| Secondary | Major Pathological Response (mPR) Rate | mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by blinded independent pathologist review (BIPR) at the time of definitive surgery in all randomized participants was presented. | Efficacy analysis population, which included all randomized participants. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to ~66 months | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). | | OG001 | Standard of Care (SOC) | Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0009.4(6.6 to 12.8)
- OG0010.0(0.0 to 1.0)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Stratified Miettinen and Nurminen | | <0.00001 | One-sided p-value for testing. H0: difference in % = 0 versus H1: difference in % > 0. | Difference in Percentage | 9.3 | | | 2-Sided | 95 | 6.7 | 12.8 | | | | | Other | Difference in percentage (calculated as % Pembrolizumab + SOC arm - % SOC arm) and 95% CI were based on Miettinen & Nurminen method stratified by primary tumor site and tumor stage. | |
|
| Secondary | mPR Rate in Participants With PD-L1 CPS ≥10 | mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by BIPR at the time of definitive surgery in participants with PD-L1 CPS ≥10 was presented. | Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥10. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to ~66 months | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). | | OG001 | Standard of Care (SOC) | Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | mPR Rate in Participants With PD-L1 CPS ≥1 | mPR rate was defined as the percentage of participants having ≤10% invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. Per protocol, mPR rate as assessed by BIPR at the time of definitive surgery in participants with PD-L1 CPS ≥1 was presented. | Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥1. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to ~66 months | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). | | OG001 | Standard of Care (SOC) | Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Pathological Complete Response (pCR) Rate | pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants was presented. | Efficacy analysis population, which included all randomized participants. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to ~66 months | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). | | OG001 | Standard of Care (SOC) | Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | pCR Rate in Participants With PD-L1 CPS ≥10 | pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants with PD-L1 CPS ≥10 was presented. | Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥10. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to ~66 months | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). | | OG001 | Standard of Care (SOC) | Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | pCR Rate in Participants With PD-L1 CPS ≥1 | pCR rate was defined as the percentage of participants having no residual invasive squamous cell carcinoma within the resected primary tumor specimen and all sampled regional lymph nodes. The pCR rate as assessed by BIPR at the time of definitive surgery in all randomized participants with PD-L1 CPS ≥1 was presented. | Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥1. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Up to ~66 months | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). | | OG001 | Standard of Care (SOC) | Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Scale Combined Score at Week 4 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants in the pembrolizumab + SOC arm was presented. | All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 4 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QOL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 4 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 6 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants in the pembrolizumab + SOC arm was presented. | All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 6 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 6 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 25 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants was presented. | All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 25 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 was presented. | All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 25 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 was presented. | All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 51 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants was presented. | All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥10 at Week 51 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥10 was presented. | All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score in Participants With PD-L1 CPS ≥1 at Week 51 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS ("How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants with PD-L1 CPS ≥1 was presented. | All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
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| Secondary | Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 4 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants in the pembrolizumab + SOC arm was presented. | All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
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| Secondary | Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 4 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
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| Secondary | Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 4 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
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| Secondary | Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 6 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants in the pembrolizumab + SOC arm was presented. | All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
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| Secondary | Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 6 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
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| Secondary | Neoadjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 6 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
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| Secondary | Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 25 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants was presented. | All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). | |
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| Secondary | Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 25 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 was presented. | All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 25 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 was presented. | All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score at Week 51 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants was presented. | All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). | |
|
| Secondary | Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥10 at Week 51 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥10 was presented. | All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score in Participants With PD-L1 CPS ≥1 at Week 51 | EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score for all randomized participants with PD-L1 CPS ≥1 was presented. | All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
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| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-Head and Neck Module 35 [H&N35] (Items 35-38) Swallowing Combined Score at Week 4 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants in the pembrolizumab + SOC arm was presented. | All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
