Pembrolizumab for Classical Hodgkin lymphoma | Primary mediastinal large B-cell lymphoma

Inclusion criteria

• {"criterion_text":"- Histologically confirmed diagnosis of classical Hodgkin lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL)"}
• {"criterion_text":"- Radiographically measurable cHL or PMBCL disease assessed by investigator as per Lugano classification"}
• {"criterion_text":"- Has a life expectancy of > 3 months"}
• {"criterion_text":"- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)"}
• {"criterion_text":"- 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 randomization"}
• {"criterion_text":"- Participants with history of hepatitis C virus (HCV) infection are eligible if they have completed curative antiviral therapy at least 4 weeks before randomization and HCV viral load is undetectable at screening"}
• {"criterion_text":"- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before or on the day of the first dose of study intervention"}

Exclusion criteria

• {"criterion_text":"- Has clinically significant (ie, active) cardiovascular disease."}
• {"criterion_text":"- Is receiving systemic antineoplastic chemotherapy, immunotherapy, or biological therapy not specified in this protocol"}
• {"criterion_text":"- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis"}
• {"criterion_text":"- Active autoimmune disease that has required systemic treatment in the past 2 years"}
• {"criterion_text":"- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease"}
• {"criterion_text":"- Active infection requiring systemic therapy except certain protocol-specified therapies"}
• {"criterion_text":"- Concurrent active hepatitis B and hepatitis C virus infection"}
• {"criterion_text":"- Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplant (SCT) within the last 5 years"}
• {"criterion_text":"- Has pericardial effusion or clinically significant pleural effusion"}
• {"criterion_text":"- Has known additional malignancy that is progressing or has required active treatment within the past 2 years"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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 AEs due to agents administered more than 4 weeks earlier"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention"}
• {"criterion_text":"- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids"}
• {"criterion_text":"- Received a live or live-attenuated vaccine within 30 days before first dose of study intervention"}

Primary endpoints

• {"endpoint_text":"- Maximum Concentration (Cmax) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase","definition_or_measurement_approach":"Cmax of pembrolizumab measured following subcutaneous (SC) administration of MK-3475A (Cycle 1) as PK parameter."}
• {"endpoint_text":"- Lowest Plasma Concentration (Ctrough) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase","definition_or_measurement_approach":"Ctrough (lowest plasma concentration) of pembrolizumab measured following SC administration of MK-3475A (Cycle 1) as PK parameter."}
• {"endpoint_text":"- Area Under the Concentration-Time Curve of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase from Week 0-Week 6 (AUC0-6weeks)","definition_or_measurement_approach":"AUC from Week 0 to Week 6 for pembrolizumab following SC administration of MK-3475A (Cycle 1) as PK parameter."}
• {"endpoint_text":"- Objective Response Rate (ORR) per Lugano Classification Criteria as Assessed by Investigator","definition_or_measurement_approach":"ORR assessed by investigator according to Lugano classification criteria (tumor response assessment)."}

Secondary endpoints

• {"endpoint_text":"- Maximum Concentration (Cmax) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase at Steady-State","definition_or_measurement_approach":"Cmax measured at steady-state (Cycle 3) following SC MK-3475A administration."}
• {"endpoint_text":"- Lowest Plasma Concentration (Ctrough) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase at Steady-State","definition_or_measurement_approach":"Ctrough measured at steady-state (Cycle 3) following SC MK-3475A administration."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"AUC0-6weeks at steady-state following SC MK-3475A administration."}
• {"endpoint_text":"- Number of Participants with Antidrug Antibodies (ADA) Level of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase","definition_or_measurement_approach":"Number of participants with detectable anti-pembrolizumab antibodies (ADA) after SC MK-3475A administration."}
• {"endpoint_text":"- Number of Participants Experiencing an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants experiencing any adverse event (AE) during the study."}
• {"endpoint_text":"- Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants who discontinue study treatment because of an AE."}
• {"endpoint_text":"- Duration of Response (DOR) per Lugano Classification Criteria as Assessed by Investigator","definition_or_measurement_approach":"Duration of response assessed per Lugano classification criteria as determined by investigator."}

Poland

Earliest CTIS Part Ii Submission Date

14-08-2024

Latest Decision Or Authorization Date

03-02-2026

Processing Time Days

538

Number Of Sites

3

Number Of Participants

20

Spain

Earliest CTIS Part Ii Submission Date

21-08-2024

Latest Decision Or Authorization Date

17-02-2026

Processing Time Days

545

Number Of Sites

3

Number Of Participants

6

Germany

Earliest CTIS Part Ii Submission Date

22-11-2024

Latest Decision Or Authorization Date

03-02-2026

Processing Time Days

438

Number Of Sites

1

Number Of Participants

4

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Global Central Labs

Name

Parexel International Corp.

Responsibilities

EUB services (call center and medical services)

Name

Bioclinica Inc.

Responsibilities

Central imaging

Name

Almac Clinical Services LLC

Third parties

• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central imaging","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}