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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)

Primary Purpose

Classical Hodgkin Lymphoma

Status

Active

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Pembrolizumab

Doxorubicin

Vinblastine

Dacarbazine

Bleomycin

Etoposide

Cyclophosphamide

Vincristine

Procarbazine

Prednisone

About this trial

This is an interventional treatment trial for Classical Hodgkin Lymphoma focused on measuring Programmed Cell Death 1 (PD-1, PD1), Programmed Cell Death-Ligand 1 (PD-L1, PDL1), Programmed Cell Death-Ligand 2 (PD-L2, PDL2)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

The main inclusion criteria include, but are not limited to the following:

Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV classical Hodgkin Lymphoma (cHL). Stage I and II participants may be enrolled, but must have at least one National Comprehensive Cancer Network (NCCN) unfavorable risk factor per protocol
Has measurable 2-fluorodeoxyglucose (FDG)-avid disease based on investigator assessment according to Lugano 2014 response criteria
Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy for the treatment of cHL before the first dose of study intervention
Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before the start of study intervention

Exclusion Criteria:

The main exclusion criteria include, but are not limited to the following:

Has confirmed nodular lymphocyte-predominant Hodgkin Lymphoma (HL)
Has an uncontrolled intercurrent cardiovascular illness
Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 protein (PD-L1), or anti- programmed cell death ligand 2 protein (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Has received or is expected to receive a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has a history or current evidence of pulmonary fibrosis
Has had an allogenic tissue/solid organ transplant

Sites / Locations

St Joseph Heritage Healthcare-Oncology ( Site 0004)
Stanford Cancer Center ( Site 0023)
Northwestern Memorial Hospital ( Site 0002)
OptumCare Cancer Care-Research Department ( Site 0005)
University of Tennessee Medical Center-Cancer Institute ( Site 0006)
Texas Oncology-Plano East ( Site 0020)
Liverpool Hospital-Haematology ( Site 0906)
Mater Misericordiae Limited ( Site 0904)
Princess Alexandra Hospital-Division of Cancer Services Trials Unit ( Site 0907)
Monash Health-Haematology Research ( Site 0908)
Peter MacCallum Cancer Centre ( Site 0905)
Cross Cancer Institute ( Site 0207)
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0205)
Jewish General Hospital ( Site 0200)
Hopital du Sacre-Coeur de Montreal ( Site 0206)
McGill University Health Centre ( Site 0209)
Centro Investigación del Cáncer James Lind ( Site 1200)
Instituto Nacional del Cancer ( Site 1205)
FALP-UIDO ( Site 1202)
Clínica Alemana de Santiago ( Site 1206)
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1204)
CHU Bordeaux Haut-Leveque ( Site 1505)
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou-haematology ( Site 1502)
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1504)
centre hospitalier lyon sud-Service Hématologie ( Site 1501)
Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen-Service d'Hématologie ( Si
Rambam Health Care Campus ( Site 1907)
Bnai Zion Medical Center-Hematology ( Site 1909)
Hadassah Medical Center ( Site 1901)
Sheba Medical Center-Hemato Oncology ( Site 1904)
ZIV Medical Center ( Site 1908)
Sourasky Medical Center ( Site 1905)
Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 1801)
ASST Grande Ospedale Metropolitano Niguarda ( Site 1803)
Policlinico S. Orsola- Malpighi-Istituto di Ematologia L. e A. Seragnoli ( Site 1800)
Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 1804)
Klinika Hematologii - Instytut Hematologii i Transfuzjologii-Klinika Hematologii ( Site 0402)
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Szpital Wojewódzki w Opolu-Hematology Department ( Site 0401)
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0403)
Moscow City Clinical Hospital S.P. Botkin ( Site 0702)
First Pavlov State Medical University of Saint Petersburg-Raisa Gorbacheva Memorial Institut for Pe
Almazov National Medical Research Centre ( Site 0704)
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 1031)
Hospital Universitario 12 de Octubre ( Site 1032)
Dokuz Eylül Üniversitesi ( Site 5002)
Ankara University Hospital Cebeci-hematology ( Site 5000)
Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 5001)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pembrolizumab Monotherapy + Chemotherapy + Pembrolizumab Consolidation