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| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 4 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 4 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 6 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants in the pembrolizumab + SOC arm was presented. | All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 6 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 6 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 25 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants was presented. | All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 25 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 was presented. | All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 25 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 was presented. | All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score at Week 51 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants was presented. | All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥10 at Week 51 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥10 was presented. | All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 35-38) Swallowing Combined Score in Participants With PD-L1 CPS ≥1 at Week 51 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the swallowing scale (Items 35-38) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 swallowing symptoms (Items 35-38) combined score for all randomized participants with PD-L1 CPS ≥1 was presented. | All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 4 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants in the pembrolizumab + SOC arm was presented. | All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 4 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 4 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 6 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants in the pembrolizumab + SOC arm was presented. | All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 6 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 6 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 25 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants was presented. | All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 25 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 was presented. | All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 25 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 was presented. | All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score at Week 51 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants was presented. | All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥10 at Week 51 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥10 was presented. | All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 46, 53-54) Speech Combined Score in Participants With PD-L1 CPS ≥1 at Week 51 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the speech scale (Items 46, 53-54) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 speech symptoms (Items 46, 53-54) combined score for all randomized participants with PD-L1 CPS ≥1 was presented. | All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 4 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants in the pembrolizumab + SOC arm was presented. | All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 4 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 4 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 4. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 6 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants in the pembrolizumab + SOC arm was presented. | All randomized participants in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 6 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥10 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Neoadjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 6 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC arm was presented. | All randomized participants with PD-L1 CPS ≥1 in the pembrolizumab + SOC treatment group who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 6. Per protocol, this outcome measure was only reported in participants in the pembrolizumab + SOC arm. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 25 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants was presented. | All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). | |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 25 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 was presented. | All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 25 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 was presented. | All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 25. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score at Week 51 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants was presented. | All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). | |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥10 at Week 51 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥10 was presented. | All randomized participants with PD-L1 CPS ≥10 who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Adjuvant Treatment: Change From Baseline in EORTC QLQ-H&N35 (Items 31-34) Pain Combined Score in Participants With PD-L1 CPS ≥1 at Week 51 | EORTC QLQ-H&N35 is a 35-item questionnaire to assess QoL of head and neck cancer participants and consists of 7 multi-item scales (pain in the mouth, problems with swallowing, senses, speech, social eating, social contact, and sexuality). Participant responses to the pain scale (Items 31-34) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100; a higher score indicated more problems. Per protocol, the change from baseline in EORTC QLQ-H&N35 pain symptoms (Items 31-34) combined score for all randomized participants with PD-L1 CPS ≥1 was presented. | All randomized participants with PD-L1 CPS ≥1 who received at least one dose of study treatment and had at least one EORTC QLQ-H&N35 assessment data available for this outcome measure at Baseline and at Week 51. | Posted | | Least Squares Mean | 95% Confidence Interval | Score on a scale | | Baseline and Week 51 | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. OS for all randomized participants was presented. | | Not Posted | | | | | | Up to ~92 months | | Participants | | | | |
| Secondary | OS in Participants With PD-L1 CPS ≥10 | OS was defined as the time from randomization to death due to any cause. OS for all randomized participants with PD-L1 CPS ≥10 was presented. | | Not Posted | | | | | | Up to ~92 months | | Participants | | | | |
| Secondary | OS in Participants With PD-L1 CPS ≥1 | OS was defined as the time from randomization to death due to any cause. OS for all randomized participants with PD-L1 CPS ≥1 was presented. | | Not Posted | | | | | | Up to ~92 months | | Participants | | | | |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who experienced one or more AEs was reported. | | Not Posted | | | | | | Up to ~92 months | | Participants | | | | |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated). The number of participants who discontinued study treatment due to an AE was reported. | | Not Posted | | | | | | Up to ~92 months | | Participants | | | | |
| Primary | Event-free Survival (EFS) | EFS was based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) and was defined as the time from randomization to any of the following events: radiographic disease progression (RDP; participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in all randomized participants was presented. | Efficacy analysis population, which included all randomized participants. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Posted | | Median | 95% Confidence Interval | Months | | Up to ~66 months | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Primary | EFS in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 | EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: RDP (participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥10 was presented. | Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥10. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Posted | | Median | 95% Confidence Interval | Months | | Up to ~66 months | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|
| Primary | EFS in Participants With PD-L1 CPS ≥1 | EFS was based on RECIST 1.1 as assessed by BICR and was defined as the time from randomization to any of the following events: RDP (participants who undergo a definitive biopsy of the progressed lesion and are found to have no histologic evidence of invasive cancer will not meet criteria for an event), RDP during the neoadjuvant phase that precluded surgery, local or distant disease progression or recurrence (as assessed with imaging or biopsy as indicated), or death due to any cause. A secondary malignancy was not considered an EFS event. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, EFS per RECIST 1.1 as assessed by BICR in participants with PD-L1 CPS ≥1 was presented. | Efficacy analysis population, which included all randomized participants with PD-L1 CPS ≥1. Per protocol, two participants in the SOC arm received neoadjuvant treatment in error (protocol deviations) and were included in the SOC arm for efficacy analysis. | Posted | | Median | 95% Confidence Interval | Months | | Up to ~66 months | | | | ID | Title | Description |
|---|
| OG000 | Pembrolizumab + Standard of Care (SOC) | Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery. Adjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks). |
|