Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors
Active, enrolledPhase 2Results postedLast updated 13 April 2026
What this trial tests
Phase 2 trial testing Cabozantinib S-malate in Metastatic Large Cell Neuroendocrine Carcinoma in 17 participants. Participants enrolled and being followed up; not accepting new ones.
18 and older, any sex, with Metastatic Large Cell Neuroendocrine Carcinoma or Metastatic Neuroendocrine Carcinoma. 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.
Number of Participants With a ResponsePrimary· Up to 3.5 years
Participants who are considered to have a response are those with either a complete response (CR) (disappearance of all target lesions) or a partial response (PR) (\>=30% decrease in the sum of the longest diameter of target lesions) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 and assessed by CT or MRI scan.
Progression Free Survival (PFS)Secondary· Up to 3.5 years
Progression is defined as a \>= 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by CT or MRI scan. The duration is from the date of registration to the time of progression or death, whichever occurs first.
Number of Participants Reporting Adverse EventsSecondary· Up to 3.5 years
Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. The population is defined as all patients who have received the study treatment. The highest grade is reported.
Disease Control Rate (DCR)Secondary· Up to 3.5 years
DCR will be defined as the achievement of Complete Response (CR) (disappearance of all target lesions), Partial Response (PR) (\>=30% decrease in the sum of the longest diameter of target lesions), or Stable Disease (SD) (between \< 30% decrease and \>20% increase in the sum of the longest diameter of target lesions) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI scan.
Duration of Response (DOR)Secondary· Up to 3.5 years
The time when measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
Time frame: About 3.5 years.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well the combination of XL184 (cabozantinib), nivolumab, and ipilimumab work in treating patients with poorly differentiated neuroendocrine tumors (i.e., neuroendocrine tumor that does not look like the normal tissue it arose from). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab and ipilimumab may shrink the cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06811116 — Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metasta
· Phase 1, PHASE2
· recruiting
NCT06006013 — Cabozantinib in Combination With Pembrolizumab for the Treatment of Patients With Locally Advanced, Metastatic, or Unres
· Phase 2
· recruiting
NCT05904080 — Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic,
· Phase 2
· recruiting
NCT05411081 — Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer, PAPMET2 Trial
· Phase 2
· active not recruiting
NCT05691478 — A Study to Test the Addition of the Drug Cabozantinib to Chemotherapy in Patients With Newly Diagnosed Osteosarcoma
· Phase 2, PHASE3
· recruiting
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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 National Cancer Institute (NCI)
Last refreshed: 13 April 2026
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/NCT04079712.