NCT03357757

Avelumab With Valproic Acid in Virus-associated Cancer

The LATENT Trial: Lytic Activation To Enhance Neoantigen-directed Therapy A Study to Evaluate the Feasibility and Efficacy of the Combined Use of Avelumab With Valproic Acid for the Treatment of Virus-associated Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: AHS Cancer Control Alberta · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-02-07
• Primary completion: 2022-03-30
• Completion: 2025-03-31
• First posted: 2017-11-30
• Last updated: 2025-06-26

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study