NCT04514484

Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV

Active, enrolled Phase 1 Last updated 23 March 2026

What this trial tests

Phase 1 trial testing Biospecimen Collection in Advanced Differentiated Thyroid Gland Carcinoma in 8 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 November 2021

Primary endpoint
11 November 2024

6 February 2027

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	22 November 2021
Primary completion	11 November 2024
Estimated completion	6 February 2027
Sites	3 locations across United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Cabozantinib S-malate — full drug profile →
• Computed Tomography
• Magnetic Resonance Imaging
• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• Advanced Differentiated Thyroid Gland Carcinoma — all drugs for Advanced Differentiated Thyroid Gland Carcinoma →
• Advanced Head and Neck Carcinoma — all drugs for Advanced Head and Neck Carcinoma →
• Advanced Hepatocellular Carcinoma — all drugs for Advanced Hepatocellular Carcinoma →
• Advanced Kaposi Sarcoma — all drugs for Advanced Kaposi Sarcoma →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Advanced Differentiated Thyroid Gland Carcinoma or Advanced Head and Neck Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial investigates the side effects of cabozantinib and nivolumab in treating patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and who are undergoing treatment for human immunodeficiency virus (HIV). 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, 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 and nivolumab may shrink or stabilize cancer in patients undergoing treatment for HIV.

Publications & conference data

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

1. Skin cancer: understanding the journey of transformation from conventional to advanced treatment approaches.
   Hasan N, Nadaf A, Imran M, Jiba U, et al · · 2023 · cited 117× · PMID 37803407 · DOI 10.1186/s12943-023-01854-3
2. 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
3. Hypoxia-dependent drivers of melanoma progression.
   D'Aguanno S, Mallone F, Marenco M, Del Bufalo D, et al · · 2021 · cited 67× · PMID 33964953 · DOI 10.1186/s13046-021-01926-6
4. Ovarian Cancer in the Era of Immune Checkpoint Inhibitors: State of the Art and Future Perspectives.
   Maiorano BA, Maiorano MFP, Lorusso D, Maiello E. · · 2021 · cited 60× · PMID 34503248 · DOI 10.3390/cancers13174438
5. 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
6. Viral oncogenesis in cancer: from mechanisms to therapeutics.
   Xiao Q, Liu Y, Li T, Wang C, et al · · 2025 · cited 45× · PMID 40350456 · DOI 10.1038/s41392-025-02197-9
7. Current Insights and Progress in the Clinical Management of Head and Neck Cancer.
   Amaral MN, Faísca P, Ferreira HA, Gaspar MM, et al · · 2022 · cited 32× · PMID 36551565 · DOI 10.3390/cancers14246079
8. Metastatic medullary thyroid carcinoma: a new way forward.
   Angelousi A, Hayes AR, Chatzellis E, Kaltsas GA, et al · · 2022 · cited 30× · PMID 35521769 · DOI 10.1530/erc-21-0368