Study on Customized Chemoradiation with or without Retifanlimab for Advanced Anal Cancer

Sponsor: Jennifer Dorth

Sponsor score: 0

ClinicalTrials ID:NCT07425054

Provider View

This clinical trial is exploring a personalized approach to treating advanced anal cancer using chemoradiation therapy, with the possibility of adding Retifanlimab for those whose cancer doesn't respond well. The study aims to improve survival and reduce side effects by adjusting treatment based on a blood test that detects cancer markers.

Patient Parameters

Program Overview

This study is for people with anal cancer who haven't started treatment yet. The usual treatment is chemoradiation therapy (CRT), which combines chemotherapy and radiation. CRT is effective in treating anal cancer and often prevents the need for surgery that might require a colostomy bag. However, the right dose of CRT is crucial. Higher doses can increase side effects, while lower doses might not be as effective. This study uses a blood test called ctDNA to check for HPV, a marker for anal cancer, to decide the right CRT dose. The goal is to see if adjusting CRT based on ctDNA levels can improve survival and reduce side effects. If the cancer doesn't respond well to CRT, participants may receive Retifanlimab, a drug that boosts the immune system and is approved for recurrent or metastatic anal cancer.

Description

For people with advanced anal cancer, it's important to adjust the amount of chemoradiation therapy (CRT) based on how well the cancer is responding. This helps doctors increase the dose for those whose cancer isn't improving or decrease it for those who are responding well, reducing the risk of side effects. The study uses a blood test for HPV ctDNA to monitor cancer response and adjust CRT doses accordingly. Participants with a good response will have their CRT dose reduced, those with an intermediate response will keep the same dose, and those with a poor response will have their dose increased and may receive Retifanlimab after CRT.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of advanced anal cancer, including specific types like squamous cell carcinoma.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Adequate kidney function.
  • HIV-positive participants are eligible if they have a stable condition and are receiving appropriate HIV treatment.
  • Must have a documented tumor size and staging imaging studies.
  • No prior chemotherapy or major surgery for anal cancer.
  • Must not be receiving other cancer treatments.
  • Must not have significant health issues that would affect study participation.
  • Must not have had significant heart disease recently.
  • Must not have a history of another cancer unless it's considered low risk.
  • Must have normal organ and marrow function.
  • Women must not be pregnant or breastfeeding and must use effective contraception.
  • Must understand and agree to the study requirements.
  • Must not have a specific genetic deficiency (DPYD deficiency).

Exclusion Criteria

  • Any previous pelvic radiation that overlaps with the study treatment.
  • Allergic reactions to similar drugs.
  • Other cancers that could interfere with the study.
  • Certain bowel diseases or genetic conditions.
  • Active autoimmune diseases requiring treatment in the past two years.
  • No prior treatment with immune checkpoint inhibitors.
  • No significant immune system deficiencies or recent use of high-dose steroids.
  • No recent live vaccines.
  • No known lung diseases that could interfere with the study.
  • No known allergies to Retifanlimab or similar drugs.
  • Must not have a specific genetic deficiency (homozygous for DPYD deficiency).

Locations

FACILITYZIPCITYSTATE
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center44106ClevelandOhio
Case Comprehensive Cancer Center, Cleveland Clinic Taussig Cancer Center44195ClevelandOhio

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.