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

April 14, 2026 updated by: TuHURA Biosciences, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Phase 2
  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Usc Norris Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • In Gino, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
        • Principal Investigator:
          • Adil Daud, MD
        • Contact:
      • Stanford, California, United States, 94304
        • Recruiting
        • Stanford Health Care - Skin Cancer Program
        • Principal Investigator:
          • Sunil Reddy, MD
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Comprehensive Cancer Center
        • Contact:
          • Phone Number: 904-953-2000
        • Principal Investigator:
          • Ruqin Chen, MD
      • Miami, Florida, United States, 33136
        • Recruiting
        • Sylvester Comprehensive Cancer Center
        • Principal Investigator:
          • Lynn Feun, MD
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Andrew Brohl, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Karam Khaddour, MD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Tassos Dimou, MD
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Andrew Pecora, MD
        • Contact:
      • Morristown, New Jersey, United States, 07960
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University
        • Principal Investigator:
          • Nasreen Vohra, MD
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center
        • Principal Investigator:
          • Melissa Burgess, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77384
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Neal Akhave, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • INOVA Schar Cancer
        • Principal Investigator:
          • Jafar Al-Mondhiry, MD
        • Contact:
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Principal Investigator:
          • Andrew Poklepovic, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center
        • Principal Investigator:
          • Shailender Bhatia, MD
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, United States, 26506

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. At least 18 years of age.
  2. Life expectancy equal to or greater than six months.
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.

  4. Must be recurrent and/or unresectable Stage III or Stage IV American Joint Committee on Cancer (AJCC) (8th edition) and have histologically confirmed Merkel cell carcinoma

    1. Must have at least one injectable lesion equal to or greater than 3 mm.
    2. Must have measurable disease as defined by RECIST v1.1.
  5. Participants should be CPI naïve i.e., no prior therapy with CPI including but not limited to Pembrolizumab, avelumab, ipilimumab, nivolumab.
  6. Tumor tissue from an archival core biopsy or resected site of disease must be provided for biomarker analyses. If archival tissue is not available, then a new biopsy should be performed.
  7. Adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol.

Exclusion Criteria:

  1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with protocol requirements.
  2. Participants with known active brain metastases with the exception of treated brain metastases that have imaging proving stability at least 4 weeks prior to the start of study treatment, no new metastases, and not requiring steroids.
  3. Participants with recurrent resectable MCC
  4. Participants with prior systemic chemotherapy
  5. Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study.
  6. Active, known, or suspected autoimmune disease. Potential Participants with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. Low-grade autoimmune toxicity is NOT an exclusion under this criterion.
  7. A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Participants randomized to the treatment arm will receive IFx-Hu2.0 (0.1 mg) via intralesional injection in a single lesion once per week for 3 consecutive weeks. Pembrolizumab (200 mg) will be administered intravenously (IV) on Day 1, followed by administration every 3 weeks during the first year of treatment. In the second year, the pembrolizumab dose will be 400 mg every 6 weeks. Pembrolizumab treatment will continue until progressive disease (PD), unacceptable immune-related toxicities, or for a maximum duration of 2 years.
Drug: IFx-Hu2.0

Therapeutic Classification:

• Innate immune agonist

Route of Administration:

• Intralesional

Other Names:
  • pAc/emm55
Drug: Pembrolizumab

Therapeutic Classification:

• Immunotherapy (Immune checkpoint inhibitor)

Route of administration:

• Intravenous (IV) infusion

Other Names:
  • KEYTRUDA
Placebo Comparator: Control Arm
Participants randomized to the control arm will receive placebo (0.9% Sodium Chloride Injection, USP) via intralesional injection in a single lesion once per week for 3 consecutive weeks. Pembrolizumab (200 mg) will be administered IV on Day 1, followed by administration every 3 weeks during the first year of treatment. In the second year, the dose will be 400 mg every 6 weeks. Pembrolizumab treatment will continue until PD, unacceptable immune-related toxicities, or for a maximum duration of 2 years.
Drug: Pembrolizumab

Therapeutic Classification:

• Immunotherapy (Immune checkpoint inhibitor)

Route of administration:

• Intravenous (IV) infusion

Other Names:
  • KEYTRUDA
Drug: Placebo

Route of Administration:

• Intralesional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 12 weeks post-treatment initiation and confirmed on a second response assessment at least 28 days after the initial response assessment
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.
12 weeks post-treatment initiation and confirmed on a second response assessment at least 28 days after the initial response assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: Up to 5 years
PFS is defined as the time (months) from the date of randomization to the date of the documented PD based on BICR assessment according to RECIST v1.1, or death, whichever occurs first. Participants without progression or death will be censored on the date of last disease assessment.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TuHURA Biosciences, Inc.

Investigators

  • Principal Investigator: Andrew S Brohl, MD, Collaborator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

December 30, 2032

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC 2021-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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