Trial Outcomes & Findings for Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11) (NCT NCT05008224)

Last Updated: 2025-06-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

146 participants

Primary outcome timeframe

Up to approximately 24 months

Results posted on

2025-06-06

Participant Flow

Male or female participants with newly diagnosed early unfavorable or advanced-stage classical Hodgkin Lymphoma (cHL), who were at least 18 years old, were enrolled in this study.

146 participants were allocated to the treatment arm and received sequential treatments beginning with pembrolizumab monotherapy, followed by chemotherapy (phases 1 and 2), and finishing with pembrolizumab consolidation. Per protocol, efficacy analysis was planned and conducted on the treatment arm of participants that received these sequential treatments. Safety outcome measures were analyzed based on the individual study treatment received by the participant at the time of the event.

Participant milestones

Participant milestones
Measure	Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation After completing Positron Emission Tomography (PET) scan 1 during eligibility screening, participants received pembrolizumab monotherapy intravenous (IV) for three 3-week cycles followed by PET scan 2. Participants next received 2 phases of chemotherapy. In chemotherapy phase 1, all participants received doxorubicin in combination with vinblastine \& dacarbazine (AVD) IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV, while participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escalated bleomycin in combination with etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, \& prednisone (escBEACOPP) IV. All participants then received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan.
Overall Study STARTED	146
Overall Study Received ≥1 Dose of Pembrolizumab	146
Overall Study Received at ≥1 Dose of AVD Chemotherapy	136
Overall Study Received at ≥1 Dose of escBEACOPP Chemotherapy	17
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	146

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation After completing Positron Emission Tomography (PET) scan 1 during eligibility screening, participants received pembrolizumab monotherapy intravenous (IV) for three 3-week cycles followed by PET scan 2. Participants next received 2 phases of chemotherapy. In chemotherapy phase 1, all participants received doxorubicin in combination with vinblastine \& dacarbazine (AVD) IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV, while participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escalated bleomycin in combination with etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, \& prednisone (escBEACOPP) IV. All participants then received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan.
Overall Study Death	3
Overall Study Lost to Follow-up	2
Overall Study Did Not Continue on Extension Study	39
Overall Study Transferred to Extension Study	100
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation n=146 Participants After completing PET scan 1 during eligibility screening, participants received pembrolizumab monotherapy IV for three 3-week cycles followed by PET scan 2. Participants next received 2 phases of chemotherapy. In chemotherapy phase 1, all participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV, while participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. All participants then received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan.
Age, Continuous	38.9 Years STANDARD_DEVIATION 16.3 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	126 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 24 months

Population: The analysis population consisted of all participants who received at least 1 dose of pembrolizumab.

Outcome measures

Outcome measures
Measure	Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation n=146 Participants Participants received pembrolizumab monotherapy IV for three 3-week cycles followed by PET scan 2. Participants next received 2 phases of chemotherapy. In chemotherapy phase 1, all participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV, while participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. All participants then received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan.	AVD Chemotherapy In chemotherapy phase 1, participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., AVD chemotherapy) at the time of the event.	escBEACOPP Chemotherapy In chemotherapy phase 2, participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., escBEACOPP chemotherapy) at the time of the event.
Complete Response (CR) Rate at the End of Study Intervention as Assessed by Blinded Independent Central Review (BICR) Per Lugano 2014 Response Criteria	67.0 Percentage of Participants Interval 58.9 to 74.7	—	—

SECONDARY outcome

Timeframe: Up to approximately 31 months

Population: The analysis population consisted of all participants who received at least 1 dose of pembrolizumab.

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.

Outcome measures

Outcome measures
Measure	Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation n=146 Participants Participants received pembrolizumab monotherapy IV for three 3-week cycles followed by PET scan 2. Participants next received 2 phases of chemotherapy. In chemotherapy phase 1, all participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV, while participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. All participants then received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan.	AVD Chemotherapy In chemotherapy phase 1, participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., AVD chemotherapy) at the time of the event.	escBEACOPP Chemotherapy In chemotherapy phase 2, participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., escBEACOPP chemotherapy) at the time of the event.
CR Rate at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria	71.9 Percentage of Participants Interval 63.9 to 79.0	—	—

