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| ID | Type | Description | Link |
|---|---|---|---|
| 152988 | Registry Identifier | JAPIC | |
| MK-3475-061 | Other Identifier | Merck Protocol Number | |
| 2014-005241-45 | EudraCT Number |
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This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet therapy. The primary study hypotheses are that pembrolizumab (MK-3475) prolongs progression free survival (PFS) and overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.
As of 20-March-2016, enrollment will be limited to PD-L1 positive participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pembrolizumab | Experimental | Participants receive 200 mg intravenous (IV) pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years). |
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| Paclitaxel | Active Comparator | Participants receive 80 mg/m^2 IV paclitaxel on Days 1, 8, and 15 of each 28-day cycle, until disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pembrolizumab | Biological | 200 mg administered as IV infusion on Day 1 of each 21-day cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants | PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval [CI]) in months was reported for PD-L1 positive participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| Overall Survival (OS) in PD-L1 Positive Participants | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and median OS (95% CI) in months was reported for PD-L1 positive participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| Measure | Description | Time Frame |
|---|---|---|
| PFS According to RECIST 1.1 Based on BICR in All Participants | PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for all participants by treatment group. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40117530 | Derived | Janjigian YY, Cecchini M, Shitara K, Enzinger PC, Wainberg ZA, Chau I, Satoh T, Lee J, Nebozhyn M, Loboda A, Kobie J, Vajdi A, Shih CS, Cristescu R, Cao ZA. Genomic Landscape of Late-Stage Gastric Cancer: Analysis From KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 Studies. JCO Precis Oncol. 2025 Mar;9:e2400456. doi: 10.1200/PO-24-00456. Epub 2025 Mar 21. | |
| 37399357 |
| Label | URL |
|---|---|
| Merck Oncology Clinical Trials Information | View source |
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Of 592 participants that were randomized to trial, 570 received treatment. At the time of the primary analysis data cut-off, 89 participants are ongoing in the study.
After 20 March 2016, enrollment was limited to programmed cell death ligand 1 (PD-L1) positive participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pembrolizumab | Participants receive 200 mg intravenous (IV) pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years). |
| FG001 | Paclitaxel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2020 |
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| paclitaxel | Drug | 80 mg/m^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle. |
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| Up to 30 months (through database cut-off date of 26 Oct 2017) |
| OS in All Participants | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and median OS (95% CI) in months was reported for all participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| PFS According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants | PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for PD-L1 positive participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| PFS According to RECIST 1.1 Based on Investigator Assessment in All Participants | PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for all participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| PFS According to Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) Based on BICR in PD-L1 Positive Participants | PFS defined as time from randomization to first documented PD per irRECIST based on BICR, or death due to any cause, whichever occurs first. Following initial PD by RECIST 1.1 (20% relative increase in SOD of target lesions), participants were assessed according to irRECIST: tumor assessment was repeated ≥4 weeks later to confirm PD with the option of continuing treatment until this scan was obtained for clinically stable participants. If PD confirmed, participant was discontinued from treatment unless investigator determined benefit. If repeat scan indicated stable disease (SD; neither sufficient shrinkage or increase of target lesion), partial response (PR; ≥30% decrease in the SOD of target lesions), or complete response (CR; disappearance of all non-nodal target lesions), participant could continue treatment at investigator's discretion. PFS analyzed using Kaplan-Meier method and median PFS (95% CI) in months was reported for PD-L1 positive participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| PFS According to irRECIST Based on BICR in All Participants | PFS defined as time from randomization to first documented PD per irRECIST based on BICR, or death due to any cause, whichever occurs first. Following initial PD by RECIST 1.1 (20% relative increase in SOD of target lesions), participants were assessed according to irRECIST: tumor assessment was repeated ≥4 weeks later to confirm PD with the option of continuing treatment until this scan was obtained for clinically stable participants. If PD confirmed, participant was discontinued from treatment unless investigator determined benefit. If repeat scan indicated SD (neither sufficient shrinkage or increase of target lesion), PR (≥30% decrease in the SOD of target lesions), or CR (disappearance of all non-nodal target lesions), participant could continue treatment at investigator's discretion. PFS analyzed using Kaplan-Meier method and median PFS (95% CI) in months was reported for all participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| Time to Tumor Progression (TTP) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants | TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for PD-L1 positive participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| TTP According to RECIST 1.1 Based on BICR in All Participants | TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for all participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| TTP According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants | TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for PD-L1 positive participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| TTP According to RECIST 1.1 Based on Investigator Assessment in All Participants | TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for all participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| Objective