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New trial tailors anal cancer treatment for people with HIV

NCT ID NCT04929028

First seen Nov 01, 2025 · Last updated Jun 22, 2026 · Updated 35 times

Summary

This phase 2 trial is testing whether adjusting treatment based on risk level can improve outcomes for people with HIV who have anal cancer. Low-risk patients receive standard chemotherapy and radiation, while high-risk patients also get the immunotherapy drug nivolumab after standard treatment. The study will monitor side effects and cancer recurrence in 40 participants.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

Locations

  • George Washington University Medical Center

    Washington D.C., District of Columbia, 20037, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Lyndon Baines Johnson General Hospital

    Houston, Texas, 77026-1967, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467, United States

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461, United States

  • Mount Sinai Hospital

    New York, New York, 10029, United States

  • Mount Sinai West

    New York, New York, 10019, United States

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Illinois

    Chicago, Illinois, 60612, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Zuckerberg San Francisco General Hospital

    San Francisco, California, 94110, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

capecitabine, mitomycin, fluorouracil, nivolumab, intensity modulated radiation therapy

What this could lead to

If successful, this could lead to a more effective treatment plan that reduces the chance of anal cancer returning in people with HIV.

What could go wrong

This is a small, early-phase trial (40 participants) focused on safety and side effects, not yet proven to improve outcomes. Adding immunotherapy may increase side effects.

Conditions

The condition(s) this trial relates to.

anal canal cancer anal carcinoma anal margin squamous cell carcinoma anal squamous cell carcinoma anus neoplasm HIV infectious disease rectal cancer rectal neoplasm squamous cell carcinoma of rectum

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.