Exelixis Clinical Trials: 54 Led Studies

Archive historyOct 2022 to Jun 2026

68 recorded changes across Exelixis trials

Every status move, completion date shift and enrollment change ComplyRx has recorded across 19 of these trials. One is shown below.

Status changeStatus moved to recruiting from not yet recruitingNCT07428616 · recorded 1 Jun 2026

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+64 more recorded changes · Track a drug to see every change the night it lands

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Most active programmes

The drugs appearing most often across Exelixis's recently active trials. Comparator arms are excluded.

cabozantinib9 trials
Nivolumab8 trials
Cabozantinib8 trials
Zanzalintinib7 trials
XL1846 trials
Atezolizumab5 trials

Upcoming readouts

Next primary completion dates among Exelixis's active phase 2 and phase 3 trials. Dates are registry estimates and move often, which is exactly what the tracker watches.

Feb 2028STELLAR-201: A Study of Zanzalintinib in Participants With Recurrent or Progressive MeningiomaPhase 2
Jun 2029STELLAR-311: Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocri…Phase 2

Top therapeutic areas

Conditions studied most often across Exelixis's recently active trials.

Cancer12 trials
Colorectal Cancer5 trials
Renal Cell Carcinoma5 trials
Prostate Cancer4 trials
Solid Tumors4 trials
Castration Resistant Prostate Cancer3 trials

Exelixis trials

The 50 most significant of Exelixis's recently active trials, soonest estimated readout first.
Select any row for the full record; the change timeline unlocks with tracking.

