Allergy & Immunology PHASE2 ● Phase II

Phase II Trial Explores Nivolumab in High-Risk HIV-Associated Anal Cancer

ClinicalTrials.gov Published March 27, 2026 National Cancer Institute (NCI) NCT04929028 ↗

Key Takeaway

Monitor for adverse events in HIV-associated anal cancer treatments involving CRT and nivolumab.

This ongoing Phase II trial, sponsored by the National Cancer Institute, is designed to evaluate the safety and efficacy of treatment regimens in patients with HIV-associated anal cancer. The study enrolls 40 participants, stratified into low-risk and high-risk groups, to assess different therapeutic approaches. Low-risk patients receive reduced intensity chemo-radiation therapy (CRT), while high-risk patients receive nivolumab following standard CRT. The primary endpoints focus on the incidence of adverse events in both strata. Secondary objectives include estimating the 2-year disease-control rate (DCR) for low-risk patients and the 2-year disease-free survival (DFS) rate for high-risk patients treated with nivolumab. Additionally, the study examines the impact of these treatments on immune function, specifically CD4+ cell counts and HIV viral load, as well as adherence to combination antiretroviral therapy (cART). Safety profiles and adverse events are monitored closely to determine the tolerability of these regimens. The trial began in August 2022, with primary completion anticipated in September 2031. Results will inform the potential integration of nivolumab into treatment protocols for high-risk HIV-associated anal cancer.

AI Accuracy Review: 9/10 · Auto-published

View Original Abstract ↓

Status: RECRUITING | Phase: PHASE2 Condition(s): AIDS-Related Anal Carcinoma, Anal Margin Squamous Cell Carcinoma, Anal Non-Keratinizing Squamous Cell Carcinoma, Anal Squamous Cell Carcinoma, HIV Infection Intervention(s): Anoscopy (PROCEDURE), Biospecimen Collection (PROCEDURE), Capecitabine (DRUG), Colonoscopy (PROCEDURE), Computed Tomography (PROCEDURE) This phase II trial studies the side effects of chemotherapy and intensity modulated radiation therapy in treating patients with low-risk HIV-associated anal cancer, and nivolumab after standard of care chemotherapy and radiation therapy in treating patients with high-risk HIV-associated anal cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. 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 nivolumab after standard of care chemotherapy and radiation therapy may help reduce the risk of the tumor coming back. Detailed: PRIMARY OBJECTIVES: I. To determine the safety of reduced intensity chemo-radiation therapy (CRT) in low-risk disease. II. To determine the safety of nivolumab after standard CRT in high-risk disease. SECONDARY OBJECTIVES: I. To estimate the efficacy (2-year disease-control rate \[DCR\]) of reduced intensity CRT in low risk disease. II. To estimate the efficacy (2-year disease-free survival \[DFS\] rate) of nivolumab after standard CRT in high risk disease. III. To evaluate the effect of low-dose CRT on immune function (CD4+ cell count) and human immunodeficiency virus (HIV) viral load. IV. To evaluate the effect of nivolumab on immune function (CD4+ cell count) and HIV viral load. V. To assess combination antiretroviral therapy (cART) adherence before, during, and after treatment Primary Outcome(s): Incidence of adverse events (Low-risk stratum); Incidence of adverse events (High-risk stratum) Enrollment: 40 (ESTIMATED) Lead Sponsor: National Cancer Institute (NCI) Start: 2022-08-09 | Primary Completion: 2031-09-15