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Risk-Adapted Therapy for HIV-Associated Anal Cancer
NCT04929028Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Aug 2022
- Primary completion
- Sep 2031
- Countries
- 1
- Sponsor
- National Cancer Institute
- Modality
- Monoclonal Antibodies
- Conditions
- anal cancer
01
Overview
Phase 2, open-label trial of nivolumab, mitomycin c, fluorouracil and capecitabine in anal cancer (2 arms), sponsored by National Cancer Institute. Primary endpoint: Incidence of adverse events up to 5 years. Started Aug 2022; status: active, not recruiting.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
High-risk stratum
Patients with high-risk disease receive adjuvant nivolumab after standard CRT.
Low-risk stratum
Patients with low-risk disease receive reduced intensity chemo-radiation therapy.
03
Who it enrols
HIV-positive patients with stage I-III squamous cell carcinoma of the anus, on stable ART with CD4 >= 100 and undetectable viral load. High-risk patients must have completed standard CRT.
04
Endpoints
Primary
Incidence of adverse events
Secondary
Disease free survival
Disease control rate
Change in CD4+ cell counts
Change in human immunodeficiency virus (HIV) viral load
Change in combination antiretroviral therapy (cART) adherence
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