Kidney Cancer Clinical Trial

A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)

Summary

The purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab (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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

144

Study ID:

NCT06099782

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 34 Locations for this study

See Locations Near You

Alaska Oncology and Hematology ( Site 0121)
Anchorage Alaska, 99508, United States More Info
Study Coordinator
Contact
907-257-9851
Highlands Oncology Group-Research Department ( Site 0133)
Springdale Arkansas, 72762, United States More Info
Study Coordinator
Contact
479-587-1700
Marin Cancer Care ( Site 0148)
Greenbrae California, 94904, United States More Info
Study Coordinator
Contact
415-925-5000
Mid Florida Hematology and Oncology Center ( Site 0113)
Orange City Florida, 32763, United States More Info
Study Coordinator
Contact
407-353-1915
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112)
Marietta Georgia, 30060, United States More Info
Study Coordinator
Contact
770-281-5100
Kadlec Clinic Hematology and Oncology ( Site 0103)
Kennewick Washington, 99336, United States More Info
Study Coordinator
Contact
509-942-2540
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
Mar del Plata Buenos Aires, B7600, Argentina More Info
Study Coordinator
Contact
+5492235937663
Fundación Respirar ( Site 0302)
Buenos Aires , C1426, Argentina More Info
Study Coordinator
Contact
+541151082017
Instituto San Marcos ( Site 0305)
San Juan , J5400, Argentina More Info
Study Coordinator
Contact
+54 9 264 5017141
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001)
Port Macquarie New South Wales, 2444, Australia More Info
Study Coordinator
Contact
61265814053
Frankston Hospital-Oncology and Haematology ( Site 1007)
Frankston Victoria, 3199, Australia More Info
Study Coordinator
Contact
0417129607
Clínica Puerto Montt ( Site 0404)
Puerto Montt Los Lagos, 55002, Chile More Info
Study Coordinator
Contact
56998634501
FALP-UIDO ( Site 0401)
Santiago Region M. De Santiago, 75009, Chile More Info
Study Coordinator
Contact
56224457254
Oncovida ( Site 0403)
Santiago Region M. De Santiago, 75100, Chile More Info
Study Coordinator
Contact
5624205100
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0407)
Santiago Region M. De Santiago, 83300, Chile More Info
Study Coordinator
Contact
56223546919
Bradfordhill-Clinical Area ( Site 0402)
Santiago Region M. De Santiago, 84203, Chile More Info
Study Coordinator
Contact
+56998744662
ONCOCENTRO APYS-ACEREY ( Site 0400)
Viña del Mar Valparaiso, 25205, Chile More Info
Study Coordinator
Contact
+56992369820
Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0604)
Caen Calvados, 14000, France More Info
Study Coordinator
Contact
33231065227
Clinique Francois Chenieux ( Site 0603)
Limoges Haute-Vienne, 87039, France More Info
Study Coordinator
Contact
33555454800
Hôpital Bichat - Claude-Bernard ( Site 0605)
Paris Ile-de-France, 75018, France More Info
Study Coordinator
Contact
33140257300
CENTRE LEON BERARD-onco dermatology ( Site 0600)
Lyon Cedex08 Rhone-Alpes, 69373, France More Info
Study Coordinator
Contact
+33478785996
HIA Sainte Anne-Pneumology ( Site 0601)
Toulon Var, 83800, France More Info
Study Coordinator
Contact
0033483162937
Bell Land General Hospital ( Site 1101)
Sakai Osaka, 599-8, Japan More Info
Study Coordinator
Contact
+81-72-234-2001
Tokyo Women's Medical University ( Site 1100)
Tokyo , 162-8, Japan More Info
Study Coordinator
Contact
+81-3-3353-8111
Auckland City Hospital-Cancer & Blood Research ( Site 1051)
Auckland , 1023, New Zealand More Info
Study Coordinator
Contact
64212407080
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
Warszawa Mazowieckie, 02-78, Poland More Info
Study Coordinator
Contact
48225463066
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702)
Koszalin Zachodniopomorskie, 75-58, Poland More Info
Study Coordinator
Contact
48502204953
Medical Oncology Centre of Rosebank ( Site 0805)
Johannesburg Gauteng, 2196, South Africa More Info
Study Coordinator
Contact
0824445473
Nosworthy Oncology ( Site 0807)
Johannesburg Gauteng, 2196, South Africa More Info
Study Coordinator
Contact
+27114823593
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0800)
Pretoria Gauteng, 0181, South Africa More Info
Study Coordinator
Contact
27123466701
Cape Town Oncology Trials ( Site 0802)
Cape Town Western Cape, 7570, South Africa More Info
Study Coordinator
Contact
27219443832
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 0903)
Adana , 01140, Turkey More Info
Study Coordinator
Contact
905056166338
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0900)
Ankara , 06230, Turkey More Info
Study Coordinator
Contact
+905334318506
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0901)
Ankara , 06800, Turkey More Info
Study Coordinator
Contact
905052933234
Ege Universitesi Hastanesi ( Site 0902)
İzmir , 35100, Turkey More Info
Study Coordinator
Contact
905332117153

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

144

Study ID:

NCT06099782

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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