NCT07230613 Neo-adjuvant Immunotherapy in Patients With Localized Melanoma
| NCT ID | NCT07230613 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | UNICANCER |
| Condition | Cutaneous Melanoma, Stage III |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-01-12 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2026-01-12 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The success of anti-PD-1 and anti-CTLA-4 therapies has initiated a paradigm shift in oncology, with drugs now targeting the immune system rather than cancer cells to stimulate the antitumor immune response. Intratumoral (IT) delivery of immunostimulating agents reduces the systemic toxicity associated with monoclonal antibodies (mAbs) targeting immune checkpoints. Notably, IT injections of immune checkpoint blockade (ICB) have been shown to induce immune-mediated tumor responses both at the injected site and at distant, non-injected tumor sites. While surgery has traditionally been the preferred treatment for stage III and IV melanoma patients, neoadjuvant therapy with anti-CTLA-4 and anti-PD-1 agents has shown promising efficacy. In patients with localized melanoma, it is hypothesized that IT administration of ipilimumab (anti-CTLA-4 Ab) combined with nivolumab (anti-PD-1 Ab) will provide the most effective and safe treatment combination. The NEO-1 study is a proof-of-concept clinical trial designed as a sub-protocol of NEOREM master protocol (NCT07262489) to validate the intratumoral immunotherapy approach, aiming to maximize the dose/efficacy ratio of combined ipilimumab and nivolumab treatment while minimizing systemic adverse events. This is an academic, open-label, multicentric, phase II clinical trial evaluating the efficacy and safety of intratumoral injections of ipilimumab and nivolumab combination as neoadjuvant treatment in localized stage III resectable cutaneous or mucosal melanoma patients. Baseline and on-treatment PORTRAIT profiling, as described in the NEOREM Master Protocol (NCT07262489), will be performed using fresh blood and tumor samples. This profiling will reveal the immune status of patients and support biomarker-driven preselection for future trials.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07230613 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cutaneous Melanoma, Stage III. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07230613 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07230613 currently recruiting?
Yes, NCT07230613 is actively recruiting participants. Contact the research team at p-devi-marulkar@unicancer.fr for enrollment information.
Where is the NCT07230613 trial being conducted?
This trial is being conducted at Villejuif, France.
Who is sponsoring the NCT07230613 clinical trial?
NCT07230613 is sponsored by UNICANCER. The trial plans to enroll 50 participants.
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