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NotablePrimary endpoints: details revised at 1 of 2 entriesEligibility criteria expanded, about 23 words · Site details revised at 1 of 124 sites · Publications: details revised at 4 of 4 entries · 1 moreShow 4 more changesShow less
Eligibility criteria expanded, about 23 words
Site details revised at 1 of 124 sites
Publications: details revised at 4 of 4 entries
Study description expanded, about 4 words
NotablePhase: Phase 1/2 to Phase 1Enrollment target: estimated 1732 to confirmed 914 · Primary completion date changed from estimate of Jul 2023 to Feb 21, 2023 · Completion date: Aug 2024 to Sep 30, 2027 · 2 morev40Show 5 more changesShow less
Enrollment target: estimated 1732 to confirmed 914
Primary completion date changed from estimate of Jul 2023 to Feb 21, 2023
Completion date: Aug 2024 to Sep 30, 2027
Secondary endpoints: details revised at 1 of 1 entry
NotablePrimary completion date: Dec 2022 to Jul 2023Completion date: Dec 2022 to Aug 2024v38Show 1 more changeShow less
Completion date: Dec 2022 to Aug 2024
MinorTrial status: Recruiting to Active, Not RecruitingSite details revised at 124 of 124 sitesv37Show 1 more changeShow less
Site details revised at 124 of 124 sites
Show 35 earlier versionsHide 35 earlier versions
NotablePrimary completion date: Dec 2021 to Dec 2022v36
NotablePrimary completion date: Dec 2020 to Dec 2021Study sites: 117 to 124 · Completion date: Dec 2021 to Dec 2022v35Show 2 more changesShow less
Study sites: 117 to 124
Completion date: Dec 2021 to Dec 2022
MinorStudy sites: 102 to 117v34
MinorStudy sites: 78 to 102v33
MinorStudy sites: 66 to 78v32
MinorStudy sites: 62 to 66v31
MinorStudy sites: 60 to 62v30
MinorStudy sites: 58 to 60v29
NotablePrimary completion date: Mar 2020 to Dec 2020Completion date: Dec 2020 to Dec 2021 · Study description expanded, about 26 words · Eligibility criteria expanded, about 5 wordsv28Show 3 more changesShow less
NotableEnrollment target: 1000 to 1732Study description expanded, about 17 words · Study arms: 21 to 25 · Eligibility criteria expanded, about 4 wordsv21Show 3 more changesShow less
NotableEnrollment target: 360 to 1000Primary completion date: Jan 2020 to Mar 2020 · Completion date: Oct 2020 to Dec 2020 · Interventions: atezolizumab (Drug), cabozantinib (Drug), cabozantinib (Drug) to atezolizumab (Drug), cabozantinib (Drug), cabozantinib (Drug), cabozantinib (Drug) · 3 morev8Show 6 more changesShow less
NotableEnrollment target: 156 to 360Study sites: 2 to 3 · Primary completion date: Aug 2019 to Jan 2020 · Completion date: Jun 2020 to Oct 2020 · 4 morev4Show 7 more changesShow less
Study sites: 2 to 3
Primary completion date: Aug 2019 to Jan 2020
Completion date: Jun 2020 to Oct 2020
Eligibility criteria expanded, about 108 words
Secondary endpoints: details revised at 1 of 1 entry
MinorStudy sites: 1 to 2Start date changed from estimate of Jul 2017 to Sep 5, 2017v3Show 1 more changeShow less
Start date changed from estimate of Jul 2017 to Sep 5, 2017
NotableTrial status: Not Yet Recruiting to RecruitingStudy sites: 0 to 1 · Start date: Jun 2017 to Jul 2017v2Show 2 more changesShow less
Study sites: 0 to 1
Start date: Jun 2017 to Jul 2017
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric cancer/gastroesophageal junction cancer/lower esophageal cancer (GC/GEJC/LEC), colorectal cancer (CRC), head and neck (H\&N) cancer, and differentiated thyroid cancer (DTC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established; in the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment in these tumor indications. Three exploratory single-agent cabozantinib (SAC) cohorts may also be enrolled with UC, NSCLC, or CRPC subjects. One exploratory single-agent atezolizumab (SAA) cohort may also be enrolled with CRPC subjects. Subjects enrolled in the SAC cohorts and SAA cohort may receive combination treatment with both cabozantinib and atezolizumab after they experience radiographic progressive disease per the Investigator per RECIST 1.1. Due to the nature of this study design, some tumor cohorts may complete enrollment earlier than others.