Studio Clinico
Patologia: Carcinoma del pancreas esocrino, Neoplasie del polmone, Tumori del colon retto, Tumori della testa e del collo
Osservazionale-Sperimentale: Sperimentale
Monocentrico-Multicentrico: Multicentrico
Randomizzato: No
Fase di studio: II
Richiesta mandatoria di tessuto: Sì
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 S. Maria delle Croci, 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