Ph1 Administration of VSV-IFNβ-NIS Monotherapy and in Combination With Avelumab in Pts With Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02923466|
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : April 27, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Malignant Solid Tumour||Biological: VSV-IFNβ-NIS Biological: VSV-IFNβ-NIS and avelumab||Phase 1|
The study consists of three parts: a single ascending dose escalation of IT VSV-IFNβ-NIS monotherapy, a monotherapy IV regimen selection phase and an expansion phase, designed to explore the safety and efficacy of the chosen monotherapy regimen alone or in combination with avelumab in patients with metastatic colorectal cancer. Monotherapy will also be explored in patients with pheochromocytoma and NET.
Patients are required to have at least 1 measurable lesion per RECIST 1.1, and in the IT-containing arms this lesion should be amenable for a one-time IT injection of VSV-IFNβ-NIS. At least one patient per IT cohort is required to have at least 2 measurable lesions per RECIST 1.1, one for a one-time IT injection of VSV-IFNβ-NIS and one to be used as a control. Priority enrollment in the IT-containing arms will be granted to patients with 2 measurable lesions per RECIST 1.1. At least one patient per dose level should have metastatic colorectal cancer. In order to fulfil these requirements, at least 3 or 4 patients will be required per escalation dose cohort. Other tumor types of particular interest based on prior experience with VSV or oncolytic viruses include malignant melanoma and endometrial cancer. When more than one cohort is open simultaneously, slot assignment will be determined by the sponsor in consultation with the PIs.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Trial of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon Beta (VSV-IFNβ-NIS) Monotherapy and in Combination With Avelumab, in Patients With Refractory Solid Tumors|
|Actual Study Start Date :||April 17, 2017|
|Actual Primary Completion Date :||February 5, 2022|
|Actual Study Completion Date :||April 22, 2022|
VSV-IFNβ-NIS will be administered intratumorally as a single dose on day 1.
Intratumoral injection of a single dose of VSV-IFNβ-NIS
Experimental: Selection of VSV-IFNβ-NIS Monotherapy
VSV-IFNβ-NIS will be administered either intratumorally, intravenously or with a combination of intratumorally and intravenously as a single dose on day 1.
Intratumoral injection of a single dose of VSV-IFNβ-NIS
Experimental: VSV-IFNβ-NIS and avelumab
VSV-IFNβ-NIS will be administered as determined in arm 2 as a single dose on day 1.
Avelumab will be administered intravenously every 2 weeks starting on day 1.
Biological: VSV-IFNβ-NIS and avelumab
Intratumoral injection of a single dose of VSV-IFNβ-NIS and intravenous infusion of avelumab
- Maximum Tolerated Dose (MTD) of VSV-IFNβ-NIS Monotherapy and Combination Therapy [ Time Frame: 21 days after VSV-IFNβ-NIS Monotherapy or Combination Therapy for each dose cohort ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Be > 18 years of age on day of signing informed consent.
- Have a histologically confirmed diagnosis of an advanced and/or metastatic solid tumor that is relapsed and/or refractory to standard therapy, as defined as progression on at least one prior line of therapy in the relapsed/metastatic setting and no existing options are felt to provide clinical benefit.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
- Adequate hematological, liver and kidney function.
- Must be willing to implement contraception throughout study and for 120 days after receiving the study drug.
- Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents or tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) of the start of study treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of study treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of study treatment.
- Has a history of a bone marrow or solid organ transplant.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
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): NCT02923466
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205/2664|
|United States, South Dakota|
|Sanford Cancer Center|
|Sioux Falls, South Dakota, United States, 57104|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|Mary Crowley Cancer Research Center|
|Dallas, Texas, United States, 75230|
|Principal Investigator:||Alice Bexon, MD||CMO|
|Responsible Party:||Vyriad, Inc.|
|Other Study ID Numbers:||
|First Posted:||October 4, 2016 Key Record Dates|
|Last Update Posted:||April 27, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
refractory solid tumor
Antineoplastic Agents, Immunological
Physiological Effects of Drugs