Trial · NCT04400474
Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study
NCT04400474, Phase 2, Completed, Grupo Espanol de Tumores Neuroendocrinos; results first posted 2025-06-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study. Trials, record NCT04400474. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04400474
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Cabozantinib Plus Atezolizumab in Advanced and Progressive Neoplasms of the Endocrine System. The CABATEN Study
- NCT number
- NCT04400474
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 93 participants, actual
- Lead sponsor
- Grupo Espanol de Tumores Neuroendocrinos
- Conditions
- Neuroendocrine Tumor, Anaplastic Thyroid Cancer, Adenocarcinoma, Pheochromocytoma, Paraganglioma
- Interventions
- Cabozantinib 40 mg
- First posted
- 2020-05-22
- Last updated
- 2025-06-19
- Other registries' IDs
- eudract:2019-002279-32
- Results first posted
- 2025-06-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | 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. |
| Secondary | Safety Profile Number of Adverse Events Reactions (TRAEs) | 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 |
| Secondary | Safety Profile Number of Adverse Events Reactions (TRAEs) Related With Atezolizumab | 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 |
| Secondary | Duration of Response (DoR) | 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). |
| Secondary | Progression-free Survival (PFS) | 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. |
| Secondary | Overall Survival (OS) | Through study period, up to 3 years after completing treatment | Median Overall Survival (mOS) is calculated as the time from date of inclusion to date of death due to any cause. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | Through study completion, average 1 year | Patients were enrolled in six cohorts. The main inclusion criteria were as follows: age \> 18 years; Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1 and adequate organ and bone marrow function. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety Profile Number of Adverse Events Reactions (TRAEs) | TRAEs reported through clinical, up to 100 days after finishing or discontinuing treatment, on average 10 months | Patients with advanced and refractory endocrine and neuroendocrine neoplasms, Patients were enrolled in six cohorts. The main inclusion criteria were as follows: age \> 18 years; Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1 and adequate organ and bone marrow function | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety Profile Number of Adverse Events Reactions (TRAEs) Related With Atezolizumab | TRAEs reported through clinical, up to 100 days after finishing or discontinuing treatment, on average 10 months | Patients with advanced and refractory endocrine and neuroendocrine neoplasms. Patients were enrolled in six cohorts. The main inclusion criteria were as follows: age \> 18 years; Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1 and adequate organ and bone marrow function. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DoR) | 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 | Patients with advanced and refractory endocrine and neuroendocrine neoplasms. Patients were enrolled in six cohorts. The main inclusion criteria were as follows: age \> 18 years; Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1 and adequate organ and bone marrow function. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | 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 | Patients with advanced and refractory endocrine and neuroendocrine neoplasms. Patients were enrolled in six cohorts. The main inclusion criteria were as follows: age \> 18 years; Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 or 1 and adequate organ and bone marrow function. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Through study period, up to 3 years after completing treatment | months | MEDIAN |
Source ClinicalTrials.gov
Results by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | LungNET (Lung Typical Andatypical Carcinoids) Cabozantinib 40 mg + Atezolizumab 1200 mg | 0 | Participants | ||
| Objective Response Rate (ORR) | ATC (Anaplastic Thyroid Cancer) Cabozantinib 40 mg + Atezolizumab 1200 mg | 2 | Participants | ||
| Objective Response Rate (ORR) | ACC (Adrenocortical Carcinoma) Cabozantinib 40 mg + Atezolizumab 1200 mg | 2 | Participants | ||
| Objective Response Rate (ORR) | PPGL (Pheochromocytoma/Paraganglioma) Cabozantinib 40 mg + Atezolizumab 1200 mg | 2 | Participants | ||
| Objective Response Rate (ORR) | G1-2 GEP-NET (Well-differentiated Gastroenteropancreatic NET) | 4 | Participants | ||
| Objective Response Rate (ORR) | G3 EP-NEN (Extrapulmonary Neuroendocrine Neoplasms.) | 0 | Participants | ||
| Safety Profile Number of Adverse Events Reactions (TRAEs) | LungNET (Lung Typical and Atypical Carcinoids) | 8 | Participants | ||
| Safety Profile Number of Adverse Events Reactions (TRAEs) | ATC (Anaplastic Thyroid Cancer) | 11 | Participants | ||
| Safety Profile Number of Adverse Events Reactions (TRAEs) | ACC (Adrenocortical Carcinoma) | 18 | Participants | ||
| Safety Profile Number of Adverse Events Reactions (TRAEs) | PPGL (Pheochromocytoma/Paraganglioma) | 11 | Participants |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LungNET (Lung Typical and Atypical Carcinoids) | 9 | |
| Overall Study | STARTED | ATC (Anaplastic Thyroid Cancer) | 14 | |
| Overall Study | STARTED | ACC (Adrenocortical Carcinoma) | 24 | |
| Overall Study | STARTED | PPGL (Pheochromocytoma/Paraganglioma) | 13 | |
| Overall Study | STARTED | G1-2 GEP-NET (Well-differentiated Gastroenteropancreatic NET) | 24 | |
| Overall Study | STARTED | G3 EP-NEN (Extrapulmonary Neuroendocrine Neoplasms.) | 9 | |
| Overall Study | COMPLETED | LungNET (Lung Typical and Atypical Carcinoids) | 9 | |
| Overall Study | COMPLETED | ATC (Anaplastic Thyroid Cancer) | 14 | |
| Overall Study | COMPLETED | ACC (Adrenocortical Carcinoma) | 24 | |
| Overall Study | COMPLETED | PPGL (Pheochromocytoma/Paraganglioma) | 13 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events75
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Advanced and Refractory Endocrine and Neuroendocrine Neoplasms | 13 | 93 | 23 |
| other | Abdominal pain | Gastrointestinal disorders | Advanced and Refractory Endocrine and Neuroendocrine Neoplasms | 22 | 93 | 26 |
| other | Infections and infestations - Other, specify | Infections and infestations | Advanced and Refractory Endocrine and Neuroendocrine Neoplasms | 15 | 93 | 18 |
| other | Fever | General disorders | Advanced and Refractory Endocrine and Neuroendocrine Neoplasms | 12 | 93 | 16 |
| other | General disorders and administration site conditions - Other, specify | General disorders | Advanced and Refractory Endocrine and Neuroendocrine Neoplasms | 9 | 93 | 10 |
| other | Diarrhea | Gastrointestinal disorders | Advanced and Refractory Endocrine and Neuroendocrine Neoplasms | 44 | 93 | 100 |
| other | Aspartate aminotransferase increased | Investigations | Advanced and Refractory Endocrine and Neuroendocrine Neoplasms | 37 | 93 | 82 |
| other | Alanine aminotransferase increased | Investigations | Advanced and Refractory Endocrine and Neuroendocrine Neoplasms | 34 | 93 | 81 |
| other | Vomiting | Gastrointestinal disorders | Advanced and Refractory Endocrine and Neuroendocrine Neoplasms | 21 | 93 | 41 |
| other | Constipation | Gastrointestinal disorders | Advanced and Refractory Endocrine and Neuroendocrine Neoplasms | 13 | 93 | 13 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Advanced and Refractory Endocrine and Neuroendocrine Neoplasms | 2 | 93 |
| Total, other adverse events | Advanced and Refractory Endocrine and Neuroendocrine Neoplasms | 91 | 93 |
| Total, serious adverse events | Advanced and Refractory Endocrine and Neuroendocrine Neoplasms | 43 | 93 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04400474
GET https://conductscience.org/api/trials/v1/NCT04400474/results?page=2