Trial · NCT04221945
Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)
NCT04221945, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2026-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047). Trials, record NCT04221945. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04221945
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)
- NCT number
- NCT04221945
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,060 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Uterine Cervical Neoplasms
- Interventions
- Pembrolizumab, Placebo for pembrolizumab, Cisplatin, External Beam Radiotherapy (EBRT), Brachytherapy
- First posted
- 2020-01-09
- Last updated
- 2026-11-05
- Other registries' IDs
- eudract:2019-003152-37
- Results first posted
- 2026-01-05
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator | Up to approximately 55 months | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate PFS. |
| Primary | Overall Survival (OS) | Up to approximately 55 months | OS is the time from randomization to death due to any cause. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate OS. |
| Secondary | PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) | Up to approximately 55 months | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate PFS. |
| Secondary | PFS Per RECIST 1.1 at Month 24 as Assessed by the Investigator | 24 months | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The percentage of participants with PFS as assessed by the investigator is presented. |
| Secondary | PFS Per RECIST 1.1 at Month 24 as Assessed by BICR | 24 months | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The percentage of participants with PFS as assessed by BICR is presented. |
| Secondary | Overall Survival (OS) at Month 36 | 36 months | OS is the time from randomization to death due to any cause. The analysis was performed via Kaplan-Meier approach to estimate the OS rate at Month 36. The percentage of participants with OS at Month 36 is presented. |
| Secondary | Complete Response (CR) Rate Per RECIST 1.1 at Week 12 as Assessed by the Investigator | 12 weeks | For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \<10mm) per RECIST 1.1, CR rate is defined as the percentage of participants who experienced a CR. The percentage of participants with CR per RECIST 1.1 as assessed by the investigator at Week 12 is presented. |
| Secondary | CR Rate Per RECIST 1.1 at Week 12 as Assessed by BICR | 12 weeks | For participants who demonstrated a confirmed CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \<10mm) per RECIST 1.1, CR rate is defined as the percentage of participants who experienced a CR. The percentage of participants with CR per RECIST 1.1 as assessed by BICR at Week 12 is presented. |
| Secondary | Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by the Investigator | Up to approximately 55 months | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \<10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1. |
| Secondary | ORR Per RECIST 1.1 as Assessed by BICR | Up to approximately 55 months | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \<10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator | Up to approximately 55 months | All randomized participants analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Up to approximately 55 months | All randomized participants analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) | Up to approximately 55 months | All randomized participants analyzed in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | PFS Per RECIST 1.1 at Month 24 as Assessed by the Investigator | 24 months | All randomized participants analyzed in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | PFS Per RECIST 1.1 at Month 24 as Assessed by BICR | 24 months | All randomized participants analyzed in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Overall Survival (OS) at Month 36 | 36 months | All randomized participants analyzed in the treatment group to which they were randomized. | Percentage of Participants | NUMBER |
| SECONDARY | Complete Response (CR) Rate Per RECIST 1.1 at Week 12 as Assessed by the Investigator | 12 weeks | All randomized participants analyzed in the treatment group to which they were randomized. Participants with measurable disease at baseline. As the BICR and Investigator each measure and collect results differently, this can result in different numbers of participants with measurable disease at baseline, and hence different numbers analyzed. | Percentage of participants | NUMBER |
| SECONDARY | CR Rate Per RECIST 1.1 at Week 12 as Assessed by BICR | 12 weeks | All randomized participants analyzed in the treatment group to which they were randomized. Participants with measurable disease at baseline. As the BICR and Investigator each measure and collect results differently, this can result in different numbers of participants with measurable disease at baseline, and hence different numbers analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by the Investigator | Up to approximately 55 months | All randomized participants analyzed in the treatment group to which they were randomized. Participants with measurable disease at baseline. As the BICR and Investigator each measure and collect results differently, this can result in different numbers of participants with measurable disease at baseline, and hence different numbers analyzed. | Percentage of participants | NUMBER |
