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Avelumab With Valproic Acid in Virus-associated Cancer

NCT03357757 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-06-26

No results posted yet for this study

Summary

Up to 20% of all cancers may be associated with a bacterial or viral infection. In some instances, the infection may be one of the reasons why the cancer developed in the first place. One such example is infection with the human papilloma virus (HPV) and the development of cervical or oral cavity cancer.

A viral infection that is chronic may not cause a person symptoms, and may be able to escape detection by a person's own immune system. One of the medications being studied in this clinical trial (Valproic acid) may be able to unmask a chronic viral infection from a person's own immune system, therefore making the virus susceptible to attack by the immune system. In this study Valproic acid is being combined with an immune therapy, Avelumab. Avelumab is an antibody that targets a person's own immune cells, or lymphocytes. Lymphocytes must be activated to fight infections or cancer, but after activation they are deactivated. Avelumab prevents the deactivation of a lymphocyte, in effect "turning off the off-switch." This leads to a re-energizing of a person's immune system, hopefully leading to an attack by the immune system on a person's cancer.

Avelumab is known to be an effective treatment for a variety of cancers, although it has not yet been tested in all cancers. By combining Valproic acid, a treatment which targets the virus that contributed to the development of this type of cancer with Avelumab the investigators hope to enhance the ability of Avelumab to restore the body's own immune defense against the cancer.

Conditions

  • Cancer That is Associated With a Chronic Viral Infection
  • 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 Lymphona

Interventions

DRUG

Valproic Acid

The target serum level for VPA will be between 75 and 100 mcg/mL checked every 2 weeks for the first 6 cycles.

BIOLOGICAL

Avelumab

10 mg/kg IV

Sponsors & Collaborators

  • EMD Serono

    collaborator INDUSTRY

  • AHS Cancer Control Alberta

    lead OTHER

Principal Investigators

  • John Walker, MD PhD FRCPC · Alberta Health services

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-07
Primary Completion
2022-03-30
Completion
2025-03-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03357757 on ClinicalTrials.gov