Patient reported preference for subcutaneous MK-3475-A over intravenous pembrolizumab formulation in multiple tumor types

JRCT ID: jRCT2051230147

Registered date:19/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Early-stage or advanced/metastatic solid tumors
• Date of first enrollment: 26/12/2023
• Target sample size: 5
• Countries of recruitment: USA,Japan,Argentina,Japan,Chile,Japan,France,Japan,Poland,Japan,South Africa,Japan,Turkey,Japan,Australia,Japan,New Zealand,Japan
• Study type: Interventional

Intervention(s)

Crossover Period:
-Arm A: MK-3475A subcutaneous (SC) every 3 weeks (Q3W) for 3 cycles followed by pembrolizumab intravenous (IV) Q3W for 3 cycles
-Arm B: pembrolizumab IV Q3W for 3 cycles followed by MK-3475A SC Q3W for 3 cycles
Continuation Period:
After completion of the crossover period, participants will enter the continuation period. Participants may continue their preferred intervention (pembrolizumab/MK-3475A) for up to a total of 17 cycles (for adjuvant melanoma and RCC participants) or 35 cycles (for metastatic NSCLC participants) of treatment.

Outcome(s)

• Primary Outcome: Participant preference

Secondary Outcome

-Reasons for participant preference
-Participant satisfaction
-Participants choice of administration for the continuation period
-Safety and tolerability

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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:
- Surgically resected Stage IIB and IIC (pathological or clinical), or III cutaneous melanoma per American Joint Committee on Cancer (AJCC) eighth edition.
- Surgically resected renal cell carcinoma (RCC) with intermediate-high or high risk of recurrence as defined by the Fuhrman grading status.
- Stage 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.
- Has a life expectancy of at least 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 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 3 days before the start of study intervention.

Exclude criteria

- Non-small cell lung cancer (NSCLC) participants with a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
- Melanoma participants with ocular, mucosal, or conjunctival melanoma.
- Renal Cell Carcinoma (RCC) participants who have had major surgery, other than nephrectomy, within 12 weeks before randomization.
- Has received prior radiotherapy for RCC.
- RCC participants who have residual thrombus post nephrectomy in the vena renalis or vena cava.
- 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).
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
-Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.
- 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.
- Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention.
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- 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.
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has active autoimmune disease that has required systemic treatment in the past 2 years.
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has active infection requiring systemic therapy.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has history of allogeneic tissue/solid organ transplant corticosteroids.
- Has severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its excipients.
- Has not adequately recovered from major surgery or have ongoing surgical complications.

Related Information

• Primary Sponsor: Fujita Tomoko
• Secondary ID(s): NCT06099782