Testing the Combination of XL184 (Cabozantinib), Nivolumab, and Ipilimumab for Poorly Differentiated Neuroendocrine Tumors

Conditions

• Metastatic Large Cell Neuroendocrine Carcinoma
• Metastatic Neuroendocrine Carcinoma
• Metastatic Neuroendocrine Neoplasm
• Metastatic Small Cell Neuroendocrine Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cabozantinib S-malate — DRUG
  Given PO
• Ipilimumab — BIOLOGICAL
  Given IV
• Nivolumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Aug 6, 2020

Status verified

Mar 2026

Primary completion

Jan 10, 2025

Completion

Aug 19, 2026

Study Design

Enrollment

17 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (cabozantinib s-malate, nivolumab, ipilimumab)
  Patients receive cabozantinib s-malate PO QD on days 1-21 of cycles 1-4 and days 1-28 of subsequent cycles, nivolumab IV over 30 minutes on day 1, and ipilimumab IV over 90 minutes on day 1 of cycles 1-4 only. Treatment repeats every 21 for 4 cycles then every 28 days for subsequent cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With a Response [ Time Frame: Up to 3.5 years ]

Locations (45)

Related coverage on Hipa.ai

• Nivolumab Combo Shows 664-Day Median DOR in Neuroendocrine Tumors
  Nivolumab · Dec 12, 2025 · ClinicalTrials.gov

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