Safety and Efficacy of Nivolumab in Treating Oral Proliferative Verrucous Leukoplakia
|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: NCT03692325|
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : October 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Leukoplakia, Oral||Drug: Nivolumab||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug or combination of drugs to learn whether it works in treating a specific disease. "Investigational" means that the drug/s is being studied.
The purpose of this study is to evaluate effectiveness (how well the drug works) of nivolumab in treating OPVL and or prolonging the onset of possible malignancy.
Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells. Nivolumab has been demonstrated to activate the immune system to attack cancer cells in participants with different types of cancers. OPVL has a high risk for turning into cancer and the investigators are testing if nivolumab may help to shrink the white lesions in the participant's mouth and reduce cancer risk.
In November 2016, the Food and Drug Administration (FDA) approved nivolumab for the treatment of participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Squamous cell carcinoma is the kind of cancer that OPVL can transform into.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Nivolumab in Treating Oral Proliferative Verrucous Leukoplakia|
|Actual Study Start Date :||December 5, 2018|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2024|
Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells.
Other Name: Opdivo
- Best Overall Response Rate [ Time Frame: 2 years ]Best response recorded from study registration until the disease progression
- Quality of Life (QOL) [ Time Frame: 2 years ]Questionnaires
- Evaluate safety and toxicity (Adverse Events and Serious Adverse Events) [ Time Frame: 2 years ]Adverse Events and Serious Adverse Events will be recorded
- Evaluate the time to the next surgery for a head and neck malignancy [ Time Frame: 2 years ]Time to the next surgery for a head and neck malignancy
- Estimate Cancer Free Survival (CFS) from the time of study registration [ Time Frame: 2 years ]Cancer Free Survival at 2 years from study registration
- Estimate Overall Survival (OS) from the time of study registration [ Time Frame: 2 years ]Overall Survival at 2 years from study registration
- Characterize distinct tumor and circulating immunophentoypes (biomarkers in biopsy and blood samples) [ Time Frame: 2 years ]Explore biomarkers in biopsy and blood samples
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): NCT03692325
|Contact: Glenn Hanna, MDfirstname.lastname@example.org|
|Contact: Alessandro Villa, DDS,PhD,MPHemail@example.com|
|United States, Massachusetts|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Glenn Hanna, MD 617-632-3090 firstname.lastname@example.org|
|Contact: Alessandro Villa, DDS,PhD,MPH 617-732-5517 email@example.com|
|Principal Investigator: Glenn Hanna, MD|
|Principal Investigator:||Glenn Hanna, MD||Dana-Farber Cancer Institute|