Informations générales (source: ClinicalTrials.gov)
Neo-adjuvant Intratumoral Anti-CTLA4 + Anti-PD1 in Patients With Localized Melanoma
Interventional
Phase 2
UNICANCER (Voir sur ClinicalTrials)
janvier 2026
décembre 2033
02 mars 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline ROBERT | 23/04/2026 13:10:05 | Contacter | ||
Critères
Tous
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
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.