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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03598608
Registration number
NCT03598608
Ethics application status
Date submitted
16/07/2018
Date registered
26/07/2018
Date last updated
25/04/2024
Titles & IDs
Public title
Study to Evaluate the Safety and Efficacy of a Combination of Favezelimab (MK-4280) and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003)
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Scientific title
A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies
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Secondary ID [1]
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MK-4280-003
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Secondary ID [2]
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4280-003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hodgkin Disease
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Lymphoma, Non-Hodgkin
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Lymphoma, B-Cell
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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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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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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
Other interventions - pembrolizumab
Other interventions - Favezelimab
Experimental: Part A: Favezelimab Dose A+pembrolizumab - Participants receive 200 mg pembrolizumab by intravenous (IV) infusion followed by favezelimab Dose A by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Experimental: Part A: Favezelimab Dose B+pembrolizumab - Participants receive 200 mg pembrolizumab by IV infusion followed by favezelimab Dose B by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Experimental: Part A: Favezelimab Dose C+Pembrolizumab - Participants receive 200 mg pembrolizumab by IV infusion followed by favezelimab Dose C by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Experimental: Part B: cHL-Combination Therapy - Participants with cHL receive 200 mg pembrolizumab by IV infusion followed by the recommended Phase 2 dose (RP2D) of favezelimab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Experimental: Part B: DLBCL-Combination Therapy - Participants with DLBCL receive 200 mg pembrolizumab by IV infusion followed by the RP2D of favezelimab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Experimental: Part B: iNHL-Combination Therapy - Participants with iNHL receive 200 mg pembrolizumab by IV infusion followed by the RP2D of favezelimab by IV infusion on Day 1 of each 3-week cycle for up to 35 cycles (up to approximately 2 years).
Experimental: Part B: Randomized cHL-Monotherapy - Participants with cHL receive either pembrolizumab by IV infusion or the RP2D of favezelimab by IV infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles (up to approximately 2 years).
Other interventions: pembrolizumab
Administered as an IV infusion every 3 weeks (Q3W)
Other interventions: Favezelimab
Administered as an IV infusion Q3W
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Intervention code [1]
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Other interventions
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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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Percentage of Participants Experiencing a Dose-limiting Toxicity (DLT)
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Assessment method [1]
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DLT will be defined as any drug-related adverse event (AE) observed during the DLT evaluation period (Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle and reported as the percentage of participants experiencing a DLT defined by the National Cancer Institute Common Terminology for Adverse Events version 4.0.
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Timepoint [1]
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Cycle 1 (up to 21 days)
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Primary outcome [2]
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Percentage of Participants Experiencing an Adverse Event (AE)
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Assessment method [2]
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Percentage of participants experiencing an AE defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study therapy and irrespective of causality to study treatment
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Timepoint [2]
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From time of signing informed consent form (ICF) until the end of follow-up (up to approximately 27 months)
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Primary outcome [3]
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Percentage of Participants with Treatment Discontinuations Due to an AE
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Assessment method [3]
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Percentage of participants discontinuing study treatment due to an AE
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Timepoint [3]
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From time of signing informed consent form (ICF) until the end of study treatment (up to approximately 24 months)
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants in the analysis population who had a Complete Response or a Partial Response per lymphoma disease response criteria (Cheson et. al., 2007) as assessed by the investigator.
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Timepoint [1]
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Up to approximately 24 months
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Secondary outcome [2]
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Serum Concentration of Favezelimab
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Assessment method [2]
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Blood samples will be collected at designated time points for the determination of the serum concentration of favezelimab. For Cycles 1 and 8: Day 1 at predose, end of infusion, and 4 hours postdose; Days 8 and 15 at any time. Cycles 2 through 7, Cycles 9 through 16 and every 4 cycles thereafter: Day 1 at predose. Blood samples will also be collected at the 30-day follow-up visit.
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Timepoint [2]
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At designated time points (Up to approximately 25 months)
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Secondary outcome [3]
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Serum Concentration of Pembrolizumab
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Assessment method [3]
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Blood samples will be collected at designated time points for the determination of the serum concentration of pembrolizumab. For Cycles 1 and 8: Day 1 at predose, end of infusion, and 4 hours postdose; Days 8 and 15 at any time. Cycles 2 through 7, Cycles 9 through 16 and every 4 cycles thereafter: Day 1 at predose. Blood samples will also be collected at the 30-day follow-up visit.
