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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-122 | Other Identifier | Merck | |
| KEYNOTE-122 | Other Identifier | Merck |
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This is a study of pembrolizumab (MK-3475) versus standard treatment (capecitabine, gemcitabine, or docetaxel) for the treatment of recurrent or metastatic nasopharyngeal cancer (NPC). Participants will be randomly assigned to receive either pembrolizumab or Investigator's choice of standard treatment.
The primary study hypothesis is that pembrolizumab treatment prolongs Overall Survival (OS) when compared to standard treatment.
With Amendment 7 (effective 2-March-2022), upon study completion, participants will be discontinued and may be enrolled in an extension study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab | Experimental | Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stop pembrolizumab with Stable Disease (SD) or better but progress after discontinuation may be able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year). |
|
| Standard Treatment | Active Comparator | Participants receive capecitabine 1000 mg/m^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Biological | IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. OS was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on blinded independent central review (BICR), or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. PFS was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36535566 | Result | Chan ATC, Lee VHF, Hong RL, Ahn MJ, Chong WQ, Kim SB, Ho GF, Caguioa PB, Ngamphaiboon N, Ho C, Aziz MASA, Ng QS, Yen CJ, Soparattanapaisarn N, Ngan RK, Kho SK, Tiambeng MLA, Yun T, Sriuranpong V, Algazi AP, Cheng A, Massarelli E, Swaby RF, Saraf S, Yuan J, Siu LL. Pembrolizumab monotherapy versus chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal cancer (KEYNOTE-122): an open-label, randomized, phase III trial. Ann Oncol. 2023 Mar;34(3):251-261. doi: 10.1016/j.annonc.2022.12.007. Epub 2022 Dec 16. | |
| 41631899 |
| Label | URL |
|---|---|
| Merck Oncology Clinical Trials Information | View source |
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Five participants randomized to the Pembrolizumab arm received a second course of pembrolizumab at the investigator's discretion as specified by the protocol. Per protocol, response/progression or adverse events (AEs) that occurred during a non-randomized second course of pembrolizumab were not counted towards efficacy or safety outcome measures, respectively. These results are for randomized treatment only.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab | Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion. |
| FG001 | Standard Treatment | Participants received capecitabine 1000 mg/m^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab | Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) until progressive disease (PD) or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab 200 mg Q3W for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | Overall Survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. OS was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | All randomized participants (Intent-to-Treat [ITT]) were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) |
|
All-Cause Mortality and Adverse Events (including first and second courses): Up to approximately 73 months (through Final Analysis cut-off date of 30-Sep-2022)
All-Cause Mortality table includes all randomized participants. Serious and Other AEs include all treated participants according to treatment received. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to drug were excluded as AEs. Five participants randomized to Pembrolizumab arm received a second course of pembrolizumab per protocol and were monitored for AEs and All-Cause Mortality separately.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pembrolizumab First Course | Participants received pembrolizumab 200 mg IV Q3W until PD or unacceptable toxicity for a maximum of up to 35 cycles (up to approximately 2 years). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2022 | Jun 26, 2023 | Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000069287 | Capecitabine |
| D000093542 | Gemcitabine |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Capecitabine | Drug | oral tablet |
|
|
| Gemcitabine | Drug | IV infusion |
|
|
| Docetaxel | Drug | IV infusion |
|
|
| Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) |
| Objective Response Rate (ORR) Per RECIST 1.1 | ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. ORR was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) |
| Duration of Response (DOR) Per RECIST 1.1 | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) |
| Percentage of Participants Surviving (OS Rate) at 12 Months | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. The percentage of participants surviving (OS rate) at 12 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | 12 months |
| Percentage of Participants Surviving (OS Rate) at 24 Months | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. The percentage of participants surviving (OS rate) at 24 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | 24 months |
| Percentage of Participants With PFS (PFS Rate) at 6 Months | PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. The percentage of participants with PFS (PFS rate) at 6 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | 6 months |
| Percentage of Participants With PFS (PFS Rate) at 12 Months | PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. The percentage of participants with PFS (PFS rate) at 12 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | 12 months |
| Percentage of Participants Who Experience One or More Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm. | Up to approximately 73 months |
