OncoMatch/Clinical Trials/NCT04929028
Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer
Is NCT04929028 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab and Capecitabine for aids-related anal carcinoma.
Treatment: Capecitabine · Fluorouracil · Mitomycin · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage T3-T4N0M0, T2-4N1M0, T1-2N0M0 (AJCC 8th edition)
stage (T3-T4N0M0 OR T2-4N1M0) ... T1-2N0M0 invasive anal canal or anal margin squamous cell carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: radiation therapy
Participant must have received at least 54 Gy of radiation to the PTVp (primary) and 45 Gy to PTVn (elective nodal region) for the treatment of the anal cancer within 9 weeks before enrollment
Must have received: antiretroviral therapy
Participant must be on a stable antiretroviral therapy (ART) regimen for at least 2 weeks prior to enrollment with no intention to change the regimen within 12 weeks after enrollment
Cannot have received: immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody)
Prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody)
Cannot have received: potentially curative surgery
Participant has had prior potentially curative surgery (i.e., abdominal-perineal resection) for carcinoma of the anus
Cannot have received: chemotherapy
History of prior chemotherapy for this malignancy
Lab requirements
Blood counts
Hemoglobin > 10 g/dL (within 2 weeks before enrollment); Absolute neutrophil count: >= 1,500/mm^3 (within 2 weeks before enrollment); Platelets: >= 100,000/mm^3 (within 2 weeks before enrollment)
Kidney function
Creatinine levels <= 1.5 X normal institutional limits; or calculated creatinine clearance must be > 50 ml/min (within 2 weeks before enrollment)
Liver function
Total bilirubin: < 2 X ULN (within 2 weeks before enrollment); AST (SGOT) / ALT (SGPT): <= 2.5 X institutional ULN (within 2 weeks before enrollment); Albumin >= 3.0 g/dL (within 2 weeks before enrollment)
Hemoglobin > 10 g/dL ... Absolute neutrophil count: >= 1,500/mm^3 ... Platelets: >= 100,000/mm^3 ... Total bilirubin: < 2 X ULN ... AST (SGOT) / ALT (SGPT): <= 2.5 X institutional ULN ... Albumin >= 3.0 g/dL ... Creatinine levels <= 1.5 X normal institutional limits; or calculated creatinine clearance must be > 50 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Zuckerberg San Francisco General Hospital · San Francisco, California
- George Washington University Medical Center · Washington D.C., District of Columbia
- Moffitt Cancer Center · Tampa, Florida
- University of Illinois · Chicago, Illinois
- Washington University School of Medicine · St Louis, Missouri
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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