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A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination with Atezolizumab to Subjects with Locally Advanced or Metastatic Solid Tumors - XL184-021

Studio Clinico

Patologia: Carcinoma della prostata, Carcinoma della vescica, Epatocarcinoma, Neoplasie della mammella, Neoplasie del polmone, Neoplasie dello stomaco, Tumori del colon retto, Tumori dell’esofago, Tumori del rene, Tumori dell’utero, Tumori dell’ovaio, Tumori della testa e del collo

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1, I B

Richiesta mandatoria di tessuto: 

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Cytologically or histologically and radiologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent:
    Dose-Escalation Stage:
        Subjects with UC (including renal pelvis, ureter, bladder, urethra) after prior platinum-based therapy, or
        Subjects with RCC (clear cell, non-clear cell histology) with or without prior systemic anticancer therapy
    Expansion Stage:
        Inoperable locally advanced or metastatic solid tumor (UC, RCC, CRPC, NSCLC, TNBC, OC, EC, HCC, GC/GEJC/LEC, CRC, - H&N cancer, and DTC as outlined above)
- Measurable disease per RECIST 1.1 as determined by the investigator.
- Tumor tissue material available (archival or recent tumor biopsy)
- Recovery to baseline or ≤ Grade 1 CTCAE v4 from toxicities related to any prior treatments, unless AE(s) are clinically - nonsignificant and/or stable on supportive therapy.
- Age eighteen years or older on the day of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Adequate organ and marrow function.
- Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception.
- Female subjects of childbearing potential must not be pregnant at screening.

Criteri di esclusione: 

- Prior treatment with cabozantinib or immune checkpoint inhibitors including anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 therapy except in Expansion Cohorts 5, 7, 9, 11, 17, 19 and 20. Other restrictions regarding prior therapy may apply.
- Known brain metastases or cranial epidural disease unless adequately treated and stable for at least 4 weeks before first dose of study treatment.
- Concomitant anticoagulation with oral anticoagulants.
- Subject is receiving systemic steroid therapy (>10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 2 weeks prior to first dose of study treatment.
- Administration of a live, attenuated vaccine within 30 days before first dose of study treatment.
- The subject has uncontrolled, significant intercurrent or recent illness, including, but not limited to, an active or history of autoimmune disease or immune deficiency; idiopathic pulmonary fibrosis, organizing pneumonia, pneumonitis; active infection requiring systemic treatment, infection with human immunodeficiency virus (HIV), AIDS-related illness, acute or chronic hepatitis B or C infection, positive test for tuberculosis, moderate to severe hepatic impairment (Child-Pugh B or C).
- Pregnant or lactating females.
- Previously identified allergy or hypersensitivity to components of the study treatment formulations.
- Diagnosis of another malignancy within 2 years before first dose of study treatment.

Trattamento sperimentale: 

Cabozantinib + Atezolizumab o Cabozantinib single agent.

Trattamento di controllo: 


Obiettivi primari dello studio: 

- Dose Escalation: MTD/Recommended Dose [ Time Frame: Up to 6 months ]
To determine the maximum tolerated dose (MTD) and/or recommended dose and schedule for the subsequent Expansion Stage of daily oral administration of cabozantinib in subjects with solid tumors when taken in combination with atezolizumab.

- Dose Expansion: ORR [ Time Frame: Up to 31 months ]
To evaluate preliminary efficacy by estimating the Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1.

Obiettivi secondari dello studio: 

- Incidence and severity of nonserious AEs and SAEs (Safety) [ Time Frame: Up to 41 months ]
To assess safety for the combination therapy through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs), including immune-related adverse events (irAEs).

Centri partecipanti

Nord Italia

IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC


IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
S.C. Oncologia Medica 1

Riferimento: Prof. Filippo De Braud


IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
S.S. Oncologia Medica Genitourinaria

Riferimento: Dr.ssa Elena Verzoni
Telefono: 0223904449


IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
S.S. Oncologia Medica Toraco-Polmonare


Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI


Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

Riferimento: Prof. Armando Santoro
Telefono: 0282246280


IRCCS Policlinico San Matteo
Viale Golgi 19 - 27100 Pavia - PV


Centro Italia

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM

Informazioni Generali


Numero di iscrizione a registro: NCT03170960

Data di inserimento: 05.08.2021



Principal Investigator ITALIA

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Riferimento: Prof. Filippo De Braud

Telefono: 0223902148


Localita: Milano


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