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Studies

Interventional Recruiting Phase 2

NCT05329792 on ClinicalTrials.gov

L19IL2/L19TNF in Skin Cancer Patients

Official title: A Phase II Study of L19IL2/L19TNF in Patients With Skin Cancers Amenable to Intralesional Treatment

  • Sponsor: Philogen S.P.A.
  • Enrollment: 70 (Estimated)
  • Study start: 2023-03-09 (Actual)
  • Primary completion: 2024-06-01 (Estimated)
  • Study completion: 2024-12-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: Phase II, open label, multicentric, proof-of-principle basket trial in patients with malignant tumors of the skin amenable to intratumoral injection, and in a curative or neoadjuvant or palliative intention.
  • Masking: None
  • PrimaryPurpose: Treatment

Brief Summary

Phase II, open label, multicentric, proof-of-principle basket trial in patients with malignant tumors of the skin amenable to intratumoral injection, and in a curative or neoadjuvant or palliative intention.

Conditions

  • BCC - Basal Cell Carcinoma
  • SCC - Squamous Cell Carcinoma
  • Merkel Cell Carcinoma
  • Keratoacanthoma of Skin
  • Malignant Adnexal Tumors of the Skin (MATS)
  • Tumors From Cutaneous T-cell Lymphoma (CTCL)
  • Kaposi Sarcoma

Intervention / Treatment

  • Drug: L19IL2/L19TNF

Primary Outcome Measures

  • Confirmed best overall response rate (BORR) (Visit will be performed at week 12)
    Efficacy of L19IL2/L19TNF measured as Confirmed best overall response rate (BORR) \[Complete Response (CR) + Partial Response (PR)\] for each tumor type measured according to RECIST v1.1 criteria. Confirmation of CR requires histopathological analysis of exeresis specimens for lesions removed by surgery or of biopsies in all other cases.

Countries

France, Italy, Spain

Locations and Investigators

  • Institut Gustave Roussy, Villejuif, France
  • Hospital Hotel Dieu, Nantes, France
  • Hôpitaux Universitaires de Marseille Timone, Marseille, France
  • Hospital Universitario 12 De Octubre, Madrid, Spain
    • Pablo Luis Ortiz, Romero
  • Hospital Universitario Virgen De La Macarena, Sevilla, Spain
    • David Moreno, Raminez
  • Hospital Clínic Barcelona, Barcelona, Spain
    • Agustí Toll, Abelló
  • Azienda Ospedaliero Universitaria di Bologna - Policlinico S. Orsola-Malpighi, Bologna, Italy
    • Emi, Dika
  • University of Trieste Maggiore Hospital, Trieste, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
    • Ketty, Peris
  • Azienda Ospedaliera Universitaria Senese, Siena, Italy
    • Anna Maria, Di Giacomo
  • Istituto Nazionale dei Tumori, Milano, Italy
    • Umberto, Cortinovis
  • Istituto Nazionale Tumori IRCCS Pascale, Napoli, Italy
    • Paolo Antonio, Ascierto
  • Istituto Oncologico Veneto, Padova, Italy
    • Francesco, Russano
  • Istituto Dermatologico San Gallicano - IFO (IRCCS), Roma, Italy
    • Laura, Eibenschutz
  • Humanitas Mirasole S.p.A., Rozzano, Italy