HPV ctDNA Response-Adapted Chemoradiation +/- Retifanlimab Treatment in Advanced-Stage Anal Cancer

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Jennifer Dorth
Study ID
NCT07425054
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HPV ctDNA Response based radiation — RADIATION
    Total radiation doses per response group: * Favorable response: 5040 cGy in 28 fractions * Intermediate response: 5400 cGy in 30 fractions * Unfavorable response: 6120 cGy in 34 fractions
  • Chemotherapy — DRUG
    1. Mitomycin-C(MMC) 12 mg/m2 on day 1 AND one of the following: 2. Capecitabine 825 mg/m2 twice daily on all days of radiotherapy for all response groups OR 5-Fluorouracil: 1000 mg/m²/day as a continuous infusion for 96 hours on days 1-4 and 29-32
  • Retifanlimab — DRUG
    Only participants who have an unfavorable response to treatment (measured on blood tests at Weeks 4 and 5) will be eligible to receive Retifanlimab. Retifanlimab is a 500 mg infusion administered intravenously (by IV) over 30 minutes and begins two weeks after participants finish chemoradiation therapy (at Weeks 7-9). Retifanlimab will be administered on Day 1 of each cycle (each cycle is 4 weeks) as tolerated for up to 1 year.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Feb 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Chemoradiation based on HPV ctDNA response
    All participants will receive CRT for one cycle (4 weeks), while undergoing HPV ctDNA testing. Investigators will then modify the treatment plan based on HPV ctDNA response: * Favorable response: Dose reduction (total of 28 fractions of CRT) * Intermediate response: Standard dose (total of 30 fractions of CRT) * Unfavorable response: Dose-intensification (total of 34 fractions of CRT)

Primary Outcome Measure

1-year Disease-free survival (DFS) by response subgroup [ Time Frame: 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Case Comprehensive Cancer Center, Cleveland Clinic Taussig Cancer CenterClevelandOhio44195
Joel Saltzman, MD
[email protected]
440-312-4569
Joel Saltzman, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106
Jennifer Dorth, MD, MHSc
[email protected]
216-844-2536

Find similar trials in Cleveland, OH

By research site
Case Comprehensive Cancer Center, Cleveland Clinic Taussig Cancer Center· Cleveland, OHUniversity Hospitals Cleveland Medical Center, Seidman Cancer Center, Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center· Cleveland, OH

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