Trial · NCT03635567

Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)

NCT03635567, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2023-10-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826). Trials, record NCT03635567. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03635567

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)
NCT number: NCT03635567
Status: Completed
Phases: Phase 3
Enrollment: 617 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Cervical Cancer
Interventions: Pembrolizumab, Paclitaxel, Cisplatin, Carboplatin, Bevacizumab, Placebo to pembrolizumab
First posted: 2018-08-17
Last updated: 2026-02-04
Other registries' IDs: eudract:2018-001440-53
Results first posted: 2023-10-12

Source ClinicalTrials.gov

Registered outcomes15

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 Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1	Up to approximately 46 months	PFS was 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 was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥1 is presented.
Primary	PFS Per RECIST 1.1 as Assessed by Investigator in All Participants	Up to approximately 46 months	PFS was 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 was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants is presented.
Primary	PFS Per RECIST 1.1 as Assessed by Investigator in Participants With PD-L1 CPS ≥10	Up to approximately 46 months	PFS was 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 was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥10 is presented.
Primary	Overall Survival (OS) in Participants With PD-L1 CPS ≥1	Up to approximately 46 months	OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥1 is presented.
Primary	OS in All Participants	Up to approximately 46 months	OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants is presented.
Primary	OS in Participants With PD-L1 CPS ≥10	Up to approximately 46 months	OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥10 is presented.
Secondary	Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator	Up to approximately 46 months	ORR was defined as the percentage of the participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters). The ORR per RECIST 1.1 as assessed by Investigator is presented.
Secondary	Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator	Up to approximately 46 months	For participants who demonstrate CR or PR, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR per RECIST 1.1 as assessed by Investigator is presented.
Secondary	Percentage of Participants That Were PFS Event-Free (PFS Rate) at Month 12 Per RECIST 1.1 as Assessed by Investigator	12 months	PFS was 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 was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. PFS Rate was defined as the percentage of participants that were PFS event-free at Month 12. The PFS Rate per RECIST 1.1 as assessed by Investigator at Month 12 is presented.
Secondary	PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR)	Up to approximately 46 months	PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by BICR is presented.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

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 Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1	Up to approximately 46 months	All randomized participants with PD-L1 CPS ≥1 based on the treatment group to which they were randomized.	Months	MEDIAN
PRIMARY	PFS Per RECIST 1.1 as Assessed by Investigator in All Participants	Up to approximately 46 months	All randomized participants based on the treatment group to which they were randomized.	Months	MEDIAN
PRIMARY	PFS Per RECIST 1.1 as Assessed by Investigator in Participants With PD-L1 CPS ≥10	Up to approximately 46 months	All randomized participants with PD-L1 CPS ≥10 based on the treatment group to which they were randomized.	Months	MEDIAN
PRIMARY	Overall Survival (OS) in Participants With PD-L1 CPS ≥1	Up to approximately 46 months	All randomized participants with PD-L1 CPS ≥1 based on the treatment group to which they were randomized.	Months	MEDIAN
PRIMARY	OS in All Participants	Up to approximately 46 months	All randomized participants based on the treatment group to which they were randomized.	Months	MEDIAN
PRIMARY	OS in Participants With PD-L1 CPS ≥10	Up to approximately 46 months	All randomized participants with PD-L1 CPS ≥10 based on the treatment group to which they were randomized.	Months	MEDIAN
SECONDARY	Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator	Up to approximately 46 months	All randomized participants based on the treatment group to which they were randomized.	Percentage of Participants	NUMBER
SECONDARY	Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator	Up to approximately 46 months	All randomized participants based on the treatment group to which they were randomized who demonstrated CR or PR.	Months	MEDIAN
SECONDARY	Percentage of Participants That Were PFS Event-Free (PFS Rate) at Month 12 Per RECIST 1.1 as Assessed by Investigator	12 months	All randomized participants based on the treatment group to which they were randomized.	Percentage of Participants	NUMBER
SECONDARY	PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR)	Up to approximately 46 months	All randomized participants based on the treatment group to which they were randomized.	Months	MEDIAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1	Pembrolizumab+Chemotherapy	10.5	95% Confidence Interval 9.7 to 12.3	Months
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1	Placebo+Chemotherapy	8.2	95% Confidence Interval 6.3 to 8.5	Months
PFS Per RECIST 1.1 as Assessed by Investigator in All Participants	Pembrolizumab+Chemotherapy	10.4	95% Confidence Interval 9.1 to 12.2	Months
PFS Per RECIST 1.1 as Assessed by Investigator in All Participants	Placebo+Chemotherapy	8.2	95% Confidence Interval 6.4 to 8.4	Months
PFS Per RECIST 1.1 as Assessed by Investigator in Participants With PD-L1 CPS ≥10	Pembrolizumab+Chemotherapy	10.4	95% Confidence Interval 8.9 to 15.1	Months
PFS Per RECIST 1.1 as Assessed by Investigator in Participants With PD-L1 CPS ≥10	Placebo+Chemotherapy	8.1	95% Confidence Interval 6.2 to 8.8	Months
Overall Survival (OS) in Participants With PD-L1 CPS ≥1	Pembrolizumab+Chemotherapy	28.6	95% Confidence Interval 22.1 to 38.0	Months
Overall Survival (OS) in Participants With PD-L1 CPS ≥1	Placebo+Chemotherapy	16.5	95% Confidence Interval 14.5 to 20.0	Months
OS in All Participants	Pembrolizumab+Chemotherapy	26.4	95% Confidence Interval 21.3 to 32.5	Months
OS in All Participants	Placebo+Chemotherapy	16.8	95% Confidence Interval 14.6 to 19.4	Months