Arm Description

Participants receive pembrolizumab monotherapy followed by chemotherapy with doxorubicin in combination with vinblastine & dacarbazine (AVD) or chemotherapy with escalated bleomycin in combination with etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, & prednisone (escBEACOPP) followed by pembrolizumab consolidation. All participants receive pembrolizumab monotherapy intravenous (IV) for 3 cycles (cycle length = 3 weeks (wks); up to 9 wks). All participants receive AVD IV for 2 cycles (cycle length = 4 wks; up to 8 wks) after Positron Emission Tomography (PET) 2. Participants who are PET 3 -ve, or +ve & age ≥ 60 years, receive up to 4 additional cycles of AVD IV (cycle length = 4 wks, up to 16 wks), or up to 4 cycles of escBEACOPP IV if PET 3 +ve, age <60 years; cycle length = 3 wks; up to 12 wks. All participants receive pembrolizumab consolidation IV for 4 cycles (cycle length = 6 wks; up to 24 wks). Total treatment duration is up to 57 wks.

Outcomes

Primary Outcome Measures

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

The percentage of participants who have CR at the end of study intervention, after the completion of pembrolizumab consolidation, as assessed by ICR per Lugano 2014 response criteria will be presented.

Secondary Outcome Measures

CR at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria

The percentage of participants who have CR at the end of study intervention, after the completion of pembrolizumab consolidation, as assessed by the investigator per Lugano 2014 response criteria will be presented.

Duration of Complete Response (DurCR) as Assessed by Independent Central Review Per Lugano 2014 Response Criteria

DurCR is defined, only for the subgroup of participants who achieve CR, as the time from the first documentation of CR to disease progression or to death due to any cause, whichever comes first as assessed by the independent central review per Lugano 2014 response criteria.

Positron Emission Tomography (PET) Negativity by Independent Central Review Per 3-Fluorodeoxyglucose (FDG)-PET 5-point Scale After Administration of Pembrolizumab Monotherapy

The rate of PET negativity is defined as the percentage of participants with a score of 1, 2, or 3, assessed by independent central review according to the FDG-PET 5-point scale, after administration of pembrolizumab monotherapy. Per FDG-PET 5-point scale: Score 1= No uptake above the background, Score 2= Uptake ≤ mediastinum, Score 3= Uptake > mediastinum but ≤ liver, Score 4= Uptake moderately higher than liver, Score 5= Uptake markedly higher than liver or new lesions. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.

PET Negativity by Independent Central Review Per FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy and Chemotherapy

The rate of PET negativity is defined as the percentage of participants with a score of 1, 2, or 3, assessed by independent central review according to the FDG-PET 5-point scale, after administration of pembrolizumab monotherapy and chemotherapy. Per FDG-PET 5-point scale: Score 1= No uptake above the background, Score 2= Uptake ≤ mediastinum, Score 3= Uptake > mediastinum but ≤ liver, Score 4= Uptake moderately higher than liver, Score 5= Uptake markedly higher than liver or new lesions. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.

Number of Participants Who Experienced an Adverse Event (AE)

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. The number of participants who experienced an AE will be reported.

Number of Participants Who Discontinued Study Treatment Due to an AE

Full Information

NCT ID

NCT05008224

First Posted

August 13, 2021

Last Updated

October 24, 2023

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT05008224

Brief Title

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

Acronym

KEYNOTE-C11

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 7, 2021 (Actual)

Primary Completion Date

October 11, 2023 (Actual)

Study Completion Date

June 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

146 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pembrolizumab Monotherapy + Chemotherapy + Pembrolizumab Consolidation

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

MK-3475, SCH 900475, KEYTRUDA®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Other Intervention Name(s)

Adriamycin, DOXIL®, Rubex®

Intervention Description

25 mg/m^2 IV administered on Days 1 and 15 of each 4-week cycle for 2 cycles in all participants after PET2 and up to 4 additional cycles after PET3 (participants who are PET3 -ve, or +ve & ≥60 years of age). 35 mg/m^2 IV administered on Day 1 of each 3-week cycle for up to 4 cycles after PET3 (participants who are PET3 +ve, <60 years of age).

