A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)
Phase 2 – studying effectiveness and dosage
Conditions:
Non-Small Cell Lung Cancer
Renal Cell Carcinoma
Melanoma
Sponsor: Merck Sharp & Dohme LLC
trial.available_in:
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Overview
The purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab pembrolizumab (+) berahyaluronidase alfa \[MK-3475A\] administered subcutaneously (SC) over pembrolizumab \[MK-3475\] administered intravenously (IV) in participants with multiple tumor types. There will be no hypothesis testing in this study.
Who can participate
Inclusion 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.
Exclusion 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.
Locations
10
Argentina (1)
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
Mar del Plata , Buenos Aires
Australia (1)
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001)
Port Macquarie , New South Wales
Chile (1)
Centro Investigacion Cancer James Lind ( Site 0408)
Temuco , Araucania
France (1)
CENTRE LEON BERARD-onco dermatology ( Site 0600)
Lyon Cedex08 , Auvergne-Rhône-Alpes
Japan (1)
Bell Land General Hospital ( Site 1101)
Sakai , Osaka
New Zealand (1)
Auckland City Hospital-Cancer & Blood Research ( Site 1051)
Auckland
Poland (1)
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701)
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
South Africa (1)
Cancer Care Langenhoven Drive Oncology Centre ( Site 0808)
Port Elizabeth , Eastern Cape
Turkey (1)
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 0903)