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New treatment option for Advanced Or Metastatic Merkel Cell Carcinoma
Official title IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)
ClinicalTrials.gov ID: NCT06940440
What this study is testing
What is IFx-Hu2.0?
IFx-Hu2.0 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced or metastatic merkel cell carcinoma.
Also referred to as pAc/emm55.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This Phase 1, multicenter, open-label trial will assess the safety and feasibility of IFx-Hu2.0 as adjunctive therapy to pembrolizumab in adult patients (≥18 years) with non-cutaneous Merkel Cell Carcinoma. Nine subjects will receive IFx-Hu2.0 as a visceral lesion injection in a single lesion followed by pembrolizumab.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years of age.
- Life expectancy equal to or greater than six months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2.
- Active disease measurable by CT or MRI, measurable lesions are lesions that can be accurately measured in at least one dimension (longest diameter in...
- Must be recurrent and/or unresectable Stage III or Stage IV American Joint Committee on Cancer (AJCC) (8th edition) and have histologically confirmed...
You likely can't join if
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina...
- people with active brain metastases, with the exception of treated brain metastases that have imaging proving stability at least 4 weeks after...
- people with recurrent resectable MCC
- people 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 people with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis...
See the full eligibility criteria
- At least 18 years of age.
- Life expectancy equal to or greater than six months.
- Eastern Cooperative Oncology Group (ECOG) Performance Status \< 2.
- Active disease measurable by CT or MRI, measurable lesions are lesions that can be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded).
- 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 a. Must have at least one visceral injectable...
- 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.
- 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...
- people 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.
- people with recurrent resectable MCC
- people 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 people with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.