Intervention Type

Drug

Intervention Name(s)

Vinblastine

Other Intervention Name(s)

Alkaban-AQ®, Velban®

Intervention Description

6 mg/m^2 IV administered on Days 1 and 15 of each 4-week cycle for 2 cycles after PET2 (all participants) and up to 4 additional cycles after PET3 (participants who are PET3 -ve, or +ve & ≥60 years of age).

Intervention Type

Drug

Intervention Name(s)

Dacarbazine

Other Intervention Name(s)

Dtic-Dome®

Intervention Description

375 mg/m^2 IV on Days 1 and 15 of each 4-week cycle for 2 cycles after PET2 (all participants) and up to 4 additional cycles after PET3 (participants who are PET3 -ve, or +ve & ≥60 years of age).

Intervention Type

Drug

Intervention Name(s)

Bleomycin

Other Intervention Name(s)

Blenoxane®

Intervention Description

10 units/m^2 IV administered on Day 8 of each 3-week cycle for up to 4 cycles after PET3 (participants who are PET3 +ve & <60 years of age).

Intervention Type

Drug

Intervention Name(s)

Etoposide

Other Intervention Name(s)

Toposar®, VePesid®, Etopophos®, VP-16, Etoposide phosphate

Intervention Description

200 mg/m^2 IV administered on Days 1-3 of each 3-week cycle for up to 4 cycles after PET3 (participants who are PET3 +ve & <60 years of age).

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

Neosar®, Cytoxan®

Intervention Description

1250 mg/m^2 IV administered on Day 1 of each 3-week cycle for up to 4 cycles after PET3 (participants who are PET3 +ve & <60 years of age).

Intervention Type

Drug

Intervention Name(s)

Vincristine

Other Intervention Name(s)

Oncovin®, Vincasar PFS®

Intervention Description

1.4 mg/m^2 IV on Day 8 of each 3-week cycle for up to 4 cycles after PET3 (participants who are PET3 +ve &<60 years of age).

Intervention Type

Drug

Intervention Name(s)

Procarbazine

Other Intervention Name(s)

Matulane®

Intervention Description

100 mg/m^2 orally (PO) administered on Days 1-7 of each 3-week cycle for up to 4 cycles after PET3 (participants who are PET3 +ve & <60 years of age).

Intervention Type

Drug

Intervention Name(s)

Prednisone

Other Intervention Name(s)

Liquid Pred®, Meticorten®, Orasone®, Deltasone®

Intervention Description

40 mg/m^2 PO administered on Days 1-14 of each 3-week cycle for up to 4 cycles after PET3 (participants who are PET3 +ve & <60 years of age).

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Up to approximately 57 weeks

Secondary Outcome Measure Information:

Title

CR at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria

Description

Time Frame

Up to approximately 57 weeks

Title

Duration of Complete Response (DurCR) as Assessed by Independent Central Review Per Lugano 2014 Response Criteria

Description

Time Frame

Up to approximately 72 months

Title

Positron Emission Tomography (PET) Negativity by Independent Central Review Per 3-Fluorodeoxyglucose (FDG)-PET 5-point Scale After Administration of Pembrolizumab Monotherapy

Description

Time Frame

Up to approximately 9 weeks

Title

PET Negativity by Independent Central Review Per FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy and Chemotherapy

Description

The rate of PET negativity is defined as the percentage of participants with a score of 1, 2, or 3, assessed by independent central review according to the FDG-PET 5-point scale, after administration of pembrolizumab monotherapy and chemotherapy. Per FDG-PET 5-point scale: Score 1= No uptake above the background, Score 2= Uptake ≤ mediastinum, Score 3= Uptake > mediastinum but ≤ liver, Score 4= Uptake moderately higher than liver, Score 5= Uptake markedly higher than liver or new lesions. In the present study, scores of 1, 2 and 3 are considered to be negative and scores of 4 and 5 are considered to be positive.

