ctHPVDNA Response-Adapted Chemoradiation +/- Retifanlimab Treatment in Locally-Advanced Anal Cancer (NCT07425054) | Clinical Trial Compass
RecruitingPhase 2
ctHPVDNA Response-Adapted Chemoradiation +/- Retifanlimab Treatment in Locally-Advanced Anal Cancer
United States33 participantsStarted 2026-06-19
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must have histologically proven stage T1-4N+M0 or T3-T4N0M0 anal canal or anal margin squamous cell carcinoma. This may include tumors of non-keratinizing histology such as basaloid, transitional cell or cloacogenic histology. Special considerations include the following:
* Participants with excision of the primary tumor but with node positive disease or residual disease at the primary if T3-T4N0 will be eligible.
* Age ≥18 years
* ECOG performance status 0-2
* Creatinine clearance \>30 ml/min by Cockcroft-Gault Equation.
* HIV-infected participants are eligible if they meet the following eligibility criteria:
* A CD4 T-cell count \>= 200/mm3 and a viral load \< 200 copies/mm3
* No history of AIDS-related complications within past year other than history of low CD4+ T-cell count (\>200/mm3) prior to initiation of combination antiretroviral therapy.
* Participant must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the anal cancer.
* Participant MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management. Participants will be eligible regardless of antiretroviral medication provided the regimen has been stable for at least 4 weeks.
* Participants must be PPD negative. Alternatively, the QuantiFERON-TB assay can be used. An individual is …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1-year Disease-free survival (DFS) by response subgroup