Response Rate (ORR) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants | ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for PD-L1 positive participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| ORR According to RECIST 1.1 Based on BICR in All Participants | ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for all participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| ORR According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants | ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for PD-L1 positive participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| ORR According to RECIST 1.1 Based on Investigator Assessment in All Participants | ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for all participants by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| Duration of Response (DOR) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants | For PD-L1 positive participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for PD-L1 positive participants with response by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| DOR According to RECIST 1.1 Based on BICR in All Participants | For participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for all participants with response by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| DOR According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants | For PD-L1 positive participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for PD-L1 positive participants with response by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| DOR According to RECIST 1.1 Based on Investigator Assessment in All Participants | For participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for all participants with response by treatment group. | Up to 30 months (through database cut-off date of 26 Oct 2017) |
| Percentage of PD-L1 Positive Participants Who Experienced an Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants with at least one AE was reported for PD-L1 positive participants by treatment group. | Up to 71 months (through database cut-off date of 10 Jun 2021) |
| Percentage of All Participants Who Experienced an AE | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants with at least one AE was reported for all participants by treatment group. | Up to 71 months (through database cut-off date of 10 Jun 2021) |
| Percentage of PD-L1 Positive Participants That Discontinued Study Treatment Due to AE | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for PD-L1 positive participants by treatment group. | Up to approximately 26.4 months |
| Percentage of All Participants That Discontinued Study Treatment Due to AE | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for all participants by treatment group. | Up to approximately 26.4 months |
| Shitara K, Di Bartolomeo M, Mandala M, Ryu MH, Caglevic C, Olesinski T, Chung HC, Muro K, Goekkurt E, McDermott RS, Mansoor W, Wainberg ZA, Shih CS, Kobie J, Nebozhyn M, Cristescu R, Cao ZA, Loboda A, Ozguroglu M. Association between gene expression signatures and clinical outcomes of pembrolizumab versus paclitaxel in advanced gastric cancer: exploratory analysis from the randomized, controlled, phase III KEYNOTE-061 trial. J Immunother Cancer. 2023 Jun;11(6):e006920. doi: 10.1136/jitc-2023-006920. |
| 37037952 | Derived | Muro K, Shitara K, Yamaguchi K, Yoshikawa T, Satake H, Hara H, Sugimoto N, Machida N, Goto M, Kawakami H, Amagai K, Omuro Y, Esaki T, Hironaka S, Nishina T, Komatsu Y, Matsubara H, Shiratori S, Han S, Satoh T, Ohtsu A. Efficacy of Pembrolizumab Monotherapy in Japanese Patients with Advanced Gastric or Gastroesophageal Junction Cancer. J Gastrointest Cancer. 2023 Sep;54(3):951-961. doi: 10.1007/s12029-023-00920-9. Epub 2023 Apr 10. |
| 35101941 | Derived | Cristescu R, Aurora-Garg D, Albright A, Xu L, Liu XQ, Loboda A, Lang L, Jin F, Rubin EH, Snyder A, Lunceford J. Tumor mutational burden predicts the efficacy of pembrolizumab monotherapy: a pan-tumor retrospective analysis of participants with advanced solid tumors. J Immunother Cancer. 2022 Jan;10(1):e003091. doi: 10.1136/jitc-2021-003091. |
| 34468869 | Derived | Fuchs CS, Ozguroglu M, Bang YJ, Di Bartolomeo M, Mandala M, Ryu MH, Fornaro L, Olesinski T, Caglevic C, Chung HC, Muro K, Van Cutsem E, Elme A, Thuss-Patience P, Chau I, Ohtsu A, Bhagia P, Wang A, Shih CS, Shitara K. Pembrolizumab versus paclitaxel for previously treated PD-L1-positive advanced gastric or gastroesophageal junction cancer: 2-year update of the randomized phase 3 KEYNOTE-061 trial. Gastric Cancer. 2022 Jan;25(1):197-206. doi: 10.1007/s10120-021-01227-z. Epub 2021 Sep 1. |
| 34363528 | Derived | Van Cutsem E, Amonkar M, Fuchs CS, Alsina M, Ozguroglu M, Bang YJ, Chung HC, Muro K, Goekkurt E, Benson AB 3rd, Sun W, Wainberg ZA, Norquist JM, Chen X, Shih CS, Shitara K. Health-related quality of life in advanced gastric/gastroesophageal junction cancer with second-line pembrolizumab in KEYNOTE-061. Gastric Cancer. 2021 Nov;24(6):1330-1340. doi: 10.1007/s10120-021-01200-w. Epub 2021 Aug 7. |
| 33792646 | Derived | Chao J, Fuchs CS, Shitara K, Tabernero J, Muro K, Van Cutsem E, Bang YJ, De Vita F, Landers G, Yen CJ, Chau I, Elme A, Lee J, Ozguroglu M, Catenacci D, Yoon HH, Chen E, Adelberg D, Shih CS, Shah S, Bhagia P, Wainberg ZA. Assessment of Pembrolizumab Therapy for the Treatment of Microsatellite Instability-High Gastric or Gastroesophageal Junction Cancer Among Patients in the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 Clinical Trials. JAMA Oncol. 2021 Jun 1;7(6):895-902. doi: 10.1001/jamaoncol.2021.0275. |
| 29880231 | Derived | Shitara K, Ozguroglu M, Bang YJ, Di Bartolomeo M, Mandala M, Ryu MH, Fornaro L, Olesinski T, Caglevic C, Chung HC, Muro K, Goekkurt E, Mansoor W, McDermott RS, Shacham-Shmueli E, Chen X, Mayo C, Kang SP, Ohtsu A, Fuchs CS; KEYNOTE-061 investigators. Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial. Lancet. 2018 Jul 14;392(10142):123-133. doi: 10.1016/S0140-6736(18)31257-1. Epub 2018 Jun 4. |
Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
| Treated |
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| PD-L1 Positive Participants |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pembrolizumab | Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years). |
| BG001 | Paclitaxel | Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| PD-L1 Status | Count of Participants | Participants |