Time Frame

Up to approximately 17 weeks

Title

Number of Participants Who Experienced an Adverse Event (AE)

Description

Time Frame

Up to approximately 64 weeks

Title

Number of Participants Who Discontinued Study Treatment Due to an AE

Description

Time Frame

Up to approximately 57 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The main inclusion criteria include, but are not limited to the following: Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV classical Hodgkin Lymphoma (cHL). Stage I and II participants may be enrolled, but must have at least one National Comprehensive Cancer Network (NCCN) unfavorable risk factor per protocol Has measurable 2-fluorodeoxyglucose (FDG)-avid disease based on investigator assessment according to Lugano 2014 response criteria Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy for the treatment of cHL before the first dose of study intervention Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before the start of study intervention Exclusion Criteria: The main exclusion criteria include, but are not limited to the following: Has confirmed nodular lymphocyte-predominant Hodgkin Lymphoma (HL) Has an uncontrolled intercurrent cardiovascular illness Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 protein (PD-L1), or anti- programmed cell death ligand 2 protein (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor Has received or is expected to receive a live or live-attenuated vaccine within 30 days before the first dose of study intervention Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication Has a known additional malignancy that is progressing or has required active treatment within the past 5 years Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis Has an active autoimmune disease that has required systemic treatment in past 2 years Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease Has a history or current evidence of pulmonary fibrosis Has had an allogenic tissue/solid organ transplant

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

St Joseph Heritage Healthcare-Oncology ( Site 0004)

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Stanford Cancer Center ( Site 0023)

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Northwestern Memorial Hospital ( Site 0002)

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

OptumCare Cancer Care-Research Department ( Site 0005)

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89102

Country

United States

Facility Name

University of Tennessee Medical Center-Cancer Institute ( Site 0006)

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

Texas Oncology-Plano East ( Site 0020)

City

Plano

State/Province

Texas

ZIP/Postal Code

75075

Country

United States

Facility Name

Liverpool Hospital-Haematology ( Site 0906)

City

Liverpool

State/Province

New South Wales

ZIP/Postal Code

2170

Country

Australia

Facility Name

Mater Misericordiae Limited ( Site 0904)

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4101

Country

Australia

Facility Name

Princess Alexandra Hospital-Division of Cancer Services Trials Unit ( Site 0907)

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Monash Health-Haematology Research ( Site 0908)

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

Facility Name

Peter MacCallum Cancer Centre ( Site 0905)

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

Facility Name

Cross Cancer Institute ( Site 0207)

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0205)

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2H1

Country

Canada

Facility Name

Jewish General Hospital ( Site 0200)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Hopital du Sacre-Coeur de Montreal ( Site 0206)

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

McGill University Health Centre ( Site 0209)

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H4A 3J1

Country

Canada

Facility Name

Centro Investigación del Cáncer James Lind ( Site 1200)

City

Temuco

State/Province

Araucania

ZIP/Postal Code

4780000

Country

Chile

Facility Name

Instituto Nacional del Cancer ( Site 1205)

City

Chile

State/Province

Region M. De Santiago

ZIP/Postal Code

8380455

Country

Chile

Facility Name

FALP-UIDO ( Site 1202)

City

Santiago

State/Province

Region M. De Santiago

ZIP/Postal Code

6900941

Country

Chile

Facility Name

Clínica Alemana de Santiago ( Site 1206)

City

Santiago

State/Province

Region M. De Santiago

ZIP/Postal Code

8320325

Country

Chile

Facility Name

Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1204)

City

Santiago

State/Province

Region M. De Santiago

ZIP/Postal Code

8330032

Country

Chile

Facility Name

CHU Bordeaux Haut-Leveque ( Site 1505)

