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

NCT ID: NCT06947928

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2032-12-30

Brief 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.

Conditions

Advanced Or Metastatic Merkel Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

IFx-Hu2.0

Intervention Type: DRUG

Therapeutic Classification:

• Innate immune agonist

Route of Administration:

• Intralesional

Pembrolizumab

Intervention Type: DRUG

Therapeutic Classification:

• Immunotherapy (Immune checkpoint inhibitor)

Route of administration:

• Intravenous (IV) infusion

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Route of Administration:

• Intralesional

Pembrolizumab

Intervention Type: DRUG

Therapeutic Classification:

• Immunotherapy (Immune checkpoint inhibitor)

Route of administration:

• Intravenous (IV) infusion

Interventions

IFx-Hu2.0

Therapeutic Classification:

• Innate immune agonist

Route of Administration:

• Intralesional

Intervention Type: DRUG

Placebo

Route of Administration:

• Intralesional

Intervention Type: DRUG

Pembrolizumab

Therapeutic Classification:

• Immunotherapy (Immune checkpoint inhibitor)

Route of administration:

• Intravenous (IV) infusion

Intervention Type: DRUG

Other Intervention Names

pAc/emm55; KEYTRUDA

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TuHURA Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew S Brohl, MD

Role: PRINCIPAL_INVESTIGATOR

Collaborator

Locations

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status: RECRUITING

Stanford Health Care - Skin Cancer Program

Palo Alto, California, United States

Site Status: RECRUITING

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

San Francisco, California, United States

Site Status: RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Atlantic Health System

Morristown, New Jersey, United States

Site Status: RECRUITING

East Carolina University

Greenville, North Carolina, United States

Site Status: RECRUITING

Virginia Commonwealth University - Massey Cancer Center

Richmond, Virginia, United States

Site Status: RECRUITING

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

James Bianco, MD

Role: CONTACT

jbianco@tuhurabio.com

8138756600 ext. 104

Facility Contacts

In Gino, MD

Role: primary

Gino.In@med.usc.ed

Sunil Reddy, MD

Role: primary

sreddy@stanford.edu

Phuong Pham

Role: backup

ppham5@stanford.edu

(650) 725-9810

Adil Daud, MD

Role: primary

Adil.Daud@ucsf.edu

Martha Arriaga

Role: backup

Martha.Arriaga@ucsf.edu

415-309-0105

Karam Khaddour, MD

Role: primary

karam_khaddour@dfci.harvard.edu

617-632-6571

Aiden Bergin

Role: backup

aidan_bergin@dfci.harvard.edu

Eric Whitman, MD

Role: primary

eric.whitman@atlantichealth.org

973-971-7111

Maureen Nowakowski

Role: backup

maureen.nowakowski@atlantichealth.org

973-971-5569

Nasreen Vohra, MD

Role: primary

vohran@ecu.edu

252-744-5418

Shahana Patel

Role: backup

patelsha22@ecu.edu

Andrew Poklepovic, MD

Role: primary

andrew.poklepovic@vcuhealth.org

Jon Radar

Role: backup

raderjp2@vcu.edu

804-828-1545

Shailender Bhatia, MD

Role: primary

sbhatia@uw.edu

Maya Yousefiasl

Role: backup

maryamyo@fredhutch.org

206-606-7172

Other Identifiers

MCC 2021-01

Identifier Type: -

Identifier Source: org_study_id