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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04291105
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Vyriad, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Alice Bexon, MDStephen J Russell, MD, Ph.D.
Principal Investigator Affiliation CMOClinical Lead
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Brazil, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma, Head and Neck Squamous Cell Carcinoma, Colo-rectal Cancer
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Experimental: 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.

Experimental: 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.

Interventions

Biological: - VV1

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

Biological: - Cemiplimab

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinical, Phoenix 5308655, Arizona 5551752

Status

Withdrawn

Address

Mayo Clinical

Phoenix 5308655, Arizona 5551752, 85054

City of Hope Medical Center, Durate, California 5332921

Status

Withdrawn

Address

City of Hope Medical Center

Durate, California 5332921, 91010

USC Norris Comprehensive Cancer Center, Los Angeles 5368361, California 5332921

Status

Withdrawn

Address

USC Norris Comprehensive Cancer Center

Los Angeles 5368361, California 5332921, 90033

HOAG Memorial Hospital Presbyterian, Newport Beach 5376890, California 5332921

Status

Withdrawn

Address

HOAG Memorial Hospital Presbyterian

Newport Beach 5376890, California 5332921, 92663

Santa Monica 5393212, California 5332921

Status

Terminated

Address

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

Santa Monica 5393212, California 5332921, 90404

Stanford Health Care, Stanford 5398563, California 5332921

Status

Withdrawn

Address

Stanford Health Care

Stanford 5398563, California 5332921, 94305

Yale University, New Haven 4839366, Connecticut 4831725

Status

Recruiting

Address

Yale University

New Haven 4839366, Connecticut 4831725, 06520-8032

Site Contact

Neta Shanwetter Levit, MPH

[email protected]

203.500.0834

Georgetown University Medical Center, Washington D.C. 4140963, District of Columbia 4138106

Status

Withdrawn

Address

Georgetown University Medical Center

Washington D.C. 4140963, District of Columbia 4138106, 20007

Mayo Clinical, Jacksonville 4160021, Florida 4155751

Status

Withdrawn

Address

Mayo Clinical

Jacksonville 4160021, Florida 4155751, 32224

University of Miami, Miami 4164138, Florida 4155751

Status

Completed

Address

University of Miami

Miami 4164138, Florida 4155751, 33136

Ochsner Clinic Foundation, New Orleans 4335045, Louisiana 4331987

Status

Recruiting

Address

Ochsner Clinic Foundation

New Orleans 4335045, Louisiana 4331987, 70121

Site Contact

Amanda Woolery, RN, BSN

[email protected]

504-842-0275.

Boston 4930956, Massachusetts 6254926

Status

Withdrawn

Address

Massachusetts General Hospital Cancer Center

Boston 4930956, Massachusetts 6254926, 02114

Minneapolis 5037649, Minnesota 5037779

Status

Withdrawn

Address

Masonic Cancer Center, University of Minnesota

Minneapolis 5037649, Minnesota 5037779, 55455

Mayo Clinic, Rochester 5043473, Minnesota 5037779

Status

Recruiting

Address

Mayo Clinic

Rochester 5043473, Minnesota 5037779, 55905

Site Contact

Clinical Trials Referal Office

[email protected]

855-776-0015

Billings 5640350, Montana 5667009

Status

Terminated

Address

Billings Clinic Montana Cancer Consortium

Billings 5640350, Montana 5667009, 59101

Atlantic Health, Morristown 5101427, New Jersey 5101760

Status

Withdrawn

Address

Atlantic Health

Morristown 5101427, New Jersey 5101760, 07960

Rutgers Cancer Institute of New Jersey, New Brunswick 5101717, New Jersey 5101760

Status

Withdrawn

Address

Rutgers Cancer Institute of New Jersey

New Brunswick 5101717, New Jersey 5101760, 08901

Icahn School of Medicine at Mount Sinai, New York 5128581, New York 5128638

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York 5128581, New York 5128638, 10029

Site Contact

Ashley Poliak Hammad, MSN

[email protected]

212-824-7309

University of Cincinnati Medical Center, Cincinnati 4508722, Ohio 5165418

Status

Recruiting

Address

University of Cincinnati Medical Center

Cincinnati 4508722, Ohio 5165418, 45219

Site Contact

Trisha Wise-Draper, MD, PhD

[email protected]

513-584-7698

Ohio State University, Columbus 4509177, Ohio 5165418

Status

Withdrawn

Address

Ohio State University

Columbus 4509177, Ohio 5165418, 43210

UPMC, Pittsburgh 5206379, Pennsylvania 6254927

Status

Withdrawn

Address

UPMC

Pittsburgh 5206379, Pennsylvania 6254927, 15213

Sanford Cancer Center, Sioux Falls 5231851, South Dakota 5769223

Status

Recruiting

Address

Sanford Cancer Center

Sioux Falls 5231851, South Dakota 5769223, 57104

Site Contact

Staci Vogel

[email protected]

605-312-3320

San Antonio 4726206, Texas 4736286

Status

Withdrawn

Address

UT Health San Antonio MD Anderson Cancer Center

San Antonio 4726206, Texas 4736286, 78229

International Sites

Hospital Sao Rafael, Salvador 3450554, BR, Brazil

Status

Recruiting

Address

Hospital Sao Rafael

Salvador 3450554, BR, 41253-190

Site Contact

Fernanda Coelho

[email protected]

9085533135

INCA, Rio de Janeiro 3451190, Rio de Janeiro 3451189, Brazil

Status

Recruiting

Address

INCA

Rio de Janeiro 3451190, Rio de Janeiro 3451189, 20231-050

Site Contact

Alexssandra Lima, MD

[email protected]

55 21 3207-2988

Hospital Moinhos de Vento, Porto Alegre 3452925, Rio Grande do Sul 3451133, Brazil

Status

Recruiting

Address

Hospital Moinhos de Vento

Porto Alegre 3452925, Rio Grande do Sul 3451133, 90035-000

Site Contact

Fabio Franke, MD

[email protected]

51-33142965

Hospital de Amor de Barretos, Barretos 3470451, São Paulo 3448433, Brazil

Status

Active, not recruiting

Address

Hospital de Amor de Barretos

Barretos 3470451, São Paulo 3448433, 14.784-400

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