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

  • STATUS
    Recruiting
  • participants needed
    152
  • sponsor
    Vyriad, Inc.
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Updated on 16 February 2024
See if I qualify
cancer
measurable disease
metastasis
immune checkpoint inhibitor
monoclonal antibodies
adenocarcinoma
antiviral drugs
antiviral therapy
sorafenib
biomarker analysis
hepatitis b surface antigen
ipilimumab
hepatitis
stage iv non-small cell lung cancer
systemic therapy
seizure
hepatitis b antigen
endometrial adenocarcinoma
metastatic melanoma
stage iv nsclc
cemiplimab
endometrioid adenocarcinoma of the endometrium
melanoma
non-small cell lung cancer
endometrial cancer

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 concurrently enroll patients with four distinct advanced malignancies in 5 separate tumor cohorts. The four cancers type are NSCLC and melanoma that are progressing on CPI treatment, CPI-nave HCC, and treatment-nave Endometrial.

Description

Patients with melanoma will be enrolled into two parallel cohorts; in one cohort (Intravenous melanoma cohort) patients will receive IV VV1 and patients in the other cohort (Intratumoral melanoma cohort) will receive both IV VV1 and Intratumoral VV1; both cohorts will receive IV cemiplimab in combination therapy with VV1 treatment. Patients with NSCLC, HCC or endometrial cancer will receive IV VV1 and IV cemiplimab combination therapy.

Details
Condition Non-Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Adenocarcinoma, Adenocarcinoma, Endometrial Carcinoma, Uterine Cancer, Uterine Cancer, melanoma, Metastatic Melanoma, melanoma, skin cancer, skin cancer, HEPATIC NEOPLASM, HEPATOCELLULAR CARCINOMA, Metastatic Melanoma
Age 18years - 100years
Treatment Cemiplimab, VV1
Clinical Study IdentifierNCT04291105
SponsorVyriad, Inc.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 18 years on day of signing informed consent
Specific by tumor cohorts
For the HCC cohort, confirmed diagnosis of inoperable HCC by histology or clinical/radiological criteria. i. No prior therapy with a PD-(L)1 immune checkpoint inhibitor (CPI) (prior sorafenib is permitted). ii. No or one prior line of systemic therapy only. iii. Child Pugh Score A or B7
For the NSCLC cohort, histologically confirmed diagnosis of advanced and/or metastatic NSCLC in which radiological progression has been demonstrated during therapy with a PD(L)1 immune CPI and for which no existing options are felt to provide clinical benefit (only one line of PD-(L)1 therapy is permitted)
Progression during or following 1 or more prior regimen(s) and no more than 3
prior therapeutic regimens for metastatic disease
For the melanoma cohorts, histologically confirmed diagnosis of advanced and/or metastatic melanoma in which radiological progression has been demonstrated during therapy with a PD(L)1 immune CPI and for which no existing options are considered to provide clinical benefit (only one line of PD(L)1 therapy is permitted). Progression on ipilimumab is not required. Note: For IT melanoma
cohort
i. At least one tumor lesion amenable to repeated IT injection via palpation or ultrasound. Injection of deep visceral lesions is not permitted
ii. Agrees to provide a newly obtained biopsy of injected and witness 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
For the endometrial cancer cohort, histologically confirmed diagnosis of advanced and/or metastatic endometrioid endometrial adenocarcinoma. Eligible patients will not have had any prior systemic therapy in the metastatic setting. 3\. For patients treated with prior anti-PD-(L)1 therapy
Last dose of anti-PD-(L)1 must be within 12 weeks of initiating study treatment
Patient must have received at least 4 doses on q2w, 3 doses on q3w or 2 doses on q4w schedule of the previous anti-PD-(L)1 therapy
Progression on prior anti-PD-(L)1 therapy must be defined by
Documented radiographic progression on a single radiographic scan, if treatment with anti-PD-(L)1 was 16 weeks
Documented radiographic progression on two consecutive radiographic scans at least 4 weeks apart, if treatment with anti-PD-(L)1 therapy was between 8 - 16 weeks; if radiographic progression is accompanied with clinical progression, then a single scan assessment may be used
If progression was only in lymph nodes, biopsy to provide histological confirmation of progression in the lymph node is required. 4\. Measurable disease based on RECIST 1.1

Exclusion Criteria

Patients meeting any of the following exclusion
criteria at screening/Day -1 of first dosing will not be enrolled in the study
Availability of and patient acceptance of an alternative curative therapeutic option
Recent or ongoing serious infection, including any active Grade 3 or higher per the National Institute of Cancer Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE, v5.0) viral, bacterial, or fungal infection within 2 weeks of registration
Known seropositivity for and with active infection by the human immunodeficiency virus (HIV)
Patients who are seropositive for HIV but are receiving antiviral therapy and
show non-detectable viral load and a normal CD4 T cell count for at least 6
months are eligible
\. Seropositive for and with evidence of active viral infection with
hepatitis B virus (HBV). Patients who are hepatitis B surface antigen (HBsAg)
negative and HBV viral DNA negative are eligible
Patients who had HBV but have received an antiviral treatment and show non-detectable viral DNA for 6 months are eligible
Patients who are seropositive because of HBV vaccine are eligible. 5\. Seropositive for and with active viral infection with hepatitis C virus (HCV)
Patients who had HCV but have received an antiviral treatment and show no
detectable HCV viral DNA for 6 months are eligible
\. Known history of active or latent TB (bacillus tuberculosis)
\. 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)
\. Prior therapy within the following timeframe before the planned start of
study treatment as follows
Small molecule inhibitors, and/or other investigational agent: 2 weeks or 5 half-lives, whichever is shorter
Chemotherapy, other monoclonal antibodies, antibody-drug conjugates, or other similar experimental therapies: 3 weeks or 5 half-lives, whichever is shorter
Antibody drug conjugates and radioimmunoconjugates or other similar experimental therapies 6 weeks or 5 half-lives, whichever is shorter. 9\. New York Heart Association (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 supraventricular tachycardia). 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. 11\. Immunodeficiency or immunosuppression 12\. History of Grade 3 or 4 immune-mediated adverse reaction to immune CPIs. 13\. Toxicities from previous therapies that have not resolved to a Grade 1 or less. 14\. History of non-infectious pneumonitis that required steroids, or current pneumonitis
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cancer
measurable disease
metastasis
immune checkpoint inhibitor
monoclonal antibodies
adenocarcinoma
antiviral drugs
antiviral therapy
sorafenib
biomarker analysis
hepatitis b surface antigen
ipilimumab
hepatitis
stage iv non-small cell lung cancer
systemic therapy
seizure
hepatitis b antigen
endometrial adenocarcinoma
metastatic melanoma
stage iv nsclc
cemiplimab
endometrioid adenocarcinoma of the endometrium
melanoma
non-small cell lung cancer
endometrial cancer

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