Chemoradiation +/- Retifanlimab for Anal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to treat anal cancer by customizing chemo and radiation doses based on a blood test for the cancer marker HPV ctDNA. The goal is to determine if tailored treatment can improve survival rates and reduce side effects. Participants whose cancer does not respond well may receive an additional drug, Retifanlimab, an immunotherapy that boosts the immune system. The trial seeks individuals with anal cancer who have not yet started treatment and may experience symptoms like pain or bleeding. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to benefit from potentially effective new therapies.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Retifanlimab, a drug potentially used in this trial, has a manageable safety profile. Studies indicate that combining Retifanlimab with chemotherapy for squamous cell carcinoma of the anal canal offers clinical benefits with acceptable safety levels. While some side effects may occur, healthcare providers can typically manage them.
The FDA has already approved Retifanlimab for treating recurring or spreading anal cancer, indicating its safety for these cases. However, discussing potential risks and benefits with a healthcare professional before joining any trial is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about chemoradiation guided by HPV ctDNA response for anal cancer because it allows for a personalized treatment approach. Unlike traditional treatments that apply a one-size-fits-all method, this approach tailors the radiation dose based on individual responses to chemotherapy, as measured by HPV ctDNA levels. This means patients with a favorable response could receive a reduced radiation dose, potentially minimizing side effects, while those with less favorable responses may have intensified treatment to improve outcomes. This tailored approach could lead to more effective and safer treatment for patients.
What evidence suggests that this trial's treatments could be effective for anal cancer?
Studies have shown that combining chemotherapy and radiation, known as chemoradiation therapy (CRT), effectively treats anal cancer. This approach can sometimes eliminate the need for surgery that would require a colostomy bag. Although CRT is known to work well, the exact dosage can vary among individuals. In this trial, all participants will receive CRT, with treatment plans adjusted based on HPV ctDNA response to optimize outcomes. Additionally, Retifanlimab, another treatment option in this trial, has shown promise in treating anal cancer that has returned or spread. It helps delay the progression of the cancer.12678
Who Is on the Research Team?
Jennifer Dorth, MD, MHSc
Principal Investigator
Case Comprehensive Cancer Center, University Hospitals
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemoradiation Treatment
Participants receive chemoradiation therapy (CRT) for one cycle (4 weeks) with HPV ctDNA testing to tailor CRT dosage
Dose Adjustment and Retifanlimab Treatment
CRT dosage is adjusted based on HPV ctDNA response; participants with unfavorable response receive Retifanlimab
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Chemotherapy
- HPV ctDNA Response based radiation
- Retifanlimab
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jennifer Dorth
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
Citations
Retifanlimab with carboplatin and paclitaxel for locally ...
Retifanlimab provides clinical benefit, with a manageable safety profile, when added to first-line chemotherapy in advanced squamous cell ...
2.
investor.incyte.com
investor.incyte.com/news-releases/news-release-details/phase-3-data-incytes-retifanlimab-zynyzr-patients-squamous-cellPhase 3 Data for Incyte's Retifanlimab (Zynyz®) in Patients ...
The study met its primary endpoint by demonstrating a statistically significant improvement in progression-free survival (PFS) in patients with inoperable ...
Survival outcomes in POD1UM-303/InterAACT-2
Overall response rate was 56.5% versus 44.8%, and disease control rates were 87.7% versus 80.5%. The results of the crossover-adjusted analysis ...
FDA approves retifanlimab-dlwr with carboplatin and ...
Additional efficacy outcome measures were overall response rate (ORR) and duration of response (DOR) as assessed by BICR. Median PFS was 9.3 ...
A phase II study of retifanlimab (INCMGA00012) in patients ...
Retifanlimab (PD-1 inhibitor) monotherapy demonstrated encouraging results in patients with platinum-refractory SCAC. · Clinically meaningful antitumor activity ...
6.
oncologynewscentral.com
oncologynewscentral.com/article/new-standard-of-care-for-advanced-anal-cancer-monoclonal-antibody-improves-pfsNew Standard of Care for Anal Cancer: POD1UM-303 Data ...
The safety of the combination was consistent with prior phase 2 data. At data cutoff, 58.4% of patients assigned to receive retifanlimab ...
Efficacy and safety of retifanlimab in gastrointestinal ...
Conclusions: Retifanlimab demonstrates clinically meaningful efficacy in certain GI malignancies, especially SCAC. Its benefit in biomarker- ...
8.
cancernetwork.com
cancernetwork.com/view/european-commission-oks-retifanlimab-combo-in-metastatic-anal-canal-cancerEuropean Commission OKs Retifanlimab Combo in ...
The safety profile of retifanlimab in combination with chemotherapy was generally consistent with the known profiles of the individual agents.
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