Clinical trial · Interventional
Imvamune Vaccine for the Treatment of Non-melanoma Skin Cancer
MVA-BN Imvamune Smallpox Vaccine Virus for Treatment of Basal Cell Carcinoma, Squamous Cell Carcinomas
NCT04410874CI-TRIAL-00074827MUSIC-01terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inability to recruit patients/lack of funding
Summary
Brief summary (as posted)
This study examines the safety and efficacy of using the Imvamune smallpox vaccine in the treatment of non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Non-melanoma Skin Cancer | Skin Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imvamune | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imvamune
- description
- Imvamune vaccine to be administered intratumorally at one of three doses on Days 0 and 4 of the study
- interventionNames
- Biological: Imvamune
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- 25 days
- description
- The MTD will be defined as the dose at which 2 or more patients experience a grade 3 or 4 adverse event (as defined by NCI Common Terminology Criteria for Adverse Events version 5.0) that is at least "probably related" to the study drug (ex: dose limiting toxicity).
- measure
- Objective Tumor Response Rate (ORR)
- timeFrame
- 25 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must have histologically confirmed, BCC and/or SCC tumors located on the chest, back, thigh, or arm/forearm. * Presence of clinically documented disease. Skin tumor should measure at least 10 mm in size and should be no larger than 5 cm in any axes. There should be no clinical suspicion of metastasis (i.e. no lymphadenopaties and no systemic symptoms). * Age \> 18 years. * Subjects must have a documented ECOG performance status of 0 or 1. * Subjects could be treatment naive or could have had previous surgery or radiation * Subjects may have had prior radiation therapy. A minimum of 28 days (4 weeks) must have elapsed between the last dose of radiation and date of registration (14 days for a single palliative fraction of radiation to a non-target lesion). Subjects must have recovered from any acute toxic effects from radiation prior to registration (unless grade 1, irreversible and considered not clinically significant). * Previous surgery is permitted. A minimum of 28 days (4 weeks) must have elapsed between any major surgery and date of registration (7 days for minor surgery), provided that wound healing has occurred * Each subject must sign a consent form prior to registration/at registration and prior to tests which are study specific. * Subjects must be accessible for treatment and follow-up. Subjects registered on this trial must be treated and followed at the McGill University Health Centre (MUHC) or McGill Affiliated/other participating hospitals * Laboratory requirements (must be done within 7 days prior to registration or at time of registration) as follows: * White blood cell count ≥3.0x10\^9/L * absolute neutrophils ≥1.5x10\^9/L * hemoglobin ≥100g/L * platelets ≥75x10\^9/L * INR ≤1.2 * bilirubin ≤1.5x upper normal limit * AST and ALT ≤3.0x upper normal limit * serum creatinine ≤1.5x upper normal limit (or creatinine clearance of ≥60mL/min) Exclusion Criteria: * Cancers located on cosmetically/functionally important areas (i.e. face, neck, genitalia, hands, feet, and lower legs). * Tumor larger than 5 cm in size (any axes). * Metastatic disease (or suspicion of metastasis). * Tumors arising as part of a genetic syndrome (i.e., Bazex-Dupré-Christol, Basal Cell Nevus Syndrome, Rombo syndromes for BCC or Xeroderma Pigmentosa, Ferguson Smith, Grzybowski, Muir-Tore syndromes for SCC). * Immunosuppressed individuals (e.g. organ transplant recipients, patient with inherited immunodeficiencies, HIV+ individuals or individuals receiving immunosuppressive medications for other reasons). * Individuals that are not able or willing to sign an informed consent. * Subjects with history of other active or current malignancies requiring active treatment. * Patients undergoing concurrent treatments with other anti-cancer therapy or other investigational agents. * Subjects with prior treatment with Imvamune * Subjects with serious illness or medical condition that would not permit management * Subjects with uncontrolled pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction. * Pregnant or lactating women. Men or women of childbearing potential who do not agree to use adequate contraception while on trial and 6 weeks following the trial. * Subjects using anti-viral medications, steroids, immunosuppressive agents, or immunization (including the flu shot) within 14 days prior to registration. Patients who are at high risk of influenza infection (65 years and older, people of any age with certain chronic medical conditions (such as asthma, diabetes, or heart disease), pregnant women and children younger than 5 years), and who have not received an influenza vaccination during the flu season (i.e., October to May). * Subjects with a condition that could have resulted in splenic dysfunction (e.g. splenectomy, sickle cell anemia, radiation to the spleen ≥ 20Gy, congenital asplenism).
References
Publications (0)
Data not yet available
No reference posted for this study.