cancer Center at Penn Medicine

Stay on your current meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?Subjects with resectable melanoma will receive neoadjuvant nivolumab followed by surgical resection. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab or ipilimumab plus nivolumab as determined by pathologic response at the time of resection.

Eligibility Criteria

Adults over 18 with stage III resectable melanoma can join this trial. They must be in good health, not pregnant or breastfeeding, and willing to use effective contraception. People with certain medical conditions, recent transfusions, active infections, or those on immunosuppressive drugs cannot participate.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I have stage III melanoma that can be surgically removed and it's not in my eyes or mucous membranes.

I am 18 years old or older.

Exclusion Criteria

I have or had lung inflammation that needed steroids.

I have been treated with specific immune system targeting drugs before.

I am currently being treated for an infection.

I have not received a live vaccine in the last 30 days.

I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

Treatment Details

The study tests nivolumab as a pre-surgery (neoadjuvant) treatment for melanoma. After surgery to remove the cancer, patients get either more nivolumab or a combination of nivolumab and ipilimumab for up to one year based on their response to the initial treatment.

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C: Adjuvant Combination (Less than Complete Response)Experimental Treatment2 Interventions

ipilimumab (1mg/kg) plus nivolumab (3mg/kg) for 4 doses and then nivolumab (480 mg) alone for a total of one year

Group II: Arm A: Adjuvant Nivolumab (Complete Pathological Response)Active Control1 Intervention

480 mg IV for up to one year

Group III: Arm B: Adjuvant Nivolumab (Less than Complete Response)Active Control1 Intervention

480 mg IV for up to one year

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸 Approved in United States as Opdivo for: