Trial · NCT02611960
Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)
NCT02611960, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2021-12-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122). Trials, record NCT02611960. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02611960
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pembrolizumab (MK-3475) in Platinum Pre-treated Recurrent/Metastatic Nasopharyngeal Cancer (MK-3475-122/KEYNOTE-122)
- NCT number
- NCT02611960
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 233 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Nasopharyngeal Neoplasms
- Interventions
- Pembrolizumab, Capecitabine, Gemcitabine, Docetaxel
- First posted
- 2015-11-23
- Last updated
- 2023-07-13
- Results first posted
- 2021-12-15
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) | Overall Survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. OS was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. |
| Secondary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) | PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on blinded independent central review (BICR), or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. PFS was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. |
| Secondary | Objective Response Rate (ORR) Per RECIST 1.1 | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) | ORR was defined as the percentage of participants in the analysis population who had a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. ORR was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. |
| Secondary | Duration of Response (DOR) Per RECIST 1.1 | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) | For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR, DOR was defined as the time from first documented evidence of confirmed CR or PR until PD or death due to any cause, whichever occurred first. DOR for participants who had not progressed or died at the time of analysis was censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. DOR was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. |
| Secondary | Percentage of Participants Surviving (OS Rate) at 12 Months | 12 months | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. The percentage of participants surviving (OS rate) at 12 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. |
| Secondary | Percentage of Participants Surviving (OS Rate) at 24 Months | 24 months | OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last known contact. The percentage of participants surviving (OS rate) at 24 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. |
| Secondary | Percentage of Participants With PFS (PFS Rate) at 6 Months | 6 months | PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. The percentage of participants with PFS (PFS rate) at 6 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. |
| Secondary | Percentage of Participants With PFS (PFS Rate) at 12 Months | 12 months | PFS was defined as the time from randomization to the first documented PD per RECIST 1.1 based on BICR, or death due to any cause, whichever occurs earlier. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. The percentage of participants with PFS (PFS rate) at 12 months is reported for each treatment arm based on the product-limit (Kaplan-Meier) method for censored data. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm, with a protocol-specified analysis data cut-off date of 30-Nov-2020. |
| Secondary | Percentage of Participants Who Experience One or More Adverse Events (AEs) | Up to approximately 73 months | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that experienced at least one AE was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm. |
| Secondary | Percentage of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 72 months | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The percentage of participants that discontinued study treatment due to an AE was reported for each treatment arm. Per protocol, analysis for this outcome measure was performed for the first pembrolizumab course and for the standard treatment arm. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) | All randomized participants (Intent-to-Treat \[ITT\]) were analyzed. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) | All randomized participants (ITT) were analyzed. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per RECIST 1.1 | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) | All randomized participants (ITT) were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per RECIST 1.1 | Up to approximately 53 months (through analysis cut-off date of 30-Nov-2020) | All randomized participants (ITT population) who demonstrated a confirmed CR or PR were analyzed. | Months | MEDIAN |
| SECONDARY | Percentage of Participants Surviving (OS Rate) at 12 Months | 12 months | All randomized participants (ITT) were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Surviving (OS Rate) at 24 Months | 24 months | All randomized participants (ITT) were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With PFS (PFS Rate) at 6 Months | 6 months | All randomized participants (ITT) were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With PFS (PFS Rate) at 12 Months | 12 months | All randomized participants (ITT) were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experience One or More Adverse Events (AEs) | Up to approximately 73 months | All randomized participants who received at least 1 dose of study treatment were analyzed. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 72 months | All randomized participants who received at least 1 dose of study treatment were analyzed. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Pembrolizumab | 17.2 | 95% Confidence Interval 11.7 to 22.9 | Months | |
| Overall Survival (OS) | Standard Treatment | 15.3 | 95% Confidence Interval 10.9 to 18.1 | Months | |
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Pembrolizumab | 4.1 | 95% Confidence Interval 2.1 to 5.6 | Months | |
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Standard Treatment | 5.5 | 95% Confidence Interval 4.0 to 8.1 | Months | |
| Objective Response Rate (ORR) Per RECIST 1.1 | Pembrolizumab | 21.4 | 95% Confidence Interval 14.3 to 29.9 | Percentage of Participants | |
| Objective Response Rate (ORR) Per RECIST 1.1 | Standard Treatment | 23.3 | 95% Confidence Interval 15.9 to 32.0 | Percentage of Participants | |
| Duration of Response (DOR) Per RECIST 1.1 | Pembrolizumab | 12.0 | 95% Confidence Interval 6.0 to 19.9 | Months | |
| Duration of Response (DOR) Per RECIST 1.1 | Standard Treatment | 13.1 | 95% Confidence Interval 9.7 to 18.9 | Months | |
| Percentage of Participants Surviving (OS Rate) at 12 Months | Pembrolizumab | 58.1 | 95% Confidence Interval 48.7 to 66.4 | Percentage of Participants | |
| Percentage of Participants Surviving (OS Rate) at 12 Months | Standard Treatment | 57.4 | 95% Confidence Interval 47.8 to 65.8 | Percentage of Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab | 117 | |
| Overall Study | STARTED | Standard Treatment | 116 | |
| Overall Study | Discontinued | Pembrolizumab | 117 | |
| Overall Study | Discontinued | Standard Treatment | 116 | |
| Overall Study | COMPLETED | Pembrolizumab | 0 | |
| Overall Study | COMPLETED | Standard Treatment | 0 | |
| Overall Study | NOT COMPLETED | Pembrolizumab | 117 | |
| Overall Study | NOT COMPLETED | Standard Treatment | 116 |
Source ClinicalTrials.gov
Adverse events387
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab First Course | 13 | 116 | 15 |
| other | Anaemia | Blood and lymphatic system disorders | Standard Treatment First Course | 33 | 112 | 47 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab Second Course | 0 | 5 | 0 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab First Course | 20 | 116 | 20 |
| other | Hypothyroidism | Endocrine disorders | Standard Treatment First Course | 11 | 112 | 12 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab Second Course | 0 | 5 | 0 |
| other | Vision blurred | Eye disorders | Pembrolizumab First Course | 6 | 116 | 6 |
| other | Vision blurred | Eye disorders | Standard Treatment First Course | 2 | 112 | 2 |
| other | Vision blurred | Eye disorders | Pembrolizumab Second Course | 0 | 5 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Pembrolizumab First Course | 6 | 116 | 8 |
1 to 10 of 387Source ClinicalTrials.gov
See all 387 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab First Course | 103 | 117 |
| Total, all-cause mortality | Standard Treatment First Course | 104 | 116 |
| Total, all-cause mortality | Pembrolizumab Second Course | 3 | 5 |
| Total, other adverse events | Pembrolizumab First Course | 100 | 116 |
| Total, other adverse events | Standard Treatment First Course | 103 | 112 |
| Total, other adverse events | Pembrolizumab Second Course | 3 | 5 |
| Total, serious adverse events | Pembrolizumab First Course | 39 | 116 |
| Total, serious adverse events | Standard Treatment First Course | 41 | 112 |
| Total, serious adverse events | Pembrolizumab Second Course | 3 | 5 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02611960
GET https://conductscience.org/api/trials/v1/NCT02611960/events?page=2