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Monoclonal Antibodies

Avelumab + Valproic Acid for Viral Associated Cancer (LATENT Trial)

Phase 2
Waitlist Available
Led By John Walker, MD PhD FRCPC
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with histologically confirmed diagnoses including p16 positive SCCHN, squamous cell carcinoma of the cervix, p16 positive squamous cell carcinoma of the vagina or vulva, p16 positive squamous cell carcinoma of the penis, p16 positive squamous cell carcinoma of the anus or anal canal, EBER positive NPC, EBER positive Hodgkins and non-hodgkins lymphoma, and p16 positive SCC of unknown primary origin meeting the minimum life expectancy and performance status requirements
Adequate organ function laboratory values must be met for hematological, renal, hepatic, and coagulation parameters
Must not have
History of interstitial lung disease
Diagnosis of immunodeficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years from final study drug dose
Awards & highlights

Summary

This trial is studying the combination of Valproic acid and Avelumab to see if it can help to treat patients with HPV-associated cancer.

Who is the study for?
Adults with certain virus-associated cancers (like HPV-related cervical or oral cavity cancer) can join this trial. They must have specific types of squamous cell carcinoma or lymphoma, be able to consent, and meet blood count and organ function criteria. Women who can get pregnant need a negative pregnancy test and must use effective birth control.Check my eligibility
What is being tested?
The trial is testing Valproic Acid combined with Avelumab, an immune therapy drug. Valproic Acid may expose chronic viral infections to the immune system while Avelumab activates immune cells to potentially enhance the body's defense against cancer.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in various organs, infusion reactions which are symptoms that occur during or after receiving a drug intravenously, fatigue, digestive issues like nausea or diarrhea, changes in blood counts leading to increased risk of infections or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a specific type of cancer that is p16 or EBER positive.
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My blood, kidney, liver, and clotting tests are within normal ranges.
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I am 18 years old or older.
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I am able to understand and agree to the study's requirements.
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I can carry out all my usual activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of lung scarring or fibrosis.
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I have been diagnosed with an immune system disorder.
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I have or had another type of cancer.
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I have active cancer spread to my brain or its coverings.
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I have had an organ or stem-cell transplant.
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I have a serious heart condition.
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I have an autoimmune disease that could worsen with immune-boosting treatments.
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I have a history of HIV, hepatitis B, or hepatitis C.
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I am currently on medication for an infection.
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I have had lung inflammation treated with steroids.
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I have lasting side effects from previous treatments that are mild.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years from final study drug dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years from final study drug dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of Avelumab and VPA
Proportion of subjects who complete 4 doses of Avelumab in combination with VPA
Secondary outcome measures
Cytotoxic T-Lymphocyte immunophenotyping
DNA viral load
Expression of lytic viral genes
+10 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Avelumab with VPAExperimental Treatment2 Interventions
Valproic Acid (VPA, 12.5 mg/kg) once per day and Avelumab (10 mg/kg IV) every 2 weeks for up to 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valproic acid
FDA approved
Avelumab
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Valproic acid and Avelumab are promising treatments for viral-associated cancers due to their unique mechanisms of action. Valproic acid unmask chronic viral infections, making the virus more detectable by the immune system, which is essential since many viral-associated cancers arise from viruses that evade immune detection. Avelumab, an immune checkpoint inhibitor, prevents the deactivation of lymphocytes, thereby maintaining a robust immune response against cancer cells. This combination enhances the immune system's ability to recognize and attack cancer cells linked to viral infections, offering a targeted approach to treatment.

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
26,792 Total Patients Enrolled
EMD SeronoIndustry Sponsor
143 Previous Clinical Trials
27,164 Total Patients Enrolled
John Walker, MD PhD FRCPCPrincipal InvestigatorAlberta Health services

Media Library

Avelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03357757 — Phase 2
Viral Associated Cancer Research Study Groups: Avelumab with VPA
Viral Associated Cancer Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT03357757 — Phase 2
Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03357757 — Phase 2
~5 spots leftby Jul 2025