CompletedPhase 2

Avelumab With Valproic Acid in Virus-associated Cancer

Canada39 participantsStarted 2018-02-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients must be 18 years of age or older. * Patients with the following histologically confirmed diagnoses will be eligible for enrolment: 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. * Note: patients with p16 positive SCC of unknown primary origin meeting the minimum life expectancy and performance status requirements will also be eligible for enrollment, as the majority of these patients may be assumed to represent HPV-associated disease. * Patients must be capable of providing consent to enrolment and treatment. * Patients with a performance status of ECOG 0-1(51) will be eligible for enrolment (see appendix 1). * Measurable disease must be present according to irRECIST criteria(50). * Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. * Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 60 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. * Not…

What they're measuring

Efficacy of Avelumab and VPA

Timeframe: 1 year after enrolment of last patient

Proportion of subjects who complete 4 doses of Avelumab in combination with VPA

Timeframe: 1 year after enrolment of last patient

Trial details

NCT IDNCT03357757

SponsorAHS Cancer Control Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-30