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Advanced Or Metastatic Merkel Cell CarcinomaPhase 2/3NCT06947928

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

A Phase 2/3 study testing IFx-Hu2.0 and Pembrolizumab in people with Advanced Or Metastatic Merkel Cell Carcinoma, run by TuHURA Biosciences, Inc. at 18 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IFx-Hu2.0 and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
118 participants
Where
18 sitesUnited States
Study dates
11 Dec 2025to 30 Dec 2032
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age.
  • Life expectancy equal to or greater than six months.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.
  • 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
  • Must have at least one injectable lesion equal to or greater than 3 mm.
  • Must have measurable disease as defined by RECIST v1.1.
Show all 9Show fewer
  • Participants should be CPI naïve i.e., no prior therapy with CPI including but not limited to Pembrolizumab, avelumab, ipilimumab, nivolumab.
  • 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.
  • Adequate hematological, hepatic, and renal function according to laboratory ranges and medical criteria defined within the study protocol.

Who cannot join

  • 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.
  • 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.
  • Participants with recurrent resectable MCC
  • Participants with prior systemic chemotherapy
  • Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study.
  • 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.
  • 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.

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Amit Pande, MD contact

8138756600

clinicaltrials@tuhurabio.com

18 sites in 1 country

United States18 sites, 18 recruiting

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

    Martin Parks, 303-724-6240, MelanomaClinicalResearch@olucdenver.onmicrosoft.com

    Theresa Medina, MD

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Aiden Bergin, 617-632-6571, aidan_bergin@dfci.harvard.edu

    Karam Khaddour, MD

    Recruiting

  • Inova Schar Cancer

    Fairfax, Virginia, 22031

    Stephanie Bebber, 571-472-4724, Stephanie.vanbebber@inova.org

    Jafar Al-Mondhiry, MD

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Shahana Patel, 252-744-5418, patelsha22@ecu.edu

    Nasreen Vohra, MD

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Nicole Caltabellotta, 551-996-1777, OncologyResearchReferral@hmhn.org

    Andrew Pecora, MD

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77384

    Shawnee Carpenter, 713-792-6363, scarpenter@mdanderson.org

    Neal Akhave, MD

    Recruiting

  • Mayo Clinic Comprehensive Cancer Center

    Jacksonville, Florida, 32224

    904-953-2000

    Ruqin Chen, MD

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    In Gino, MD, Gino.In@med.usc.ed

    In Gino, MD

    Recruiting

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Kendal Payne, 305-243-1084, CRScutaneous@miami.edu

    Lynn Feun, MD

    Recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506

    Meg Zafiris, margaret.zafiris@hsc.wvu.edu

    Joanna Kolodney, MD

    Recruiting

  • Atlantic Health System

    Morristown, New Jersey, 07960

    Maureen Nowakowski, 973-971-5569, maureen.nowakowski@atlantichealth.org

    Eric Whitman, MD

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Kaitlin Bocian, 412-623-4115, Bocianka2@upmc.edu

    Melissa Burgess, MD

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Jon Radar, 804-828-1545, raderjp2@vcu.edu

    Andrew Poklepovic, MD

    Recruiting

  • Mayo Clinic Comprehensive Cancer Center

    Rochester, Minnesota, 55905

    Madalyn Helvig, 507-266-9955, helvig.madalyn@mayo.edu

    Tassos Dimou, MD

    Recruiting

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

    San Francisco, California, 94143

    Martha Arriaga, 415-309-0105, Martha.Arriaga@ucsf.edu

    Adil Daud, MD

    Recruiting

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

    Maya Yousefiasl, 206-606-7172, maryamyo@fredhutch.org

    Shailender Bhatia, MD

    Recruiting

  • Stanford Health Care - Skin Cancer Program

    Stanford, California, 94304

    Phuong Pham, (650) 725-9810, ppham5@stanford.edu

    Sunil Reddy, MD

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Inayaa Johnson, 813-745-8336, inayaa.johnson@moffitt.org

    Andrew Brohl, MD

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
IFx-Hu2.0, Placebo, Pembrolizumab
Keywords
Merkel Cell Carcinoma, Advanced, Metastatic, MCC, pembrolizumab, Innate Immune Agonist, Skin Cancer, X-Mark, X Mark, Rare Skin Cancers
Medical subject headings
Carcinoma, Merkel Cell, Neoplasm Metastasis, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IFx-Hu2.0Drug

    Also called pAc/emm55

    Therapeutic Classification:

    • Innate immune agonist

    Route of Administration:

    • Intralesional

  • PlaceboDrug

    Route of Administration:

    • Intralesional

  • PembrolizumabDrug

    Also called KEYTRUDA

    Therapeutic Classification:

    • Immunotherapy (Immune checkpoint inhibitor)

    Route of administration:

    • Intravenous (IV) infusion
Study groups in NCT06947928
Study groupRoleWhat they receive
Treatment ArmExperimentalParticipants 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.
Receives: Drug: IFx-Hu2.0; Drug: Pembrolizumab
Control ArmPlacebo comparatorParticipants 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.
Receives: Drug: Placebo; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    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.

    Measured: 12 weeks post-treatment initiation and confirmed on a second response assessment at least 28 days after the initial response assessment

Secondary outcomes (1)

  1. Progression free survival (PFS)

    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.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2025
  2. Study start11 Dec 2025
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion30 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06947928
Sponsor's protocol ID
MCC 2021-01
Status last verified
Apr 2026
First submitted
14 Apr 2025
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing IFx-Hu2.0 and Pembrolizumab in people with Advanced Or Metastatic Merkel Cell Carcinoma, run by TuHURA Biosciences, Inc. at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amit Pande, MD (8138756600, clinicaltrials@tuhurabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06947928.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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