Infections

All Conditions

Neoplasms

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Communicable Diseases

Carcinoma, Squamous Cell

Vaginal Neoplasms

Virus Diseases

Anus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Genital Neoplasms, Female

Urogenital Neoplasms

Vaginal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Chronic Graft Versus Host Disease

Vaginal Cancer

Penile Cancer

Anal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anticonvulsants

Central Nervous System Depressants

Psychotropic Drugs

Avelumab

Valproic Acid

Antineoplastic Agents, Immunological

Enzyme Inhibitors

Neurotransmitter Agents

Valproic Acid (VPA, 12.5 mg/kg) once per day and Avelumab (10 mg/kg IV) every 2 weeks for up to 2 years.

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

John Walker, MD PhD FRCPC

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.

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

• Assessment of the clinical response rate according to the immune-related RECIST criteria (iRECIST)

• Feasibility analysis, defined as the proportion of subjects who complete 4 doses of Avelumab in combination with VPA over the total duration of the study.

defined as the time from the date of enrollment to the date of death, whatever the cause.

Progression free survival is defined as the time between the date of treatment initiation and the date of disease progression or death (whatever the cause), whichever occurs first.

• Incidence of adverse events (assessed as the incidence and severity of adverse events, including immune-related adverse events, and the number of discontinuations due to adverse events).

EMD Serono

AHS Cancer Control Alberta

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Avelumab With Valproic Acid in Virus-associated Cancer	NCT03357757	Cancer That is ... p16 Positive SC... Squamous Cell C... p16 Positive Sq... p16 Positive Sq... p16 Positive Sq... EBER Positive N... EBER Positive H...	Valproic Acid Avelumab	18 Years -	AHS Cancer Control Alberta
Avelumab With Valproic Acid in Virus-associated Cancer	NCT03357757	Cancer That is ... p16 Positive SC... Squamous Cell C... p16 Positive Sq... p16 Positive Sq... p16 Positive Sq... EBER Positive N... EBER Positive H...	Valproic Acid Avelumab	18 Years -	AHS Cancer Control Alberta

Spots Global Cancer Trial Database for p16 positive squamous cell carcinoma of the anus or anal canal