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Neoadjuvant L19IL2/L19TNF- Pivotal Study

NCT02938299 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2024-09-19

No results posted yet for this study

Summary

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.

Conditions

  • Malignant Melanoma

Interventions

DRUG

L19IL2 + L19TNF

Mixture of L19IL2 and L19TNF once weekly

PROCEDURE

Surgery

Surgical resection of melanoma tumor lesions

Sponsors & Collaborators

  • Philogen S.p.A.

    lead INDUSTRY

Principal Investigators

  • Katharina C. Kähler, MD · University Hospital Schleswig-Holstein

  • Mario Santinami, MD · Istituto Nazionale Tumori Milano

  • Piotr Rutkowski, MD · Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie Warszawa

  • Caroline Robert, MD · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2024-10-31
Completion
2028-12-31

Countries

  • France
  • Germany
  • Italy
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02938299 on ClinicalTrials.gov