CompletedPhase 2

Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study

Spain93 participantsStarted 2020-10-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female subjects ≥ 18 years old.
✓. Willingness to participate in the study by signing informed consent form (ICF) approved by the trial Central Ethic Committee (CEIm).
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Measurable disease per RECIST 1.1 as determined by the investigator.
✓. Patients with an histopathologically confirmed disease (as per local pathology report), meeting one of the following (according to WHO 2010 classification):
✓. Cohort 1: Well-differentiated neuroendocrine tumours of the lung and thymus (WHO grade 1 and 2, typical and atypical carcinoids) after progression to somatostatin analogs, targeted agents, PRRT, and/or chemotherapy.
✓. Cohort 2: Anaplastic thyroid cancer in first-line or after progression to chemotherapy or investigational drugs. Primary tumour can be resected or not but risk of aerodigestive compression or bleeding should be ruled out.
✓. Cohort 3: Adrenocortical carcinoma after progression to chemotherapy and/or mitotane.

Exclusion criteria

What they're measuring

Objective Response Rate (ORR)

Timeframe: Through study completion, average 1 year

Trial details

NCT IDNCT04400474

SponsorGrupo Espanol de Tumores Neuroendocrinos

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-23

Results submitted2025-04-02

View on ClinicalTrials.gov More Neuroendocrine Tumor trials