Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
NCT ID: NCT04291105
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
87 participants
INTERVENTIONAL
2020-04-24
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Melanoma intratumoral
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.
VV1
VV1 is to be administered on Day 1 and every 3 weeks as long as there is clinical benefit
Cemiplimab
Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle.
Head and Neck SCC intratumoral
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.
VV1
VV1 is to be administered on Day 1 and every 3 weeks as long as there is clinical benefit
Cemiplimab
Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle.
Colo-rectal Carcinoma intratumoral (Arm closed)
(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.
VV1
VV1 is to be administered on Day 1 and every 3 weeks as long as there is clinical benefit
Cemiplimab
Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle.
Interventions
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VV1
VV1 is to be administered on Day 1 and every 3 weeks as long as there is clinical benefit
Cemiplimab
Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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:
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Vyriad, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alice Bexon, MD
Role: STUDY_CHAIR
CMO
Stephen J Russell, MD, Ph.D.
Role: STUDY_DIRECTOR
Clinical Lead
Locations
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Mayo Clinical
Phoenix, Arizona, United States
City of Hope Medical Center
Durate, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
HOAG Memorial Hospital Presbyterian
Newport Beach, California, United States
Saint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica, California, United States
Stanford Health Care
Stanford, California, United States
Yale University
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Mayo Clinical
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Billings Clinic Montana Cancer Consortium
Billings, Montana, United States
Atlantic Health
Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
UPMC
Pittsburgh, Pennsylvania, United States
Sanford Cancer Center
Sioux Falls, South Dakota, United States
UT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas, United States
Hospital Sao Rafael
Salvador, BR, Brazil
INCA
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Amor de Barretos
Barretos, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referal Office
Role: primary
Fernanda Coelho
Role: primary
Fabio Franke, MD
Role: primary
Other Identifiers
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VYR-VSV2-203
Identifier Type: -
Identifier Source: org_study_id
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