Trial results for the Phase 2 study (NCT04526730) investigating neoadjuvant immunotherapy with tavo + electroporation in combination with nivolumab for melanoma patients were posted on ClinicalTrials.gov on 2025-05-06. The study reported a 93% 1-year relapse-free survival probability and a 94% 1-year overall survival probability.
Background
Nivolumab is an immunotherapy drug. This study investigated its use in combination with tavo and electroporation as a neoadjuvant treatment for locally-regionally advanced melanoma.
Trial design
The Phase 2 open-label, single-arm study (NCT04526730) enrolled 17 participants with pathological diagnosis of operable locally-regionally advanced melanoma. The trial investigated neoadjuvant treatment with intratumoral tavo + electroporation plus nivolumab IV infusion.
Key results
The trial reported several key outcome measurements for the neoadjuvant treatment group:
- Pathologic Complete Response was observed in 9 participants.
- Objective Response Rate was achieved by 10 participants.
- The 1-year Relapse Free Survival Probability was 93% (95% Confidence Interval).
- The 1-year Overall Survival Percent Probability was 94% (95% Confidence Interval).
- Risk of Surgical Delay was reported for 1 participant.
What this means
The results from this Phase 2 study suggest that the neoadjuvant combination of intratumoral tavo + electroporation with nivolumab may offer favorable outcomes for patients with operable locally-regionally advanced melanoma. The observed high rates of pathologic complete response, objective response, and particularly the 93% 1-year relapse-free survival and 94% 1-year overall survival probabilities indicate potential efficacy for this treatment approach. The low incidence of surgical delay further supports the feasibility of this neoadjuvant regimen.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04526730, titled 'Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients,' were posted on 2025-05-06 on clinicaltrials.gov.