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Combining Voyager V1 with Cemiplimab for Cancer Treatment

Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Patients With Select Solid Tumors

Phase 2 Interventional Vyriad, Inc. · NCT04291105

This study is testing if a new treatment combining Voyager V1 with cemiplimab can help patients with melanoma, head and neck cancer, or colorectal cancer that hasn't improved with previous therapies.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment87 (estimated)
Ages18 Years and up
SexAll
SponsorVyriad, Inc. Industry-sponsored
Drugs / interventionsipilimumab, chemotherapy, immunotherapy, radiation, prednisone, cemiplimab
Locations27 sites (Phoenix, Arizona and 26 other locations)
Trial IDNCT04291105 on ClinicalTrials.gov

What this trial studies

This Phase 2 trial evaluates the effectiveness and safety of Voyager V1 in combination with cemiplimab for patients with melanoma, head and neck squamous cell carcinoma, and colorectal cancer that are progressing on prior checkpoint inhibitor treatments. Patients will be enrolled in three separate cohorts and receive direct tumor injections of Voyager V1 alongside intravenous infusions of cemiplimab. The study will monitor patients for clinical benefit and toxicity, with efficacy assessments occurring every six weeks.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced melanoma, head and neck squamous cell carcinoma, or colorectal cancer that have progressed on prior immunotherapy.

Not a fit: Patients with nasopharyngeal or salivary gland tumors, or those who have not undergone prior full-dose systemic chemotherapy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that have not responded to existing immunotherapies.

How similar studies have performed: Other studies combining immunotherapies have shown promising results, suggesting potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion:

1. Age ≥18 years on day of signing informed consent.
2. Specific by tumor cohorts:

   a. For the HSNCC cohort, histologically confirmed diagnosis of advanced and/or metastatic HSNCC suitable for first line immunotherapy.

   i. HPV+ and HPV- patients are allowed.

   ii. 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.

   iii. PD-L1 status ≥ 1% per local CPS score. Samples should be provided to central lab for post-hoc centralized testing.

   iv. 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.

   b. 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.

   i. Best response of uPR, SD or PD to an anti-PD-(L)1-containing regimen.

   ii. Prior anti-PD-(L)1 therapy must have lasted ≥ 12 weeks.

   iii. 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.

   iv. 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.

   v. 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

   c. For the CRC cohort, a histologically confirmed diagnosis of advanced and/or metastatic CRC.

   i. Received or are not eligible for standard of care fluoropyrimidine(s), oxaliplatin, irinotecan, anti-VEGF and EGFR-targeted therapies.

   ii. Non-microsatellite instability high (non-MSI high).

   iii. Progression on previous systemic therapy.
3. At least one tumor lesion amenable to IT injection and biopsy that has not been previously irradiated.
4. Measurable disease based on RECIST 1.1., including ≥ 1 measurable lesion(s) to be injected
5. Performance status of 0 or 1 on the ECOG Performance Scale
6. Life expectancy of \>3 months.
7. Willingness to provide biological samples required for the duration of the study, including a fresh tumor biopsy sample whilst on study.
8. Adequate organ function assessed by laboratory values obtained ≤14 days prior to enrollment

Exclusion:

Patients meeting any of the following exclusion criteria at screening/Day -1 of first dosing will not be enrolled in the study:

1. Availability of and patient acceptance of an alternative curative therapeutic option.
2. Patients with tumor lesion(s) \> 5cm in diameter.
3. 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.
4. Patients who have a diagnosis of ocular, mucosal or acral melanoma.
5. Known seropositivity for and with active infection with HIV.
6. Seropositive for and with evidence of active viral infection with HBV.
7. Seropositive for and with active viral infection with HCV.
8. Known history of active or latent TB.
9. 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).
10. Prior therapy within the following timeframe before the planned start of study treatment as follows:

    1. Small molecule inhibitors, and/or other investigational agent: ≤ 2 weeks or 5 half-lives, whichever is shorter.
    2. Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: ≤ 3 weeks or 5 half-lives, whichever is shorter.
    3. Radioimmunoconjugates or other similar experimental therapies ≤ 6 weeks or 5 half-lives, whichever is shorter.
11. 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).
12. 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
13. Immunodeficiency or immunosuppression, including systemic corticosteroids at \>10 mg/day prednisone or equivalent within 1 week prior to planned start of study treatment.
14. History of Grade 3 or 4 immune-mediated adverse reaction to immune CPIs.
15. Toxicities from previous therapies that have not resolved to a Grade 1 or less.
16. History of non-infectious pneumonitis that required steroids, or current pneumonitis.
17. High volume disease, as assessed clinically by the medical monitor via parameters such as radiologic impression and tumor markers or lactate dehydrogenase (LDH).
18. 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.

Where this trial is running

Phoenix, Arizona and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions MelanomaHead and Neck Squamous Cell CarcinomaColo-rectal CancerSolid Tumor
Last reviewed 2026-06-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.