| Percentage of Participants Who Discontinue Study Treatment Due to an AE | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm. | Up to approximately 72 months |
| Derived |
| Chan ATC, Lee VHF, Hong RL, Ahn MJ, Chong WQ, Spreafico A, Kim SB, Ho GF, Caguioa PB, Ngamphaiboon N, Swaby RF, Wei B, Webber AL, Kang J, Gumuscu B, Yuan J, Siu LL. Analysis of Plasma Epstein-Barr Virus DNA and Clinical Outcomes to Pembrolizumab or Chemotherapy in Recurrent/Metastatic Nasopharyngeal Cancer in KEYNOTE-122. Cancer Med. 2026 Feb;15(2):e71496. doi: 10.1002/cam4.71496. |
| Withdrawal by Subject |
|
| Sponsor Decision |
|
| BG001 | Standard Treatment | Participants received capecitabine 1000 mg/m^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Presence of Baseline Liver Metastasis | The presence or absence of baseline liver metastasis(es) was reported and applied to statistical analyses. "Liver Metastasis Present" was defined as the presence of any liver metastasis and "Liver Metastasis Absent" was defined as the absence of all liver metastasis. | Count of Participants | Participants |
|
| OG001 | Standard Treatment | Participants received capecitabine 1000 mg/m^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity. |
|
|
|
| Secondary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on blinded independent central review (BICR), or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. PFS was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | All randomized participants (ITT) were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) |
|
|
|
|
| Secondary | Objective Response Rate (ORR) Per RECIST 1.1 | ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. ORR was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | All randomized participants (ITT) were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) |
|
|
|
|
| Secondary | Duration of Response (DOR) Per RECIST 1.1 | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | All randomized participants (ITT population) who demonstrated a confirmed CR or PR were analyzed. | Posted | Median | 95% Confidence Interval | Months | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) |
|
|
|
| Secondary | Percentage of Participants Surviving (OS Rate) at 12 Months | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. The percentage of participants surviving (OS rate) at 12 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | All randomized participants (ITT) were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 months |
|
|
|
| Secondary | Percentage of Participants Surviving (OS Rate) at 24 Months | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. The percentage of participants surviving (OS rate) at 24 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | All randomized participants (ITT) were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 24 months |
|
|
|
| Secondary | Percentage of Participants With PFS (PFS Rate) at 6 Months | PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. The percentage of participants with PFS (PFS rate) at 6 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | All randomized participants (ITT) were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 6 months |
|
|
|
| Secondary | Percentage of Participants With PFS (PFS Rate) at 12 Months | PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. The percentage of participants with PFS (PFS rate) at 12 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. | All randomized participants (ITT) were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 months |
|
|
|
| Secondary | Percentage of Participants Who Experience One or More Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm. | All randomized participants who received at least 1 dose of study treatment were analyzed. | Posted | Number | Percentage of Participants | Up to approximately 73 months |
|
|
|
| Secondary | Percentage of Participants Who Discontinue Study Treatment Due to an AE | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm. | All randomized participants who received at least 1 dose of study treatment were analyzed. | Posted | Number | Percentage of Participants | Up to approximately 72 months |
|
|
|
| 103 |
| 117 |
| 39 |
| 116 |
| 100 |
| 116 |
| EG001 | Standard Treatment First Course | Participants received capecitabine 1000 mg/m^2 orally (PO) twice each day (BID) on Days 1-14 of each 3-week cycle, or gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each 3-week cycle, or docetaxel 75 mg/m^2 IV on Day 1 of each 3-week cycle until PD or unacceptable toxicity. | 104 | 116 | 41 | 112 | 103 | 112 |
| EG002 | Pembrolizumab Second Course | Eligible participants randomized to the pembrolizumab arm who stopped pembrolizumab with SD or better but progressed after discontinuation initiated a second course of pembrolizumab at the investigator's discretion at the same dose and schedule (200 mg Q3W) for up to 17 cycles (up to approximately 1 additional year). | 3 | 5 | 3 | 5 | 3 | 5 |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal wall abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Abscess jaw | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Abscess neck | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Chest wall abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Muscle abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Pharyngeal abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Pulmonary sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Squamous cell carcinoma of the tongue | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
|
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
|
| Cauda equina syndrome | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Trigeminal neuralgia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Autoimmune nephritis | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Lichenoid keratosis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |