Concomitant Immune Check Point Inhibitor With Radiochemotherapy in Head And Neck Cancer
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|ClinicalTrials.gov Identifier: NCT03532737|
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : September 3, 2020
Background: Locally advanced head and neck cancer (HNC) is a challenge as, in spite of initial good control with chemoradiation, the majority of patients fails systemically. In the last 2 years, immune check points inhibitors (mainly Programmed Death (PD)-1 inhibitors) were approved for metastatic/recurrent HNC. The favorable toxicity profile and durable responses was the main benefit of these drugs along the scope of cancers they were approved for.
Aim of the study and methods: This will be a phase II non-randomized trial to define safety and efficacy of combining the PD-1 inhibitor pembrolizumab given concomitantly with the usual standard of care chemoradiation/bioradiation for locally advanced non-nasopharyngeal HNC. Primary end point will be assessment of toxicity and tolerability while the secondary end points will be response rates (RR) and progression free survival (PFS)
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Head and Neck Cancer||Drug: Pembrolizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Non-Randomised Controlled Trial Of Concomitant Immune Check Point Inhibitor With Radiotherapy And Chemotherapy Or Cetuximab In Advanced Non Metastatic Head And Neck Cancer|
|Actual Study Start Date :||October 7, 2018|
|Estimated Primary Completion Date :||September 30, 2021|
|Estimated Study Completion Date :||October 31, 2022|
Experimental: Investigational Arm
All patients will receive radical chemoradiation in addition to the investigational concomitant check point inhibitor CHEMOTHERAPY: Cisplatin: 100 mg/m2 Q21d D1, D22, D43. OR Cetuximab Loading dose 400 mg/m², one week before radiation then maintenance dose 250 mg/m² weekly, D8, D15, D22, D29, D36, D43.
PD-1 inhibitor: Pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks 21 days prior to radiation, then Day 1 of radiation and then every 21 days for total 6 doses
Intensity modulated radiotherapy (IMRT) techniques will be used. A total dose of 66-70 Gy/ 30-35 Fr over 6-7 weeks will be delivered to the primary site and draining lymphatics using simultaneous Integrated Boost (SIB).
Adding PD-1 inhibitor to the standard of care
Other Name: Keytruda
- Dose Limiting Toxicity (DLT) [ Time Frame: From the first dose of pembrolizumab to 28 days after the completion of radiation therapy ]
A pembrolizumab attributable, dose-limiting toxicity (DLT) will be defined as follows:
1) Any ≥ grade 3 adverse event (CTCAE, v. 4) that is related to pembrolizumab that does not resolve to grade 1 or less within 28 days; 2) A delay in radiotherapy of > 2 weeks due to toxicity related to pembrolizumab; 3) Inability to complete radiotherapy due to toxicity related to pembrolizumab; 4) Inability to receive an adequate dose (≥ 70%) of cisplatin or cetuximab due to toxicity definitely related to pembrolizumab.
- Response Rate [ Time Frame: 3 years ]Response rates according to irRECIST criteria
- Locoregional control rates [ Time Frame: 5 years ]Number of local disease progression events
- Progression free survival [ Time Frame: 5 years ]Number of local or distant disease progression events
- Overall survival [ Time Frame: 5 years initially (longer follow up will be done) ]Number of cancer-related deaths
- Patients' Quality of life (QoL) [ Time Frame: 5 years initially ]QoL assessment by the patients
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): NCT03532737
|Contact: Mustafa S El-Sherify, MD||+965 554 email@example.com|
|Kuwait Cancer Control Center||Recruiting|
|Contact: Mustafa El-Sherify|
|Principal Investigator:||Mustafa S El-Sherify, MD||Kuwait Cancer Control Center|