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Pembrolizumab+Chemotherapy	308
Overall Study	STARTED	Placebo+Chemotherapy	309
Overall Study	Treated	Pembrolizumab+Chemotherapy	307
Overall Study	Treated	Placebo+Chemotherapy	309
Overall Study	Received Second Course of Pembrolizumab	Pembrolizumab+Chemotherapy	12
Overall Study	Received Second Course of Pembrolizumab	Placebo+Chemotherapy	0
Overall Study	COMPLETED	Pembrolizumab+Chemotherapy	0
Overall Study	COMPLETED	Placebo+Chemotherapy	0
Overall Study	NOT COMPLETED	Pembrolizumab+Chemotherapy	308
Overall Study	NOT COMPLETED	Placebo+Chemotherapy	309

Source ClinicalTrials.gov

Adverse events969

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+Chemotherapy	182	307	264
other	Anaemia	Blood and lymphatic system disorders	Placebo+Chemotherapy	159	309	247
other	Anaemia	Blood and lymphatic system disorders	Pembrolizumab (Second Course)	2	12	2
other	Leukopenia	Blood and lymphatic system disorders	Pembrolizumab+Chemotherapy	40	307	71
other	Leukopenia	Blood and lymphatic system disorders	Placebo+Chemotherapy	33	309	55
other	Leukopenia	Blood and lymphatic system disorders	Pembrolizumab (Second Course)	2	12	2
other	Lymphopenia	Blood and lymphatic system disorders	Pembrolizumab+Chemotherapy	15	307	29
other	Lymphopenia	Blood and lymphatic system disorders	Placebo+Chemotherapy	7	309	7
other	Lymphopenia	Blood and lymphatic system disorders	Pembrolizumab (Second Course)	1	12	1
other	Neutropenia	Blood and lymphatic system disorders	Pembrolizumab+Chemotherapy	71	307	142

1 to 10 of 969Source ClinicalTrials.gov

See all 969 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Pembrolizumab+Chemotherapy	195	308
Total, all-cause mortality	Placebo+Chemotherapy	241	309
Total, all-cause mortality	Pembrolizumab (Second Course)	4	12
Total, other adverse events	Pembrolizumab+Chemotherapy	298	307
Total, other adverse events	Placebo+Chemotherapy	299	309
Total, other adverse events	Pembrolizumab (Second Course)	8	12
Total, serious adverse events	Pembrolizumab+Chemotherapy	157	307
Total, serious adverse events	Placebo+Chemotherapy	132	309
Total, serious adverse events	Pembrolizumab (Second Course)	4	12

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34534429	DERIVED	PubMed
36878237	DERIVED	PubMed
37910822	RESULT	PubMed
38095881	DERIVED	PubMed
39393777	DERIVED	PubMed
39499492	DERIVED	PubMed
40590325	DERIVED	PubMed
42720936	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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