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NCT06947928 · ClinicalTrials.gov registry record · Phase 2
Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
A Phase 2 study of Advanced Or Metastatic Merkel Cell Carcinoma, sponsored by TuHURA Biosciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
- 8
- Study locations
NCT06947928: Recruiting Phase 2 study of Advanced Or Metastatic Merkel Cell Carcinoma, sponsored by TuHURA Biosciences.
NCT06947928 is a Phase 2 study of Advanced Or Metastatic Merkel Cell Carcinoma that is actively recruiting participants, run by TuHURA Biosciences. The registered enrollment target is 118 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06947928, a Phase 2 study of Advanced Or Metastatic Merkel Cell Carcinoma, is actively recruiting participants, sponsored by TuHURA Biosciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
- 8
- Study locations
Study 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.
Primary Outcome
ORR defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) at 12 weeks and confirmed on a second response assessment at least 28 days after the initial response assessment, in the treatment arm based on BICR assessment according to RECIST v1.1. Confirmed response persisting at the time of response assessment, at approximately 24 weeks will constitute the data utilized for the endpoint analysis.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Placebo
- DRUG IFx-Hu2.0
Study Locations (8)
California
- USC Norris Comprehensive Cancer Center - Los Angeles
- Stanford Health Care - Skin Cancer Program - Palo Alto
- University of California San Francisco - Helen Diller Family Comprehensive Cancer Center - San Francisco
Massachusetts
- Dana-Farber Cancer Institute - Boston
New Jersey
- Atlantic Health System - Morristown
North Carolina
- East Carolina University - Greenville
Virginia
- Virginia Commonwealth University - Massey Cancer Center - Richmond
Washington
- Fred Hutchinson Cancer Research Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2025-10 |
| Est. Completion | 2032-12-30 |
| Phase | Phase 2 |
What NCT06947928 shows while recruiting
NCT06947928 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
The record links to 1 condition, with Advanced Or Metastatic Merkel Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT06947928 lists 8 locations in 6 states (California, Massachusetts, New Jersey).
Frequently Asked Questions
What is clinical trial NCT06947928 about?
NCT06947928 is a clinical study titled "Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma". 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...
What is the current status of trial NCT06947928?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2025-10. Estimated completion is 2032-12-30.
What conditions does trial NCT06947928 study?
This clinical trial studies the following conditions: Advanced Or Metastatic Merkel Cell Carcinoma.
What interventions are being tested in trial NCT06947928?
The interventions under investigation include: Pembrolizumab (DRUG), Placebo (DRUG), IFx-Hu2.0 (DRUG).
Who is sponsoring clinical trial NCT06947928?
This trial is sponsored by TuHURA Biosciences, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06947928 being conducted?
This trial has 8 study locations across California, Massachusetts, New Jersey, North Carolina, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06947928's enrollment target sits among peer trials
118 618th of 2000 higher than 1,378 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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