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MelanomaPhase 2NCT04291105

Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients

A Phase 2 study testing VV1 and Cemiplimab in people with Melanoma and Head and Neck Squamous Cell Carcinoma, run by Vyriad, Inc. at 13 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase 2 study designed to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VV1 and Cemiplimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
13 sitesin 2 countries
Study dates
24 Apr 2020to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years on day of signing informed consent.
  • Specific by tumor cohorts:
  • For the HSNCC cohort, histologically confirmed diagnosis of advanced and/or metastatic HSNCC suitable for first line immunotherapy.
  • HPV+ and HPV- patients are allowed.
  • Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx. Participants may not have a primary tumor site of nasopharynx (any histology) or salivary gland tumors.
  • PD-L1 status ≥ 1% per local CPS score. Samples should be provided to central lab for post-hoc centralized testing.
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  • At least 12 months between last dose of prior adjuvant therapy and date of relapse diagnosis (if given). For the purposes of this protocol, "prior adjuvant therapy" only applies to full dose systemic chemotherapy (such as pre-operative systemic induction chemotherapy), but does not include radiation + surgery, or radiation + low or partial dose platinum radiosensitization. There is no time limit (washout) between the end of any prior radiation/ chemoradiation and the start of study drug v. No prior anti-PD-(L)1 treatment for HNSCC.
  • For the melanoma cohorts, histologically confirmed diagnosis of advanced and/or metastatic cutaneous melanoma for which no existing options are considered to provide clinical benefit.
  • Best response of uPR, SD or PD to an anti-PD-(L)1-containing regimen.
  • Prior anti-PD-(L)1 therapy must have lasted ≥ 12 weeks.
  • Radiological progression was demonstrated during or after therapy with a PD-(L)1 immune CPI (only one prior line of PD-(L)1 therapy is permitted.
  • If patient received anti-PD-1 as prior adjuvant therapy, patient should have relapsed during therapy or within the subsequent 6 months after last dose. Note: Progression on ipilimumab is not required.
  • Patients with BRAF V600-positive tumor(s) should have received prior treatment with a BRAF inhibitor (alone or in combination with a MEK inhibitor) in addition to treatment with an anti-PD-1 or to have declined targeted therapy. Note: Patients with BRAF V600-positive tumors with no clinically significant tumor-related symptoms nor evidence of rapidly progressive disease are not required to be treated with a BRAF inhibitor (alone or in combination with a MEK inhibitor) based on investigator's decision
  • For the CRC cohort, a histologically confirmed diagnosis of advanced and/or metastatic CRC.
  • Received or are not eligible for standard of care fluoropyrimidine(s), oxaliplatin, irinotecan, anti-VEGF and EGFR-targeted therapies.
  • Non-microsatellite instability high (non-MSI high).
  • Progression on previous systemic therapy.
  • At least one tumor lesion amenable to IT injection and biopsy that has not been previously irradiated.
  • Measurable disease based on RECIST 1.1., including ≥ 1 measurable lesion(s) to be injected
  • Performance status of 0 or 1 on the ECOG Performance Scale
  • Life expectancy of >3 months.
  • Willingness to provide biological samples required for the duration of the study, including a fresh tumor biopsy sample whilst on study.
  • Adequate organ function assessed by laboratory values obtained ≤14 days prior to enrollment

