Trial · NCT04875195
A Study of Pembrolizumab (MK-3475) in Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-B68)
NCT04875195, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2025-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Pembrolizumab (MK-3475) in Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-B68). Trials, record NCT04875195. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04875195
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pembrolizumab (MK-3475) in Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-B68)
- NCT number
- NCT04875195
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hodgkin's Lymphoma, Primary Mediastinal Large B-cell Lymphoma (PMBCL)
- Interventions
- Pembrolizumab
- First posted
- 2021-05-06
- Last updated
- 2026-10-27
- Other registries' IDs
- eudract:2020-005609-20
- Results first posted
- 2025-02-10
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Per Lugano Classification as Assessed by Investigator | Up to approximately 30 months | ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose- positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). The percentage of participants treated with pembrolizumab Q6W, by cohort, rrcHL and rrPMBCL, who experienced CR or PR as assessed by investigator is presented. |
| Secondary | ORR Per Lugano Classification as Assessed by Blinded Independent Central Review (BICR) | Up to approximately 30 months | ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and metabolic imaging (fluorodeoxyglucose-positron emission tomography (FDG-PET)). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). The percentage of participants treated with pembrolizumab Q6W, by cohort, rrcHL and rrPMBCL, who experienced CR or PR as assessed by BICR is presented. |
| Secondary | Duration of Response (DOR) Per Lugano Classification as Assessed by Investigator | Up to approximately 51 months | For participants who demonstrate a CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. Participants were evaluated using CT and metabolic imaging (FDG-PET). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). DOR as assessed by investigator is presented among participants who demonstrated CR or PR. |
| Secondary | DOR Per Lugano Classification as Assessed by BICR | Up to approximately 51 months | For participants who demonstrate a CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. Participants were evaluated using CT and metabolic imaging (FDG-PET). CR is complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). DOR as assessed by BICR is presented among participants who demonstrated CR or PR. |
| Secondary | Area Under the Curve (AUC) Early Cycle of Pembrolizumab | Predose on Day 1 and Day 42 of Cycle 1 (cycle length=6 weeks) | AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time. Blood samples were collected to determine the AUC of pembrolizumab during Cycle 1 (early cycle). A cycle was 6 weeks. |
| Secondary | Area Under the Curve (AUC) Steady State of Pembrolizumab | Predose on Day 1 and Day 42 of Cycle 4 (cycle length=6 weeks) | AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time. Blood samples were collected to determine the AUC of pembrolizumab during Cycle 4 (steady state). A cycle was 6 weeks. |
| Secondary | Maximum Serum Concentration (Cmax) Early Cycle of Pembrolizumab | Predose on Day 1 of Cycle 1 and end of infusion on Day 1 of Cycle 1 (cycle length = 6 weeks) | Cmax is defined as the maximum serum drug concentration. Blood samples were collected to determine the Cmax of pembrolizumab during Cycle 1 (early cycle). |
| Secondary | Maximum Serum Concentration (Cmax) Steady State of Pembrolizumab | Predose on Day 1 of Cycle 4, and end of infusion on Day 1 of Cycle 4 (cycle length = 6 weeks) | Cmax is defined as the maximum serum drug concentration. Blood samples were collected to determine the Cmax of pembrolizumab during Cycle 4 (steady state). |
| Secondary | Trough Serum Concentration (Ctrough) Early Cycle of Pembrolizumab | Predose on Day 1 of Cycle 1 and Day 42 of Cycle 1 (cycle length = 6 weeks) | Ctrough is defined as the lowest serum drug concentration at the end of dosing interval. Blood samples were collected to determine the Ctrough of pembrolizumab during Cycle 1 (early cycle). |
| Secondary | Trough Serum Concentration (Ctrough) Steady State of Pembrolizumab | Predose on Day 1 of Cycle 1 and Day 42 of Cycle 4 (cycle length = 6 weeks) | Ctrough is defined as the lowest serum drug concentration at the end of dosing interval. Blood samples were collected to determine the Ctrough of pembrolizumab during Cycle 4 (steady state). |
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 | Objective Response Rate (ORR) Per Lugano Classification as Assessed by Investigator | Up to approximately 30 months | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Percentage of Participants | NUMBER |
| SECONDARY | ORR Per Lugano Classification as Assessed by Blinded Independent Central Review (BICR) | Up to approximately 30 months | The analysis population consisted of all participants who received ≥1 dose of study treatment. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Response (DOR) Per Lugano Classification as Assessed by Investigator | Up to approximately 54 months | |||
| SECONDARY | DOR Per Lugano Classification as Assessed by BICR | Up to approximately 54 months | |||
| SECONDARY | Area Under the Curve (AUC) Early Cycle of Pembrolizumab | Predose on Day 1 and Day 42 of Cycle 1 (cycle length=6 weeks) | The analysis population consisted of all participants who received ≥1 dose of study treatment. The analysis was pre-specified to be a pooled analysis of all participants rrcHL or rrPMBCL. | day*µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve (AUC) Steady State of Pembrolizumab | Predose on Day 1 and Day 42 of Cycle 4 (cycle length=6 weeks) | The analysis population consisted of all participants who received ≥1 dose of study treatment. The analysis was pre-specified to be a pooled analysis of all participants rrcHL or rrPMBCL. | day*µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Serum Concentration (Cmax) Early Cycle of Pembrolizumab | Predose on Day 1 of Cycle 1 and end of infusion on Day 1 of Cycle 1 (cycle length = 6 weeks) | The analysis population consisted of all participants who received ≥1 dose of study treatment and had Cycle 1 end of infusion concentration available. A cycle is 6 weeks. The analysis was pre-specified to be a pooled analysis of all participants rrcHL or rrPMBCL. | μg/ml | GEOMETRIC_MEAN |