SECONDARY outcome

Timeframe: Up to approximately 31 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation n=121 Participants Participants received pembrolizumab monotherapy IV for three 3-week cycles followed by PET scan 2. Participants next received 2 phases of chemotherapy. In chemotherapy phase 1, all participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV, while participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. All participants then received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan.	AVD Chemotherapy In chemotherapy phase 1, participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., AVD chemotherapy) at the time of the event.	escBEACOPP Chemotherapy In chemotherapy phase 2, participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., escBEACOPP chemotherapy) at the time of the event.
Duration of Complete Response (DurCR) as Assessed by BICR Per Lugano 2014 Response Criteria	NA Months NA = Median DurCR and upper and lower 95% confidence limits not reached at time of data cut-off due to an insufficient number of responding participants with relapse.	—	—

SECONDARY outcome

Timeframe: Up to approximately 10 weeks

Population: The analysis population consisted of all participants who had completed 3 cycles of pembrolizumab monotherapy.

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.

Outcome measures

Outcome measures
Measure	Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation n=146 Participants Participants received pembrolizumab monotherapy IV for three 3-week cycles followed by PET scan 2. Participants next received 2 phases of chemotherapy. In chemotherapy phase 1, all participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV, while participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. All participants then received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan.	AVD Chemotherapy In chemotherapy phase 1, participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., AVD chemotherapy) at the time of the event.	escBEACOPP Chemotherapy In chemotherapy phase 2, participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., escBEACOPP chemotherapy) at the time of the event.
Rate of PET Negativity Assessed by BICR According to the FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy (PET Scan 2)	19.9 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Up to approximately 5 months

Population: The analysis population consisted of all participants who had completed 3 cycles of pembrolizumab monotherapy and phase 1 AVD chemotherapy (2 AVD cycles).

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.

Outcome measures

Outcome measures
Measure	Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation n=146 Participants Participants received pembrolizumab monotherapy IV for three 3-week cycles followed by PET scan 2. Participants next received 2 phases of chemotherapy. In chemotherapy phase 1, all participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV, while participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. All participants then received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan.	AVD Chemotherapy In chemotherapy phase 1, participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., AVD chemotherapy) at the time of the event.	escBEACOPP Chemotherapy In chemotherapy phase 2, participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., escBEACOPP chemotherapy) at the time of the event.
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)	70.5 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: Up to approximately 31 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation n=146 Participants Participants received pembrolizumab monotherapy IV for three 3-week cycles followed by PET scan 2. Participants next received 2 phases of chemotherapy. In chemotherapy phase 1, all participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV, while participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. All participants then received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan.	AVD Chemotherapy n=136 Participants In chemotherapy phase 1, participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., AVD chemotherapy) at the time of the event.	escBEACOPP Chemotherapy n=17 Participants In chemotherapy phase 2, participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., escBEACOPP chemotherapy) at the time of the event.
Number of Participants Who Experienced an Adverse Event (AE)	135 Participants	132 Participants	17 Participants

SECONDARY outcome

Timeframe: Up to approximately 17 months

Outcome measures

Outcome measures
Measure	Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation n=146 Participants Participants received pembrolizumab monotherapy IV for three 3-week cycles followed by PET scan 2. Participants next received 2 phases of chemotherapy. In chemotherapy phase 1, all participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV, while participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. All participants then received pembrolizumab consolidation IV for four 6-week cycles followed by a final PET scan.	AVD Chemotherapy n=136 Participants In chemotherapy phase 1, participants received AVD IV for two 4-week cycles followed by PET scan 3. In chemotherapy phase 2, participants who were PET scan 3 negative, or positive and age ≥60 years, received up to 4 additional cycles of AVD IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., AVD chemotherapy) at the time of the event.	escBEACOPP Chemotherapy n=17 Participants In chemotherapy phase 2, participants who were PET scan 3 positive and age \<60 years received up to four 3-week cycles of escBEACOPP IV. Per protocol, collection and reporting of AEs was based on the individual study treatment received by the participant (i.e., escBEACOPP chemotherapy) at the time of the event.
Number of Participants Who Discontinued Study Treatment Due to an AE	15 Participants	1 Participants	0 Participants

Adverse Events

Pembrolizumab Monotherapy and Consolidation

Serious events: 26 serious events

Other events: 122 other events

Deaths: 0 deaths

AVD Chemotherapy

Serious events: 26 serious events

Other events: 131 other events

Deaths: 3 deaths

escBEACOPP Chemotherapy

Serious events: 6 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results of this study may be published or presented at scientific meetings. The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors requirements.
Publication restrictions are in place

Restriction type: OTHER