Trial · NCT04003636
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)
NCT04003636, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2023-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966). Trials, record NCT04003636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04003636
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)
- NCT number
- NCT04003636
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,069 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Biliary Tract Carcinoma
- Interventions
- Pembrolizumab, Gemcitabine, Cisplatin, Placebo
- First posted
- 2019-07-01
- Last updated
- 2026-03-24
- Other registries' IDs
- eudract:2019-000944-82
- Results first posted
- 2023-12-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to approximately 38 months | Overall survival was defined as the time from randomization to death due to any cause. |
| Secondary | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR) | Up to approximately 26 months | PFS was defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurred first. 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 must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by BICR per RECIST 1.1 was presented. |
| Secondary | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | Up to approximately 26 months | ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a ≥30% decrease in the sum of diameters \[SOD\] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ. |
| Secondary | Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | Up to approximately 38 months | 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, DOR was defined as the time from first documented evidence of a CR or PR until PD or death. DOR for participants who had not progressed or died at the time of analysis was to be 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 as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented. |
| Secondary | Number of Participants Who Experience One or More Adverse Events (AE) | Up to approximately 65 months | An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study. Number of participants who experienced one or more AEs were reported. |
| Secondary | Number of Participants Who Discontinued Study Intervention Due to an AE | Up to approximately 63 months | An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurs during the course of the study. Number of participants who discontinued study intervention due to an AE were reported. |
Source ClinicalTrials.gov
Outcomes6
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 38 months | All randomized participants | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR) | Up to approximately 26 months | All randomized participants | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | Up to approximately 26 months | All randomized participants | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | Up to approximately 38 months | All randomized participants with CR or PR | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experience One or More Adverse Events (AE) | Up to approximately 38 months | All Participants as Treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE) | Up to approximately 38 months | All Participants as Treated (APaT) population, which consisted of all randomized participants who received at least 1 dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Arm A (Pembrolizumab+Gemcitabine+Cisplatin) | 12.7 | 95% Confidence Interval 11.5 to 13.6 | Months | |
| Overall Survival (OS) | Arm B (Placebo+Gemcitabine+Cisplatin) | 10.9 | 95% Confidence Interval 9.9 to 11.6 | Months | |
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR) | Arm A (Pembrolizumab+Gemcitabine+Cisplatin) | 6.5 | 95% Confidence Interval 5.7 to 6.9 | Months | |
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR) | Arm B (Placebo+Gemcitabine+Cisplatin) | 5.6 | 95% Confidence Interval 5.1 to 6.6 | Months | |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | Arm A (Pembrolizumab+Gemcitabine+Cisplatin) | 28.7 | 95% Confidence Interval 24.9 to 32.8 | Percentage of Participants | |
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | Arm B (Placebo+Gemcitabine+Cisplatin) | 28.5 | 95% Confidence Interval 24.8 to 32.6 | Percentage of Participants | |
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | Arm A (Pembrolizumab+Gemcitabine+Cisplatin) | 9.7 | 95% Confidence Interval 1.2 to 22.7 | Months | |
| Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR | Arm B (Placebo+Gemcitabine+Cisplatin) | 6.9 | 95% Confidence Interval 0.0 to 19.2 | Months | |
| Number of Participants Who Experience One or More Adverse Events (AE) | Arm A (Pembrolizumab+Gemcitabine+Cisplatin) | 524 | Participants | ||
| Number of Participants Who Experience One or More Adverse Events (AE) | Arm B (Placebo+Gemcitabine+Cisplatin) | 532 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Pembrolizumab+Gemcitabine+Cisplatin) | 533 | |
| Overall Study | STARTED | Arm B (Placebo+Gemcitabine+Cisplatin) | 536 | |
| Overall Study | COMPLETED | Arm A (Pembrolizumab+Gemcitabine+Cisplatin) | 0 | |
| Overall Study | COMPLETED | Arm B (Placebo+Gemcitabine+Cisplatin) | 0 | |
| Overall Study | NOT COMPLETED | Arm A (Pembrolizumab+Gemcitabine+Cisplatin) | 533 | |
| Overall Study | NOT COMPLETED | Arm B (Placebo+Gemcitabine+Cisplatin) | 536 |
Source ClinicalTrials.gov
Adverse events1,104
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 | 315 | 529 | 528 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Chemotherapy | 306 | 534 | 486 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab Second Course | 0 | 2 | 0 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab + Chemotherapy | 45 | 529 | 46 |
| other | Hypothyroidism | Endocrine disorders | Placebo + Chemotherapy | 14 | 534 | 14 |
| other | Hypothyroidism | Endocrine disorders | Pembrolizumab Second Course | 0 | 2 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Pembrolizumab + Chemotherapy | 37 | 529 | 41 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo + Chemotherapy | 34 | 534 | 43 |
| other | Abdominal distension | Gastrointestinal disorders | Pembrolizumab Second Course | 0 | 2 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Pembrolizumab + Chemotherapy | 88 | 529 | 122 |
1 to 10 of 1,104Source ClinicalTrials.gov
See all 1,104 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab + Chemotherapy | 413 | 533 |
| Total, all-cause mortality | Placebo + Chemotherapy | 443 | 536 |
| Total, all-cause mortality | Pembrolizumab Second Course | 1 | 2 |
| Total, other adverse events | Pembrolizumab + Chemotherapy | 512 | 529 |
| Total, other adverse events | Placebo + Chemotherapy | 522 | 534 |
| Total, other adverse events | Pembrolizumab Second Course | 2 | 2 |
| Total, serious adverse events | Pembrolizumab + Chemotherapy | 276 | 529 |
| Total, serious adverse events | Placebo + Chemotherapy | 263 | 534 |
| Total, serious adverse events | Pembrolizumab Second Course | 0 | 2 |
Source ClinicalTrials.gov
Papers6
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Pembrolizumab+Gemcitabine+Cisplatin) vs Arm B (Placebo+Gemcitabine+Cisplatin): Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE) | Trial comparisons |
| Arm A (Pembrolizumab+Gemcitabine+Cisplatin) vs Arm B (Placebo+Gemcitabine+Cisplatin): Number of Participants Who Experience One or More Adverse Events (AE) | 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/NCT04003636
GET https://conductscience.org/api/trials/v1/NCT04003636/events?page=2