Trial · NCT05008224
Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)
NCT05008224, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2024-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11). Trials, record NCT05008224. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05008224
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)
- NCT number
- NCT05008224
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 146 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Classical Hodgkin Lymphoma
- Interventions
- Pembrolizumab, Doxorubicin, Vinblastine, Dacarbazine, Bleomycin, Etoposide, Cyclophosphamide, Vincristine, Procarbazine, Prednisone
- First posted
- 2021-08-17
- Last updated
- 2025-06-06
- Other registries' IDs
- eudract:2021-001244-95
- Results first posted
- 2024-10-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response (CR) Rate at the End of Study Intervention as Assessed by Blinded Independent Central Review (BICR) Per Lugano 2014 Response Criteria | Up to approximately 24 months | CR rate was assessed by BICR using Computed Tomography (CT) and PET scan according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). At each timepoint, CR was determined by combining the anatomic response, metabolic response, and clinical data. The criteria for CR included complete metabolic (no/minimal 2-fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. Per protocol, participants who discontinued study intervention during pembrolizumab monotherapy, chemotherapy, or pembrolizumab consolidation, or are lost to follow-up, or receive any new non-study anticancer therapy prior to end of treatment were classified as non-responders. The percentage of participants who had CR after the completion of pembrolizumab consolidation is presented. |
| Secondary | CR Rate at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria | Up to approximately 31 months | CR rate was assessed by the investigator using CT and PET scan according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). At each timepoint, CR was determined by combining the anatomic response, metabolic response, and clinical data. The criteria for CR included 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. Per protocol, participants who discontinued study intervention during pembrolizumab monotherapy, chemotherapy, or pembrolizumab consolidation, or are lost to follow-up, or receive any new non-study anticancer therapy prior to end of treatment were classified as non-responders. The percentage of participants who had CR after the completion of pembrolizumab consolidation is presented. |
| Secondary | Duration of Complete Response (DurCR) as Assessed by BICR Per Lugano 2014 Response Criteria | Up to approximately 31 months | DurCR was defined as the time from CR to progressive disease (PD) or death due to any cause, whichever came first. CR was assessed by BICR using CT and PET scan according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). At each timepoint, CR was determined by combining the anatomic response, metabolic response, and clinical data. The criteria for CR included 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. PD was defined as uptake moderately or markedly higher than the liver and/or new lesions. DurCR was analyzed by the Kaplan-Meier method for censored data and is presented for participants who demonstrated CR. |
| Secondary | Rate of PET Negativity Assessed by BICR According to the FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy (PET Scan 2) | Up to approximately 10 weeks | The rate of PET negativity was defined as the percentage of participants considered negative on the FDG-PET 5-point scale, as assessed by BICR according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). Participants were assigned a single score on the FDG-PET 5-point scale measuring FDG uptake (1 = no uptake above background, 2 = uptake above background but ≤ mediastinum, 3 = uptake \> mediastinum but ≤ liver, 4 = uptake moderately \> liver, 5 = uptake markedly \> liver or new FDG-positive lesions). Higher scores corresponded to greater uptake (greater disease). FDG-PET 5-point scale scores of 1, 2, and 3 were considered negative and scores of 4 and 5 were considered positive. The percentage of participants who were assessed as negative at PET scan 2, after completion of 3 cycles of pembrolizumab monotherapy, is presented. |
| Secondary | Rate of PET Negativity Assessed by BICR According to the FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy and AVD Chemotherapy (PET Scan 3) | Up to approximately 5 months | The rate of PET negativity was defined as the percentage of participants considered negative on the FDG-PET 5-point scale, as assessed by BICR according to Lugano 2014 response criteria (Cheson, B.D. et al, Journal of Clinical Oncology, 2014). Participants were assigned a single score on the FDG-PET 5-point scale measuring FDG uptake (1 = no uptake above background, 2 = uptake above background but ≤ mediastinum, 3 = uptake \> mediastinum but ≤ liver, 4 = uptake moderately \> liver, 5 = uptake markedly \> liver or new FDG-positive lesions). Higher scores corresponded to greater uptake (greater disease). FDG-PET 5-point scale scores of 1, 2, and 3 were considered negative and scores of 4 and 5 were considered positive. The percentage of participants who were assessed as negative at PET scan 3, after completion of 3 cycles of pembrolizumab monotherapy and phase 1 AVD chemotherapy (2 AVD cycles), is presented. |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 31 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Per protocol, collection and reporting of AEs was based on the study treatment received by the participant (pembrolizumab, AVD chemotherapy, or escBEACOPP chemotherapy) at the time of the event. The number of participants who experienced an AE is reported. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 17 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Per protocol, collection and reporting of AEs was based on the study treatment received by the participant (pembrolizumab, AVD chemotherapy, or escBEACOPP chemotherapy) at the time of the event. The number of participants who discontinued study intervention due to an AE is reported. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response (CR) Rate at the End of Study Intervention as Assessed by Blinded Independent Central Review (BICR) Per Lugano 2014 Response Criteria | Up to approximately 24 months | The analysis population consisted of all participants who received at least 1 dose of pembrolizumab. | Percentage of Participants | NUMBER |
