A Study of Chemoradiation Plus Pembrolizumab for Locally Advanced Laryngeal Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT02759575|
Recruitment Status : Completed
First Posted : May 3, 2016
Results First Posted : March 12, 2021
Last Update Posted : March 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Pembrolizumab Radiation: Radiation Therapy Drug: Cisplatin||Phase 1 Phase 2|
This study is an open label, single arm study which will enroll patients with locally advanced squamous cell carcinomas of the larynx. Positive tumor PDL1 expression by IHC will not be required for enrollment.
All patients with receive Pembrolizumab and cisplatin in combination with radiation. Pembrolizumab 200 mg flat dose given Q21 days will begin 3 weeks prior to initiation of chemoradiation and continued through the 21-day cycle until completion of chemoradiation. Cisplatin will be given 100 mg/m2 every 21 days during radiation as per standard of care.
Pembrolizumab has well defined toxicities as single agent and has non-overlapping mechanisms of action with cisplatin and radiation. The safety of these agents used in combination has not been previously described, therefore the study will begin with a safety run-in phase 1 followed by the phase II design. See statistical section for details.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Chemo Radiation Plus the Anti-Programmed Death-1 (Anti-PD-1) Antibody, Pembrolizumab (MK-3475) for Locally Advanced Laryngeal Squamous Cell Carcinoma|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||January 24, 2019|
|Actual Study Completion Date :||February 2021|
Pembrolizumab every 3 weeks in combination with 7 weeks of radiation therapy and every 3 week cisplatin
200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses
Other Name: Keytruda
Radiation: Radiation Therapy
70 Gy in 35 fractions over 7 weeks
100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.
Other Name: Platinol
- Number of Participants With Treatment-Related Grade 3 or 4 Adverse Events as Assessed by CTCAE V4.0 [ Time Frame: 30 days following completion of treatment for the first 6 participants ]Greater than 2 grade 3 or 4 adverse events that are definitely, probably or possibly related to the pembrolizumab in the first cohort of 6 participants
- Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma [ Time Frame: 18 months ]This is the number of subjects that are laryngectomy-free at 18 months.
- Laryngectomy-free Survival in Locally Advanced Laryngeal Squamous Cell Carcinoma [ Time Frame: 12 months ]This is the number of subjects that are laryngectomy-free at 12 months.
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): NCT02759575
|United States, Ohio|
|University of Cincinnati Medical Center|
|Cincinnati, Ohio, United States, 45219|
|Principal Investigator:||Vinita Takiar, MD||University of Cincinnati|