Ph2 Study of MK-3475A in Hematologic Malignances in Participants with Relapsed or Refractory Classical Hodgkin Lymphoma or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma

Phase 2

Recruiting

• Conditions: Relapsed or Refractory Classical Hodgkin’s Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)

• Registration Number: 2024-510969-42-00
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

1. To characterize the pharmacokinetics (PK) profile of pembrolizumab following subcutaneous (SC) injection of MK-3475A (Cycle 1)

2. To evaluate MK-3475A SC by cohort with respect to objective response rate (ORR) as assessed by the investigator according to Lugano classification criteria

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-09-16
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

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

Has 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 randomization

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

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study intervention

Exclusion Criteria

Has clinically significant (ie, active) cardiovascular disease.

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

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 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

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) per Lugano Classification Criteria as Assessed by Investigator		Objective Response Rate (ORR) per Lugano Classification Criteria as Assessed by Investigator
Maximum Concentration (Cmax) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase		Maximum Concentration (Cmax) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase
Lowest Plasma Concentration (Ctrough) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase		Lowest Plasma Concentration (Ctrough) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase
Area Under the Concentration-Time Curve of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase from Week 0-Week 6 (AUC0-6weeks)		Area Under the Concentration-Time Curve of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase from Week 0-Week 6 (AUC0-6weeks)

Secondary Outcome Measures

Name	Time	Method
Maximum Concentration (Cmax) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase at Steady State		Maximum Concentration (Cmax) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase at Steady State
Lowest Plasma Concentration (Ctrough) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase at Steady State		Lowest Plasma Concentration (Ctrough) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase at Steady State
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		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
Number of Participants with Antidrug Antibodies (ADA) Level of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase		Number of Participants with Antidrug Antibodies (ADA) Level of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase
Number of Participants Experiencing an Adverse Event (AE)		Number of Participants Experiencing an Adverse Event (AE)
Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)		Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)
Duration of Response (DOR) per Lugano Classification Criteria as Assessed by Investigator		Duration of Response (DOR) per Lugano Classification Criteria as Assessed by Investigator

Trial Locations

Locations (7)

Institut Catala D'oncologia; 🇪🇸 L'hospitalet De Llobregat, Spain

Hospital Universitario 12 De Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario De Salamanca; 🇪🇸 Salamanca, Spain

Uniwersyteckie Centrum Kliniczne; 🇵🇱 Gdansk, Poland

Pratia S.A.; 🇵🇱 Cracow, Poland

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy; 🇵🇱 Warsaw, Poland

Universitaetsklinikum Essen AöR; 🇩🇪 Essen, Germany

Institut Catala D'oncologia

🇪🇸L'hospitalet De Llobregat, Spain

Ana Sureda

Site contact

+34932607750

asureda@iconcologia.net