NCT05008224|CompletedPhase 2ResultsFDA Drug

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

KEYNOTE-C11

Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)

Merck Sharp & Dohme LLC ClinicalTrials.gov

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6 other identifiers

3475-C11MK-3475-C11KEYNOTE-C112022-501615-14-00U1111-1281-53472021-001244-95

Study Type

interventional

Target

146

Locations

11 countries

Sites

Timeline

RegisteredAug 2021

StartedOct 2021

CompletionMay 2024

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) monotherapy, followed by chemotherapy, followed by pembrolizumab consolidation. The primary hypothesis of the study is that the complete response (CR) rate at the end of study intervention according to Lugano 2014 response criteria is higher than conventional chemotherapy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

146

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2021

Geographic Reach

11 countries

48 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

First Submitted

Initial submission to the registry

August 13, 2021

Completed

4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed

2 months until next milestone

Study Start

First participant enrolled

October 7, 2021

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2023

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2024

Completed

5 months until next milestone

Results Posted

Study results publicly available

October 16, 2024

Completed

Last Updated

June 6, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

August 13, 2021

Results QC Date

September 25, 2024

Last Update Submit

May 23, 2025

Conditions

Classical Hodgkin Lymphoma

Keywords

Programmed Cell Death 1 (PD-1, PD1)Programmed Cell Death-Ligand 1 (PD-L1, PDL1)Programmed Cell Death-Ligand 2 (PD-L2, PDL2)

Outcome Measures

Primary Outcomes (1)

Complete Response (CR) Rate at the End of Study Intervention as Assessed by Blinded Independent Central Review (BICR) Per Lugano 2014 Response Criteria
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.
Up to approximately 24 months

Secondary Outcomes (6)

CR Rate at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria
Up to approximately 31 months
Duration of Complete Response (DurCR) as Assessed by BICR Per Lugano 2014 Response Criteria
Up to approximately 31 months
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
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
Number of Participants Who Experienced an Adverse Event (AE)
Up to approximately 31 months
+1 more secondary outcomes

Study Arms (1)

Pembrolizumab Monotherapy + AVD Chemotherapy/escBEACOPP Chemotherapy + Pembrolizumab Consolidation

EXPERIMENTAL

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.

Biological: PembrolizumabDrug: DoxorubicinDrug: VinblastineDrug: DacarbazineDrug: BleomycinDrug: EtoposideDrug: CyclophosphamideDrug: VincristineDrug: ProcarbazineDrug: Prednisone

Interventions

PembrolizumabBIOLOGICAL

200 mg IV administered on Day 1 of each 3-week cycle for 3 cycles during pembrolizumab monotherapy. 400 mg IV administered on Day 1 of each 6-week cycle for 4 cycles as pembrolizumab consolidation.

Also known as: MK-3475, SCH 900475, KEYTRUDA®