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cabozantinib s-malate

Generic: CABOZANTINIB S-MALATE·Brand: CABOMETYX, COMETRIQ

cabozantinib s-malate: developed by 1 company · 13 clinical trials tracked · 2 FDA decisions.

cabozantinib s-malate evidence translation

What we can confirm

2 FDA records · 13 tracked trials

What it means

Source-backed records connect cabozantinib s-malate to EXEL; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could cabozantinib s-malate → EXEL affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 2 study sponsors

Related indications

Advanced renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), differentiated thyroid cancer (DTC), pancreatic neuroendocrine tumors (pNET), extra-pancreatic neuroendocrine tumors (epNET)Progressive, metastatic medullary thyroid cancer (MTC)Advanced MelanomaClear Cell Renal Cell CarcinomaMetastatic Malignant Solid NeoplasmMetastatic Renal Cell CarcinomaMetastatic Urothelial CarcinomaPapillary Renal Cell Carcinoma
Development Pipeline (2)
CompanyPhase
EXELIXIS, INC. (EXEL)
Advanced renal cell carcinoma (RCC), hepatocellular carcinom…
Approved
EXELIXIS, INC. (EXEL)
Progressive, metastatic medullary thyroid cancer (MTC)
Approved
Clinical Trials (13)showing 10 most recent

A Phase I/II Trial of Sapanisertib in Combination With Cabozantinib in β-catenin-mutated Hepatocellular Carcinoma (SAPHIRE)

NCT06811116·Phase 1·RPRX
Recruiting

Primary endpoint: Dose-limiting toxicities and incidence of adverse events

InterventionalRandomizedopen92 targetStarted 2025-11Completion 2027-084 sites · United StatesNational Cancer Institute (NCI)

Phase II Open Label, Single-Arm Study of Cabozantinib in Combination With Pembrolizumab in the Treatment of Locally Advanced or Metastatic Adrenocortical Carcinoma

NCT06006013·Phase 2·RPRX
Recruiting

Primary endpoint: Overall response rate (ORR)

Interventionalopen21 targetStarted 2025-01Completion 2028-122 sites · United StatesEmory University

Randomized Phase 2 Study of Nivolumab and Ipilimumab With or Without Cabozantinib in Patients With Advanced Nasopharyngeal Carcinoma That Have Progressed After Platinum Treatment and Immunotherapy

NCT05904080·Phase 2·RPRX
Recruiting

Primary endpoint: Progression-free survival (PFS)

InterventionalRandomizedopen50 targetStarted 2024-02Completion 2028-0650 sites · United StatesNational Cancer Institute (NCI)

A Phase II Randomized Trial of Cabozantinib (NSC #761968) With or Without Atezolizumab (NSC #783608) in Patients With Advanced Papillary Renal Cell Carcinoma (PAPMET2)

NCT05411081·Phase 2·RPRX
Suspended

Primary endpoint: Progression free survival

InterventionalRandomizedopen200 targetStarted 2023-03Completion 2027-0750 sites · United StatesNational Cancer Institute (NCI)

A Feasibility and Randomized Phase 2/3 Study of the VEGFR2/MET Inhibitor Cabozantinib in Combination With Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma

NCT05691478·Phase 3·VALN
Recruiting

Primary endpoint: Occurrence of dose-limiting toxicity (Feasibility)

InterventionalRandomizedopen1,122 targetStarted 2023-03Completion 2030-0350 sites · United StatesNational Cancer Institute (NCI)

Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study

NCT05136196·Phase 2·RPRX
Recruiting

Primary endpoint: Biomarker results turnaround time

Interventionalopen150 targetStarted 2022-12Completion 2027-0150 sites · United StatesNational Cancer Institute (NCI)

A Randomized Phase II Trial of Adjuvant Nivolumab With or Without Cabozantinib in Patients With Resected Mucosal Melanoma

NCT05111574·Phase 2·RPRX
Recruiting

Primary endpoint: Recurrence free survival (RFS)

InterventionalRandomizeddouble99 targetStarted 2022-08Completion 2026-0650 sites · United StatesNational Cancer Institute (NCI)

MAIN-CAV: Phase III Randomized Trial of Maintenance Cabozantinib and Avelumab vs Maintenance Avelumab After First-Line Platinum-Based Chemotherapy in Patients With Metastatic Urothelial Cancer

NCT05092958·Phase 3·RPRX
Active, not recruiting

Primary endpoint: Overall survival (OS)

InterventionalRandomizedopen654 targetStarted 2022-06Completion 2026-0650 sites · United StatesNational Cancer Institute (NCI)

Pilot Trial of Nivolumab Plus Cabozantinib for Advanced Solid Tumors in Patients With HIV Infection

NCT04514484·Phase 1·RPRX
Active, not recruiting

Primary endpoint: Incidence of dose limiting toxicities (DLTs)

Interventionalopen8 targetStarted 2021-11Completion 2027-023 sites · United StatesNational Cancer Institute (NCI)

A Phase I/Ib Open Label, Single-Arm Study of Cabozantinib in Combination With Enfortumab Vedotin (EV) in the Treatment of Locally Advanced or Metastatic Urothelial Cancer

NCT04878029·Phase 1
Recruiting

Primary endpoint: Incidence of adverse events

Interventionalopen32 targetStarted 2021-07Completion 2028-121 site · United StatesEmory University
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab ( 1.1 ) patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib ( 1.2 ) adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progress(EXEL)FDA ↗
NDA208692Type 3 - New Dosage FormOrphan DrugPriorityOralTablet
Approval1 INDICATIONS AND USAGE COMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). COMETRIQ is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). ( 1 )(EXEL)FDA ↗
NDA203756Type 1 - New Molecular EntityOrphan DrugPriorityOralCapsule

Frequently asked questions

Who is developing cabozantinib s-malate?

cabozantinib s-malate is being developed by EXELIXIS, INC..

How many clinical trials involve cabozantinib s-malate?

BioSniper tracks 13 clinical trials involving cabozantinib s-malate.

What is cabozantinib s-malate's latest FDA decision?

The most recent tracked FDA decision for cabozantinib s-malate is Approval for 1 INDICATIONS AND USAGE CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab ( 1.1 ) patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib ( 1.2 ) adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progress, dated April 25, 2016.