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| Time To Progression (TTP) on first-line therapy | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants | PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval [CI]) in months was reported for PD-L1 positive participants by treatment group. | All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Primary | Overall Survival (OS) in PD-L1 Positive Participants | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and median OS (95% CI) in months was reported for PD-L1 positive participants by treatment group. | All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | PFS According to RECIST 1.1 Based on BICR in All Participants | PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for all participants by treatment group. | All randomized participants. Participants were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | OS in All Participants | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. OS was analyzed using the Kaplan-Meier method and median OS (95% CI) in months was reported for all participants by treatment group. | All randomized participants. Participants were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | PFS According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants | PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for PD-L1 positive participants by treatment group. | All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | PFS According to RECIST 1.1 Based on Investigator Assessment in All Participants | PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first. According to RECIST 1.1, PD was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% CI) in months was reported for all participants by treatment group. | All randomized participants. Participants were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | PFS According to Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) Based on BICR in PD-L1 Positive Participants | PFS defined as time from randomization to first documented PD per irRECIST based on BICR, or death due to any cause, whichever occurs first. Following initial PD by RECIST 1.1 (20% relative increase in SOD of target lesions), participants were assessed according to irRECIST: tumor assessment was repeated ≥4 weeks later to confirm PD with the option of continuing treatment until this scan was obtained for clinically stable participants. If PD confirmed, participant was discontinued from treatment unless investigator determined benefit. If repeat scan indicated stable disease (SD; neither sufficient shrinkage or increase of target lesion), partial response (PR; ≥30% decrease in the SOD of target lesions), or complete response (CR; disappearance of all non-nodal target lesions), participant could continue treatment at investigator's discretion. PFS analyzed using Kaplan-Meier method and median PFS (95% CI) in months was reported for PD-L1 positive participants by treatment group. | All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | PFS According to irRECIST Based on BICR in All Participants | PFS defined as time from randomization to first documented PD per irRECIST based on BICR, or death due to any cause, whichever occurs first. Following initial PD by RECIST 1.1 (20% relative increase in SOD of target lesions), participants were assessed according to irRECIST: tumor assessment was repeated ≥4 weeks later to confirm PD with the option of continuing treatment until this scan was obtained for clinically stable participants. If PD confirmed, participant was discontinued from treatment unless investigator determined benefit. If repeat scan indicated SD (neither sufficient shrinkage or increase of target lesion), PR (≥30% decrease in the SOD of target lesions), or CR (disappearance of all non-nodal target lesions), participant could continue treatment at investigator's discretion. PFS analyzed using Kaplan-Meier method and median PFS (95% CI) in months was reported for all participants by treatment group. | All randomized participants. Participants were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | Time to Tumor Progression (TTP) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants | TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for PD-L1 positive participants by treatment group. | All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | TTP According to RECIST 1.1 Based on BICR in All Participants | TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for all participants by treatment group. | All randomized participants. Participants were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | TTP According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants | TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for PD-L1 positive participants by treatment group. | All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | TTP According to RECIST 1.1 Based on Investigator Assessment in All Participants | TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment. Using RECIST 1.1, progressive disease was defined as a 20% relative increase in the SOD of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. If there was no documented disease progression, TTP was censored at last tumor assessment date. TTP was analyzed using the Kaplan-Meier method and median TTP (95% CI) in months was reported for all participants by treatment group. | All randomized participants. Participants were included in the treatment group to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | Objective Response Rate (ORR) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants | ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for PD-L1 positive participants by treatment group. | All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | ORR According to RECIST 1.1 Based on BICR in All Participants | ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for all participants by treatment group. | All randomized participants. Participants were included in the treatment group to which they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | ORR According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants | ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for PD-L1 positive participants by treatment group. | All randomized PD-L1 positive participants. Participants were included in the treatment group to which they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | ORR According to RECIST 1.1 Based on Investigator Assessment in All Participants | ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment. ORR was analyzed using the stratified Miettinen and Nurminen method, and reported with 95% CI for all participants by treatment group. | All randomized participants. Participants were included in the treatment group to which they were randomized. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | Duration of Response (DOR) According to RECIST 1.1 Based on BICR in PD-L1 Positive Participants | For PD-L1 positive participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for PD-L1 positive participants with response by treatment group. | The subset of all randomized PD-L1 positive participants that showed a CR or PR according to RECIST 1.1 and based on BICR. Participants were included in the treatment group to which they were randomized. | Posted | Median | Full Range | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | DOR According to RECIST 1.1 Based on BICR in All Participants | For participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on BICR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for all participants with response by treatment group. | The subset of all randomized participants that showed a CR or PR according to RECIST 1.1 and based on BICR. Participants were included in the treatment group to which they were randomized. | Posted | Median | Full Range | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | DOR According to RECIST 1.1 Based on Investigator Assessment in PD-L1 Positive Participants | For PD-L1 positive participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for PD-L1 positive participants with response by treatment group. | The subset of all randomized PD-L1 positive participants that showed a CR or PR according to RECIST 1.1 and based on investigator assessment. Participants were included in the treatment group to which they were randomized. | Posted | Median | Full Range | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | DOR According to RECIST 1.1 Based on Investigator Assessment in All Participants | For participants who demonstrated CR (disappearance of all non-nodal target lesions and any pathological lymph nodes must have become normal) or PR (at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD) according to RECIST 1.1 and based on investigator assessment, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. DOR was analyzed using the Kaplan-Meier method and median DOR (range) in months was reported for all participants with response by treatment group. | The subset of all randomized participants that showed a CR or PR according to RECIST 1.1 and based on investigator assessment. Participants were included in the treatment group to which they were randomized. | Posted | Median | Full Range | months | Up to 30 months (through database cut-off date of 26 Oct 2017) |
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| Secondary | Percentage of PD-L1 Positive Participants Who Experienced an Adverse Event (AE) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants with at least one AE was reported for PD-L1 positive participants by treatment group. | All randomized PD-L1 positive participants who received at least 1 dose of study treatment. | Posted | Number | Percentage of participants | Up to 71 months (through database cut-off date of 10 Jun 2021) |
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| Secondary | Percentage of All Participants Who Experienced an AE | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants with at least one AE was reported for all participants by treatment group. | All randomized participants who received at least 1 dose of study treatment. | Posted | Number | Percentage of participants | Up to 71 months (through database cut-off date of 10 Jun 2021) |
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| Secondary | Percentage of PD-L1 Positive Participants That Discontinued Study Treatment Due to AE | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for PD-L1 positive participants by treatment group. | All randomized PD-L1 positive participants who received at least 1 dose of study treatment. | Posted | Number | Percentage of participants | Up to approximately 26.4 months |
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| Secondary | Percentage of All Participants That Discontinued Study Treatment Due to AE | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for all participants by treatment group. | All randomized participants who received at least 1 dose of study treatment. | Posted | Number | Percentage of participants | Up to approximately 26.4 months |
|
Up to 71 months (through database cut-off date of 10 Jun 2021)
All-Cause Mortality was reported for all randomized participants.
Serious AEs and Other AEs were reported for the Safety Population: all randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pembrolizumab First Course | Participants receive 200 mg IV pembrolizumab on Day 1 of each 21-day cycle, for up to 35 administrations (approximately 2 years). | 278 | 296 | 108 | 294 | 256 | 294 |
| EG001 | Paclitaxel | Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity. | 287 | 296 | 68 | 276 | 260 | 276 |
| EG002 | Pembrolizumab Second Course | Qualified participants who received pembrolizumab as a first course and stopped the first course of pembrolizumab due to complete response (CR) or completed the first course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional). | 2 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Splenic infarction | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Addison's disease | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastric hypomotility | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastric stenosis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Gastrosplenic fistula | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ileal perforation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mechanical ileus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatic failure | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Biliary obstruction | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Biliary sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Enterobacter infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Medical device site infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Skin wound | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract stoma complication | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscle disorder | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intracranial mass | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 24.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 24.0 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Panic disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea paroxysmal nocturnal | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vascular compression | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| May 12, 2022 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asia |
|
| Rest of World |
|
| Negative |
|
| Unknown |
|
| ≥6 months |
|
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Participants receive paclitaxel 80 mg/m^2 IV, on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity. |
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