Trial results for a Phase 1 study evaluating nivolumab in combination with cabozantinib for patients with advanced cancer and HIV were posted on ClinicalTrials.gov on 2026-05-28. The study reported 0 patients experiencing dose-limiting toxicities and a 12-month progression-free survival rate of 63%.
Background
This study investigated the combination of cabozantinib and nivolumab in patients with various types of advanced cancer who are also undergoing treatment for human immunodeficiency virus (HIV). Cabozantinib is thought to stop the growth of tumor cells by blocking enzymes essential for cell growth. Nivolumab, an immunotherapy, is a monoclonal antibody that may enhance the body's immune system to attack cancer cells and interfere with tumor cell growth and spread.
Trial design
The Phase 1 study (NCT04514484) enrolled 8 participants with advanced cancer and HIV, including several specific carcinoma types. The trial investigated cabozantinib s-malate and nivolumab.
Key results
The trial reported the following key measurements for the combination of cabozantinib s-malate and nivolumab:
- Incidence of Dose Limiting Toxicities (DLTs): 0 patients.
- Objective Response Rate (ORR): 0 percentage of patients (95% Confidence Interval).
- Best Overall Response: Reported values included 83.3 percentage of patients and 16.7 percentage of patients (95% Confidence Interval).
- Best Overall Response (Off Treatment): Reported values included 83.3 percentage of patients and 16.7 percentage of patients (95% Confidence Interval).
- 12-month Progression-free Survival (PFS): 63 percentage of patients (95% Confidence Interval).
- 24-month Progression-free Survival (PFS): 0 percentage of patients (95% Confidence Interval).
What this means
This Phase 1 study provides initial safety and preliminary efficacy data for nivolumab and cabozantinib in patients with advanced cancer and HIV. The absence of dose-limiting toxicities in 0 patients indicates a manageable safety profile, a key objective for a Phase 1 trial. While the Objective Response Rate was 0 percentage of patients, a 12-month progression-free survival rate of 63% suggests disease control or stabilization for a year in a significant portion of patients. The 24-month progression-free survival rate of 0% indicates this benefit did not persist long-term. With only 8 participants, these findings are preliminary and require further confirmation in larger studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04514484, titled "Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV", were posted on 2026-05-28 on clinicaltrials.gov.