Advanced Or Metastatic Merkel Cell CarcinomaPhase 1NCT06940440
IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)
A Phase 1 study testing IFx-Hu2.0 and Pembrolizumab in people with Advanced Or Metastatic Merkel Cell Carcinoma, run by TuHURA Biosciences, Inc. at 2 sites in United States.
Trial summary
This Phase 1, multicenter, open-label trial will assess the safety and feasibility of IFx-Hu2.0 as adjunctive therapy to pembrolizumab in adult participant (≥18 years) with non-cutaneous Merkel Cell Carcinoma. Nine participants will receive IFx-Hu2.0 as a visceral/nodal lesion injection followed by pembrolizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Or Metastatic Merkel Cell Carcinoma
- What is being tested?
- IFx-Hu2.0 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2026to 31 May 2028
- Phase
- Phase 1
- 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.
- Has measurable disease as defined by RECIST v1.1
- Must be recurrent and/or unresectable Stage III or Stage IV American Joint Committee on Cancer (AJCC) (8th edition) and have histologically confirmed advanced or metastatic Merkel cell carcinoma
- Must have at least one deep-seated visceral/nodal greater than 3 mm in its longest diameter
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- Subject 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.
- Subjects with active brain metastases, with the exception of treated brain metastases that have imaging proving stability at least 4 weeks after treatment, no new metastases, and not requiring steroids.
- Subjects with recurrent resectable MCC
- Subjects who have received 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 subjects 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 IFx-Hu2.0 administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
Ma Vincent, MD, 800-622-8922, clinicaltrials@cancer.wisc.edu
Ma Vincent, MD
- Recruiting
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
Andrew S Brohl, MD, 813-745-4673, andrew.brohl@moffitt.org
Andrew S Brohl, MD
About this study
Official title: IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
This Phase 1, multicenter, open-label trial will assess the safety and feasibility of IFx-Hu2.0 as adjunctive therapy to pembrolizumab in adult participant (≥18 years) with non-cutaneous Merkel Cell Carcinoma. Nine participants will receive IFx-Hu2.0 as a visceral/nodal lesion injection followed by pembrolizumab.
- Being tested
- IFx-Hu2.0, Pembrolizumab
- Keywords
- Metastatic, Advanced, Merkel Cell Carcinoma
- Medical subject headings
- Neoplasm Metastasis, Carcinoma, Merkel Cell
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
PembrolizumabDrug
Also called KEYTRUDA
Therapeutic Classification:
- Immunotherapy (Immune checkpointinhibitor)
Route of administration:
- Intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| IFx-Hu2.0 | Experimental | Participants will receive IFx-Hu2.0 0.1 mg as a visceral/nodal lesion injection in a single lesion once per week for 3 consecutive weeks. At the discretion of the investigator, the same lesion will be injected at each injection visit, unless the initially injected lesion is no longer suitable for injection; alternatively, another lesion may be injected if the participant has other visceral/nodal lesions that meet the protocol injection criteria and are considered safe to inject. Pembrolizumab (200 mg) will be administered IV at Visit 1 (within 48 hours after the first IFx-Hu2.0 injection) and then every 3 weeks for approximately 6 months until disease progression or unacceptable immune-related toxicity. Receives: Drug: IFx-Hu2.0; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety is defined as the absence of any grade 3-5, treatment-related Adverse Events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from first injection Day 1 to 28-day follow-up after the final dose of IFx-Hu2.0.
Measured: 28 days from last dose of IFx-Hu2.0
Feasibility
Feasibility is defined as the ability to treat ≥50% of participants (i.e. 5/9) with all 3 doses of intralesional IFx-Hu2.0 in the per-protocol analysis.
Measured: 28 days from last dose of IFx-Hu2.0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start27 Jan 2026
- Primary completionApr 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Or Metastatic Merkel Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TuHURA Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew S Brohl, MD, Principal investigator, Collaborator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940440
- Sponsor's protocol ID
- MCC 2023-01
- Status last verified
- Oct 2026
- First submitted
- 3 Apr 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06940440
- Acronym / sponsor ID
- MCC 2023-01
- Keywords
- Metastatic, Advanced, Merkel Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- TuHURA Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1, multicenter, open-label trial will assess the safety and feasibility of IFx-Hu2.0 as adjunctive therapy to pembrolizumab in adult participant (≥18 years) with non-cutaneous Merkel Cell Carcinoma. Nine participants will receive IFx-Hu2.0 as a visceral/nodal lesion injection followed by pembrolizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IFx-Hu2.0 | Experimental | Drug: IFx-Hu2.0, Drug: PembrolizumabParticipants will receive IFx-Hu2.0 0.1 mg as a visceral/nodal lesion injection in a single lesion once per week for 3 consecutive weeks. At the discretion of the investigator, the same lesion will be injected at each injection visit, unless the initially injected lesion is no longer suitable for injection; alternatively, another lesion may be injected if the participant has other visceral/nodal lesions that meet the protocol injection criteria and are considered safe to inject. Pembrolizumab (200 mg) will be administered IV at Visit 1 (within 48 hours after the first IFx-Hu2.0 injection) and then every 3 weeks for approximately 6 months until disease progression or unacceptable immune-related toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years of age.
- Life expectancy equal to or greater than six months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.
- Has measurable disease as defined by RECIST v1.1
- Must be recurrent and/or unresectable Stage III or Stage IV American Joint Committee on Cancer (AJCC) (8th edition) and have histologically confirmed advanced or metastatic Merkel cell carcinoma
Key exclusion criteria (7 listed)
- 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.
- Subjects with active brain metastases, with the exception of treated brain metastases that have imaging proving stability at least 4 weeks after treatment, no new metastases, and not requiring steroids.
- Subjects with recurrent resectable MCC
- Subjects who have received prior systemic chemotherapy
- Pregnant or breastfeeding females and females desiring to become pregnant or breastfeed within the timeframe of this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IFx-Hu2.0Also: pAc/emm55Therapeutic Classification: • Innate immune agonist Route of Administration: • Intralesional | Drug | IFx-Hu2.0 |
| PembrolizumabAlso: KEYTRUDATherapeutic Classification: • Immunotherapy (Immune checkpointinhibitor) Route of administration: • Intravenous (IV) infusion | Drug | IFx-Hu2.0 |
Primary outcome
Safety
Time frame: 28 days from last dose of IFx-Hu2.0
Safety is defined as the absence of any grade 3-5, treatment-related Adverse Events (AEs) per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 from first injection Day 1 to 28-day follow-up after the final dose of IFx-Hu2.0.
Feasibility
Time frame: 28 days from last dose of IFx-Hu2.0
Feasibility is defined as the ability to treat ≥50% of participants (i.e. 5/9) with all 3 doses of intralesional IFx-Hu2.0 in the per-protocol analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew S Brohl, MD principal investigator
Collaborator
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IFx-Hu2.0 and Pembrolizumab in people with Advanced Or Metastatic Merkel Cell Carcinoma, run by TuHURA Biosciences, Inc. at 2 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 James Bianco, MD (8138756600 ext. 104, jbianco@tuhurabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 28 days from last dose of IFx-Hu2.0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2026.