Trial · NCT02453594
Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087)
NCT02453594, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2024-10-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087). Trials, record NCT02453594. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02453594
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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 Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (MK-3475-087/KEYNOTE-087)
- NCT number
- NCT02453594
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 211 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hodgkin Lymphoma
- Interventions
- pembrolizumab
- First posted
- 2015-05-25
- Last updated
- 2024-10-29
- Other registries' IDs
- eudract:2014-004482-24
- Results first posted
- 2024-10-29
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) by BICR Based on IWG Criteria | Up to approximately 99 months | ORR is the percentage of participants who had a complete response (CR) or partial response (PR) prior to disease progression based on the International Working Group (IWG) criteria using blinded independent central review (BICR). CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The point estimate and 95% 2-sided exact confidence interval (CI) used the Clopper-Pearson method. An exact binomial test was conducted for each cohort versus a fixed control rate for each cohort. It is hypothesized that ORR will be greater than 20% in each of the 3 cohorts. |
| Primary | Percentage of Participants Experiencing at Least One Adverse Event (AE) | Up to 27 months | An adverse event (AE) is 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 is considered related to the medical treatment or procedure, that occurs during the course of the study |
| Primary | Percentage of Participants Discontinuing Study Drug Due to AEs | Up to 24 months | An AE is 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 is considered related to the medical treatment or procedure, that occurs during the course of the study |
| Secondary | Overall Response Rate (ORR) by BICR Based on Lugano Criteria | Up to approximately 99 months | ORR is the percentage of participants who had a CR or PR prior to disease progression based on the Lugano criteria using BICR. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The point estimate and 95% 2-sided exact confidence interval (CI) used the Clopper-Pearson method. An exact binomial test was conducted for each cohort versus a fixed control rate for each cohort. |
| Secondary | Overall Response Rate (ORR) Assessed by Investigator Based on IWG Criteria | Up to approximately 99 months | ORR is the percentage of participants who had a CR or PR prior to disease progression assessed by the investigator using IWG criteria. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The point estimate and 95% 2-sided exact confidence interval (CI) used the Clopper-Pearson method. An exact binomial test was conducted for each cohort versus a fixed control rate for each cohort. |
| Secondary | Complete Remission Rate (CRR) by BICR Based on IWG Criteria | Up to approximately 99 months | CRR is the percentage of participants with complete remission as demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes based on the IWG criteria using BICR. The analysis consisted of the point estimate and 95% 2-sided exact CI, separately by Cohort using the Clopper-Pearson method. Additional analyses were based on site assessment and by central review using the Lugano (2014) criteria. |
| Secondary | Complete Remission Rate (CRR) by BICR Based on Lugano Criteria | Up to approximately 99 months | CRR is the percentage of participants with complete remission as demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes based on the Lugano criteria using BICR. The analysis consisted of the point estimate and 95% 2-sided exact CI, separately by Cohort using the Clopper-Pearson method. Additional analyses were based on site assessment and by central review using the Lugano (2014) criteria. |
| Secondary | Complete Remission Rate (CRR) Assessed by Investigator Based on IWG Criteria | Up to approximately 99 months | CRR is the percentage of participants with complete remission as demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes assessed by the investigator using IWG criteria. The analysis consisted of the point estimate and 95% 2-sided exact CI, separately by Cohort using the Clopper-Pearson method. Additional analyses were based on site assessment and by central review using the Lugano (2014) criteria. |
| Secondary | Progression-free Survival (PFS) Based on BICR | Up to approximately 99 months | PFS is the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first based on BICR. For those who have PD, the true date of disease progression was approximated by the date of the first assessment at which PD is objectively documented per IWG criteria, regardless of discontinuation of study drug. Death is always considered as a confirmed PD event. The non-parametric Kaplan-Meier method was used to estimate the PFS curve with missing data censored at last assessment. |