Trial	Phase	Stability	Status	Enrollment	Est. readout
STELLAR-001A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid TumorsNCT03845166XL092	Phase 1	Locked · track to reveal	OngoingActive, not recruiting	325 est.	31 Aug 2026
Study of XB010 in Subjects With Solid TumorsNCT06545331XB010	Phase 1	Locked · track to reveal	OngoingRecruiting	396 est.	23 Nov 2026
A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid TumorsNCT06952010XB628	Phase 1	Locked · track to reveal	OngoingRecruiting	303 est.	31 May 2027
A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid TumorsNCT07123103XB371	Phase 1	Locked · track to reveal	OngoingRecruiting	150 est.	Nov 2027
STELLAR-201A Study of Zanzalintinib in Participants With Recurrent or Progressive MeningiomaNCT07428616Zanzalintinib	Phase 2	Locked · track to reveal	OngoingRecruiting	100 est.	29 Feb 2028
STELLAR-305Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell CarcinomaNCT06082167Zanzalintinib	Phase 2	Locked · track to reveal	OngoingActive, not recruiting	600 est.	Aug 2028
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid TumorsNCT05932862XL309	Phase 1	Locked · track to reveal	OngoingRecruiting	429 est.	3 Jan 2029
STELLAR-311Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine TumorsNCT06943755Zanzalintinib	Phase 2	Locked · track to reveal	OngoingRecruiting	440 est.	30 Jun 2029
Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored StudyNCT07620574Cabozantinib	Phase 3	Locked · track to reveal	OngoingNot yet recruiting	5,000 est.	31 May 2030
STELLAR-002Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid TumorsNCT05176483Zanzalintinib	Phase 1	Locked · track to reveal	OngoingRecruiting	1,314 est.	28 Jun 2030
STELLAR-303Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal CancerNCT05425940XL092	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	901 est.	16 Jun 2026
Pharmacokinetics (PK) and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment (HI)NCT06962332Zanzalintinib	Phase 1	Locked · track to reveal	OngoingRecruiting	20 est.	Dec 2025
STELLAR-304Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell CarcinomaNCT05678673XL092	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	317 est.	Jul 2025
Study of Zanzalintinib (XL092) + AB521 and Zanzalintinib + AB521 + Nivolumab in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Other Advanced Solid Tumors (STELLAR-009)NCT06191796zanzalintinib	Phase 1	Locked · track to reveal	StoppedTerminated	25 est.	12 May 2025
A Dose-escalation, Dose-finding, and Expansion Study of XL495 in Participants With Locally Advanced or Metastatic Solid TumorsNCT06630247XL495	Phase 1	Locked · track to reveal	StoppedTerminated	9 est.	7 May 2025
Study of XB002 in Subjects With Solid Tumors (JEWEL-101)NCT04925284XB002	Phase 1	Locked · track to reveal	Completed	269 est.	10 Mar 2025
Study of XL102 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (QUARTZ-101)NCT04726332XL102	Phase 1	Locked · track to reveal	StoppedTerminated	52 est.	2 May 2024
CONTACT-02Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPCNCT04446117Cabozantinib	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	575 est.	19 Apr 2024
Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid TumorsNCT03170960cabozantinib	Phase 1	Locked · track to reveal	OngoingActive, not recruiting	914 est.	21 Feb 2023
Study of XL114 in Subjects With Non-Hodgkin's LymphomaNCT05144347XL114	Phase 1	Locked · track to reveal	StoppedTerminated	2 est.	1 Nov 2022
COSMIC-313Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell CarcinomaNCT03937219Cabozantinib	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	855 est.	31 Jan 2022
COSMIC-312Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer TherapyNCT03755791Cabozantinib	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	837 est.	30 Nov 2021
A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted TherapyNCT03690388Cabozantinib	Phase 3	Locked · track to reveal	OngoingActive, not recruiting	187 est.	19 Aug 2020
EXAMINERA Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid CancerNCT01896479Cabozantinib (XL184) 140 mg	Phase 4	Locked · track to reveal	OngoingActive, not recruiting	247 est.	15 Jul 2020
CELESTIALStudy of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior SorafenibNCT01908426Cabozantinib tablets	Phase 3	Locked · track to reveal	Completed	707 est.	16 Oct 2017
METEORA Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell CarcinomaNCT01865747Cabozantinib tablets	Phase 3	Locked · track to reveal	Completed	658 est.	22 May 2015
Dose-Finding Study of Cabozantinib (XL184) in Japanese Subjects With Advanced CancerNCT01553656cabozantinib capsules	Phase 1	Locked · track to reveal	Completed	85 est.	May 2015
Combo of Cabozantinib With Abiraterone in Chemotherapy-Naïve Subjects With Bone-Metastatic CRPCNCT01995058cabozantinib	Phase 2	Locked · track to reveal	StoppedTerminated	54 est.	Nov 2014
COMET-2Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate CancerNCT01522443cabozantinib	Phase 3	Locked · track to reveal	StoppedTerminated	119 est.	Oct 2014
COMET-1Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100NCT01605227cabozantinib	Phase 3	Locked · track to reveal	Completed	1,028 est.	Sept 2014
Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult SubjectsNCT01493869cabozantinib	Phase 1	Locked · track to reveal	Completed	26 est.	May 2014
Study of Cabozantinib (XL184) in Adults With Advanced MalignanciesNCT00940225Cabozantinib	Phase 2	Locked · track to reveal	Completed	730 est.	May 2013
A Single-Dose Study to Assess the Pharmacokinetics of Cabozantinib (XL184) Capsules in Subjects With Impaired Renal FunctionNCT01761773cabozantinib	Phase 1	Locked · track to reveal	Completed	32 est.	Apr 2013
Safety Study of XL184 (Cabozantinib) in Combination With Temozolomide and Radiation Therapy in the Initial Treatment of Adults With GlioblastomaNCT00960492XL184	Phase 1	Locked · track to reveal	Completed	26 est.	Nov 2012
A Drug-Drug Interaction Study of the Effects of XL184 (Cabozantinib) on Rosiglitazone in Subjects With Solid TumorsNCT01100619rosiglitazone	Phase 1	Locked · track to reveal	Completed	40 est.	Aug 2012
A Study of XL184 (Cabozantinib) With or Without Erlotinib in Subjects With Non-Small Cell Lung Cancer (NSCLC)NCT00596648XL184	Phase 1	Locked · track to reveal	Completed	92 est.	2 Aug 2012
Study of XL184 (Cabozantinib) in Adults With Glioblastoma MultiformeNCT00704288XL184	Phase 2	Locked · track to reveal	Completed	222 est.	Jun 2012
EXAMEfficacy of XL184 (Cabozantinib) in Advanced Medullary Thyroid CancerNCT00704730XL184	Phase 3	Locked · track to reveal	Completed	330 est.	Oct 2011
Study of XL281 in Adults With Solid TumorsNCT00451880XL281	Phase 1	Locked · track to reveal	Completed	180 est.	Oct 2011
Multiple Doses and Regimens of Cabozantinib in Subjects With Grade IV Astrocytic Tumors in First or Second RelapseNCT01068782Cabozantinib	Phase 2	Locked · track to reveal	StoppedTerminated	19 est.	May 2011
Study of XL184 (Cabozantinib) in Adults With Advanced MalignanciesNCT00215605XL184	Phase 1	Locked · track to reveal	Completed	85 est.	Apr 2011
Study of XL228 Administered Intravenously to Subjects With Advanced MalignanciesNCT00526838XL228	Phase 1	Locked · track to reveal	StoppedTerminated	84 est.	Dec 2010
Study of XL228 in Subjects With Chronic Myeloid Leukemia or Philadelphia-Chromosome-Positive Acute Lymphocytic LeukemiaNCT00464113XL228	Phase 1	Locked · track to reveal	StoppedTerminated	49 est.	Dec 2010
Safety Study of Pharmacokinetics of XL888 in Adults With Solid TumorsNCT00796484XL888	Phase 1	Locked · track to reveal	StoppedTerminated	33 est.	Nov 2010
Safety Study of XL647 and XL147 Administered in Combination Daily in Adults With Solid TumorsNCT00704392XL647	Phase 1	Locked · track to reveal	StoppedWithdrawn	0 est.	Dec 2009
A Phase 2 Study of XL820 in Adults With Advanced GIST Resistant to Imatinib and/or SunitinibNCT00570635XL820	Phase 2	Locked · track to reveal	Completed	16 est.	May 2009
A Phase 1 Study of XL019 in Adults With Polycythemia VeraNCT00595829XL019	Phase 1	Locked · track to reveal	StoppedTerminated	3 est.	Feb 2009
A Study of XL844 Administered as a Single Agent and in Combination With Gemcitabine in Adults With Advanced MalignanciesNCT00475917XL844	Phase 1	Locked · track to reveal	StoppedTerminated	28 est.	Dec 2008
Study of XL820 Given Orally Daily to Subjects With Solid TumorsNCT00350831XL820	Phase 1	Locked · track to reveal	Completed	30 est.	—
Study of XL820 in Adults With Solid TumorsNCT00129571XL820	Phase 1	Locked · track to reveal	Completed	—	—

