Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Trial acronym
MAST/IMUGENE
Clinical summary
Summary
This trial is testing a new cancer treatment called VAXINIA (or CF33-hNIS), which is a type of virus designed to help th eimmune system fight cancer. It's being studied on its own (monotherapy) or with other treatments, including pembrolizumab immunotherapy or mFOLFOX chemotherapy.
The goal is to see how safe and effective these treatments are, and how they affect the immune system inside the tumour.
You may be eligible if you have advanced or metastatic solid cancer, have had at least two previous treatments. For people with cholangiocarcinoma (bile duct cancer), you need:
- at least one prior chemotherapy treatment
- If your cancer has a targetable mutation, you must have tried a targeted therapy
- If you're in the IV cholangiocarcinoma group, you cannot have had certain chemotherapy drugs before (leucovorin, fluorouracil, or oxaliplatin).
CF33-hNISS is given by injection either directly into the tumour (IT) or into a vein (IV).
- In the IT/IV groups, CF33-nHIS is given:
- On Day 1 and Day 8 of the first cycle
- Then on Day 1 of each following cycle
- If you're also receiving pembrolizumab, it starts on Cycle 2, Day 1
- In the IV cholangiocarcinoma group, CF33-hNIS is given:
- On Day 3 and DAy 17 of each 28-day cycle
- Alongside a modified FOLFOX chemotherapy regimen
Conditions
This trial is treating people with locally advanced or metastatic solid cancers who have progressed on prior treatment
Eligibility
Inclusion
- 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
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Imugene Limited
Scientific Title
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).
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Cancer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information