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Checkpoint Inhibitor

Voyager V1 + Cemiplimab for Melanoma

Phase 2

Recruiting

Research Sponsored by Vyriad, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least one tumor lesion amenable to IT injection and biopsy that has not been previously irradiated.

Performance status of 0 or 1 on the ECOG Performance Scale

Must not have

Seropositive for and with evidence of active viral infection with HBV.

Recent or ongoing serious infection, including any active Grade 3 or higher per the NCI CTCAE, v5.0 viral, bacterial, or fungal infection within 2 weeks of registration.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug, VV1, to see if it is safe and effective when used with cemiplimab to treat patients with NSCLC or melanoma.

Who is the study for?

Adults with certain progressing cancers (oral, head and neck carcinoma, melanoma, colorectal) previously treated with CPI can join. They must have a tumor lesion suitable for injection/biopsy, measurable disease, good performance status (ECOG 0 or 1), over three months life expectancy, and proper organ function. Exclusions include ocular/mucosal/acral melanoma patients; active HBV/HCV/TB infections; serious health risks like uncontrolled hypertension/diabetes; recent use of certain drugs; heart issues; autoimmune diseases except controlled hypothyroidism/type 1 diabetes; immunosuppression conditions.

What is being tested?

The trial is testing the combination of VV1 and Cemiplimab to see how well they work together against specific types of cancer that are not responding to previous treatments. It's in Phase 2 which means it's checking both effectiveness and safety in treating these cancers.

What are the potential side effects?

Possible side effects may include typical reactions from immune therapies such as inflammation in different parts of the body, allergic reactions at the infusion site, fatigue, changes in blood tests indicating liver or kidney issues. Each patient might experience side effects differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a tumor that can be injected and biopsied, and it hasn't been treated with radiation.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently infected with hepatitis B.

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I haven't had a severe infection in the last 2 weeks.

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I am HIV positive with an active infection.

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I am not on high doses of steroids or have a weak immune system.

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I have severe heart issues, including arrhythmias or symptomatic coronary artery disease.

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I have a history of active or latent tuberculosis.

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I have been diagnosed with a specific type of melanoma affecting the eyes, mucous membranes, or extremities.

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I am currently infected with Hepatitis C.

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I have another type of cancer besides the one being treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR) per imaging assessment

Secondary study objectives

Incidence of Treatment-Emergent Adverse Events assessed by CTCAE v5.0

Serum concentration time

To investigate the pharmacodynamics (PD) of VV1 by measuring serum IFNβ

Side effects data

From 2023 Phase 3 trial • 608 Patients • NCT03257267

25%

Pyrexia

13%

Infusion related reaction

13%

Vomiting

13%

Nausea

13%

Constipation

13%

Diarrhoea

13%

Subcutaneous abscess

13%

Hyperthyroidism

100%

80%

60%

40%

20%

Study treatment Arm

Chemotherapy to Cemiplimab*

Cemiplimab

Chemotherapy*

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Melanoma intratumoralExperimental Treatment2 Interventions

Melanoma, IT VV1 + IV cemiplimab Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses.

Group II: Head and Neck SCC intratumoralExperimental Treatment2 Interventions

HNSCC, IT VV1 + IV cemiplimab, Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses.

Group III: Colo-rectal Carcinoma intratumoral (Arm closed)Experimental Treatment2 Interventions

(CLOSED) IT VV1 + IV cemiplimab, Patients will receive both treatments on Day 1 and every 3 weeks thereafter until lack of clinical benefit or limiting toxicity. VV1 or cemiplimab can continue after the first dose in combination or as a single agent treatment in subsequent doses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab

2015

Completed Phase 3

~1470

0 / 11Eligibility criteria met