View all trials54

STELLAR-001: A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors

Phase 1Active, not recruitingNCT03845166 ↗

Primary completion: Aug 2026; estimated
Enrollment: 325; estimated
Start: Mar 2019; Exelixis

Conditions

Neoplasm Malignant
Renal Cell Carcinoma
Hormone Receptor Positive Breast Carcinoma
Metastatic Castration-resistant Prostate Cancer
Colorectal Cancer

Interventions

XL092
Atezolizumab
Avelumab

Brief summary

This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.

Full record on ClinicalTrials.gov ↗

Change timeline

6 recorded · latest 1 Jan 2025

Enrollment change · 3

Completion date move · 2

Status change · 1

Track Exelixis drugs to see every change the night it lands.

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Study of XB010 in Subjects With Solid Tumors

Phase 1RecruitingNCT06545331 ↗

Primary completion: Nov 2026; estimated
Enrollment: 396; estimated
Start: Aug 2024; Exelixis

Conditions

Locally Advanced or Metastatic Solid Tumors
Esophageal Squamous Cell Cancer
Head and Neck Squamous Cell Cancer
NSCLC (Non-small Cell Lung Cancer)
Hormone-receptor-positive Breast Cancer
Triple Negative Breast Cancer (TNBC)

Interventions

XB010
Pembrolizumab

Brief summary

This is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are…

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.