Who cannot join

  • Patients meeting any of the following exclusion criteria at screening/Day -1 of first dosing will not be enrolled in the study:
  • Availability of and patient acceptance of an alternative curative therapeutic option.
  • Patients with tumor lesion(s) > 5cm in diameter.
  • 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.
  • Patients who have a diagnosis of ocular, mucosal or acral melanoma.
  • Known seropositivity for and with active infection with HIV.
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  • Seropositive for and with evidence of active viral infection with HBV.
  • Seropositive for and with active viral infection with HCV.
  • Known history of active or latent TB.
  • Any concomitant serious health condition, which, in the opinion of the investigator, would place the patient at undue risk from the study, including uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 3 months) or neurological disorder (e.g., seizure disorder active within 3 months).
  • Prior therapy within the following timeframe before the planned start of study treatment as follows:
  • Small molecule inhibitors, and/or other investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter.
  • Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤ 3 weeks or 5 half-lives, whichever is shorter.
  • Radioimmunoconjugates or other similar experimental therapies ≤ 6 weeks or 5 half-lives, whichever is shorter.
  • NYHA classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or SVT).
  • Any known or suspected active organ-threatening autoimmune disease, such as inflammatory bowel disease, autoimmune hepatitis, lupus, or pneumonitis, with the exception of hypothyroidism and type 1 diabetes that are controlled with treatment
  • Immunodeficiency or immunosuppression, including systemic corticosteroids at >10 mg/day prednisone or equivalent within 1 week prior to planned start of study treatment.
  • History of Grade 3 or 4 immune-mediated adverse reaction to immune CPIs.
  • Toxicities from previous therapies that have not resolved to a Grade 1 or less.
  • History of non-infectious pneumonitis that required steroids, or current pneumonitis.
  • High volume disease, as assessed clinically by the medical monitor via parameters such as radiologic impression and tumor markers or lactate dehydrogenase (LDH).
  • Portal vein thrombosis involving more than intrahepatic portal vein branches: thrombosis of the right or left portal vein branch or the bifurcation, partial or complete obstruction of the portal vein trunk.
  • 18.19. Known concurrent malignancy.

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

United States9 sites

  • Billings Clinic Montana Cancer Consortium

    Billings, Montana, 59101

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • University of Miami

    Miami, Florida, 33136

  • Yale University

    New Haven, Connecticut, 06520-8032

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Saint John's Health Center - John Wayne Cancer Institute (JWCI)

    Santa Monica, California, 90404

  • Sanford Cancer Center

    Sioux Falls, South Dakota, 57104

Other trials in United States

Brazil4 sites

  • Hospital de Amor de Barretos

    Barretos, São Paulo, 14.784-400

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-000

  • INCA

    Rio de Janeiro, Rio de Janeiro, 20231-050

  • Hospital Sao Rafael

    Salvador, BR, 41253-190

Other trials in Brazil

About this study

Official title: Phase 2 Trial of Voyager VI (Vesicular Stomatitis Virus Expressing NIS and Human Interferon Beta, VV1), in Combination With Cemiplimab in Patients With Select Solid Tumors

This is a Phase 2 study designed to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with cemiplimab. The study will enroll patients with three distinct separate tumor cohorts. The cancers types are colorectal, head and neck carcinoma, and melanoma that are progressing on CPI treatment. (CRC and melenoma cohorts are now closed to new patients)

Read the detailed description

Patients enrolled into three parallel doublet cohorts with an optimal Simon's two stage design. Patients will receive Voyager V1 as a direct to tumor injection (IT) in all 3 cancer groups and cemiplimab via IV infusion. Patients will return for treatment every 3 weeks until lack of clinical benefit or limiting toxicity. Efficacy evaluations will be conducted every 6 weeks.

Being tested
VV1, Cemiplimab
Keywords
Solid Tumor
Medical subject headings
Melanoma, Squamous Cell Carcinoma of Head and Neck, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VV1Biological

    Also called VSV-IFNβ-NIS, Voyager V1, VV1

    VV1 is to be administered on Day 1 and every 3 weeks as long as there is clinical benefit

  • CemiplimabBiological

    Also called Libtayo

    Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle.

Study groups in NCT04291105
Study groupRoleWhat they receive
Melanoma intratumoralExperimental(CLOSED): 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.
Receives: Biological: VV1; Biological: Cemiplimab
Head and Neck SCC intratumoralExperimentalHNSCC, 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.
Receives: Biological: VV1; Biological: Cemiplimab
Colo-rectal Carcinoma intratumoral (Arm closed)Experimental(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.
Receives: Biological: VV1; Biological: Cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR) per imaging assessment

    Percentage of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through disease progression, by investigator review based on RECIST version 1.1

    Measured: within 24 months

Secondary outcomes (3)

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

    Safety and tolerability

    Measured: within 24 months

  2. Serum concentration time

    Serum concentration time data using RT-PCR of VSV-IFNβ-NIS and systemic cemiplimab levels

    Measured: within 24 months

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

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

    Measured: within 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start24 Apr 2020
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
87 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04291105
Sponsor's protocol ID
VYR-VSV2-203
Status last verified
Mar 2026
First submitted
25 Feb 2020
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VV1 and Cemiplimab in people with Melanoma and Head and Neck Squamous Cell Carcinoma, run by Vyriad, Inc. at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) per imaging assessment (time frame: within 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04291105.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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