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Virus Therapy

VAXINIA + Pembrolizumab for Cancer (MAST Trial)

Phase 1
Recruiting
Research Sponsored by Imugene Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old on the date of consent
ECOG performance status 0 - 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from first dose of study drug.
Awards & highlights

MAST Trial Summary

This trial is testing a new cancer treatment that can be given either intravenously or directly into tumors. The safety of the treatment will be evaluated in patients with advanced solid tumors.

Who is the study for?
Adults with metastatic or advanced solid tumors who have tried at least two treatments can join this trial. They must be over 18, able to perform daily activities (ECOG 0-2), and have good kidney, liver, and blood function. People with active autoimmune diseases, poor heart or lung function, brain metastases that aren't controlled, recent radiotherapy or those on high-dose steroids or other immune-suppressing drugs cannot participate.Check my eligibility
What is being tested?
The study is testing CF33-hNIS (an oncolytic virus) given directly into the tumor or through the vein as a single agent or combined with Pembrolizumab. It's an early-phase trial to see how safe these treatments are and what doses might work best for people with hard-to-treat cancers.See study design
What are the potential side effects?
Possible side effects include typical reactions from immunotherapy like flu-like symptoms, fatigue, skin reactions at injection sites for IT administration; when combined with Pembrolizumab there may also be risks of immune-related adverse events affecting organs.

MAST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of the day.
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My cancer has spread and worsened after two treatments.

MAST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from first dose of study drug.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from first dose of study drug. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and severity of Adverse Events of IV and IT CF33-hNIS as a monotherapy or in combination with pembrolizumab
Recommended Phase 2 Dose (RP2D) of CF33-hNIS as a monotherapy or in combination with pembrolizumab
Secondary outcome measures
Disease Control Rate (DCR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.
Duration of Response (DOR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab.
Objective Response Rate (ORR) of CF33-hNIS administered as a monotherapy or in combination with pembrolizumab
+4 more
Other outcome measures
To evaluation antiviral immune activation

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

MAST Trial Design

4Treatment groups
Experimental Treatment
Group I: CF33-hNIS IV Administration in Combination with PembrolizumabExperimental Treatment2 Interventions
Group II: CF33-hNIS IV Administration MonotherapyExperimental Treatment1 Intervention
Group III: CF33-hNIS IT Administration in Combination with PembrolizumabExperimental Treatment2 Interventions
Group IV: CF33-hNIS IT Administration MonotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Imugene LimitedLead Sponsor
6 Previous Clinical Trials
248 Total Patients Enrolled

Media Library

CF33-hNIS (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05346484 — Phase 1
Cancer Research Study Groups: CF33-hNIS IV Administration in Combination with Pembrolizumab, CF33-hNIS IV Administration Monotherapy, CF33-hNIS IT Administration in Combination with Pembrolizumab, CF33-hNIS IT Administration Monotherapy
Cancer Clinical Trial 2023: CF33-hNIS Highlights & Side Effects. Trial Name: NCT05346484 — Phase 1
CF33-hNIS (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05346484 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what areas is the research project being conducted?

"The 5 sites for this trial include Huntsman Cancer Institute in Salt Lake City, Barbara Ann Karmanos Cancer Institute in Detroit, and City of Hope Medical Center in Duarte. Additionally, there are two other locations that have been selected to take part."

Answered by AI

What potential risks could patients be exposed to when using CF33-hNIS?

"The safety of CF33-hNIS was assigned a score of 1, due to the paucity of information regarding its efficacy and safety in clinical trials."

Answered by AI

What is the upper bound of participants in this clinical experiment?

"100 participants who meet the prerequisites set by Imugene Limited are needed in order to execute this trial. The sponsor will be running it from numerous locations, including Huntsman Cancer Institute located in Salt Lake City and Barbara Ann Karmanos Cancer Institute situated in Detroit."

Answered by AI

Are patients currently being accepted to participate in this clinical trial?

"As indicated on clinicaltrials.gov, the research is actively recruiting patients. It was first published in May 17th 2022 and updated as recently as November 16th 2022."

Answered by AI

What is the ultimate aim of this experiment?

"Per the clinical trial sponsor, Imugene Limited, this study's main objective is to evaluate Adverse Events occurring over a 21-42 day period following first dose of treatment. Secondary objectives include assessing infection levels via SPECT technetium-99 imaging and viral titers through VPA and PCR testing from bodily samples; as well as determining Duration of Response (DOR) when CF33-hNIS is administered alone or in combination with pembrolizumab."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors
2022. "A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05346484.
~23 spots leftby Dec 2024
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