STELLAR-305: Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Phase 2Active, not recruitingNCT06082167 ↗

Primary completion: Aug 2028; estimated
Enrollment: 600; estimated
Start: Jun 2024; Exelixis

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

Zanzalintinib
Zanzalintinib-matched Placebo
Pembrolizumab

Brief summary

This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with programmed death-ligand 1 (PD-L1) positive recurrent or metastatic head and neck squamous cell carcinoma…

Full record on ClinicalTrials.gov ↗

Change timeline

3 recorded · latest 1 Sept 2025

Status change · 1

Enrollment change · 1

Completion date move · 1

Track Exelixis drugs to see every change the night it lands.

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A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors

Phase 1RecruitingNCT05932862 ↗

Primary completion: Jan 2029; estimated
Enrollment: 429; estimated
Start: Apr 2024; Exelixis

Conditions

Advanced Solid Tumor

Interventions

XL309
Olaparib

Brief summary

This is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as pharmacokinetics (PK) and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in participants with advanced solid…

Full record on ClinicalTrials.gov ↗

Change timeline

2 recorded · latest 1 Jul 2024

Completion date move · 1

Enrollment change · 1

Track Exelixis drugs to see every change the night it lands.

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Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study

Phase 3Not yet recruitingNCT07620574 ↗

Primary completion: May 2030; estimated
Enrollment: 5,000; estimated
Start: May 2026; Exelixis

Conditions

Cancer
Renal Cell Carcinoma (RCC)
Pancreatic Neuroendocrine Tumors (pNET)
Extra-Pancreatic NET (epNET)
Hepatocellular Carcinoma (HCC)
Differentiated Thyroid Cancer (DTC)
Non-Clear Cell Renal Cell Carcinoma (nccRCC)
Colorectal Cancer

Interventions

Cabozantinib
Zanzalintinib
Atezolizumab
Nivolumab
Abiraterone
Prednisone
Enzalutamide

Brief summary

The primary objective of this long-term extension study is to allow continued access to study treatment for eligible participants who are deriving clinical benefit in an Exelixis-sponsored study who do not have access to treatment locally.

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.

STELLAR-002: Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors

Phase 1RecruitingNCT05176483 ↗

Primary completion: Jun 2030; estimated
Enrollment: 1,314; estimated
Start: Dec 2021; Exelixis

Conditions

Renal Cell Carcinoma (RCC)
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Urothelial Carcinoma (UC)
Solid Tumor
Hepatocellular Carcinoma (HCC)
Non-small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

Zanzalintinib
Nivolumab
Ipilimumab
Nivolumab
Nivolumab
Nivolumab + Relatlimab

Brief summary

This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet)…

Full record on ClinicalTrials.gov ↗

Change timeline

6 recorded · latest 1 Mar 2026

Enrollment change · 3

Status change · 2

Completion date move · 1

Track Exelixis drugs to see every change the night it lands.

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STELLAR-303: Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer

Phase 3Active, not recruitingNCT05425940 ↗

Primary completion: Jun 2026; actual
Enrollment: 901; estimated
Start: Sept 2022; Exelixis

Conditions

Colorectal Cancer

Interventions

XL092
Atezolizumab
Regorafenib

Brief summary

The primary purpose of this study is to evaluate XL092 + atezolizumab versus regorafenib in participants with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed during, after or are intolerant to standard-of-care (SOC) therapy.

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Nov 2025

Enrollment change · 2

Completion date move · 1

Status change · 1

Track Exelixis drugs to see every change the night it lands.

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STELLAR-304: Study of XL092 + Nivolumab vs Sunitinib in Subjects With Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Phase 3Active, not recruitingNCT05678673 ↗

Primary completion: Jul 2025; estimated
Enrollment: 317; estimated
Start: Jan 2023; Exelixis

Conditions

Non-Clear Cell Renal Cell Carcinoma

Interventions

XL092
Nivolumab
Sunitinib Malate

Brief summary

This is a multicenter, randomized (2:1), open-label, controlled Phase 3 trial of XL092 in combination with nivolumab versus sunitinib in subjects with unresectable, locally advanced or metastatic nccRCC who have not received prior systemic anticancer therapy.

Full record on ClinicalTrials.gov ↗

Change timeline

2 recorded · latest 1 Aug 2025

Enrollment change · 1

Status change · 1

Track Exelixis drugs to see every change the night it lands.

