ASTX727 + Retifanlimab for Skin Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether combining two drugs, ASTX727 and retifanlimab, can more effectively treat advanced Merkel cell cancer, a rare skin cancer. Researchers aim to determine if these drugs can shrink the cancer and prevent its spread more effectively than current treatments. Participants will take one drug orally and receive the other through an IV (a needle into a vein) every two weeks for about two years. The trial seeks participants with Merkel cell cancer that has returned or hasn't responded to previous treatments. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.
Is there any evidence suggesting that the combination of ASTX727 and retifanlimab is likely to be safe for humans?
A previous study found retifanlimab to be fairly safe for people with Merkel cell carcinoma. About 105 patients received the treatment; although some experienced serious side effects, most tolerated the drug well. Additionally, the FDA has granted fast-track approval for retifanlimab in treating this type of cancer, recognizing its safety for this use.
Less information is available about the safety of ASTX727 when used with retifanlimab. However, as this trial is in its early stages, researchers are closely monitoring any potential side effects. This phase of the trial focuses on assessing the safety of the combination, emphasizing safety as a priority.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ASTX727 + Retifanlimab for treating Merkel cell carcinoma because of its novel approach. Unlike standard treatments, which often rely on traditional chemotherapy or standalone immune checkpoint inhibitors like PD-1 or PD-L1 inhibitors, this combination targets the cancer more aggressively. ASTX727 includes a DNA methyltransferase inhibitor, which helps reactivate silenced genes that can suppress tumors, while Retifanlimab is a PD-1 inhibitor that boosts the immune system's ability to fight cancer. This dual-action strategy could offer new hope for patients whose cancer has progressed despite prior treatments.
What evidence suggests that the combination of ASTX727 and retifanlimab could be effective for Merkel cell cancer?
Research has shown that retifanlimab, a drug that helps the immune system fight cancer, is approved for treating Merkel cell carcinoma (MCC). This approval followed studies demonstrating its effectiveness in controlling the cancer for extended periods and its good tolerance among patients. Meanwhile, ASTX727, a combination of two drugs, has shown promise in enhancing the effects of other treatments. This trial examines the combination of ASTX727 with retifanlimab, as early results suggest they might work better together to shrink tumors and slow the cancer's spread. The trial aims to determine if using these two drugs together can provide better outcomes for patients with MCC.12345
Who Is on the Research Team?
Vincent Ma, MD
Principal Investigator
University of Wisconsin, Madison
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
Treatment
Participants take oral ASTX727 and retifanlimab through a vein in the arm
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ASTX727
- Retifanlimab-dlwr
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants with unresectable Merkel cell carcinoma who progressed on prior PD-1 or PD-L1 inhibitor
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor
Citations
ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell ...
This study is being done to see if combining ASTX727 (decitabine/cedazuridine) with retifanlimab-dlwr is safe and confers clinical benefit in patients with ...
Phase II study of retifanlimab in patients with recurrent locally ...
Systematic literature review of efficacy, safety and tolerability outcomes of chemotherapy regimens in patients with metastatic Merkel cell carcinoma.
3.
ctv.veeva.com
ctv.veeva.com/study/astx727-retifanlimab-dlwr-for-advanced-merkel-cell-after-progression-on-anti-pd-l1ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After ...
The goal of this clinical trial is to learn if ASTX727 can be combined with retifanlimab to treat Merkel cell cancer.
ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell ...
Study Details. "The goal of this clinical trial is to learn if ASTX727 can be combined with retifanlimab to treat Merkel cell cancer.
Phase II study of retifanlimab in patients with recurrent locally ...
It is now a standard therapy for Merkel cell carcinoma (MCC) ... These results helped the FDA approve retifanlimab as a new treatment for MCC.
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