| SECONDARY | Maximum Serum Concentration (Cmax) Steady State of Pembrolizumab | Predose on Day 1 of Cycle 4, and end of infusion on Day 1 of Cycle 4 (cycle length = 6 weeks) | The analysis population consisted of all participants who received ≥1 dose of study treatment and had Cycle 4 end of infusion concentration available. A cycle is 6 weeks. The analysis was pre-specified to be a pooled analysis of all participants rrcHL or rrPMBCL. | μg/ml | GEOMETRIC_MEAN |
| SECONDARY | Trough Serum Concentration (Ctrough) Early Cycle of Pembrolizumab | Predose on Day 1 of Cycle 1 and Day 42 of Cycle 1 (cycle length = 6 weeks) | The analysis population consisted of all participants who received ≥1 dose of study treatment and had Cycle 1 trough concentration available. A cycle is 6 weeks. The analysis was pre-specified to be a pooled analysis of all participants with rrcHL or rrPMBCL. | μg/ml | GEOMETRIC_MEAN |
| SECONDARY | Trough Serum Concentration (Ctrough) Steady State of Pembrolizumab | Predose on Day 1 of Cycle 1 and Day 42 of Cycle 4 (cycle length = 6 weeks) | The analysis population consisted of all participants who received ≥1 dose of study treatment and had Cycle 4 trough concentration available. A cycle is 6 weeks. The analysis was pre-specified to be a pooled analysis of all participants with rrcHL or rrPMBCL. | μg/ml | GEOMETRIC_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Per Lugano Classification as Assessed by Investigator | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | 66.7 | 95% Confidence Interval 53.3 to 78.3 | Percentage of Participants | |
| Objective Response Rate (ORR) Per Lugano Classification as Assessed by Investigator | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 50.0 | 95% Confidence Interval 11.8 to 88.2 | Percentage of Participants | |
| ORR Per Lugano Classification as Assessed by Blinded Independent Central Review (BICR) | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | 70.0 | 95% Confidence Interval 56.8 to 81.2 | Percentage of Participants | |
| ORR Per Lugano Classification as Assessed by Blinded Independent Central Review (BICR) | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 66.7 | 95% Confidence Interval 22.3 to 95.7 | Percentage of Participants | |
| Area Under the Curve (AUC) Early Cycle of Pembrolizumab | rrcHL or rrPMBCL | NA | 95% Confidence Interval NA to NA | day*µg/mL | |
| Area Under the Curve (AUC) Steady State of Pembrolizumab | rrcHL or rrPMBCL | NA | 95% Confidence Interval NA to NA | day*µg/mL | |
| Maximum Serum Concentration (Cmax) Early Cycle of Pembrolizumab | rrcHL or rrPMBCL | 127.5 | 95% Confidence Interval 120.0 to 135.4 | μg/ml | |
| Maximum Serum Concentration (Cmax) Steady State of Pembrolizumab | rrcHL or rrPMBCL | 154.8 | 95% Confidence Interval 141.5 to 169.4 | μg/ml | |
| Trough Serum Concentration (Ctrough) Early Cycle of Pembrolizumab | rrcHL or rrPMBCL | 17.9 | 95% Confidence Interval 16.3 to 19.7 | μg/ml | |
| Trough Serum Concentration (Ctrough) Steady State of Pembrolizumab | rrcHL or rrPMBCL | 33.8 | 95% Confidence Interval 29.9 to 38.4 | μg/ml |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | 60 | |
| Overall Study | STARTED | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 6 | |
| Overall Study | COMPLETED | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | 0 | |
| Overall Study | COMPLETED | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 0 | |
| Overall Study | NOT COMPLETED | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | 60 | |
| Overall Study | NOT COMPLETED | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 6 |
Source ClinicalTrials.gov
Adverse events64
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 | Neutropenia | Blood and lymphatic system disorders | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | 4 | 60 | 5 |
| other | Neutropenia | Blood and lymphatic system disorders | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 1 | 6 | 3 |
| other | Atrial fibrillation | Cardiac disorders | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | 0 | 60 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 1 | 6 | 1 |
| other | Tachycardia | Cardiac disorders | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | 0 | 60 | 0 |
| other | Tachycardia | Cardiac disorders | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 1 | 6 | 1 |
| other | Hypothyroidism | Endocrine disorders | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | 8 | 60 | 8 |
| other | Hypothyroidism | Endocrine disorders | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 1 | 6 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | 5 | 60 | 7 |
| other | Abdominal pain | Gastrointestinal disorders | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 1 | 6 | 1 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | 9 | 60 |
| Total, all-cause mortality | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 3 | 6 |
| Total, other adverse events | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | 38 | 60 |
| Total, other adverse events | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 4 | 6 |
| Total, serious adverse events | Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) | 5 | 60 |
| Total, serious adverse events | Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) vs Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL): deaths from any cause | Trial comparisons |
| Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) vs Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL): 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/NCT04875195
GET https://conductscience.org/api/trials/v1/NCT04875195/events?page=2