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Study of Zanzalintinib (XL092) + AB521 and Zanzalintinib + AB521 + Nivolumab in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Other Advanced Solid Tumors (STELLAR-009)

Phase 1TerminatedNCT06191796 ↗

Primary completion: May 2025; actual
Enrollment: 25; estimated
Start: Jan 2024; Exelixis

Conditions

Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors

Interventions

zanzalintinib
AB521
Nivolumab

Brief summary

The goal of this clinical trial is to learn about the safety and preliminary antitumor activity of zanzalintinib in combination with AB521 (doublet) and in combination with AB521 plus nivolumab (triplet) in participants with advanced ccRCC or other advanced solid tumors. The main questions it aims to answer are: *…

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Jul 2025

Status change · 2

Completion date move · 1

Enrollment change · 1

Track Exelixis drugs to see every change the night it lands.

Track nivolumab

A Dose-escalation, Dose-finding, and Expansion Study of XL495 in Participants With Locally Advanced or Metastatic Solid Tumors

Phase 1TerminatedNCT06630247 ↗

Primary completion: May 2025; actual
Enrollment: 9; estimated
Start: Oct 2024; Exelixis

Conditions

Solid Cancers
Solid Tumor Cancer
Solid Tumor Malignancy
Urothelial Cancer (Urinary Bladder, Ureters, or Renal Pelvis Cancer)
Metastatic Solid Tumor
Locally Advanced Solid Tumor
Urothelial Cancer of Renal Pelvis

Interventions

XL495
ADC cytotoxic agents

Brief summary

The goal of this study is to obtain safety, tolerability, PK, and preliminary clinical antitumor activity for XL495 as a single agent and in combination with select cytotoxic agents in participants with locally advanced or metastatic tumors for whom life-prolonging therapies do not exist or available therapies are…

Full record on ClinicalTrials.gov ↗

Change timeline

3 recorded · latest 1 Jul 2025

Enrollment change · 1

Status change · 1

Completion date move · 1

Track Exelixis drugs to see every change the night it lands.

Track nivolumab

Study of XB002 in Subjects With Solid Tumors (JEWEL-101)

Phase 1CompletedNCT04925284 ↗

Primary completion: Mar 2025; actual
Enrollment: 269; estimated
Start: Jun 2021; Exelixis

Conditions

Non Small Cell Lung Cancer
Cervical Cancer
SCCHN
Pancreatic Cancer
Esophageal SCC
Metastatic Castration-resistant Prostate Cancer
Triple Negative Breast Cancer
Hormone Receptor-positive Breast Cancer

Interventions

XB002
Nivolumab
Bevacizumab

Brief summary

This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w alone and in combination with nivolumab or bevacizumab to subjects with advanced solid tumors.

Full record on ClinicalTrials.gov ↗

Change timeline

7 recorded · latest 1 Jul 2025

Completion date move · 3

Status change · 2

Enrollment change · 2

Track Exelixis drugs to see every change the night it lands.

Track nivolumab

Study of XL102 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (QUARTZ-101)

Phase 1TerminatedNCT04726332 ↗

Primary completion: May 2024; actual
Enrollment: 52; estimated
Start: Feb 2021; Exelixis

Conditions

Neoplasm Malignant
Epithelial Ovarian Cancer
Triple Negative Breast Cancer
Hormone Receptor Positive Breast Carcinoma
Metastatic Castration-resistant Prostate Cancer

Interventions

XL102
Fulvestrant
Abiraterone
Prednisone

Brief summary

This is a Phase 1, open-label, dose-escalation and expansion study evaluating the safety, tolerability, PK, antitumor activity, and effect on biomarkers of XL102 administered orally alone and in multiple combination regimens to subjects with advanced solid tumors.

Full record on ClinicalTrials.gov ↗

Change timeline

5 recorded · latest 1 Jul 2024

Enrollment change · 2

Status change · 2

Completion date move · 1

Track Exelixis drugs to see every change the night it lands.

