Pembrolizumab in Combination With CRT for LA-SCCHN
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|ClinicalTrials.gov Identifier: NCT02586207|
Recruitment Status : Active, not recruiting
First Posted : October 26, 2015
Results First Posted : January 15, 2021
Last Update Posted : February 23, 2021
This is a single-arm, multi-site, open-label trial of pembrolizumab (MK-3475) used in combination with standard, cisplatin-based, definitive chemoradiotherapy (CRT) in patients with stage III-IVB squamous cell carcinoma of the head and neck (SCCHN). Approximately 39 patients with Stage III-IVB SCCHN will be enrolled to evaluate both the safety and efficacy of this novel combination. Subjects will not be randomized and will all receive the study treatment.
Treatment will consist of a loading dose of pembrolizumab 200 mg IV given 7 days prior to initiation of CRT (day-7). CRT with cisplatin 40 mg/m2 IV weekly and head and neck radiation at 70 Gy fractionated at 2 Gy once daily over 35 days, will begin on day 1. CRT will end on approximately day 46-50. Pembrolizumab 200 mg IV will continue following CRT in an adjuvant fashion starting on day 57 for an additional 5 doses, as tolerated, through day 141. Subjects will be evaluated for response following treatment.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Squamous Cell Carcinoma Oral Cavity Cancer Oropharynx Cancer Hypopharynx Cancer Larynx Cancer Laryngeal Cancer||Drug: pembrolizumab (MK-3475) Drug: Cisplatin Radiation: Radiation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib Study of Pembrolizumab in Combination With Chemo Radiotherapy (CRT) for Locally-advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||September 29, 2020|
|Estimated Study Completion Date :||September 2023|
Experimental: Single Arm
Pembrolizumab + Cisplatin + Radiation
Drug: pembrolizumab (MK-3475)
200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.
Other Name: Keytruda
Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36
Other Name: Platinol, Platinol-AQ
70 Gy fractionated over 35 days
- Adverse Events Will be Assessed and Graded Using CTCAE 4.0. Occurrences With Max Grade and Percentage/Number of Participants Affected by AEs Will be Provided. [ Time Frame: through day 240 (this time frame allows capturing of AEs that occurred up to 90 days after completion of treatment) ]
To determine the safety and tolerability of pembrolizumab given in combination with cisplatin-based chemoradiotherapy (CRT) in subjects with treatment naive Stage III-IVB squamous cell carcinoma of the head and neck (SCCHN).
Number of participants affected by AEs will be reported by grade and percentage of participants affected.
Safety and tolerability will be assessed by clinical review of all relevant parameters including adverse events (AEs), laboratory tests, and vital signs. Count and percentage of AE will be provided.
- Evaluation of the Efficacy of Pembrolizumab Given in Combination With Definitive CRT by Determining the Number of Participants With Complete Response at Treatment End (Day 150) [ Time Frame: Day 150 (post treatment imaging) ]
Response was determined using a composite end point of overall end-of-treatment (EOT) complete response (CR) at day 150 (approximately 12 weeks after completion of chemoradiotherapy) by CT of the neck (RECIST 1.1).
Optional positron emission tomography (PET) imaging was allowed rather than neck dissection if CT could not confirm CR. Complete metabolic response was assessed using Hopkins score of 1, 2, or 3 on PET imaging. For those without an imaging CR, pathologic confirmation was recommend (but not required) by selective neck dissection and/or directed biopsy of the suspected active disease site. If pathologic evaluation of the potential disease site confirmed no residual invasive or in situ cancer, the patient was determined to have a pathologic CR. In cases with both an imaging CR and pathologic response assessment, the pathologic response defined final overall response. Therefore, patients with a final EOT CR included those with either an imaging (CT or PET) or pathologic CR.
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): NCT02586207
|United States, California|
|UCSD Moores Cancer Center|
|La Jolla, California, United States, 92093-0698|
|United States, North Dakota|
|Sanford-Bismarck Medical Center|
|Bismarck, North Dakota, United States, 58501|
|Sanford-Roger Maris Cancer Center|
|Fargo, North Dakota, United States, 58122|
|United States, South Dakota|
|Sanford Health Cancer Center|
|Sioux Falls, South Dakota, United States, 57104|
|Principal Investigator:||Steven F Powell, MD||Sanford Research|