M7824 in Subjects With HPV Associated Malignancies (NCT03427411) | Clinical Trial Compass
CompletedPhase 2
M7824 in Subjects With HPV Associated Malignancies
United States57 participantsStarted 2018-02-27
Plain-language summary
Background:
In the United States, each year there are more than 30,000 cases of human papillomavirus (HPV) associated cancers. Some of these cancers are often incurable and are not improved by standard therapies. Researchers want to see if a new drug M7824, which targets and blocks a pathway that prevents the immune system from effectively fighting the cancer can shrink tumors in people with some HPV cancers.
Objectives:
To see if the drug M7824 causes tumors to shrink.
Eligibility:
Adults age 18 and older who have a cancer associated with HPV infection.
Design:
Participants will be screened with medical history and physical exam. They will review their symptoms and how they perform normal activities. They will have body scans. They will give blood and urine samples. They will have a sample of their tumor tissue taken if one is not available.
Participants will have an electrocardiogram to evaluate their heart. Then they will get the study drug through a thin tube in an arm vein.
Participants will get the drug every 2 weeks for 26 times (1 year). This is 1 course.
After the course, participants will be monitored but will not take the study drug. If their condition gets worse, they will start another course with the drug. This process can be repeated as many times as needed.
Treatment will stop if the participant has bad side effects or the drug stops working.
Throughout the study, participants will repeat some or all the screening tests.
After participants stop taking the drug, they will have a follow-up visit and repeat some screening tests. They will get periodic follow-up phone calls.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITIERIA:
* Age greater than or equal to 18 years.
* Ability of subject to understand and the willingness to sign a written informed consent document.
* Subjects with cytologically or histologically confirmed locally advanced or metastatic human papillomavirus (HPV) associated malignancies including:
* Non-Neuroendocrine Cervical cancers
* P16 positive (P16+) Oropharyngeal cancers
* Anal cancers
* Vulvar, vaginal, penile, squamous cell rectal and neuroendocrine cervical cancers
* Other locally advanced or metastatic solid tumors (e.g. lung, esophagus) that are known HPV+
* Patients must have disease that is not amenable to potentially curative resection
* Subjects must have measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Adequate hematologic function at screening, as follows:
* Absolute neutrophil count (ANC) greater than or equal to 1 x 109/L
* Hemoglobin greater than or equal to 9 g/dL
* Platelets greater than or equal to 75,000/microliter.
* Adequate renal and hepatic function at screening, as follows:
* Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) greater than or equal to 40 mL/min per institutional standard
* Bilirubin less than or equal to 1.5 x ULN OR in subjects with Gilbert's syndrome, a total bilirubin less than or equal to 3.0 x ULN
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants That Achieved an Objective Confirmed Complete or Partial Overall Tumor Response