Pembrolizumab for Classical Hodgkin lymphoma | Melanoma | Solid tumours (MSI-H/dMMR) | Solid tumours (TMB-H)

Inclusion criteria

• {"criterion_text":"- Must have 1 of the following histologically or cytologically confirmed diagnosis of Relapsed or refractory classical Hodgkin lymphoma (cHL), that may be programmed cell death 1 protein (PD-1) naïve or PD-1 exposed (eligible for Arm 1 only), advanced melanoma that may be PD-1 naïve or PD-1 exposed (eligible for Arm 2 only), solid tumors that are microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR), that may be PD-1 naïve or PD-1 exposed (eligible for Arm 2 only) or solid tumors that are tumor mutational burden-high (TMB-H), that may be PD-1 naïve or PD-1 exposed (eligible for Arm 2 only)."}
• {"criterion_text":"- Must have recovered from all AEs from previous anticancer therapies"}
• {"criterion_text":"- Human immunodeficiency virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy (ART)"}

Exclusion criteria

• {"criterion_text":"- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease."}
• {"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."}
• {"criterion_text":"- Concurrent active Hepatitis B and Hepatitis C virus infection."}
• {"criterion_text":"- History of allogenic tissue/solid organ transplant."}
• {"criterion_text":"- Has symptoms of or is being treated for graft versus host disease (GVHD)"}
• {"criterion_text":"- Has not adequately recovered from major surgery or have ongoing surgical complications."}
• {"criterion_text":"- Known tumors involving the brainstem."}
• {"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 the first dose of study intervention."}
• {"criterion_text":"- Received prior anticancer therapy with an anti-PD-1, anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) in combination with either an Anti- lymphocyte-activation gene 3 (LAG-3) agent or an Anti- T-cell immunoreceptor with immunoglobulin (Ig) and ITIM domains (TIGIT) agent."}
• {"criterion_text":"- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention."}
• {"criterion_text":"- Known additional malignancy that is progressing or has required active treatment within the past 1 year."}
• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Part 1: Area Under the Curve (AUC)","definition_or_measurement_approach":"Pharmacokinetic AUC measurement (Part 1)."}
• {"endpoint_text":"- Part 1: Maximum Concentration (Cmax)","definition_or_measurement_approach":"Pharmacokinetic Cmax measurement (Part 1)."}
• {"endpoint_text":"- Part 1: Concentration in the Blood Immediately Before the Next Dose (Ctrough)","definition_or_measurement_approach":"Pharmacokinetic trough concentration measurement (Part 1)."}
• {"endpoint_text":"- Part 1: Number of Participants Who Experience Dose-limiting Toxicities (DLTs)","definition_or_measurement_approach":"Assessment of dose-limiting toxicities during cycle 1 (Part 1)."}
• {"endpoint_text":"- Parts 1 and 2: Number of Participants Who Report at Least 1 Adverse Event (AE)","definition_or_measurement_approach":"Safety endpoint: count of participants reporting ≥1 AE (Parts 1 and 2)."}
• {"endpoint_text":"- Parts 1 and 2 : Number of Participants Who Discontinue Study Drug Due to an AE","definition_or_measurement_approach":"Safety endpoint: count of participants discontinuing study drug because of AEs (Parts 1 and 2)."}
• {"endpoint_text":"- Parts 1 and 2: Objective Response Rate (ORR) per Lugano Response Criteria by Blinded Independent Central Review (BICR)","definition_or_measurement_approach":"Efficacy endpoint: ORR assessed per Lugano criteria by BICR for cHL (Parts 1 and 2)."}
• {"endpoint_text":"- Parts 1 and 2: ORR per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator","definition_or_measurement_approach":"Efficacy endpoint: ORR per RECIST 1.1 assessed by investigator for solid tumours (Parts 1 and 2)."}

Secondary endpoints

• {"endpoint_text":"- Parts 1 and 2: ORR per Lugano Response Criteria by Investigator","definition_or_measurement_approach":"ORR assessed per Lugano criteria by investigator (Parts 1 and 2)."}
• {"endpoint_text":"- Parts 1 and 2: Disease Control Rate (DCR) per Lugano Response Criteria by BICR","definition_or_measurement_approach":"DCR per Lugano criteria assessed by BICR."}
• {"endpoint_text":"- Parts 1 and 2: DCR per RECIST 1.1 by Investigator","definition_or_measurement_approach":"DCR per RECIST 1.1 assessed by investigator."}
• {"endpoint_text":"- Parts 1 and 2: Duration of response (DOR) per Lugano Response Criteria by BICR","definition_or_measurement_approach":"DOR per Lugano criteria assessed by BICR."}
• {"endpoint_text":"- Parts 1 and 2: DOR per RECIST 1.1 by Investigator","definition_or_measurement_approach":"DOR per RECIST 1.1 assessed by investigator."}
• {"endpoint_text":"- Parts 1 and 2: Progression Free Survival (PFS) per Lugano Response Criteria by BICR","definition_or_measurement_approach":"PFS per Lugano criteria assessed by BICR."}
• {"endpoint_text":"- Parts 1 and 2: PFS per RECIST 1.1 by Investigator","definition_or_measurement_approach":"PFS per RECIST 1.1 assessed by investigator."}
• {"endpoint_text":"- Parts 1 and 2: Overall Survival (OS)","definition_or_measurement_approach":"Overall Survival measured for participants (Parts 1 and 2)."}
• {"endpoint_text":"- Part 2: Area Under the Curve (AUC)","definition_or_measurement_approach":"Pharmacokinetic AUC measurement (Part 2)."}
• {"endpoint_text":"- Part 2: Maximum Concentration (Cmax)","definition_or_measurement_approach":"Pharmacokinetic Cmax measurement (Part 2)."}
• {"endpoint_text":"- Part 2: Concentration in the Blood Immediately Before the Next Dose (Ctrough)","definition_or_measurement_approach":"Pharmacokinetic trough concentration measurement (Part 2)."}
• {"endpoint_text":"- Parts 1 and 2: Antidrug Antibody (ADA) Levels","definition_or_measurement_approach":"Measurement of antidrug antibody levels (Parts 1 and 2)."}
• {"endpoint_text":"- Parts and 2: Biomarkers for Classical Hodgkin Lymphoma (cHL)","definition_or_measurement_approach":"Exploratory biomarker assessments for cHL participants with available biopsy material."}

Denmark

Earliest CTIS Part Ii Submission Date

18-03-2024

Latest Decision Or Authorization Date

15-04-2024

Processing Time Days

28

Number Of Sites

1

Number Of Participants

2

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Pharmaceutical Product Development LLC

Name

Parexel International Corp.

Responsibilities

Medical information (Physician Consulting)

Name

Perceptive Eclinical Limited

Responsibilities

EUB Call center and medical escalation service

Name

Almac Clinical Technologies LLC

Name

Covance Central Laboratory Services Inc.

Name

Eresearchtechnology Inc.

Responsibilities

central imaging

Third parties

• {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"Genomic Analysis of clinical trial samples","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"EUB Call center and medical escalation service","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Medical information (Physician Consulting)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"central imaging","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Covance Central Laboratory Services Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}