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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 below

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My tumor is PD-L1 positive with at least 5% area positivity.

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My tumor is HPV16-positive confirmed by a specific lab test.

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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.

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I have completed at least 4 cycles of pembrolizumab treatment.

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I am 18 years old or older.

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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:

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My cancer is a neuroendocrine carcinoma located in the cervix.

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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.

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 year for reporting.

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 more

Trial 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

0 / 23Eligibility criteria met

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

~87 spots leftby May 2027

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