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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 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. The trial reports 8 study locations across 6 states.

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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.

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

FieldValue
Enrollment Target 118 participants
Start Date 2025-10
Est. Completion 2032-12-30
Phase Phase 2

Sponsor

TuHURA Biosciences

5 total trials

What the Registry Record Tells You About NCT06947928

The ClinicalTrials.gov registry entry for NCT06947928 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TuHURA Biosciences, which has 5 total studies on file at ClinicalTrials.gov.

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 reports 8 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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