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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501615-14-00

Acronym

MK-3475-C11

Enrollment

Registered

2023-08-25

Start date

2021-11-08

Completion date

2024-05-21

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Classical Hodgkin Lymphoma

Brief summary

Complete Response (CR) at the End of Study Intervention as Assessed by Independent Central Review Per Lugano 2014 Response Criteria

Detailed description

CR at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria, Duration of Complete Response (DurCR) as Assessed by Independent Central Review Per Lugano 2014 Response Criteria, Positron Emission Tomography (PET) Negativity by Independent Central Review Per 2-Fluorodeoxyglucose (FDG)-PET 5-point Scale After Administration of Pembrolizumab Monotherapy, PET Negativity by Independent Central Review Per FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy and Chemotherapy, Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an AE

Interventions

DRUGDOXORUBICIN

DRUGETOPOSIDE

DRUGVINBLASTINE

DRUGBLEOMYCIN

DRUGVINCRISTINE

DRUGPREDNISONE

DRUGCYCLOPHOSPHAMIDE

DRUGDACARBAZINE

DRUGPROCARBAZINE

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Complete Response (CR) at the End of Study Intervention as Assessed by Independent Central Review Per Lugano 2014 Response Criteria	—

Secondary

Measure	Time frame
CR at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria, Duration of Complete Response (DurCR) as Assessed by Independent Central Review Per Lugano 2014 Response Criteria, Positron Emission Tomography (PET) Negativity by Independent Central Review Per 2-Fluorodeoxyglucose (FDG)-PET 5-point Scale After Administration of Pembrolizumab Monotherapy, PET Negativity by Independent Central Review Per FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy and Chemotherapy, Number of Participants Who Experienced an Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an AE	—

Measure

Time frame

—

Countries

France, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026