Neoadjuvant intratumoral ipilimumab plus nivolumab for resectable stage III melanoma
Neo-adjuvant Intratumoral Anti-CTLA4 + Anti-PD1 in Patients With Localized Melanoma
This trial tests whether injecting ipilimumab and nivolumab directly into tumors before surgery helps adults with resectable stage III cutaneous or mucosal melanoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unicancer Academic / other |
| Drugs / interventions | nivolumab, ipilimumab, immunotherapy |
| Locations | 1 site (Villejuif) |
| Trial ID | NCT07230613 on ClinicalTrials.gov |
What this trial studies
NEO-1 is a multicenter phase II proof-of-concept trial testing intratumoral (image-guided) injections of ipilimumab combined with nivolumab given before surgical resection in patients with resectable stage III cutaneous or mucosal melanoma. The approach aims to concentrate immune checkpoint blockade in the tumor to boost local and systemic anti-tumor immunity while reducing the systemic toxicity seen with full-dose intravenous combination therapy. Fresh blood and tumor samples are collected at baseline and during treatment for PORTRAIT profiling to characterize the tumor microenvironment and identify predictive biomarkers. Patients proceed to planned surgery after the neoadjuvant intratumoral treatment and safety and anti-tumor response are monitored throughout.
Who should consider this trial
Good fit: Adults (≥18) with resectable, measurable stage III cutaneous or mucosal melanoma without distant metastases, including those who stopped prior anti-PD-1 therapy >6 months or targeted therapy >3 months ago, are the intended participants.
Not a fit: Patients with clinically or radiologically detectable distant metastases, uveal melanoma, hypersensitivity to nivolumab or ipilimumab, or without evaluable disease per RECIST are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could shrink tumors and trigger systemic immune responses while reducing the severe systemic side effects associated with intravenous combination immunotherapy.
How similar studies have performed: Systemic neoadjuvant ipilimumab plus nivolumab has shown improved outcomes but high toxicity in randomized trials, and early intratumoral immune-checkpoint blockade studies have produced local and distant responses but remain largely proof-of-concept.
Eligibility criteria
Show full inclusion / exclusion criteria
In addition to NEOREM Master Protocol inclusion and exclusion criteria, the following inclusion and exclusion criteria must be verified before inclusion in the NEO-1 trial: Inclusion Criteria: 1. Patients ≥ 18 years old. 2. Patients with resectable and measurable (according to RECIST v1.1 criteria) stage III cutaneous and mucosal melanoma. 3. Patients who received anti-PD-1 and stopped treatment \> 6 months prior to their inclusion in NEO-1 trial are eligible. 4. Patients who received target therapy and stopped treatment \> 3 months prior to their inclusion in NEO-1 trial are eligible. Exclusion Criteria: 1. Patients with clinically or radiologically detectable distant metastases. 2. Patients with uveal melanoma. 3. Patients with any hypersensitivity to the active ingredient or to any of the excipients of nivolumab and/ ipilimumab. 4. Patients without pathological evaluable disease according to RECIST v1.1 criteria.
Where this trial is running
Villejuif
- Gustave Roussy — Villejuif, France (Recruiting)
Study contacts
- Study coordinator: Priyanka DEVI-MARULKAR, PhD, MBA
- Email: p-devi-marulkar@unicancer.fr
- Phone: +33(0)662536043
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.