Clincosm LogoSign in Get a demo

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

Sponsor
Vyriad, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04291105
Collaborator
Regeneron Pharmaceuticals (Industry)
152
Enrollment
23
Locations
4
Arms
58.2
Anticipated Duration (Months)
6.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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 two distinct advanced malignancies in separate tumor cohorts. The two cancers types are NSCLC and melanoma that are progressing on CPI treatment.

Condition or Disease Intervention/Treatment Phase
  • Biological: VV1
  • Biological: Cemiplimab
  • Biological: Ipilumumab
 Phase 2

Detailed Description

Patients with melanoma will be enrolled into one of three cohorts; 1. (Intravenous melanoma cohort) patients will receive IV VV1. 2. (Intratumoral melanoma cohort) will receive both IV VV1 and Intratumoral VV1; both cohorts will receive IV cemiplimab in combination therapy with VV1 treatment. The third (Intravenous melanoma triplet) will receive IV VV1, 1 dose of ipilumumab, and cemiplimab. First-line patients with NSCLC will receive the triplet combination of IV VV1, IV ipilumumab, and IV cemiplimab therapy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
152 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Patients With Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Melanoma or Endometrial Carcinoma
Actual Study Start Date :
Apr 24, 2020
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Melanoma intratumoral

Melanoma, IV & IT VV1 + cemiplimab Patients will receive both intravenous (IV) VV1 and intratumoral (IT) VV1 on Day 1. Will also receive an infusion of cemiplimab on Day 8.

Biological: VV1
VV1 is to be administered on Day 1
Other Names:
  • VSV-IFNβ-NIS, Voyager V1

    • Biological: Cemiplimab
    Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle.
    Other Names:
  • Libtayo

    		•
    Experimental: Melanoma IV

    Melanoma, IV + cemiplimab Patients will receive both IV VV1 and cemiplimab on Day 8.

    Biological: VV1
    VV1 is to be administered on Day 1
    Other Names:
  • VSV-IFNβ-NIS, Voyager V1

    • Biological: Cemiplimab
    Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle.
    Other Names:
  • Libtayo

    		•
    Experimental: Melanoma IV Triplet

    Melanoma Patients will receive IV VV1 and ipilumumab (single dose) on Day 1 and cemiplimab on Day 8 and then every 21 days.

    Biological: VV1
    VV1 is to be administered on Day 1
    Other Names:
  • VSV-IFNβ-NIS, Voyager V1

    • Biological: Cemiplimab
    Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle.
    Other Names:
  • Libtayo

    • Biological: Ipilumumab
    Ipilumumab should be given on Day 1 only.
    Other Names:
  • Yervoy

    		•
    Experimental: Non-small Cell Lung Cancer First Line Triplet

    IV VV1 and ipilumumab (single dose) on Day 1 and cemiplimab on Day 8, then every 21 days.

    Biological: VV1
    VV1 is to be administered on Day 1
    Other Names:
  • VSV-IFNβ-NIS, Voyager V1

    • Biological: Cemiplimab
    Cemiplimab should be given on Day 8 of Cycle 1 (28 days) and then Day 1 of each subsequent 21-day cycle.
    Other Names:
  • Libtayo

    • Biological: Ipilumumab
    Ipilumumab should be given on Day 1 only.
    Other Names:
  • Yervoy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) per imaging assessment [within 24 months]

      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

    Secondary Outcome Measures

    1. Incidence of Treatment-Emergent Adverse Events assessed by CTCAE v5.0 [within 24 months]

      Safety and tolerability

    2. Serum concentration time [within 24 months]

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

    3. To investigate the pharmacodynamics (PD) of VV1 by measuring serum IFNβ [within 24 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion:

