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Checkpoint Inhibitor
VB10.16 + Atezolizumab for Cervical Cancer
Phase 2
Recruiting
Led By Ritu Salani, MD MBA
Research Sponsored by Nykode Therapeutics ASA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
PD-L1-positive tumor confirmed by Ventana SP263 clone with tumor area positivity ≥5% in designated central laboratory
HPV16-positive tumor confirmed by nucleic acid amplification test in designated central laboratory
Must not have
Neuroendocrine carcinoma of the cervix
Prior therapy with certain antibodies or molecules
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 2 year
Awards & highlights
Summary
"This trial is looking at patients with advanced cervical cancer that is positive for certain markers. They will be trying out a new treatment called VB10.16 alone or with atezolizumab,
Who is the study for?
This trial is for adults over 18 with advanced cervical cancer that's HPV16-positive and PD-L1 positive. They must have seen their cancer progress after first-line treatment including pembrolizumab and chemotherapy, possibly with bevacizumab, and should not have had more than one prior treatment regimen for recurrent/metastatic cervical cancer.
What is being tested?
The study tests VB10.16 alone or combined with atezolizumab in patients whose cervical cancer has worsened despite previous treatments. It has two parts: the first compares VB10.16 + placebo to VB10.16 + atezolizumab in about 30 patients each; the second extends the better-performing treatment to an additional 70 patients.
What are the potential side effects?
Possible side effects include typical immune therapy reactions like fatigue, skin issues, inflammation of organs (like lungs or intestines), hormonal imbalances, infusion-related reactions, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is PD-L1 positive with at least 5% area positivity.
Select...
My tumor is HPV16-positive confirmed by a specific lab test.
Select...
I have at least one tumor that can be measured.
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I can carry out all my self-care activities without assistance.
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I have had only one treatment for my recurrent or metastatic cervical cancer.
Select...
I have completed at least 4 cycles of pembrolizumab treatment.
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I am 18 years old or older.
Select...
My cervical cancer is advanced, PD-L1 positive, and has worsened despite treatment.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer is a neuroendocrine carcinoma located in the cervix.
Select...
I have previously been treated with specific antibodies or molecules.
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My condition can be treated with the goal of curing it.
Select...
I have received a therapeutic HPV16 vaccine before.
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I have had a stem cell transplant before.
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I have received CAR-T therapy before.
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I have previously been treated with tisotumab vedotin.
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I have lasting side effects from pembrolizumab treatment.
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I have not had radiotherapy in the last 14 days or am still experiencing side effects from a previous treatment.
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I have previously received immunotherapy for my cancer when it was in an advanced but not yet widespread stage.
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I am currently taking medication that affects my immune system.
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I am on long-term steroids.
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I have had cancer other than the one I am seeking treatment for.
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I have had an organ or tissue transplant, but not a corneal transplant.
Select...
I have a major surgery planned.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 2 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 2 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Disease Control Rate (DCR)
Duration of Disease Control (DODC)
Duration of Response (DOR)
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: VB10.16 + placeboExperimental Treatment2 Interventions
9 mg VB10.16 via i.m. needle free injections in the deltoid muscles and quadricep or gluteus muscle.
Placebo will be given via IV infusions.
Group II: VB10.16 + atezolizumabExperimental Treatment2 Interventions
9 mg VB10.16 via i.m. needle free injections in the deltoid muscles and quadricep or gluteus muscle.
Atezolizumab will be given via IV infusions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VB10.16
2020
Completed Phase 2
~60
Placebo
1995
Completed Phase 3
~2670
Atezolizumab Injection [Tecentriq]
2019
Completed Phase 4
~100
Find a Location
Who is running the clinical trial?
Nykode Therapeutics ASALead Sponsor
6 Previous Clinical Trials
306 Total Patients Enrolled
Roche Pharma AGIndustry Sponsor
409 Previous Clinical Trials
411,295 Total Patients Enrolled
GOG FoundationNETWORK
46 Previous Clinical Trials
17,824 Total Patients Enrolled
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