PEMBROLIZUMAB for Melanoma | Renal cell carcinoma | Non-small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Has a histologically- or cytologically-confirmed early stage or advanced/ metastatic solid tumor by pathology report and meet the following conditions based on tumor type: •\tSurgically resected Stage IIB and IIC (pathological or clinical), or III cutaneous melanoma per American Joint Committee on Cancer (AJCC) eighth edition. •\tSurgically resected renal cell carcinoma (RCC) with intermediate-high or high risk of recurrence as defined by the Fuhrman grading status. •\tStage IV non–small cell lung cancer (NSCLC) per AJCC eight edition, with an anti-programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50% determined using the Dako PD-L1 immunohistochemistry (IHC) 22C3 pharmDx diagnostic kit, and confirmation that epidermal growth factor receptor (EGFR-), anaplastic lymphoma kinase (ALK-), or c-ros oncogene 1 (ROS1)-directed therapy is not indicated as primary therapy."}
• {"criterion_text":"- Has a life expectancy of at least 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 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 3 days before the start of study intervention"}

Exclusion criteria

• {"criterion_text":"- Non-small cell lung cancer (NSCLC) participants with a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements"}
• {"criterion_text":"- Received prior systemic anticancer therapy for their metastatic NSCLC. Note: Prior treatment with neoadjuvant or adjuvant therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC."}
• {"criterion_text":"- Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention."}
• {"criterion_text":"- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration"}
• {"criterion_text":"- Has 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 medication"}
• {"criterion_text":"- Has known additional malignancy that is progressing or has required active treatment within the past 3 years"}
• {"criterion_text":"- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis"}
• {"criterion_text":"- Has active autoimmune disease that has required systemic treatment in the past 2 years"}
• {"criterion_text":"- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease"}
• {"criterion_text":"- Has active infection requiring systemic therapy"}
• {"criterion_text":"- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease"}
• {"criterion_text":"- Melanoma participants with ocular, mucosal, or conjunctival melanoma"}
• {"criterion_text":"- Has history of allogeneic tissue/solid organ transplant"}
• {"criterion_text":"- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients"}
• {"criterion_text":"- Has not adequately recovered from major surgery or have ongoing surgical complications"}
• {"criterion_text":"- Renal Cell Carcinoma (RCC) participants who have had major surgery, other than nephrectomy, within 12 weeks before randomization"}
• {"criterion_text":"- Has received prior radiotherapy for RCC"}
• {"criterion_text":"- RCC participants who have residual thrombus post nephrectomy in the vena renalis or vena cava"}
• {"criterion_text":"- Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)"}
• {"criterion_text":"- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization"}
• {"criterion_text":"- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed"}
• {"criterion_text":"- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids"}

Primary endpoints

• {"endpoint_text":"- Percentage of Participants Who Prefer MK-3475A Subcutaneous (SC) on Patient Preference Questionnaire (PPQ) Question 1","definition_or_measurement_approach":"Assessed using Patient Preference Questionnaire (PPQ) Question 1 (participant response indicating preference for MK-3475A SC)."}

Secondary endpoints

• {"endpoint_text":"- Percentage of Responses From Participants to the Two Main Reasons for Their Preferred Method of Administration as Assessed on PPQ Question 3","definition_or_measurement_approach":"Assessed using PPQ Question 3 (participant responses listing reasons for preferred administration method)."}
• {"endpoint_text":"- Percentage of Participants by Their Level of Satisfaction With the SC Method of Administration as assessed on Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) Question 1","definition_or_measurement_approach":"Assessed using TASQ-SC Question 1 (participant-rated level of satisfaction with SC administration)."}
• {"endpoint_text":"- Percentage of Participants by Their Level of Satisfaction With the IV Method of Administration as assessed on Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) Question 1","definition_or_measurement_approach":"Assessed using TASQ-IV Question 1 (participant-rated level of satisfaction with IV administration)."}
• {"endpoint_text":"- Percentage of Participants Who Choose MK-3475A SC for the Study Treatment Continuation Period","definition_or_measurement_approach":"Participant choice recorded for the Study Treatment Continuation Period (proportion selecting MK-3475A SC)."}
• {"endpoint_text":"- Number of Participants Who Experience an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants experiencing any adverse event (AE) as recorded during the study."}
• {"endpoint_text":"- Number of Participants Who Discontinue Study Treatment Due to an AE","definition_or_measurement_approach":"Count of participants who discontinue study treatment due to an adverse event (AE)."}

France

Earliest CTIS Part Ii Submission Date

26-10-2023

Latest Decision Or Authorization Date

25-08-2025

Processing Time Days

669

Number Of Sites

5

Number Of Participants

20

Poland

Earliest CTIS Part Ii Submission Date

04-12-2023

Latest Decision Or Authorization Date

16-03-2026

Processing Time Days

833

Number Of Sites

3

Number Of Participants

24

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International Corp.

Responsibilities

EUB services (call center and medical services)

Name

Medidata Solutions Inc.

Responsibilities

System development is excluded

Name

Almac Clinical Technologies LLC

Responsibilities

System development is excluded

Third parties

• {"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":"Medidata Solutions Inc.","duties_or_roles":"System development is excluded","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"System development is excluded","organisation_type":"Pharmaceutical company"}