Using an oncolytic virus with pembrolizumab for advanced solid tumors
A Phase I, Dose Escalation Safety and Tolerability Study of VAXINIA (CF33-hNIS), Administered Intratumorally or Intravenously as a Monotherapy or in Combination With Pembrolizumab in Adult Patients With Metastatic or Advanced Solid Tumors (MAST).
This study is testing a new virus treatment, alone or with pembrolizumab, to see if it can help adults with advanced solid tumors that haven't responded to other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Imugene Limited Industry-sponsored |
| Drugs / interventions | prednisone, pembrolizumab |
| Locations | 12 sites (Tucson, Arizona and 11 other locations) |
| Trial ID | NCT05346484 on ClinicalTrials.gov |
What this trial studies
This phase I clinical trial evaluates the safety and efficacy of CF33-hNIS, an oncolytic virus, administered either alone or in combination with pembrolizumab in adults with metastatic or advanced solid tumors. The study involves a dose-escalation approach where patients receive treatment via intratumoral or intravenous routes. Participants must have experienced radiological progression after at least two prior lines of therapy. The trial aims to assess both the treatment's safety and the immunological changes in the tumor microenvironment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with metastatic or advanced solid tumors that have shown progression after at least two prior treatments.
Not a fit: Patients who have previously received treatment with a poxvirus-based oncolytic virus or those with active autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment options.
How similar studies have performed: While this approach is novel, other studies involving oncolytic viruses have shown promising results in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent from patient or legally authorized representative * Age ≥ 18 years old on the date of consent * Any metastatic or advanced solid tumor with documented radiological progression following at least two prior lines of treatment (which may have included prior immune checkpoint inhibitor treatment) * ECOG performance status 0 - 2 * At least one measurable lesion * Adequate renal function * Adequate liver function * Adequate hematologic function * Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures Exclusion Criteria: * Prior treatment with a poxvirus based oncolytic virus. * Continuous systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 4 weeks prior to first dose of study treatment. * Prior radiotherapy within 2 weeks of start of study treatment. * Active autoimmune disease * Prior allogenic tissue/organ transplant or other medical conditions requiring ongoing treatment with immunosuppressive drugs or any condition resulting in a systemic immunosuppressed state * Inadequate pulmonary function per Investigator assessment. * Uncontrolled brain or other central nervous system (CNS) metastases. * History of documented congestive heart failure (New York Heart Association \[NYHA\] class III - IV), unstable angina, poorly controlled hypertension, clinically significant valvular heart disease or high-risk uncontrolled arrhythmias
Where this trial is running
Tucson, Arizona and 11 other locations
- University of Arizona Cancer Center — Tucson, Arizona, United States (Recruiting)
- Highlands Oncology — Springdale, Arkansas, United States (Recruiting)
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
- UC San Diego Moores Cancer Center — La Jolla, California, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Corewell Health — Grand Rapids, Michigan, United States (Recruiting)
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
- Huntsman Cancer Institute — Salt Lake City, Utah, United States (Recruiting)
- NEXT Oncology — Fairfax, Virginia, United States (Recruiting)
- Tasman Oncology Research — Southport, Queensland, Australia (Recruiting)
- St. Vincent's Hospital — Fitzroy, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Lisa Guttman
- Email: info@imugene.com
- Phone: 61 2 9423 0881
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.