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

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ClinicalTrials.gov Identifier: NCT04291105
Recruitment Status : Recruiting
First Posted : March 2, 2020
Last Update Posted : April 28, 2022
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Vyriad, Inc.

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
Melanoma Non Small Cell Lung Cancer 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 24, 2020
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Libtayo

Biological: Ipilumumab
Ipilumumab should be given on Day 1 only.
Other Name: 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 Name: 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 Name: Libtayo

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




Primary Outcome Measures :
  1. Objective response rate (ORR) per imaging assessment [ Time Frame: 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 [ Time Frame: within 24 months ]
    Safety and tolerability

  2. Serum concentration time [ Time Frame: 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 [ Time Frame: within 24 months ]
    To investigate the pharmacodynamics (PD) of VV1 by measuring serum IFNβ expression



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

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

    a. 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.

    ii. PD-L1 status of ≥50% per local standardized testing. Samples should be provided to the central lab for post-hoc centralized testing.

    b. 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:

    i. 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.

  3. 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.
  4. Measurable disease based on RECIST 1.1.
  5. Performance status of 0 or 1 on the ECOG Performance Scale
  6. 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).

10. 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).

11. 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.

13. Known concurrent malignancy.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04291105


Contacts
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Contact: Jennifer boughton 9085533135 Jboughton@vyriad.com
Contact: Barbara Duckett 5072890944 bduckett@vyriad.com

Locations
Show Show 23 study locations
Sponsors and Collaborators
Vyriad, Inc.
Regeneron Pharmaceuticals
Investigators
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Study Chair: Alice Bexon, MD CMO
Study Director: Stephen J Russell, MD, Ph.D. Clinical Lead
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Responsible Party: Vyriad, Inc.
ClinicalTrials.gov Identifier: NCT04291105    
Other Study ID Numbers: VYR-VSV2-203
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents