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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years from final study drug dose

Awards & highlights

LATENT Trial 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.

LATENT Trial 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.

LATENT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years from final study drug dose

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

LATENT 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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor

182 Previous Clinical Trials

36,173 Total Patients Enrolled

EMD SeronoIndustry Sponsor

143 Previous Clinical Trials

27,162 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

Frequently Asked Questions

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

Are there any available slots for participants in this trial?

"According to clinicaltrials.gov, this trial is in the process of finding participants who meet its criteria. It was initially posted on February 7th 2018 and has been revised as recently as July 2nd 2019."

Answered by AI

What is the current overall enrollment size of this research venture?

"That is correct. According to clinicaltrials.gov, this medical study was initially posted in February 2018 and was recently updated on July 2019. The trial is recruiting 39 volunteers at a single site."

Answered by AI

Has the regulatory body sanctioned Avelumab for clinical use?

"Our team at Power assigned Avelumab a score of 2 as it has only undergone Phase 2 trials, and while there is some data suggesting safety, efficacy has yet to be established."

Answered by AI