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Cancer Vaccine

VB10.NEO + Atezolizumab for Cancer

Phase 1
Recruiting
Research Sponsored by Nykode Therapeutics AS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years at time of signing the Informed Consent Form
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years.
Awards & highlights

Study Summary

This trial is designed to test the safety and effectiveness of a new drug combination for treating cancer.

Who is the study for?
Adults with advanced solid tumors that have worsened after standard therapy or for whom standard therapy isn't suitable. Participants must be expected to live at least 6 months, have good organ function, and an ECOG Performance Status of 0 or 1. They should not be pregnant or breastfeeding and must agree to use effective contraception.Check my eligibility
What is being tested?
The trial is testing VB10.NEO in combination with Atezolizumab to see how safe it is, how the body responds, and if it can shrink tumors. It's a phase 1b study where doses are increased gradually (dose-escalation) to find the right dose for future studies.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells (autoimmune responses), infusion-related reactions from receiving drugs through a vein, fatigue, liver issues, blood disorders like low platelet counts or anemia, and potential risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes from baseline in clinical laboratory parameters
Changes from baseline in vital signs
Incidence and severity of adverse events (AEs)
Secondary outcome measures
Assessment of the antigen-specific immune response elicited by VB10.NEO administered in combination with atezolizumab
Characterize the pharmacokinetic of atezolizumab when administered in combination with VB10.NEO.
Duration of response (DOR)
+4 more
Other outcome measures
Dose finding objective

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Trial Design

3Treatment groups
Experimental Treatment
Group I: VB10.NEO 9 mg in combination with Atezolizumab 1200 mgExperimental Treatment1 Intervention
VB10.NEO 9 mg will be administered by IM injection for an induction course Q3W (4 doses) followed by maintenance doses Q6W (6 doses) and Q12W (5 doses). Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of 21 day cycles.
Group II: VB10.NEO 6 mg in combination with Atezolizumab 1200 mgExperimental Treatment1 Intervention
VB10.NEO 6 mg will be administered by IM injection for an induction course Q3W (4 doses) followed by maintenance doses Q6W (6 doses) and Q12W (5 doses). Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of 21 day cycles.
Group III: VB10.NEO 3 mg in combination with Atezolizumab 1200 mgExperimental Treatment1 Intervention
VB10.NEO 3 mg will be administered by IM injection for an induction course Q3W (4 doses) followed by maintenance doses Q6W (6 doses) and Q12W (5 doses). Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of 21 day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VB10.NEO
2018
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Nykode Therapeutics ASLead Sponsor
4 Previous Clinical Trials
195 Total Patients Enrolled
Nykode Therapeutics ASALead Sponsor
6 Previous Clinical Trials
376 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,083 Total Patients Enrolled

Media Library

VB10.NEO (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05018273 — Phase 1
Solid Tumors Research Study Groups: VB10.NEO 3 mg in combination with Atezolizumab 1200 mg, VB10.NEO 6 mg in combination with Atezolizumab 1200 mg, VB10.NEO 9 mg in combination with Atezolizumab 1200 mg
Solid Tumors Clinical Trial 2023: VB10.NEO Highlights & Side Effects. Trial Name: NCT05018273 — Phase 1
VB10.NEO (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05018273 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For which diseases is VB10.NEO typically prescribed?

"VB10.NEO is the accepted intervention for small cell lung cancer (sclc) and it has been used to treat a myriad of other conditions such as malignant neoplasms, non-small cell lung carcinoma, postoperative states."

Answered by AI

Are there any enrollment opportunities available to interested participants?

"Affirmative, clinicaltrials.gov has registered this trial as actively recruiting patients. This research endeavour was first made available on December 21st 2021 and the most recently updated information is from July 11th 2022. As of now, 40 individuals are being sought out for the 5 study sites nationwide."

Answered by AI

How many locales is this trial administered in?

"At the moment, this clinical trial is enlisting individuals from 5 sites. These destinations are situated in New Haven, San Francisco and Houston alongside 5 other cities. If you decide to join the study, it's essential to select a site closeby to limit travel requirements."

Answered by AI

Has this kind of experiment ever been conducted before?

"Right now, 350 clinical trials for VB10.NEO are taking place in 1646 cities and 74 countries around the world. This journey began back in 2008 with Hoffmann-La Roche sponsoring a Phase 2 study involving 720 individuals that eventually concluded successfully. Since then, an additional 80 investigations have been conducted utilizing this medication."

Answered by AI

What is the ultimate ambition of this research?

"The primary purpose of this clinical trial, evaluated over 27 months from baseline, is to determine the incidence and intensity of adverse effects. Secondary objectives include characterizing pharmacokinetics of atezolizumab when administered alongside VB10.NEO., calculating progression-free survival (PFS) according to RECIST v1.1 criteria, as well as recording overall survival (OS)."

Answered by AI

What is the scope of participation in this clinical trial?

"Nykode Therapeutics ASA is responsible for the conduct of this investigation, and has determined that 40 eligible participants are required to initiate the trial. These clinical locations have been selected as primary sites: Yale Cancer Institute in New Haven, Connecticut; The Regents of the University of California in San Francisco, California."

Answered by AI

Has VB10.NEO been investigated experimentally in other trials?

"VB10.NEO first came to fruition in 2008 at SCRI Tennessee Oncology Chattanooga, and has since then been studied extensively with 80 completed clinical trials. Currently, there are 350 active studies occurring across the country with a significant number of them conducted out of New Haven, Connecticut."

Answered by AI

Has the FDA sanctioned VB10.NEO for sale?

"Our organisation's assessment of VB10.NEO's safety is 1 out of 3 because this Phase 1 trial has restricted data demonstrating both efficacy and precautionary measures."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors
2021. "Study of VB10.NEO in Combination With Atezolizumab in Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05018273.
~12 spots leftby Dec 2024
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