    1. Age ≥18 years on day of signing informed consent.

    2. Specific by tumor cohorts:

    1. For the NSCLC cohort, histologically confirmed diagnosis of advanced and/or metastatic NSCLC suitable for first line immunotherapy. NSCLC harboring an activating EGFR mutation or anaplastic lymphoma kinase (ALK) rearrangement must have progressed following available EGFR or ALK targeted therapy in addition to treatment with platinum-based chemotherapy (unless ineligible for platinum therapy). i. Able to supply archival (or fresh) formalin-fixed, paraffin- embedded tumor tissue collected within 6 months prior to enrollment for determination of programmed death ligand 1 (PD- L1) status.
    1. PD-L1 status of ≥50% per local standardized testing. Samples should be provided to the central lab for post-hoc centralized testing.
    1. For the melanoma cohorts, histologically confirmed diagnosis of advanced and/or metastatic cutaneous melanoma in which radiological progression has been demonstrated during therapy with a PD-(L)1 immune checkpoint inhibitor and for which no existing options are considered to provide clinical benefit (only one line of PD-(L)1 therapy is permitted). Progression on ipilumumab is not required. BRAF V600 mutation patients must have progressed on, or are intolerant to, BRAF +/- MEK inhibitor therapy.
    Note: For IV/IT melanoma cohort:
    1. At least one tumor lesion amenable to IT injection via palpation or ultrasound. Injection of deep visceral lesions is not permitted. ii. Agrees to provide a newly obtained biopsy of injected lesions prior to start of study treatment, and to repeat biopsies twice during study treatment, and to providing the acquired tissue for biomarker analysis. Tissue obtained for the biopsy must not be previously irradiated, but a new or progressing lesion in the radiation field is acceptable.

    1. For patients treated with prior anti-PD-(L)1 therapy, last dose of anti-PD-(L)1 must be within 16 weeks of initiating study treatment.

    2. Measurable disease based on RECIST 1.1.

    3. Performance status of 0 or 1 on the ECOG Performance Scale

    4. Life expectancy of >3 months.

    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. 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.

    3. Patients who have a diagnosis of ocular, mucosal or acral melanoma.

    4. Known seropositivity for and with active infection with HIV.

    5. Seropositive for and with evidence of active viral infection with HBV.

    6. Seropositive for and with active viral infection with HCV.

    7. Known history of active or latent TB.

    8. 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).

    9. 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).

    10. 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 12. Immunodeficiency or immunosuppression, including systemic corticosteroids at >10 mg/day prednisone or equivalent within 1 week prior to planned start of study treatment.

    11. Known concurrent malignancy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinical Phoenix Arizona United States 85054
    2 City of Hope Medical Center Duarte California United States 91010
    3 USC Norris Comprehensive Cancer Center Los Angeles California United States 90033
    4 HOAG Memorial Hospital Presbyterian Newport Beach California United States 92663
    5 Saint John's Health Center - John Wayne Cancer Institute (JWCI) Santa Monica California United States 90404
    6 Stanford Health Care Stanford California United States 94305
    7 Yale University New Haven Connecticut United States 06520-8032
    8 Georgetown University Medical Center Washington District of Columbia United States 20007
    9 Mayo Clinical Jacksonville Florida United States 32224
    10 University of Miami Miami Florida United States 33136
    11 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    12 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    13 Masonic Cancer Center, University of Minnesota Minneapolis Minnesota United States 55455
    14 Mayo Clinic Rochester Minnesota United States 55905
    15 Billings Clinic Montana Cancer Consortium Billings Montana United States 59101
    16 Atlantic Health Morristown New Jersey United States 07960
    17 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
    18 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    19 University of Cincinnati Medical Center Cincinnati Ohio United States 45219
    20 Ohio State University Columbus Ohio United States 43210
    21 UPMC Pittsburgh Pennsylvania United States 15213
    22 Sanford Cancer Center Sioux Falls South Dakota United States 57104
    23 UT Health San Antonio MD Anderson Cancer Center San Antonio Texas United States 78229

    Sponsors and Collaborators

    • Vyriad, Inc.
    • Regeneron Pharmaceuticals

    Investigators

    • Study Chair: Alice Bexon, MD, CMO
    • Study Director: Stephen J Russell, MD, Ph.D., Clinical Lead

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vyriad, Inc.
    ClinicalTrials.gov Identifier:
    NCT04291105
    Other Study ID Numbers:
    • VYR-VSV2-203
    First Posted:
    Mar 2, 2020
    Last Update Posted:
    Apr 28, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Vyriad, Inc.
    Solid Tumor
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Melanoma
    Cemiplimab

    Study Results

    No Results Posted as of Apr 28, 2022