Brief Title
Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients
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
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.
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective response rate (ORR) per imaging assessment
Secondary Outcome
Incidence of Treatment-Emergent Adverse Events assessed by CTCAE v5.0
Condition
Melanoma
Intervention
VV1
Study Arms / Comparison Groups
Melanoma intratumoral
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
152
Start Date
April 24, 2020
Completion Date
March 2025
Primary Completion Date
March 2024
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Alice Bexon, MD, 9085533135, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04291105
Organization ID
VYR-VSV2-203
Responsible Party
Sponsor
Study Sponsor
Vyriad, Inc.
Collaborators
Regeneron Pharmaceuticals
Study Sponsor
Alice Bexon, MD, Study Chair, CMO
Verification Date
April 2022