City

Pessac

State/Province

Aquitaine

ZIP/Postal Code

33600

Country

France

Facility Name

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou-haematology ( Site 1502)

City

Rennes

State/Province

Bretagne

ZIP/Postal Code

35033

Country

France

Facility Name

Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand ( Site 1504)

City

Dijon

State/Province

Cote-d Or

ZIP/Postal Code

21000

Country

France

Facility Name

centre hospitalier lyon sud-Service Hématologie ( Site 1501)

City

Pierre-Bénite

State/Province

Rhone

ZIP/Postal Code

69310

Country

France

Facility Name

Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen-Service d'Hématologie ( Si

City

Rouen

State/Province

Seine-Maritime

ZIP/Postal Code

76000

Country

France

Facility Name

Rambam Health Care Campus ( Site 1907)

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Bnai Zion Medical Center-Hematology ( Site 1909)

City

Haifa

ZIP/Postal Code

3339419

Country

Israel

Facility Name

Hadassah Medical Center ( Site 1901)

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Sheba Medical Center-Hemato Oncology ( Site 1904)

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Facility Name

ZIV Medical Center ( Site 1908)

City

Safed

ZIP/Postal Code

1311001

Country

Israel

Facility Name

Sourasky Medical Center ( Site 1905)

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 1801)

City

Brescia

State/Province

Lombardia

ZIP/Postal Code

25123

Country

Italy

Facility Name

ASST Grande Ospedale Metropolitano Niguarda ( Site 1803)

City

Milan

State/Province

Milano

Country

Italy

Facility Name

Policlinico S. Orsola- Malpighi-Istituto di Ematologia L. e A. Seragnoli ( Site 1800)

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 1804)

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Klinika Hematologii - Instytut Hematologii i Transfuzjologii-Klinika Hematologii ( Site 0402)

City

Warsaw

State/Province

Mazowieckie

ZIP/Postal Code

02-776

Country

Poland

Facility Name

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

City

Warszawa

State/Province

Mazowieckie

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Szpital Wojewódzki w Opolu-Hematology Department ( Site 0401)

City

Opole

State/Province

Opolskie

ZIP/Postal Code

46-020

Country

Poland

Facility Name

Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0403)

City

Gdańsk

State/Province

Pomorskie

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Moscow City Clinical Hospital S.P. Botkin ( Site 0702)

City

Moscow

State/Province

Moskva

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

First Pavlov State Medical University of Saint Petersburg-Raisa Gorbacheva Memorial Institut for Pe

City

Saint Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Almazov National Medical Research Centre ( Site 0704)

City

Saint Petersburg

State/Province

Sankt-Peterburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 1031)

City

L'Hospitalet Del Llobregat

State/Province

Barcelona

ZIP/Postal Code

08908

Country

Spain

Facility Name

Hospital Universitario 12 de Octubre ( Site 1032)

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Dokuz Eylül Üniversitesi ( Site 5002)

City

Balçova

State/Province

Izmir

Country

Turkey

Facility Name

Ankara University Hospital Cebeci-hematology ( Site 5000)

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 5001)

City

Istanbul

ZIP/Postal Code

34365

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

36083129

Citation

Allen PB, Lu X, Chen Q, O'Shea K, Chmiel JS, Slonim LB, Sukhanova M, Savas H, Evens AM, Advani R, Pro B, Karmali R, Palmer B, Bayer RA, Eisner RM, Mou E, Dillehay G, Gordon LI, Winter JN. Sequential pembrolizumab and AVD are highly effective at any PD-L1 expression level in untreated Hodgkin lymphoma. Blood Adv. 2023 Jun 27;7(12):2670-2676. doi: 10.1182/bloodadvances.2022008116.

Results Reference

derived

Links:

URL

https://www.merckclinicaltrials.com/

Description

Merck Clinical Trials Information

URL

https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-C11&kw=3475-C11

Description

Plain Language Summary

Learn more about this trial

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

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