| Secondary | Progression-free Survival (PFS) Assessed by the Investigator | Up to approximately 99 months | PFS is the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by the investigator based on the IWG criteria. For those who have PD, the true date of disease progression was approximated by the date of the first assessment at which PD is objectively documented per IWG criteria, regardless of discontinuation of study drug. Death is always considered as a confirmed PD event. The non-parametric Kaplan-Meier method was used to estimate the PFS curve with missing data censored at last assessment. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate (ORR) by BICR Based on IWG Criteria | Up to approximately 99 months | All allocated participants who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Experiencing at Least One Adverse Event (AE) | Up to 27 months | All allocated participants who received at least 1 dose of study treatment. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Discontinuing Study Drug Due to AEs | Up to 24 months | All allocated participants who received at least 1 dose of study treatment | Percentage of Participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) by BICR Based on Lugano Criteria | Up to approximately 99 months | All allocated participants who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) Assessed by Investigator Based on IWG Criteria | Up to approximately 99 months | All allocated participants who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Complete Remission Rate (CRR) by BICR Based on IWG Criteria | Up to approximately 99 months | All allocated participants who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Complete Remission Rate (CRR) by BICR Based on Lugano Criteria | Up to approximately 99 months | All allocated participants who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Complete Remission Rate (CRR) Assessed by Investigator Based on IWG Criteria | Up to approximately 99 months | All allocated participants who received at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) Based on BICR | Up to approximately 99 months | All allocated participants who received at least 1 dose of study treatment. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) Assessed by the Investigator | Up to approximately 99 months | All allocated participants who received at least 1 dose of study treatment. | Months | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) by BICR Based on IWG Criteria | Cohort 1 | 78.3 | 95% Confidence Interval 66.7 to 87.3 | Percentage of participants | |
| Overall Response Rate (ORR) by BICR Based on IWG Criteria | Cohort 2 | 64.2 | 95% Confidence Interval 52.8 to 74.6 | Percentage of participants | |
| Overall Response Rate (ORR) by BICR Based on IWG Criteria | Cohort 3 | 73.3 | 95% Confidence Interval 60.3 to 83.9 | Percentage of participants | |
| Percentage of Participants Experiencing at Least One Adverse Event (AE) | Cohort 1 | 98.6 | Percentage of Participants | ||
| Percentage of Participants Experiencing at Least One Adverse Event (AE) | Cohort 2 | 98.8 | Percentage of Participants | ||
| Percentage of Participants Experiencing at Least One Adverse Event (AE) | Cohort 3 | 95.0 | Percentage of Participants | ||
| Percentage of Participants Discontinuing Study Drug Due to AEs | Cohort 1 | 11.6 | Percentage of Participants | ||
| Percentage of Participants Discontinuing Study Drug Due to AEs | Cohort 2 | 6.2 | Percentage of Participants | ||
| Percentage of Participants Discontinuing Study Drug Due to AEs | Cohort 3 | 8.3 | Percentage of Participants | ||
| Overall Response Rate (ORR) by BICR Based on Lugano Criteria | Cohort 1 | 82.6 | 95% Confidence Interval 71.6 to 90.7 | Percentage of participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 69 | |
| Overall Study | STARTED | Cohort 2 | 81 | |
| Overall Study | STARTED | Cohort 3 | 61 | |
| Overall Study | Treated | Cohort 1 | 69 | |
| Overall Study | Treated | Cohort 2 | 81 | |
| Overall Study | Treated | Cohort 3 | 60 | |
| Overall Study | Second Course Pembrolizumab | Cohort 1 | 10 | |
| Overall Study | Second Course Pembrolizumab | Cohort 2 | 7 | |
| Overall Study | Second Course Pembrolizumab | Cohort 3 | 3 | |
| Overall Study | COMPLETED | Cohort 1 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events942
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 | Cohort 1 (First Course) | 7 | 69 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 (First Course) | 8 | 81 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3 (First Course) | 5 | 60 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1 (Second Course) | 0 | 10 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 (Second Course) | 1 | 7 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3 (Second Course) | 0 | 3 | 0 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1 (First Course) | 5 | 69 | 6 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 2 (First Course) | 4 | 81 | 6 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 3 (First Course) | 4 | 60 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1 (Second Course) | 0 | 10 | 0 |
1 to 10 of 942Source ClinicalTrials.gov
See all 942 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (First Course) | 21 | 69 |
| Total, all-cause mortality | Cohort 2 (First Course) | 28 | 81 |
| Total, all-cause mortality | Cohort 3 (First Course) | 19 | 61 |
| Total, all-cause mortality | Cohort 1 (Second Course) | 2 | 10 |
| Total, all-cause mortality | Cohort 2 (Second Course) | 0 | 7 |
| Total, all-cause mortality | Cohort 3 (Second Course) | 0 | 3 |
| Total, other adverse events | Cohort 1 (First Course) | 68 | 69 |
| Total, other adverse events | Cohort 2 (First Course) | 76 | 81 |
| Total, other adverse events | Cohort 3 (First Course) | 56 | 60 |
| Total, other adverse events | Cohort 1 (Second Course) | 10 | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers6
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/NCT02453594
GET https://conductscience.org/api/trials/v1/NCT02453594/results?page=2