| SECONDARY | CR Rate at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria | Up to approximately 31 months | The analysis population consisted of all participants who received at least 1 dose of pembrolizumab. | Percentage of Participants | NUMBER |
| SECONDARY | Duration of Complete Response (DurCR) as Assessed by BICR Per Lugano 2014 Response Criteria | Up to approximately 31 months | The analysis population consisted of all participants who received at least 1 dose of pembrolizumab and who had achieved CR.~DurCR data was censored on the date of the last disease assessment documenting absence of PD for participants who do not have progression and are still on study at the time of an analysis, are given antitumor treatment other than the study treatment, or are removed from study prior to documentation of tumor progression. | Months | MEDIAN |
| SECONDARY | Rate of PET Negativity Assessed by BICR According to the FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy (PET Scan 2) | Up to approximately 10 weeks | The analysis population consisted of all participants who had completed 3 cycles of pembrolizumab monotherapy. | Percentage of Participants | NUMBER |
| SECONDARY | Rate of PET Negativity Assessed by BICR According to the FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy and AVD Chemotherapy (PET Scan 3) | Up to approximately 5 months | The analysis population consisted of all participants who had completed 3 cycles of pembrolizumab monotherapy and phase 1 AVD chemotherapy (2 AVD cycles). | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 31 months | The analysis population consisted of all participants who received at least 1 dose of study intervention. Per protocol, analysis was based on the study treatment received by the participant (pembrolizumab, AVD chemotherapy, or escBEACOPP chemotherapy) at the time of the event. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 17 months | The analysis population consisted of all participants who received at least 1 dose of study intervention. Per protocol, analysis was based on the study treatment received by the participant (pembrolizumab, AVD chemotherapy, or escBEACOPP chemotherapy) at the time of the event. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response (CR) Rate at the End of Study Intervention as Assessed by Blinded Independent Central Review (BICR) Per Lugano 2014 Response Criteria | Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation | 67.0 | 95% Confidence Interval 58.9 to 74.7 | Percentage of Participants | |
| CR Rate at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria | Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation | 71.9 | 95% Confidence Interval 63.9 to 79.0 | Percentage of Participants | |
| Duration of Complete Response (DurCR) as Assessed by BICR Per Lugano 2014 Response Criteria | Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation | NA | 95% Confidence Interval NA to NA | Months | |
| Rate of PET Negativity Assessed by BICR According to the FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy (PET Scan 2) | Pembrolizumab Monotherapy | 19.9 | Percentage of Participants | ||
| Rate of PET Negativity Assessed by BICR According to the FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy and AVD Chemotherapy (PET Scan 3) | Pembrolizumab Monotherapy + AVD Chemotherapy | 70.5 | Percentage of Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | Pembrolizumab Monotherapy and Consolidation | 135 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | AVD Chemotherapy | 132 | Participants | ||
| Number of Participants Who Experienced an Adverse Event (AE) | escBEACOPP Chemotherapy | 17 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | Pembrolizumab Monotherapy and Consolidation | 15 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | AVD Chemotherapy | 1 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation | 146 | |
| Overall Study | Received ≥1 Dose of Pembrolizumab | Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation | 146 | |
| Overall Study | Received at ≥1 Dose of AVD Chemotherapy | Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation | 136 | |
| Overall Study | Received at ≥1 Dose of escBEACOPP Chemotherapy | Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation | 17 | |
| Overall Study | COMPLETED | Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation | 0 | |
| Overall Study | NOT COMPLETED | Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation | 146 |
Source ClinicalTrials.gov
Adverse events351
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 Monotherapy and Consolidation | 9 | 146 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | AVD Chemotherapy | 19 | 136 | 26 |
| other | Anaemia | Blood and lymphatic system disorders | escBEACOPP Chemotherapy | 8 | 17 | 9 |
| other | Eosinophilia | Blood and lymphatic system disorders | Pembrolizumab Monotherapy and Consolidation | 12 | 146 | 16 |
| other | Eosinophilia | Blood and lymphatic system disorders | AVD Chemotherapy | 3 | 136 | 3 |
| other | Eosinophilia | Blood and lymphatic system disorders | escBEACOPP Chemotherapy | 1 | 17 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab Monotherapy and Consolidation | 1 | 146 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | AVD Chemotherapy | 8 | 136 | 17 |
| other | Leukopenia | Blood and lymphatic system disorders | escBEACOPP Chemotherapy | 1 | 17 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab Monotherapy and Consolidation | 3 | 146 | 5 |
1 to 10 of 351Source ClinicalTrials.gov
See all 351 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab Monotherapy and Consolidation | 0 | 146 |
| Total, all-cause mortality | AVD Chemotherapy | 3 | 136 |
| Total, all-cause mortality | escBEACOPP Chemotherapy | 0 | 17 |
| Total, other adverse events | Pembrolizumab Monotherapy and Consolidation | 122 | 146 |
| Total, other adverse events | AVD Chemotherapy | 131 | 136 |
| Total, other adverse events | escBEACOPP Chemotherapy | 17 | 17 |
| Total, serious adverse events | Pembrolizumab Monotherapy and Consolidation | 26 | 146 |
| Total, serious adverse events | AVD Chemotherapy | 26 | 136 |
| Total, serious adverse events | escBEACOPP Chemotherapy | 6 | 17 |
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 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/NCT05008224
GET https://conductscience.org/api/trials/v1/NCT05008224/events?page=2