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Timepoint [3]
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At designated time points (Up to approximately 25 months)
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Eligibility
Key inclusion criteria
- Has measurable disease, defined as =1 lesion that can be accurately measured in 2
dimensions with diagnostic quality cross sectional anatomic imaging (computed
tomography or magnetic resonance imaging). Minimum measurement must be >15 mm in the
longest diameter or >10 mm in the short axis
- Is able to provide a core or excisional tumor biopsy for biomarker analysis from an
archival (within 3 months) or newly obtained biopsy at screening
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
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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
- Has known clinically active central nervous system (CNS) involvement
- Has received prior therapy with an anti-lymphocyte activation gene-3 (LAG-3) antibody
- Has received chimeric antigen receptors (CAR)-T-cell therapy for cHL and DLBCL Cohorts
- Has received prior anticancer therapy or thoracic radiation therapy within 14 days
before the first dose of study treatment
- Has =Grade 2 non-hematological residual toxicities from prior therapy
- Has had a prior anticancer monoclonal antibody within 4 weeks prior to study Day 1 or
who has not recovered (i.e., =Grade 1 or at baseline) from AEs due to agents
administered =4 weeks earlier
- Has received a live vaccine within 30 days prior to first dose of study treatment.
Administration of killed vaccines are allowed
- Has received an investigational agent or used an investigational device within 4 weeks
prior to intervention administration
- 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 drug
- Has a known additional malignancy that is progressing or requires active treatment
with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the
skin, or in situ cervical cancer that has undergone potentially curative therapy
- Has active autoimmune disease that has required systemic treatment in past 2 years
(i.e., with use of disease modifying agents, corticosteroids or immunosuppressive
drugs)
- Has a history of (non-infectious) pneumonitis that required steroids or current
pneumonitis
- Has an active infection requiring intravenous systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection
- Has known, active hepatitis B or hepatitis C infection
- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of study treatment
- Has had an allogeneic hematopoetic stem cell/solid organ transplantation within the
last 5 years
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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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
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
17/10/2018
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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
19/04/2028
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Actual
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Sample size
Target
174
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Concord Repatriation & General Hospital ( Site 0203) - Concord
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Recruitment hospital [2]
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Princess Alexandra Hospital ( Site 0204) - Woollongabba
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Recruitment hospital [3]
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Monash Health ( Site 0201) - Clayton
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Recruitment hospital [4]
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St Vincent s Hospital (Melbourne) Limited ( Site 0202) - Fitzroy
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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4102 - Woollongabba
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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Pennsylvania
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Country [5]
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United States of America
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State/province [5]
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Texas
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Country [6]
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Canada
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State/province [6]
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British Columbia
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Country [7]
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Canada
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State/province [7]
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Manitoba
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Country [8]
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Canada
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State/province [8]
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Ontario
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Country [9]
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Canada
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State/province [9]
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Quebec
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Country [10]
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Germany
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State/province [10]
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Nordrhein-Westfalen
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Country [11]
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Germany
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State/province [11]
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Sachsen
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Country [12]
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Israel
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State/province [12]
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Haifa
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Country [13]
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Israel
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State/province [13]
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Jerusalem
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Country [14]
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Israel
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State/province [14]
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Ramat Gan
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Country [15]
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Israel
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State/province [15]
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Tel Aviv
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Country [16]
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Italy
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State/province [16]
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Emilia-Romagna
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Country [17]
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Italy
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Forli-Cesena
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Country [18]
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Italy
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State/province [18]
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Milano
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the safety and efficacy of favezelimab (MK-4280) in combination with
pembrolizumab (MK-3475) using a non-randomized study design in participants with the
following hematological malignancies:
- classical Hodgkin lymphoma (cHL)
- diffuse large B-cell lymphoma (DLBCL)
- indolent non-Hodgkin lymphoma (iNHL)
This study will also evaluate the safety and efficacy of pembrolizumab or favezelimab
administered as monotherapy in participants with cHL using a 1:1 randomized study design.
The study will have 2 phases: a safety lead-in and an efficacy expansion phase. The
recommended Phase 2 dose (RP2D) will be determined in the safety lead-in phase by evaluating
dose-limiting toxicities.
There is no primary hypothesis for this study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03598608
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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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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Toll Free Number
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Address
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Phone
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1-888-577-8839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03598608
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