๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-16

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (NCT04929028)

Risk-Adapted Therapy for HIV-Associated Anal Cancer

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: National Cancer Institute (NCI)

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Zuckerberg San Francisco General Hospital โ€” San Francisco, California

Age range: 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (14 Sites)

  • Zuckerberg San Francisco General Hospital โ€” San Francisco, California
  • George Washington University Medical Center โ€” Washington D.C., District of Columbia
  • Moffitt Cancer Center โ€” Tampa, Florida
  • University of Illinois โ€” Chicago, Illinois
  • Washington University School of Medicine โ€” St Louis, Missouri
  • Mount Sinai West โ€” New York, New York
  • Icahn School of Medicine at Mount Sinai โ€” New York, New York
  • Mount Sinai Hospital โ€” New York, New York
  • Montefiore Medical Center-Einstein Campus โ€” The Bronx, New York
  • Montefiore Medical Center - Moses Campus โ€” The Bronx, New York
  • Pennsylvania Hospital โ€” Philadelphia, Pennsylvania
  • Lyndon Baines Johnson General Hospital โ€” Houston, Texas
  • UT MD Anderson Cancer Center โ€” Houston, Texas
  • Virginia Mason Medical Center โ€” Seattle, Washington

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—