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Experimental tumor injection aims to supercharge immunotherapy in rare skin cancer

NCT ID NCT06947928

Disease control Sponsor: TuHURA Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding an experimental drug called IFx-Hu2.0 (injected directly into a tumor) to the standard immunotherapy pembrolizumab can improve outcomes for people with advanced or metastatic Merkel cell carcinoma. About 118 adults who have not received checkpoint inhibitors before will be randomly assigned to get either IFx-Hu2.0 or a placebo injection, followed by pembrolizumab. The main goal is to see if the combination leads to more tumor shrinkage or disappearance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IFx-Hu2.0 (an experimental immune-boosting drug injected into tumors) combined with pembrolizumab (an immunotherapy given intravenously)
What this could lead to
If it works, this combination could shrink or eliminate tumors in more people with advanced Merkel cell carcinoma than pembrolizumab alone.
What could go wrong
This is an early-to-mid stage trial with only 118 participants. The added benefit of IFx-Hu2.0 is unproven, and side effects from the combination may be greater than with standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 118 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

cutaneous neuroendocrine carcinoma Neoplasm Metastasis skin neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced or metastatic merkel cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    18 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Atlantic Health System

    RECRUITING

    Morristown, New Jersey, 07960, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • East Carolina University

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Fred Hutchinson Cancer Research Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

    Contact Email: •••••@•••••

  • Inova Schar Cancer

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Mayo Clinic Comprehensive Cancer Center

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Comprehensive Cancer Center

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Stanford Health Care - Skin Cancer Program

    RECRUITING

    Stanford, California, 94304, United States

  • Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77384, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of California San Francisco - Helen Diller Family Comprehensive Cancer Center

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    RECRUITING

    Aurora, Colorado, 80045, United States

    Contact Email: •••••@•••••

  • Virginia Commonwealth University

    RECRUITING

    Richmond, Virginia, 23298, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

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