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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05008224
Registration number
NCT05008224
Ethics application status
Date submitted
13/08/2021
Date registered
17/08/2021
Date last updated
25/06/2024
Titles & IDs
Public title
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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Scientific title
Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)
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Secondary ID [1]
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MK-3475-C11
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Secondary ID [2]
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3475-C11
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Universal Trial Number (UTN)
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Trial acronym
KEYNOTE-C11
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Classical Hodgkin Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Hodgkin's
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vinblastine
Treatment: Drugs - Dacarbazine
Treatment: Drugs - Bleomycin
Treatment: Drugs - Etoposide
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Vincristine
Treatment: Drugs - Procarbazine
Treatment: Drugs - Prednisone
Experimental: Pembrolizumab Monotherapy + Chemotherapy + Pembrolizumab Consolidation - 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.
Treatment: Other: Pembrolizumab
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.
Treatment: Drugs: Doxorubicin
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).
Treatment: Drugs: Vinblastine
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).
Treatment: Drugs: Dacarbazine
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).
Treatment: Drugs: Bleomycin
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).
Treatment: Drugs: Etoposide
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).
Treatment: Drugs: Cyclophosphamide
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).
Treatment: Drugs: Vincristine
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).
Treatment: Drugs: Procarbazine
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).
Treatment: Drugs: Prednisone
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).
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Complete Response (CR) at the End of Study Intervention as Assessed by Independent Central Review (ICR) Per Lugano 2014 Response Criteria
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 57 weeks
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Secondary outcome [1]
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CR at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 57 weeks
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Secondary outcome [2]
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Duration of Complete Response (DurCR) as Assessed by Independent Central Review Per Lugano 2014 Response Criteria
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 72 months
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Secondary outcome [3]
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Positron Emission Tomography (PET) Negativity by Independent Central Review Per 3-Fluorodeoxyglucose (FDG)-PET 5-point Scale After Administration of Pembrolizumab Monotherapy
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Assessment method [3]
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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.
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Timepoint [3]
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Up to approximately 9 weeks
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Secondary outcome [4]
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PET Negativity by Independent Central Review Per FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy and Chemotherapy
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Assessment method [4]
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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.
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Timepoint [4]
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Up to approximately 17 weeks
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Secondary outcome [5]
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Number of Participants Who Experienced an Adverse Event (AE)
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Assessment method [5]
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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.
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Timepoint [5]
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Up to approximately 64 weeks
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Secondary outcome [6]
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Number of Participants Who Discontinued Study Treatment Due to an AE
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Assessment method [6]
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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 discontinue study treatment due to an AE will be reported.
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Timepoint [6]
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Up to approximately 57 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/05/2024
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Sample size
Target
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Accrual to date
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Final
146
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Liverpool Hospital-Haematology ( Site 0906) - Liverpool
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Recruitment hospital [2]
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Mater Misericordiae Limited ( Site 0904) - Brisbane
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Recruitment hospital [3]
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Princess Alexandra Hospital-Division of Cancer Services Trials Unit ( Site 0907) - Woolloongabba
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Recruitment hospital [4]
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Monash Health-Haematology Research ( Site 0908) - Clayton
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Recruitment hospital [5]
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Peter MacCallum Cancer Centre ( Site 0905) - Melbourne
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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4101 - Brisbane
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3000 - Melbourne
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Recruitment outside Australia
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United States of America
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California
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Illinois
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Nevada
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United States of America
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Tennessee
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Texas
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Canada
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Alberta
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Canada
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Quebec
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Chile
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Araucania
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Chile
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Region M. De Santiago
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France
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Aquitaine
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France
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Bretagne
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France
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Cote-d Or
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France
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France
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Seine-Maritime
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Ramat Gan
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Israel
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Safed
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Israel
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Tel Aviv
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Italy
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Lombardia
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Italy
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Milano
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Italy
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Bologna
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Italy
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Roma
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Poland
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Mazowieckie
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Opolskie
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Poland
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Pomorskie
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Russian Federation
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Moskva
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Russian Federation
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Sankt-Peterburg
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Spain
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Barcelona
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Spain
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Madrid
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Turkey
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Izmir
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Turkey
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Ankara
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Turkey
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State/province [33]
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Istanbul
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05008224
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/study/NCT05008224
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