Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
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
Sponsor: Exelixis
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Dose Escalation: MTD/Recommended Dose
Time frame: Up to Day 21
Dose Expansion: ORR
Time frame: Up to a maximum of 59 months
Secondary Endpoints
Incidence and severity of nonserious AEs and SAEs (Safety)
Eligibility Criteria
Inclusion Criteria: 1. 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) 2. Measurable disease per RECIST 1.1 as determined by the investigator. 3. Tumor tissue material available (archival or recent tumor biopsy) 4. 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. 5. Age eighteen years or older on the day of consent. 6. Eastern Cooperative Onco…
Read full criteria on CT.gov →✦ Analyst Commentary
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