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Checkpoint Inhibitor
Combination Immunotherapy + VSV-IFNβ-NIS for Solid Tumors
Phase 1 & 2
Recruiting
Led By Alex Adjei, MD, PhD
Research Sponsored by Vyriad, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment combination and is designed to find the best dose of the new combination. The study will have three parts: a safety run-in, a dose escalation, and an expansion. The safety run-in will test the new combination on a small group of patients to check for side effects. The dose escalation will test different doses of the new combination on groups of patients to find the best dose. The expansion will test the best dose on a larger group of patients.
Who is the study for?
This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) or neuroendocrine carcinoma (NEC) that worsened on PD-1/PD-L1 inhibitor therapy. They should have a life expectancy over 3 months, no active brain cancer involvement, good organ function, and be willing to provide tissue samples. Pregnant women, those with certain autoimmune diseases or unresolved treatment toxicities, and individuals with other serious health risks are excluded.Check my eligibility
What is being tested?
The study tests different doses of VSV-IFNβ-NIS combined with pembrolizumab to find the safest and most effective dose for treating solid tumors including NSCLC and NEC. It starts by testing safety in small groups using a '3+3 design' before expanding to more patients once the optimal dose is found.See study design
What are the potential side effects?
Potential side effects may include typical reactions from immunotherapy like inflammation in various organs, flu-like symptoms due to the viral component of VSV-IFNβ-NIS, fatigue, possible infusion-related reactions from pembrolizumab administration, as well as increased risk of infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Expansion arms: Overall response rate (ORR)
Safety run-in arm: Number of participants with treatment related adverse events (NCI CTCAE; Version 4.03)
Secondary outcome measures
Adverse events
Disease Control Rate (DCR)
Duration of response
+2 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Safety Run-in Dose Level 2Experimental Treatment2 Interventions
Patients with pembrolizumab refractory Neuroendocrine Carcinoma (NEC) or non small cell lung cancer (NSCLC) will receive a single IV dose of 1.0e11 TCID50 VSV-IFNβ-NIS in combination with Pembrolizumab at standard labeled dose administered on day 8, then every 21 days, up to 2 years.
Group II: Safety Run-in Dose Level 1Experimental Treatment2 Interventions
Patients with pembrolizumab refractory solid tumors will receive a single IV dose of 5e10 TCID50 VSV-IFNβ-NIS in combination with Pembrolizumab at standard labeled dose administered on day 1, then every 21 days, up to 2 years.
Group III: Expansion Part DExperimental Treatment2 Interventions
Patients with non small cell lung cancer (NSCLC) or Neuroendocrine Carcinoma (NEC) will receive a single IV dose of VSV-IFNβ-NIS on Day 4 in combination with ipilumumab + nivolumab at standard labeled dose administered on Day 1 then every 21 days up to 2 years.
Group IV: Expansion NSCLC armExperimental Treatment2 Interventions
Patients with pembrolizumab refractory non small cell lung cancer (NSCLC) will receive a single IV dose of 1.0e11 TCID50 VSV-IFNβ-NIS in combination with Pembrolizumab at standard labeled dose administered on day 8, then every 21 days, up to 2 years.
Group V: Expansion NECExperimental Treatment2 Interventions
Patients with pembrolizumab refractory Neuroendocrine Carcinoma (NEC) will receive a single IV dose of 1.0e11 TCID50 VSV-IFNβ-NIS in combination with Pembrolizumab at standard labeled dose administered on day 8, then every 21 days, up to 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
VSV-IFNβ-NIS
2017
Completed Phase 1
~80
Find a Location
Who is running the clinical trial?
Vyriad, Inc.Lead Sponsor
5 Previous Clinical Trials
207 Total Patients Enrolled
Mayo ClinicOTHER
3,213 Previous Clinical Trials
3,766,941 Total Patients Enrolled
Alex Adjei, MD, PhDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
226 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a lung condition that needed steroids in the past, or you currently have a lung condition.You have a serious autoimmune disease that is currently active and could harm your organs.Your disease is in an advanced stage, as confirmed by medical tests and markers.You are expected to live for more than 3 months without receiving cancer treatment.You have been diagnosed with advanced or metastatic lung cancer that has not responded to treatment with a specific kind of medication.You do not have any active involvement of the central nervous system (brain or spinal cord).Your organs are working well based on recent lab tests.Women who can have children must have a negative pregnancy test.You have had a serious bad reaction to immune checkpoint inhibitors in the past.You have side effects from past treatments that have not improved to a mild level or better.You have a blood clot in the main vein leading to the liver.You are receiving treatment for cancer with other medications at the same time.You are able to carry out your daily activities without any problems or with only a little restriction due to your health condition.You are willing to receive a treatment that can cure your condition.You have had a serious infection in the past 2 weeks.You have HIV or an active HIV infection.You have recently been diagnosed with hepatitis B or hepatitis C.You have a current or past history of active tuberculosis.You have severe heart problems or symptoms of heart disease.You have a weakened immune system, including taking high doses of corticosteroids within a week before the study.You have another type of cancer that is getting worse or needs treatment.Women who are breastfeedingYou have been diagnosed with advanced or metastatic solid tumors for which current treatments are not expected to help.
Research Study Groups:
This trial has the following groups:- Group 1: Safety Run-in Dose Level 2
- Group 2: Expansion NEC
- Group 3: Expansion Part D
- Group 4: Safety Run-in Dose Level 1
- Group 5: Expansion NSCLC arm
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been selected for inclusion in this clinical investigation?
"Affirmative, clinicaltrials.gov's data suggests that this research project is actively seeking enrolment of 40 participants at a single site. The trial was first published on April 9th 2019 and the most recent updates were made on September 26th 2022."
Answered by AI
What key goals is this research trying to accomplish?
"The primary objective that the team plans to measure over a 21 day period is overall response rate (ORR). Secondary goals include duration of response, progression-free survival, and overall survival."
Answered by AI
To what conditions has VSV-IFNβ-NIS traditionally been administered?
"VSV-IFNβ-NIS has a proven record of treating malignant neoplasms. It is also frequently administered to patients with unresectable melanoma, those experiencing microsatellite instability high, and those whose cancer continues advancing despite chemotherapy treatment."
Answered by AI
Are individuals currently being admitted for participation in this clinical trial?
"The clinical trial, initially posted on April 9th 2019 and most recently updated September 26th 2022, is still actively seeking participants."
Answered by AI
What other research efforts have explored the efficacy of VSV-IFNβ-NIS?
"At the moment, a total of 961 clinical trials for VSV-IFNβ-NIS are in progress with 122 in Phase 3. Although Houston is home to many studies concerning this medication, there are 35727 sites conducting such research worldwide."
Answered by AI
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