Track nivolumab

CONTACT-02: Study of Cabozantinib in Combination With Atezolizumab Versus Second NHT in Subjects With mCRPC

Phase 3Active, not recruitingNCT04446117 ↗

Primary completion: Apr 2024; actual
Enrollment: 575; estimated
Start: Oct 2020; Exelixis

Conditions

Metastatic Prostate Cancer
Prostate Adenocarcinoma

Interventions

Cabozantinib
Atezolizumab
Abiraterone Acetate
Enzalutamide
Prednisone

Brief summary

This is a Phase 3, multi-center, randomized, open-label, controlled study designed to evaluate the safety and efficacy of cabozantinib given in combination with atezolizumab versus a second novel hormonal therapy (NHT) in men with metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated…

Full record on ClinicalTrials.gov ↗

Change timeline

5 recorded · latest 1 Oct 2024

Completion date move · 3

Status change · 1

Enrollment change · 1

Track Exelixis drugs to see every change the night it lands.

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Study of Cabozantinib Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

Phase 1Active, not recruitingNCT03170960 ↗

Primary completion: Feb 2023; actual
Enrollment: 914; estimated
Start: Sept 2017; Exelixis

Conditions

Urothelial Carcinoma
Renal Cell Carcinoma
Non-Small Cell Lung Cancer
Castration-resistant Prostate Cancer
Triple Negative Breast Cancer
Ovarian Cancer
Endometrial Cancer
Hepatocellular Carcinoma

Interventions

cabozantinib
atezolizumab
cabozantinib
cabozantinib

Brief summary

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),…

Full record on ClinicalTrials.gov ↗

Change timeline

5 recorded · latest 1 Sept 2025

Completion date move · 2

Status change · 2

Enrollment change · 1

Track Exelixis drugs to see every change the night it lands.

Track nivolumab

Study of XL114 in Subjects With Non-Hodgkin's Lymphoma

Phase 1TerminatedNCT05144347 ↗

Primary completion: Nov 2022; actual
Enrollment: 2; estimated
Start: Apr 2022; Exelixis

Conditions

Non-Hodgkin's Lymphoma (NHL)
Activated B-Cell Type Diffuse Large B-Cell Lymphoma (ABC-DLBCL)
Mantle Cell Lymphoma (MCL)
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)

Interventions

XL114

Brief summary

This is a Phase 1, non-randomized, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical antitumor activity of XL114 administered alone orally to subjects with Non-Hodgkin's Lymphoma (NHL). The objectives of the…

Full record on ClinicalTrials.gov ↗

Change timeline

3 recorded · latest 1 Oct 2023

Enrollment change · 1

Completion date move · 1

Status change · 1

Track Exelixis drugs to see every change the night it lands.

Track nivolumab

COSMIC-313: Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Phase 3Active, not recruitingNCT03937219 ↗

Primary completion: Jan 2022; actual
Enrollment: 855; estimated
Start: Jun 2019; Exelixis

Conditions

Renal Cell Carcinoma

Interventions

Cabozantinib
Nivolumab
Ipilimumab
Cabozantinib-matched placebo

Brief summary

This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria…

Full record on ClinicalTrials.gov ↗

Change timeline

4 recorded · latest 1 Apr 2025

Status change · 2

Enrollment change · 1

Completion date move · 1

Track Exelixis drugs to see every change the night it lands.

Track nivolumab

COSMIC-312: Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy

Phase 3Active, not recruitingNCT03755791 ↗

Primary completion: Nov 2021; actual
Enrollment: 837; estimated
Start: Jun 2018; Exelixis

Conditions

Hepatocellular Carcinoma

Interventions

Cabozantinib
Cabozantinib
Sorafenib
Atezolizumab

Brief summary

This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which…

Full record on ClinicalTrials.gov ↗

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3 recorded · latest 1 Jan 2026

Completion date move · 1

Enrollment change · 1

Status change · 1

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A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Factor Receptor (VEGFR) -Targeted Therapy

Phase 3Active, not recruitingNCT03690388 ↗

Primary completion: Aug 2020; actual
Enrollment: 187; estimated
Start: Oct 2018; Exelixis

Conditions

Differentiated Thyroid Cancer

Interventions

Cabozantinib
Placebo

Brief summary

The objective of this study is to evaluate the effect of cabozantinib compared with placebo on progression free survival (PFS) and objective response rate (ORR) in subjects with Radioiodine-Refractory Differentiated Thyroid Cancer (DTC) who have progressed after prior vascular endothelial growth factor receptor…

