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RECRUITING Phase 2

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

NCT04929028 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Capecitabine
  • PROCEDURE Anoscopy
  • PROCEDURE Colonoscopy

Study Locations (14)

New York

  • Mount Sinai West — New York
  • Icahn School of Medicine at Mount Sinai — New York
  • Mount Sinai Hospital — New York
  • Montefiore Medical Center-Einstein Campus — The Bronx
  • Montefiore Medical Center - Moses Campus — The Bronx

Texas

  • Lyndon Baines Johnson General Hospital — Houston
  • M D Anderson Cancer Center — Houston

California

  • Zuckerberg San Francisco General Hospital — San Francisco

District of Columbia

  • George Washington University Medical Center — Washington D.C.

Florida

  • Moffitt Cancer Center — Tampa

Illinois

  • University of Illinois — Chicago

Missouri

  • Washington University School of Medicine — St Louis

Pennsylvania

  • Pennsylvania Hospital — Philadelphia

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2022-08-09
Est. Completion 2031-09-15
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04929028

The ClinicalTrials.gov registry entry for NCT04929028 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with HIV Infection appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04929028 reports 14 study locations spanning 9 distinct geographic areas — top geographies include New York, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04929028 about?

NCT04929028 is a clinical study titled "Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer". 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...

What is the current status of trial NCT04929028?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2022-08-09. Estimated completion is 2031-09-15.

What conditions does trial NCT04929028 study?

This clinical trial studies the following conditions: HIV Infection, Stage III Rectal Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Anal Squamous Cell Carcinoma, Anal Margin Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04929028?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Capecitabine (DRUG), Anoscopy (PROCEDURE), Colonoscopy (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04929028?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04929028 being conducted?

This trial has 14 study locations across California, District of Columbia, Florida, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial