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

Recruiting in Palo Alto (17 mi)

Overseen byJohn Walker, MD PhD FRCPC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AHS Cancer Control Alberta

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing a combination of Valproic acid and Avelumab to treat cancers linked to chronic viral infections. Valproic acid helps reveal these hidden infections, while Avelumab keeps immune cells active to fight the cancer more effectively. Avelumab has shown promise in treating various cancers, including non-small cell lung cancer, genitourinary tumors, and urothelial carcinoma.

Eligibility Criteria

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.

Inclusion Criteria

Patients of childbearing/reproductive potential should use highly effective birth control methods during the study treatment period and for 60 days after the last dose of study drug

I have a specific type of cancer that is p16 or EBER positive.

Absence of any condition hampering compliance with the study protocol and follow-up schedule

+7 more

Exclusion Criteria

I have a history of lung scarring or fibrosis.

I have been diagnosed with an immune system disorder.

I do not have any severe health or mental conditions that could affect my participation.

+13 more

Participant Groups

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.

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.

Avelumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Bavencio for: