Neoadjuvant Ipilimumab + Nivolumab for Melanoma (NADINA Trial)

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: The Netherlands Cancer Institute

Stay on your current meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 8 jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing two treatment plans for patients with stage III melanoma. One plan uses two drugs before surgery, while the other uses surgery first followed by one of the drugs. The goal is to see which plan works better at stopping the cancer from coming back. These drugs have been shown to improve survival rates in patients with advanced melanoma.

Eligibility Criteria

This trial is for adults and teens (16+) with stage III melanoma that can be surgically removed. Participants must not have used immunosuppressive drugs in the last 6 months, should have good health status, no history of certain cancers or treatments targeting BRAF/MEK or CTLA-4/PD-1/PD-L1, and no active infections or autoimmune diseases. Women who can bear children and sexually active men must use contraception.

Inclusion Criteria

I have no other cancers, or if I do, they are under control and not expected to affect my life expectancy significantly.

I have not had immunotherapy targeting CTLA-4, PD-1, or PD-L1.

My melanoma is at stage III and can be surgically removed.

I am fully active or able to carry out light work.

I have not had treatments targeting BRAF or MEK.

Exclusion Criteria

I have undergone radiotherapy before.

I am not pregnant or breastfeeding.

I am taking medication that weakens my immune system.

I have an active autoimmune disease or a history of one.

My melanoma is in the eye or mucous membranes.

My melanoma has spread to distant parts of my body.

Participant Groups

The study compares two approaches: one group receives neoadjuvant ipilimumab + nivolumab before surgery followed by adjuvant nivolumab; the other has standard surgery first then adjuvant nivolumab. Some may get additional treatment if they don't respond well initially. The goal is to see which method works better for preventing cancer progression.

2Treatment groups

Experimental Treatment

Active Control

Group I: A: NeoadjuvantExperimental Treatment1 Intervention

2 cycles of neoadjuvant ipilimumab (80mg) + nivolumab (240mg) every 3 weeks followed by a total lymph node dissection (TLND) and if applicable, resection of in-transit metastases. Patients with a pathologic partial or non-response in arm A will also receive adjuvant nivolumab 480 mg every 4 weeks 11 cycles. In case of BRAF V600E/K mutation-positivity, patients will be treated with adjuvant dabrafenib plus trametinib for 46 weeks instead.

Group II: B: AdjuvantActive Control1 Intervention

Standard upfront total lymph node dissection (TLND) and if applicable, resection of in-transit metastases followed by 12 cycles adjuvant nivolumab 480 mg every 4 weeks

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

🇺🇸 Approved in United States as Yervoy for: