Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients (NCT04291105)

🧪 Interventions in This Study

• VV1 (BIOLOGICAL)
• Cemiplimab (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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:
9. Availability of and patient acceptance of an alternative curative therapeutic option.
10. Patients with tumor lesion(s) \> 5cm in diameter.
11. 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.
12. Patients who have a diagnosis of ocular, mucosal or acral melanoma.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (13 Sites)

• Saint John's Health Center - John Wayne Cancer Institute (JWCI) — Santa Monica, California
• Yale University — New Haven, Connecticut
• University of Miami — Miami, Florida
• Ochsner Clinic Foundation — New Orleans, Louisiana
• Mayo Clinic — Rochester, Minnesota
• Billings Clinic Montana Cancer Consortium — Billings, Montana
• Icahn School of Medicine at Mount Sinai — New York, New York
• University of Cincinnati Medical Center — Cincinnati, Ohio
• Sanford Cancer Center — Sioux Falls, South Dakota
• Hospital Sao Rafael — Salvador, BR
• INCA — Rio de Janeiro, Rio de Janeiro
• Hospital Moinhos de Vento — Porto Alegre, Rio Grande do Sul
• Hospital de Amor de Barretos — Barretos, São Paulo

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: Patients will receive Voyager V1 as a direct to tumor injection (IT) in all 3 cancer groups and cemiplimab via IV infusion.

More studies in Melanoma

• Feasibility of an Enhanced Symptom Monitoring and Expedited Subspecialty Care Referral Intervention to Improve Side Effect Management for Patients With Melanoma Receiving an Immune Checkpoint Inhibitor — Portland, Oregon
• Phase I/IIa Dose Finding Study of Triplet Regimen of Relatlimab Ipilimumab and NIvolumab in First Line Therapy of Metastatic Melanoma (TRINITY) — Houston, Texas
• Storage and Research Use of Human Bio-specimens From Melanoma Patients and Clinical Testing for Assignment of Treatment — Nashville, Tennessee
• Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy — San Francisco, California
• A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3 — La Jolla, California
• In Vivo Real-time Detection of Circulating Melanoma Cells — Little Rock, Arkansas

Explore by condition: All Melanoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.