18 and older, any sex, with Neuroendocrine Tumor or Anaplastic Thyroid Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR)Primary· Through study completion, average 1 year
Radiological objective response rate (ORR) evaluated per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan ORR= CR (confirmed complete response) + PR (confirmed partial response) as best response PR (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
Safety Profile Number of Adverse Events Reactions (TRAEs)Secondary· TRAEs reported through clinical, up to 100 days after finishing or discontinuing treatment, on average 10 months
Number of patients adverse events reaction (TRAEs) related to Cabozantinib
Safety Profile Number of Adverse Events Reactions (TRAEs) Related With AtezolizumabSecondary· TRAEs reported through clinical, up to 100 days after finishing or discontinuing treatment, on average 10 months
Number of patients with adverse events reaction related to Atezolizumab as assessed by CTCAE v4.0
Duration of Response (DoR)Secondary· From date of first documented clinical response (PR, CR) until the date of first documented progression, date of death from any cause or patient withdrawal, whichever came first, assessed up to 36 months
the time from the date of first documented CR or PR to the first documented progression or death due to underlying cancer. DoR will be determined based on tumour assessment (RECIST version 1.1 criteria).
Progression-free Survival (PFS)Secondary· From date of randomization until the date of first documented progression, date of death from any cause or patient withdrawal, whichever came first, assessed up to 36 months
Median Progression free survival (mPFS) is defined as the time from the date of inclusion to the date of the first documented disease progression or death due to any cause, whichever occurs first. PFS will be determined based on tumour assessment (RECIST version 1.1 criteria). The local Investigator's assessments will be used for analyses.
Time frame: Adverse events will be reported through clinical study up to 100 days after the date of the decision to discontinue treatment, on average 3 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Advanced and Refractory Endocrine and Neuroendocrine Neoplasms
Serious: 43/93 (46%)
Deaths: 2/93
Serious adverse events (56 terms)
Reaction
System
Advanced and Refractory En…
Abdominal pain
Gastrointestinal disorders
—
Fever
General disorders
—
Alanine amino transferanse increased
Investigations
—
Aspatate amino ransferanse increased
Investigations
—
Small intestinal obstruction
Gastrointestinal disorders
—
Diarrhea
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Constipation
Gastrointestinal disorders
—
urinary tract infection
Endocrine disorders
—
Hyperglycemia
Metabolism and nutrition disorders
—
adrenal insufficiency
Endocrine disorders
—
Hepatic failure
Hepatobiliary disorders
—
Hip fracture
Injury, poisoning and procedural complications
—
Gastroenteritis
Gastrointestinal disorders
—
Fatigue
General disorders
—
Back pain
Musculoskeletal and connective tissue disorders
—
Hypomagnesemia
Metabolism and nutrition disorders
—
Peripheral sensory neuropathy
Nervous system disorders
—
Edema limbs
General disorders
—
Hypokalemia
Metabolism and nutrition disorders
—
Pain
General disorders
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Hyperthyroidism
Endocrine disorders
—
Bone pain
Musculoskeletal and connective tissue disorders
—
Epistaxis
Respiratory, thoracic and mediastinal disorders
—
Other adverse events (19 terms — click to expand)
Reaction
System
Advanced and Refractory En…
Fatigue
General disorders
—
Diarrhea
Gastrointestinal disorders
—
Aspartate aminotransferase increased
Investigations
—
Alanine aminotransferase increased
Investigations
—
Abdominal pain
Gastrointestinal disorders
—
Investigations - Other, specify
Investigations
—
Vomiting
Gastrointestinal disorders
—
Infections and infestations - Other, specify
Infections and infestations
—
Skin and subcutaneous tissue disorders - Other, specify
Skin and subcutaneous tissue disorders
—
Gastrointestinal disorders - Other, specify
Gastrointestinal disorders
—
Constipation
Gastrointestinal disorders
—
Fever
General disorders
—
General disorders and administration site conditions - Other, specify
CABATEN is a multicohort phase II study of cabozantinib plus atezolizumab in advanced and progressive tumors from endocrine system.
The primary objective is to assess the efficacy of cabozantinib plus atezolizumab combination by means of radiological objective response rate (ORR) evaluated following RECIST v1.1 criteria in advanced endocrine tumors.
Endocrine tumors from different origins (thyroid, lung, pancreas and digestive tract, adrenal gland and paraganglia) are characterized by being remarkably vascular and expressing several growth factors including vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), insulin-like growth factor 1 (IGF-1), basic fibroblast growth factor (BFGF), and transforming growth factor (TGF)-α and -β. The (over) expression of some of these factors has been linked to poor prognosis. Cabozaninib, a VEGF inhibitor, in combination with atezolizumab, an inhibitor of PD-L1, may be active in endocrine tumors by overcoming the resistance to prior antiangiogenic drugs.
The trial will include patients with advanced and refractory tumors of endocrine system and patients would be allocated to six different cohorts according to the following tumor types.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07132645 — An Investigational Scan ([68Ga] Ga-FAPI-04 PET/CT) for the Imaging of Patients With High-Grade Neuroendocrine Cancer
· EARLY_PHASE1
· recruiting
NCT06788886 — Breathing Practice for Brain and Mental Health in Cancer and Neurodegenerative Diseases
· NA
· recruiting
NCT04907643 — Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes
· NA
· recruiting
NCT04837885 — Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Meta
· Phase 2
· recruiting
NCT03375320 — Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
· Phase 3
· active not recruiting
Other Grupo Espanol de Tumores Neuroendocrinos trials
Trials by the same sponsor.
NCT06837090 — Retrospective Analysis of the Experience With Larotrectinib in Patients With Solid Neoplasms With NTRK Fusion in Spain (
· completed
NCT04986085 — Nutrition in Gastroenteropancreatic Neuroendocrine Tumor
· completed
NCT03980925 — Platinum-doublet Chemotherapy and Nivolumab for the Treatment of Subjects With Neuroendocrine Neoplasms (NENs) of the Ga
· Phase 2
· completed
NCT03753919 — Durvalumab Plus Tremelimumab for the Treatment of Patients With Progressive, Refractory Advanced Thyroid Carcinoma -The
· Phase 2
· terminated
NCT03095274 — Durvalumab (MEDI4736) Plus Tremelimumab for Advanced Neuroendocrine Neoplasms of Gastroenteropancreatic or Lung Origin
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Grupo Espanol de Tumores Neuroendocrinos
Last refreshed: 19 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04400474.