NCT06947928

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of IFx-Hu2.0 as an Adjunctive Therapy to Pembrolizumab in Checkpoint-Inhibitor Naïve Participants With Advanced or Metastatic Merkel Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: TuHURA Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Or Metastatic Merkel Cell Carcinoma

Interventions

Type	Name	Description
DRUG	IFx-Hu2.0	Therapeutic Classification: • Innate immune agonist Route of Administration: • Intralesional
DRUG	Placebo	Route of Administration: • Intralesional
DRUG	Pembrolizumab	Therapeutic Classification: • Immunotherapy (Immune checkpoint inhibitor) Route of administration: • Intravenous (IV) infusion

Timeline

• Start date: 2025-12-11
• Primary completion: 2027-03-31
• Completion: 2032-12-30
• First posted: 2025-04-27
• Last updated: 2026-04-17

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study