Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer
Public ClinicalTrials.gov record NCT04929028. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Risk-Adapted Therapy for HIV-Associated Anal Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04929028
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 40 participants
Conditions and interventions
Conditions
- AIDS-Related Anal Carcinoma
- Anal Margin Squamous Cell Carcinoma
- Anal Non-Keratinizing Squamous Cell Carcinoma
- Anal Squamous Cell Carcinoma
- HIV Infection
- Rectal Squamous Cell Carcinoma
- Stage II Rectal Cancer AJCC v8
- Stage IIB Anal Cancer AJCC v8
- Stage III Anal Cancer AJCC v8
- Stage III Rectal Cancer AJCC v8
Interventions
- Anoscopy Procedure
- Biospecimen Collection Procedure
- Capecitabine Drug
- Colonoscopy Procedure
- Computed Tomography Procedure
- Digital Rectal Examination Procedure
- Echocardiography Test Procedure
- Fludeoxyglucose F-18 Other
- Fluorouracil Drug
- Intensity-Modulated Radiation Therapy Radiation
- Lymph Node Biopsy Procedure
- Magnetic Resonance Imaging Procedure
- Mitomycin Drug
- Nivolumab Biological
- Positron Emission Tomography Procedure
- Proctoscopy Procedure
- Questionnaire Administration Other
- Sigmoidoscopy Procedure
Procedure · Drug · Other + 2 more
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 9, 2022 (Actual)
- Primary completion
- Sep 15, 2031 (Estimated)
- Completion
- Sep 15, 2031 (Estimated)
- Last update posted
- Oct 5, 2026
2022 – 2031
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital | San Francisco | California | 94110 | — |
| George Washington University Medical Center | Washington D.C. | District of Columbia | 20037 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Mount Sinai West | New York | New York | 10019 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | — |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | — |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Lyndon Baines Johnson General Hospital | Houston | Texas | 77026-1967 | — |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04929028, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 5, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04929028 live on ClinicalTrials.gov.