NCT03866382

Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors

Recruiting now Phase 2 Last updated 16 April 2026

What this trial tests

Phase 2 trial testing Biospecimen Collection in Bladder Adenocarcinoma in 314 participants. Currently enrolling.

Timeline

13 May 2019

Primary endpoint
28 February 2027

28 February 2027

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	314
Start date	13 May 2019
Primary completion	28 February 2027
Estimated completion	28 February 2027
Sites	580 locations across Puerto Rico, United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Bone Scan — full drug profile →
• Cabozantinib S-malate
• Computed Tomography
• Echocardiography Test
• Ipilimumab — full drug profile →
• Magnetic Resonance Imaging
• Nivolumab (nivolumab) — full drug profile →
• Positron Emission Tomography

Conditions studied

• Bladder Adenocarcinoma — all drugs for Bladder Adenocarcinoma →
• Bladder Clear Cell Adenocarcinoma — all drugs for Bladder Clear Cell Adenocarcinoma →
• Bladder Mixed Adenocarcinoma — all drugs for Bladder Mixed Adenocarcinoma →
• Bladder Neuroendocrine Carcinoma — all drugs for Bladder Neuroendocrine Carcinoma →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Bladder Adenocarcinoma or Bladder Clear Cell Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. 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 work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. MET-dependent solid tumours - molecular diagnosis and targeted therapy.
   Guo R, Luo J, Chang J, Rekhtman N, et al · · 2020 · cited 262× · PMID 32514147 · DOI 10.1038/s41571-020-0377-z
2. How to turn up the heat on the cold immune microenvironment of metastatic prostate cancer.
   Stultz J, Fong L. · · 2021 · cited 173× · PMID 33820953 · DOI 10.1038/s41391-021-00340-5
3. Phase I Study of Cabozantinib and Nivolumab Alone or With Ipilimumab for Advanced or Metastatic Urothelial Carcinoma and Other Genitourinary Tumors.
   Apolo AB, Nadal R, Girardi DM, Niglio SA, et al · · 2020 · cited 96× · PMID 32915679 · DOI 10.1200/jco.20.01652
4. The Immune Landscape of Thyroid Cancer in the Context of Immune Checkpoint Inhibition.
   Varricchi G, Loffredo S, Marone G, Modestino L, et al · · 2019 · cited 78× · PMID 31412566 · DOI 10.3390/ijms20163934
5. Current Strategies and Novel Therapeutic Approaches for Metastatic Urothelial Carcinoma.
   Mollica V, Rizzo A, Montironi R, Cheng L, et al · · 2020 · cited 75× · PMID 32498352 · DOI 10.3390/cancers12061449
6. Dissecting the Role of AXL in Cancer Immune Escape and Resistance to Immune Checkpoint Inhibition.
   Engelsen AST, Lotsberg ML, Abou Khouzam R, Thiery JP, et al · · 2022 · cited 74× · PMID 35572601 · DOI 10.3389/fimmu.2022.869676
7. Neuroendocrine and Aggressive-Variant Prostate Cancer.
   Spetsieris N, Boukovala M, Patsakis G, Alafis I, et al · · 2020 · cited 62× · PMID 33339136 · DOI 10.3390/cancers12123792
8. BDNF and its signaling in cancer.
   Malekan M, Nezamabadi SS, Samami E, Mohebalizadeh M, et al · · 2023 · cited 48× · PMID 36173463 · DOI 10.1007/s00432-022-04365-8