A Pivotal Phase III, Open-label, Randomized, Controlled Multi-center Study of the Efficacy of L19IL2/L19TNF Neoadjuvant Intratumoral Treatment Followed by Surgery Versus Surgery Alone in Clinical Stage III B/C Melanoma Patients

NCT02938299 Phase 3 ACTIVE_NOT_RECRUITING

Phase III, open-label, randomized, controlled multi-center study of the efficacy of L19IL2/L19TNF neoadjuvant intratumoral treatment in Stage III B/C melanoma patients.

Details

Lead sponsor	Philogen S.p.A.
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	214
Start date	2016-07-01
Completion	2028-12

Conditions

• Malignant Melanoma

Interventions

• L19IL2 + L19TNF
• Surgery

Primary outcomes

• Recurrence-free survival (RFS) rate — 1 year after randomization
  Recurrence-free survival (RFS) in the treatment arm (L19IL2/L19TNF plus surgery; Arm 1) versus control arm (Arm 2).

Countries

France, Germany, Italy, Poland