Clinical Trial

Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma

Recruiting Phase 2/3
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-04-24; most recent amendment 2026-04-14.
Status change: Not Yet Recruiting → Recruiting 2025-10-10
Trial Details
NCT Number NCT06947928
Lead Sponsor TuHURA Biosciences, Inc.
Conditions Advanced Or Metastatic Merkel Cell Carcinoma
Enrollment 118 participants
Start Date 2025-12-11
Primary Completion 2027-03-31 (estimated)
Study Completion 2032-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-17