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NCT03170960PHASE1ACTIVE_NOT_RECRUITING

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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Key Facts

Study type
INTERVENTIONAL
Conditions
Urothelial Carcinoma, Renal Cell Carcinoma, Non-Small Cell Lung Cancer, Castration-resistant Prostate Cancer, Triple Negative Breast Cancer
Interventions
cabozantinib, atezolizumab, cabozantinib, cabozantinib
Enrollment
914 participants
Primary completion
Feb 2023
Study completion
Sep 2027
First posted
May 2017
Last updated
Aug 2025

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

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov