ctHPVDNA Response-Adapted Chemoradiation +/- Retifanlimab Treatment in Locally-Advanced Anal Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This study is for people who have anal cancer and have not yet had treatment. The regular treatment for people who have anal cancer is chemoradiation therapy (CRT). CRT is when chemotherapy and radiation therapy are given at the same time. Studies show that CRT works well to treat anal cancer and prevents many people from needing surgery which may require a colostomy bag. Doctors know that CRT is an effective way to treat anal cancer. But, they are doing studies to find out how much dose of radiation and chemotherapy should be given during the CRT. Higher doses of chemotherapy and radiation could increase the risk of side effects, but lowering the dose of chemoradiation has the risk of not being as effective to treat the cancer. One way to predict whether participants need higher or lower doses of radiation therapy is to do a blood test called ctDNA (circulating tumor DNA) to test for the presence of human papillomavirus (HPV). This test is done at certain times while participants are getting CRT. This has been shown to be a marker for the presence of anal cancer. In this study, doctors will tailor lower versus higher doses of CRT based on the tumor response that is measured by ctDNA. The purpose of this study is to see if customizing the dose of chemoradiation based on the amount of ctDNA will increase survival in participants with anal cancer and/or decrease the risk of side effects. Some participants in this study whose cancer does not respond as well to the CRT may have the opportunity to receive a drug called Retifanlimab that stimulates the body's immune system. Retifanlimab is approved by the Federal Drug Administration (FDA) for treating anal cancer that is recurrent or metastatic since there is proven benefit in these situations.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Zdiagnozowany rak odbytowy lub krawędzi odbytu potwierdzony biopsją
- •Wiek co najmniej 18 lat
- •Ogólny stan zdrowia pozwalający na leczenie (ECOG 0-2)
- •Wystarczająca funkcja nerek (klirens kreatyniny >30 ml/min)
- •Pacjenci z HIV mogą uczestniczyć, jeśli liczba CD4 ≥200/mm3 i wirus <200 kopii/mm3
- •Pacjenci z HIV muszą być w stałym leczeniu antyretrowirusowym przez co najmniej 4 tygodnie
- •Rozmiar guza zmierzony badaniem fizykalnym i/lub endoskopią
- •Pacjenci z TB lub dodatnim testem TB mogą uczestniczyć po profilaktyce
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 14, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (2)
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, United States
Case Comprehensive Cancer Center, Cleveland Clinic Taussig Cancer Center
Cleveland, United States
Trial contact
Jennifer Dorth, MD, MHSc
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/15/2026.
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