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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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A single-arm phase II trial to assess the efficacy and safety profile of pembrolizumab in patients with performance status of 2 with recurrent or metastatic squamous cell carcinoma of the head and neck. Patients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pembrolizumab + best supportive care | Experimental | Best supportive care and pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Patients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate at 24 weeks assessed using iRECIST | Disease control rate (proportion of patients with CR, PR or SD) assessed using iRECIST | 24 weeks after registration |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate assessed using iRECIST | Disease control rate (proportion of patients with CR, PR or SD) assessed using iRECIST | 12 months after registration |
| Best Response Rate- measured using the change from baseline tumour size. Assessed using iRECIST. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Forster, FRCP PhD | University College, London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aberdeen Royal Infirmary (NHS Grampian) | Aberdeen | United Kingdom | ||||
| Bristol Haematology and Oncology Centre (University Hospital Bristol NHS Foundation Trust) |
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Best Response Rate, defined as proportion of patients who have a CR or PR as their best response, measured using the change from baseline tumour size, assessed using iRECIST |
| 6 months after registration |
| Clinical Benefit Rate -defined as patient's best response rate lasting at least 18 weeks | Clinical Benefit Rate, defined as proportion patients who have achieved CR, PR or SD as their best response lasting at least 18 weeks | From start of treatment to 30 months post start of treatment |
| Duration of Response- defined as the time from first documented evidence of CR or PR until disease progression or death. | Duration of Response, defined as the time from first documented evidence of CR or PR until disease progression or death | From start of treatment to 30 months post start of treatment |
| Time to Progression -defined as time from registration to the first documented disease progression | Time to Progression, defined as time from registration to the first documented disease progression | From registration to 30 months post start of treatment |
| Progression Free Survival defined as the time from registration to the first documented disease progression or death due to any cause, whichever occurs first. | Progression Free Survival, defined as the time from registration to the first documented disease progression or death due to any cause, whichever occurs first. | From registration to 30 months post start of treatment |
| Overall Survival- defined as the time from registration to death due to any cause. | Overall Survival, defined as the time from registration to death due to any cause. | From registration to 30 months post start of treatment |
| Frequency and severity of adverse events- throughout the patient's treatment and until 6 months after completion of trial treatment. | Frequency and severity of adverse events | From date of registration until 6 months after completion of trial treatment |
| Bristol |
| United Kingdom |
| Western General Hospital (NHS Lothian) | Edinburgh | United Kingdom |
| East Suffolk and North Essex NHS Foundation Trust | Ipswich | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust | London | United Kingdom |
| University College London Hospital | London | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Metropolitan Borough of Wirral | United Kingdom |
| East and North Hertfordshire NHS Trust | Northwood | United Kingdom |
| Queens Hospital (Barking, Havering and Redbridge University Hospitals NHS Trust) | Romford | United Kingdom |
| Musgrove Park Hospital (Somerset NHS Foundation Trust) | Taunton | United Kingdom |
| Royal Cornwall Hospital Trust | Truro | United Kingdom |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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