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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06504394




Registration number
NCT06504394
Ethics application status
Date submitted
11/07/2024
Date registered
16/07/2024

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Coformulated With Berahyaluronidase Alfa (MK-3475A) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)(MK-3475A-F65)
Scientific title
A Phase 2 Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)
Secondary ID [1] 0 0
MK-3475A-065
Secondary ID [2] 0 0
3475A-F65
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Classical Hodgkin Lymphoma Recurrent 0 0
Classical Hodgkin Lymphoma Refractory 0 0
Primary Mediastinal Large B-cell Lymphoma Recurrent 0 0
Primary Mediastinal Large B-cell Lymphoma Refractory 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab (+) Berahyaluronidase alfa

Experimental: Pembrolizumab Coformulated With Hyaluronidase - Participants with rrCHL and rrPMBCL receive pembrolizumab coformulated with hyaluronidase subcutaneous (SC) injection on Day 1 of each 6-week cycle (Q6W) for up to 18 cycles (approximately 2 years) until documented disease progression per investigator assessment.


Treatment: Other: Pembrolizumab (+) Berahyaluronidase alfa
SC injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) per Lugano Classification Criteria as Assessed by Investigator
Timepoint [1] 0 0
Up to approximately 48 months
Primary outcome [2] 0 0
Maximum Concentration (Cmax) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase
Timepoint [2] 0 0
At designated time points (up to ~6 weeks)
Primary outcome [3] 0 0
Lowest Plasma Concentration (Ctrough) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase
Timepoint [3] 0 0
At designated time points (up to ~6 weeks)
Primary outcome [4] 0 0
Area Under the Concentration-Time Curve of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase from Week 0-Week 6 (AUC0-6weeks)
Timepoint [4] 0 0
At designated time points (up to ~6 weeks)
Secondary outcome [1] 0 0
Duration of Response (DOR) per Lugano Classification Criteria as Assessed by Investigator
Timepoint [1] 0 0
Up to approximately 48 months
Secondary outcome [2] 0 0
Number of Participants with Antidrug Antibodies (ADA) Level of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase
Timepoint [2] 0 0
At designated timepoints (Up to approximately 27 months)
Secondary outcome [3] 0 0
Maximum Concentration (Cmax) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase at Steady State
Timepoint [3] 0 0
At designated time points (up to ~6 weeks)
Secondary outcome [4] 0 0
Lowest Plasma Concentration (Ctrough) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase at Steady State
Timepoint [4] 0 0
At designated time points (up to ~6 weeks)
Secondary outcome [5] 0 0
Area Under the Concentration-Time Curve of Pembrolizumab After Administration of SC Pembrolizumab coformulated with Hyaluronidase from Week 0-Week 6 (AUC0-6weeks) at Steady State
Timepoint [5] 0 0
At designated time points (up to ~6 weeks)
Secondary outcome [6] 0 0
Number of Participants Experiencing an Adverse Event (AE)
Timepoint [6] 0 0
Up to approximately 30 months
Secondary outcome [7] 0 0
Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)
Timepoint [7] 0 0
Up to approximately 2 years

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

* Histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL)
* Radiographically measurable cHL or PMBCL disease assessed by investigator as per Lugano classification
* Have a life expectancy of >3 months
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before enrollment
* Participants with history of hepatitis C virus (HCV) infection are eligible if they have completed curative antiviral therapy at least 4 weeks before enrollment and HCV viral load is undetectable at screening
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study intervention
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The main exclusion criteria include but are not limited to the following:

* Has clinically significant (i.e., active) cardiovascular disease
* Has pericardial effusion or clinically significant pleural effusion
* Has known additional malignancy that is progressing or has required active treatment within the past 2 years
* Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
* Received prior monoclonal antibody within 4 weeks prior to first dose of study intervention or has not recovered (i.e., =Grade 1 or at baseline) from adverse events (AEs) due to agents administered more than 4 weeks earlier
* Received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before first dose of study intervention
* Is receiving systemic antineoplastic chemotherapy, immunotherapy, or biological therapy not specified in this protocol
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Active autoimmune disease that has required systemic treatment in the past 2 years
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Active infection requiring systemic therapy
* Concurrent active hepatitis B and hepatitis C virus infection
* Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplant (SCT) within the last 5 years

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/10/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/11/2028
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital ( Site 0901) - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Chile
State/province [2] 0 0
Biobio
Country [3] 0 0
Chile
State/province [3] 0 0
Coquimbo
Country [4] 0 0
Chile
State/province [4] 0 0
Region M. De Santiago
Country [5] 0 0
Germany
State/province [5] 0 0
Nordrhein-Westfalen
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul
Country [7] 0 0
Mexico
State/province [7] 0 0
Distrito Federal
Country [8] 0 0
Mexico
State/province [8] 0 0
Oaxaca
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
Poland
State/province [10] 0 0
Malopolskie
Country [11] 0 0
Poland
State/province [11] 0 0
Mazowieckie
Country [12] 0 0
Poland
State/province [12] 0 0
Pomorskie
Country [13] 0 0
Poland
State/province [13] 0 0
Slaskie
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Spain
State/province [15] 0 0
Castilla Y Leon
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
Turkey
State/province [17] 0 0
Ankara
Country [18] 0 0
Turkey
State/province [18] 0 0
Samsun
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Denbighshire
Country [20] 0 0
United Kingdom
State/province [20] 0 0
London, City Of
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Oxfordshire
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06504394