| SECONDARY | ORR Per RECIST 1.1 as Assessed by BICR | Up to approximately 55 months | All randomized participants analyzed in the treatment group to which they were randomized. Participants with measurable disease at baseline. As the BICR and Investigator each measure and collect results differently, this can result in different numbers of participants with measurable disease at baseline, and hence different numbers analyzed. | Percentage of participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator | Chemoradiotherapy + Pembrolizumab | 47.6 | 95% Confidence Interval 47.6 to NA | Months | |
| Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator | Chemoradiotherapy + Placebo for Pembrolizumab | 47.5 | 95% Confidence Interval 41.0 to NA | Months | |
| Overall Survival (OS) | Chemoradiotherapy + Pembrolizumab | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) | Chemoradiotherapy + Placebo for Pembrolizumab | NA | 95% Confidence Interval NA to NA | Months | |
| PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) | Chemoradiotherapy + Pembrolizumab | 48.9 | 95% Confidence Interval 48.9 to NA | Months | |
| PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR) | Chemoradiotherapy + Placebo for Pembrolizumab | NA | 95% Confidence Interval 46.8 to NA | Months | |
| PFS Per RECIST 1.1 at Month 24 as Assessed by the Investigator | Chemoradiotherapy + Pembrolizumab | 70.6 | 95% Confidence Interval 66.4 to 74.3 | Percentage of Participants | |
| PFS Per RECIST 1.1 at Month 24 as Assessed by the Investigator | Chemoradiotherapy + Placebo for Pembrolizumab | 59.7 | 95% Confidence Interval 55.3 to 63.8 | Percentage of Participants | |
| PFS Per RECIST 1.1 at Month 24 as Assessed by BICR | Chemoradiotherapy + Pembrolizumab | 76.0 | 95% Confidence Interval 72.0 to 79.5 | Percentage of Participants | |
| PFS Per RECIST 1.1 at Month 24 as Assessed by BICR | Chemoradiotherapy + Placebo for Pembrolizumab | 68.1 | 95% Confidence Interval 63.8 to 72.0 | Percentage of Participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chemoradiotherapy + Pembrolizumab | 529 | |
| Overall Study | STARTED | Chemoradiotherapy + Placebo for Pembrolizumab | 531 | |
| Overall Study | Treated | Chemoradiotherapy + Pembrolizumab | 528 | |
| Overall Study | Treated | Chemoradiotherapy + Placebo for Pembrolizumab | 530 | |
| Overall Study | COMPLETED | Chemoradiotherapy + Pembrolizumab | 0 | |
| Overall Study | COMPLETED | Chemoradiotherapy + Placebo for Pembrolizumab | 0 | |
| Overall Study | NOT COMPLETED | Chemoradiotherapy + Pembrolizumab | 529 | |
| Overall Study | NOT COMPLETED | Chemoradiotherapy + Placebo for Pembrolizumab | 531 |
Source ClinicalTrials.gov
Adverse events592
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 + CCRT | 356 | 528 | 549 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + CCRT | 342 | 530 | 489 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab + CCRT | 129 | 528 | 216 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + CCRT | 97 | 530 | 160 |
| other | Lymphopenia | Blood and lymphatic system disorders | Pembrolizumab + CCRT | 52 | 528 | 77 |
| other | Lymphopenia | Blood and lymphatic system disorders | Placebo + CCRT | 56 | 530 | 80 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab + CCRT | 124 | 528 | 200 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + CCRT | 107 | 530 | 161 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pembrolizumab + CCRT | 80 | 528 | 89 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + CCRT | 69 | 530 | 86 |
1 to 10 of 592Source ClinicalTrials.gov
See all 592 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab + CCRT | 107 | 529 |
| Total, all-cause mortality | Placebo + CCRT | 140 | 531 |
| Total, other adverse events | Pembrolizumab + CCRT | 528 | 528 |
| Total, other adverse events | Placebo + CCRT | 525 | 530 |
| Total, serious adverse events | Pembrolizumab + CCRT | 175 | 528 |
| Total, serious adverse events | Placebo + CCRT | 153 | 530 |
Source ClinicalTrials.gov
Papers3
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Chemoradiotherapy + Pembrolizumab vs Chemoradiotherapy + Placebo for Pembrolizumab: Number of Participants Who Experience One or More Adverse Events (AEs) | Trial comparisons |
| Pembrolizumab + CCRT vs Placebo + CCRT: deaths from any cause | Trial comparisons |
| Chemoradiotherapy + Pembrolizumab vs Chemoradiotherapy + Placebo for Pembrolizumab: Number of Participants Who Discontinue Study Treatment Due to an AE | Trial comparisons |
| Pembrolizumab + CCRT vs Placebo + CCRT: serious adverse events | Trial comparisons |
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/NCT04221945
GET https://conductscience.org/api/trials/v1/NCT04221945/results?page=2