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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
Must not have
Prior radiotherapy within 2 weeks of start of study treatment
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from first dose of study drug.
Awards & highlights

Summary

This trial is testing a new virus-based treatment alone or with an immune-boosting drug in patients with advanced cancers who haven't responded to other treatments. The virus kills cancer cells, and the drug helps the immune system fight the cancer. These viruses are designed to target and kill tumor cells while leaving the normal cells unharmed, and they have shown promising results in earlier studies.

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had radiotherapy in the last 2 weeks.
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I have serious heart conditions, such as severe heart failure or uncontrolled high blood pressure.
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I have been treated with a poxvirus-based cancer-killing virus before.
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I haven't taken high-dose steroids or immunosuppressants in the last 4 weeks.
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I have had an organ transplant or need medicine that weakens my immune system.
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My lung function is not good, as assessed by my doctor.
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I have untreated or uncontrollable brain/CNS cancer spread.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 study objectives
To evaluation antiviral immune activation

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Pneumonia aspiration
3%
Sepsis
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab + CRT Followed by Pembrolizumab
Placebo + CRT Followed by Placebo

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 3
~2850

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for cholangiocarcinoma include systemic chemotherapy, chemoradiotherapy, and locoregional treatments like radioembolization. Systemic chemotherapy, often using combinations like gemcitabine and cisplatin, works by interfering with DNA replication in cancer cells, leading to cell death. Chemoradiotherapy combines chemotherapy with radiation to enhance the DNA-damaging effects of radiation on cancer cells. Locoregional treatments, such as radioembolization with yttrium-90, deliver targeted radiation directly to the tumor, minimizing damage to surrounding tissues. These treatments are crucial for cholangiocarcinoma patients as they aim to control tumor growth, alleviate symptoms, and improve survival rates. The CF33-hNIS trial explores an oncolytic virus that selectively infects and kills cancer cells, potentially offering a novel and targeted approach similar to these existing therapies.

Find a Location

Who is running the clinical trial?

Imugene LimitedLead Sponsor
6 Previous Clinical Trials
257 Total Patients Enrolled

Media Library

CF33-hNIS (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05346484 — Phase 1
Bile Duct 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
Bile Duct 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
~3 spots leftby Dec 2024