Full record on ClinicalTrials.gov ↗

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1 recorded · latest 1 Oct 2023

Enrollment change · 1

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EXAMINER: A Study of Two Different Doses of Cabozantinib (XL184) in Progressive, Metastatic Medullary Thyroid Cancer

Phase 4Active, not recruitingNCT01896479 ↗

Primary completion: Jul 2020; actual
Enrollment: 247; estimated
Start: Feb 2015; Exelixis

Conditions

Medullary Thyroid Cancer

Interventions

Cabozantinib (XL184) 140 mg
Cabozantinib (XL184) 60 mg
Placebo tablet
Placebo capsule

Brief summary

The objective of this study is to evaluate the efficacy and safety of oral cabozantinib at a 60 mg dose compared with a 140 mg dose in subjects with progressive, metastatic MTC. It will test if the lower dose results in similar progression free survival (PFS) and overall response rate (ORR) with fewer adverse events…

Full record on ClinicalTrials.gov ↗

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3 recorded · latest 1 Oct 2025

Status change · 2

Enrollment change · 1

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COMET-2: Study of Cabozantinib (XL184) Versus Mitoxantrone Plus Prednisone in Men With Previously Treated Symptomatic Castration-resistant Prostate Cancer

Phase 3TerminatedNCT01522443 ↗

Primary completion: Oct 2014; actual
Enrollment: 119; estimated
Start: Mar 2012; Exelixis

Conditions

Prostate Cancer
Castration Resistant Prostate Cancer
Pain
Prostatic Neoplasms

Interventions

cabozantinib
mitoxantrone
prednisone

Brief summary

Bone metastases and associated pain are a major cause of morbidity and mortality in castration-resistant prostate cancer (CRPC). Most approved therapies have shown some ability to reduce soft tissue lesions but none meaningfully impacts bone metastases (as demonstrated by lack of resolution of lesions on bone scan…

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.

COMET-1: Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100

Phase 3CompletedNCT01605227 ↗

Primary completion: Sept 2014; actual
Enrollment: 1,028; estimated
Start: Jul 2012; Exelixis

Conditions

Prostate Cancer
Castration Resistant Prostate Cancer
Pain
Prostatic Neoplasms

Interventions

cabozantinib
prednisone

Brief summary

This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.

Safety Study of XL184 (Cabozantinib) in Combination With Temozolomide and Radiation Therapy in the Initial Treatment of Adults With Glioblastoma

Phase 1CompletedNCT00960492 ↗

Primary completion: Nov 2012; actual
Enrollment: 26; estimated
Start: Sept 2009; Exelixis

Conditions

Glioblastoma
Giant Cell Glioblastoma
Gliosarcoma

Interventions

XL184
temozolomide
temozolomide
Radiation Therapy
temozolomide

Brief summary

The purpose of this study is to determine the highest safe dose of XL184 administered orally in combination with temozolomide (TMZ, Temodar®) and radiation therapy (RT). XL184 is a new chemical entity that inhibits VEGFR2, MET, and RET, kinases implicated in tumor formation, growth and migration. Temozolomide (TMZ,…

Full record on ClinicalTrials.gov ↗

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No changes recorded on this trial in the observed window.

A Drug-Drug Interaction Study of the Effects of XL184 (Cabozantinib) on Rosiglitazone in Subjects With Solid Tumors

Phase 1CompletedNCT01100619 ↗

Primary completion: Aug 2012; actual
Enrollment: 40; estimated
Start: Apr 2010; Exelixis

Conditions

Papillary Thyroid Cancer
Follicular Thyroid Cancer
Huerthle Cell Thyroid Cancer
Renal Cell Carcinoma

Interventions

rosiglitazone
XL184

Brief summary

The primary objective of this clinical study is to determine whether the inhibition of cytochrome P450 (CYP) isozyme CYP2C8 by XL184 observed in in vitro preclinical studies translates into the potential for clinically significant drug-drug interactions in humans. The study will measure the effect of once daily dosing…

Full record on ClinicalTrials.gov ↗

Change timeline

No changes recorded on this trial in the observed window.