What side effects are associated with this type of intervention?

Common treatments for cholangiocarcinoma, such as gemcitabine, cisplatin, and capecitabine, often cause side effects including nausea, vomiting, fatigue, and myelosuppression (reduced bone marrow activity leading to fewer blood cells). Targeted therapies like pembrolizumab can lead to immune-related adverse effects such as colitis, hepatitis, endocrinopathies, and pneumonitis. These side effects vary in severity and frequency among patients, and careful monitoring is essential during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for cholangiocarcinoma, focusing primarily on systemic chemotherapy and targeted therapies. Notable approved treatments include gemcitabine and cisplatin, which are commonly used as first-line therapy. Additionally, pembrolizumab, an immune checkpoint inhibitor, has been approved for tumors with specific genetic markers such as deficient mismatch repair (dMMR) or high microsatellite instability (MSI-H). These treatments are somewhat related to the ongoing study of CF33-hNIS, which explores the combination of an oncolytic virus with pembrolizumab, aiming to enhance the immune response against metastatic or advanced solid tumors.

What other types of research exist?

Promising novel alternatives to CF33-hNIS for cholangiocarcinoma patients include: 1) Durvalumab combined with gemcitabine and cisplatin, which has shown efficacy in advanced biliary tract cancer. 2) Molecularly targeted therapies such as those targeting VEGF and mTOR inhibitors like everolimus. 3) Yttrium-90 microsphere radioembolization, which has been effective in treating liver malignancies, including cholangiocarcinoma.

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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years from first dose of study drug.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3150

0 / 10Eligibility criteria met

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.