Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck
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|ClinicalTrials.gov Identifier: NCT02289209|
Recruitment Status : Recruiting
First Posted : November 13, 2014
Last Update Posted : February 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Head and Neck Cancer Carcinoma, Squamous Cell of Head and Neck||Radiation: Reirradiation Drug: MK-3475||Phase 2|
Each participant will undergo screening and then be treated with reirradiation with 1.2 Gy BID, 5 days a week (weeks 1-5). MK-3475 (generic name: pembrolizumab, trade name Keytruda®) will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued in all participants until 3 months post completion of reirradiation, at which time a PET/CT will be done to evaluate response. Participants with progressive disease (PD) will be taken off MK-3475 and followed for survival. Participants that have a complete response (CR) will be followed clinically and radiographically, and if disease recurs may be eligible to be retreated with MK-3475 for up to one year. Participants with partial response (PR) or stable disease (SD) will continue treatment with MK-3475 for up to two years unless one of the following occurs:
- documented disease progression
- unacceptable adverse event(s)
- intercurrent illness that prevents further administration of treatment
- investigator decision to withdraw the subject
- withdrawal of consent
- administrative reasons (i.e. trial is closed prematurely).
Participants who have not progressed at completion of 24 months of therapy will be observed, but may be eligible for 1 year of retreatment with MK-3475 if they develop recurrence/progression and qualify for retreatment as detailed in the protocol,and if the trial is still ongoing.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Reirradiation Combined With Open Label Pembrolizumab in Patients With Locoregional Inoperable Recurrence or Second Primary Squamous Cell Carcinoma of the Head and Neck (SCCHN)|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: Reirradiation + MK-3475
Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation.
Reirradiation 1.2 GY BID 5 days a week for 5 weeks.
MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Other Name: Keytruda, pembrolizumab
- Progression free survival [ Time Frame: Up to 36 months after starting reirradiation and MK-3475 ]Progression free survival will be measured in all patients with locoregional inoperable recurrence or second primary squamous cell carcinoma of the head and neck treated with reirradiation in combination with MK-3475.
- Incidence and severity of adverse events from reirradiation and/or MK-3475. [ Time Frame: Up to 36 months after starting reirradiation and MK-3475 ]Adverse events will be recorded for all patients after starting combination radiation and MK-3475 therapy.
- Best overall response rate (ORR) [ Time Frame: Up to 36 months after starting treatment with reirradiation and MK-3475 ]Best overall response rate will be assessed using RECIST 1.1 in patients treated with reirradiation in combination with MK-3475
- Time to in field disease progression will be assessed using RECIST 1.1 [ Time Frame: Up to 36 months after starting treatment with reirradiation and MK-3475 ]Time to in field disease progression will be assessed using RECIST 1.1
- Overall survival (OS) [ Time Frame: Up to 36 months after starting combination reirradiation and MK-3475 ]The length of overall survival will be measured in patients treated with reirradiation in combination with MK-3475.
- Subject quality of life as measured by the EORTC QLQ-C-30 and EORTC QLQ-H&N 35 [ Time Frame: Up to 36 months after starting combination reirradiation and MK-3475 ]Quality of life will be assessed using the EORTC QLQ-C30 and EORTC QLQ-H&N 35.
- Clinical Benefit Rate (CBR) [ Time Frame: Up to 36 months after starting combination reirradiation and MK-3475 ]Clinical Benefit Rate will be assessed using RECIST 1.1 in patients treated with reirradiation in combination with MK-3475
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): NCT02289209
|Contact: Navid Saeidi||410-328-6465||Navid.firstname.lastname@example.org|
|Contact: Dan Zandberg, MDemail@example.com|
|United States, Maryland|
|University of Maryland Greenebaum Cancer Center 22 S. Greene Street||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Navid Saeidi 410-328-6465 firstname.lastname@example.org|
|Contact: Dan Zandberg, MD 410-328-6373 email@example.com|
|Baltimore, Maryland, United States, 21287|
|Contact: Ana Kiess, MD 410-502-8000 firstname.lastname@example.org|
|Contact: Megan Kummerlowe, BS 410-502-2971 email@example.com|
|Principal Investigator: Ana Kiess, MD|
|United States, New York|
|Perlmutter Cancer Center - NYU Langone Medical Center||Recruiting|
|New York, New York, United States, 10016|
|Contact: Zujun Li, MD 212-731-6465 firstname.lastname@example.org|
|United States, Pennsylvania|
|Fox Chase Cancer Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19111|
|Contact: Thomas Galloway, MD 215-728-4300 email@example.com|
|Principal Investigator: Thomas Galloway, MD|
|Principal Investigator:||Dan Zandberg, MD||University of Maryland Greenebaum Cancer Center|