Trial Now Recruiting: Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma (NCT06947928)
WHY IT MATTERS
This is the first Phase 2/3 trial testing IFx-Hu2.0 as an add-on therapy for Merkel cell carcinoma, offering checkpoint inhibitor-naïve patients a potential new treatment option beyond standard pembrolizumab alone.
Researchers are testing a new treatment called IFx-Hu2.0 combined with a cancer drug called pembrolizumab for people with Merkel cell carcinoma, a rare and aggressive skin cancer. In this study, some patients will receive the new treatment while others receive a placebo (fake treatment) to see which works better. The trial is looking for 118 adults to participate and is currently accepting new patients.
NCT ID: NCT06947928 Status: RECRUITING Conditions: Advanced Or Metastatic Merkel Cell Carcinoma Phase: PHASE2, PHASE3 Enrollment: 118 Sponsor: TuHURA Biosciences, Inc. Summary: This Phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the Objective Response Rate (ORR) of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in adult participants (≥18 years) with advanced or metastatic Merkel Cell Carcinoma. A total of 118 participants will be randomized to receive either IFx-Hu2.0 or placebo via intralesional injection in a single lesion, followed by pembrolizumab.
YOU CAN ACT ON THIS
If you have advanced or metastatic Merkel cell carcinoma and haven't received checkpoint inhibitor therapy yet, contact your oncologist immediately to discuss eligibility for this trial or visit clinicaltrials.gov (NCT06947928) to find participating sites near you.