M7824 in Subjects With HPV Associated Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03427411|
Recruitment Status : Recruiting
First Posted : February 9, 2018
Last Update Posted : February 23, 2021
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.
To see if the drug M7824 causes tumors to shrink.
Adults age 18 and older who have a cancer associated with HPV infection.
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.
|Condition or disease||Intervention/treatment||Phase|
|Human Papilloma Virus Cervical Cancer Oropharyngeal Cancer Anal Cancer Vaginal or Penile Cancer||Drug: M7824||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of M7824 in Subjects With HPV Associated Malignancies|
|Actual Study Start Date :||February 27, 2018|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: 1/Arm 1
M7824 at a flat dose of 1,200 mg IV once every 2 weeks
Flat dose of 1,200 mg IV once every 2 weeks
- Objective response rate (ORR) [ Time Frame: Every Six weeks ]The percentage of subjects that achieve an objective confirmed complete or partial overall tumor response using RECIST Version 1.1
- To determine the ratio of patients hospitalized because of adverse events attributed to disease progression [ Time Frame: disease progression ]Hospitalization
- duration of response [ Time Frame: disease progression ]The time from CR or PR (whichever is first recorded) until the first date that recurrent or PD is objectively documented
- overall survival (OS) [ Time Frame: death ]The time from the date of first treatment to the date of death
- progression-free survival time (PFS) [ Time Frame: disease progression or death ]The time from the date of first treatment to the date of disease progression or death
- disease control rate (DCR) [ Time Frame: 6 month ]The percentage of subjects that achieve an objective confirmed complete or partial overall tumor response using RECIST Version 1.1
- safety and tolerability of M7824 [ Time Frame: 28 days after treatment ]List of adverse event frequency
- To combine checkpoint inhibitor na(SqrRoot) ve subjects if permitted based on adequate similarity of results in the cohorts 1 and 2 [ Time Frame: after the primary completion date. ]The response rates from both cohorts including checkpoint na(SqrRoot) ve subjects, cohort 1 and cohort 2, will be compared with a two-sided Fisher s exact test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427411
|Contact: Cynthia Boyle, R.N.||(240) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Julius Y Strauss, M.D.||National Cancer Institute (NCI)|