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innovaTV 207: Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors - SGNTV-001 (NCT03485209)

Studio Clinico

Patologia: Tumori della testa e del collo, Neoplasie del polmone, Tumori del colon retto, Carcinoma del pancreas esocrino

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

  • Relapsed, locally-advanced or metastatic colorectal or pancreatic cancer, squamous NSCLC, or SCCHN patients who are not candidates for standard therapy.
  • All patients must have experienced disease progression on or after their most recent systemic therapy.
  • Baseline measurable disease as measured by RECIST v1. 1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Colorectal cancer patients must have received prior therapy with each of following agents, if eligible: a fluoropyrimidine, oxaliplatin, irinotecean, and/or bevacizumab. Patients should have received no more than 3 systemic regimens in the metastatic setting.
  • Patients with NSCLC must have predominant squamous histology. Patients must have received prior therapy with a platinum-based treatment, a tyrosine kinase inhibitor, and a checkpoint inhibitor (CPI), if eligible. Patients should have received no more than 2 systemic regimens in the locally advanced or metastatic setting.
  • Patients with exocrine pancreatic adenocarcinoma must have predominant adenocarcinoma histology. Patients must have received prior therapy with a gemcitabine-based or 5FU-based regimen, if eligible, and should have received no more than 1 systemic regimen in the unresectable or metastatic setting.
  • Patients with SCCHN must have received prior therapy with a platinum-based regimen and a checkpoint inhibitor (CPI), if eligible, and should have received no more than 2 systemic regimens in the recurrent/metastatic setting.

Criteri di esclusione: 

  • Active bleeding conditions
  • Ocular surface disease at the time of enrollment
  • Pulmonary disease requiring chronic medical therapy, unrelated to underlying cancer
  • Uncontrolled tumor-related pain
  • Peripheral neuropathy greater than or equal to Grade 2
  • History of another malignancy within 3 years of the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
  • Active or previous brain metastasis
  • Patients who are breastfeeding, pregnant, or planning to become pregnant from the time of informed consent until 6 months after the final study dose is administered
  • For patients with SCCHN or NSCLC, ongoing anticoagulant therapy

Trattamento sperimentale: 

Tisotumab Vedotin
Intravenous (IV) infusion [2.0 mg/kg] every 3 weeks

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

Confirmed Objective Response Rate (ORR) [Time Frame: Through 1 month following last dose]

Obiettivi secondari dello studio: 

- Incidence of Adverse Events [Time Frame: Through 1 month following last dose]
- Confirmed and Unconfirmed ORR [Time Frame: Through 1 month following last dose]
- Disease Control Rate (DCR) [Time Frame: Through 1 month following last dose]
- Duration of Response (DOR) [Time Frame: Up to approximately 2 years]
- Time to Response (TTR) [Time Frame: Through 1 month following last dose]
- Progression-free survival (PFS) [Time Frame: Up to approximately 2 years]
- Overall Survival (OS) [Time Frame: Up to approximately 2 years]
- Cmax [Time Frame: Through 8 days after dosing]
- Ctrough [Time Frame: Through 8 days after dosing]

Note generali: 

- NSCLC: seconda-terza linea di trattamento, arruolamento aperto
- Pancreas: seconda linea di trattamento, arruolamento momentaneamente sospeso
- le altri coorti sono chiuse

Centri partecipanti

Nord Italia

Ospedale di Ravenna
Viale Randi 5 - 48121 Ravenna - RA

Riferimento: Dr. Federico Cappuzzo
Telefono: 0544285206
Email: federico.cappuzzo@auslromagna.it

 

Centro Italia

Università Campus Bio-medico
Via Álvaro del Portillo 200 - 00128 Roma - RM

Riferimento: Prof. Giuseppe Tonini
Telefono: 06225411201
Email: g.tonini@unicampus.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-005076-26

Data di inserimento: 09.04.2019

Promotore

Seattle Genetics, Inc. (collab: Genmab)

CRO

NA

Principal Investigator ITALIA

AUSL Romagna, Ravenna

Riferimento: Dr. Federico Cappuzzo

Telefono: 0544285206

Email: federico.cappuzzo@auslromagna.it

Localita: Ravenna

 

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