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NCT06099782Active, not recruitingPhase 2

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)

A Phase 2 Study to Evaluate Patient Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab Formulation in Participants With Multiple Tumor Types (MK-3475A-F11)

Source: ClinicalTrials.gov · Last updated 8 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
147 (actual)
First submitted
19 Oct 2023
Start date
26 Dec 2023
Primary completion date
9 Apr 2025
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT06099782
EU CT number
2023-506017-22-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 147
  • From 26 Dec 2023 to the primary completion date, 9 Apr 2025
  • 44 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Renal Cell Carcinoma (RCC) participants who have had major surgery, other than nephrectomy, within 12 weeks before randomization.
  • Has received prior radiotherapy for RCC.
  • 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 not adequately recovered from major surgery or have ongoing surgical complications.

Other illness

  • Non-small cell lung cancer (NSCLC) participants with a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • 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.

Lab values

  • 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).

Other

  • Melanoma participants with ocular, mucosal, or conjunctival melanoma.
  • RCC participants who have residual thrombus post nephrectomy in the vena renalis or vena cava.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (44)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fundación Respirar ( Site 0302)
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
Coordinator of this site? Confirm its status
Mar del PlataArgentinaUnknown status
Instituto San Marcos ( Site 0305)
Coordinator of this site? Confirm its status
San JuanArgentinaUnknown status
Frankston Hospital-Oncology and Haematology ( Site 1007)
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FrankstonAustraliaUnknown status
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001)
Coordinator of this site? Confirm its status
Port MacquarieAustraliaUnknown status
Clínica Puerto Montt ( Site 0404)
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Port MonttChileUnknown status
Oncovida ( Site 0403)
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SantiagoChileUnknown status
Bradfordhill-Clinical Area ( Site 0402)
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SantiagoChileUnknown status
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0407)
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SantiagoChileUnknown status
FALP-UIDO ( Site 0401)
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SantiagoChileUnknown status
Centro Investigacion Cancer James Lind ( Site 0408)
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TemucoChileUnknown status
ONCOCENTRO APYS-ACEREY ( Site 0400)
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Viña del MarChileUnknown status
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceCompleted
Polyclinique De Limoges
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Limoges Cedex IFranceCompleted
Centre Leon Berard
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LyonFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceCompleted
HIA Sainte Anne
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Toulon Cedex 9FranceCompleted
Bell Land General Hospital ( Site 1101)
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SakaiJapanUnknown status
Tokyo Women's Medical University ( Site 1100)
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TokyoJapanUnknown status
Auckland City Hospital-Cancer & Blood Research ( Site 1051)
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AucklandNew ZealandUnknown status
Bowen Hospital ( Site 1050)
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WellingtonNew ZealandUnknown status
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandCompleted
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
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KoszalinPolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
Russell Medical ( Site 0160)
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Alexander CityUnited StatesUnknown status
Alaska Oncology and Hematology ( Site 0121)
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AnchorageUnited StatesUnknown status
Holy Cross Hospital-Clinical Research ( Site 0159)
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Fort LauderdaleUnited StatesUnknown status
Marin Cancer Care ( Site 0148)
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GreenbraeUnited StatesUnknown status
Kadlec Clinic Hematology and Oncology ( Site 0103)
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KennewickUnited StatesUnknown status
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112)
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MariettaUnited StatesUnknown status
Mid Florida Hematology and Oncology Center ( Site 0113)
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Orange CityUnited StatesUnknown status
Highlands Oncology Group-Research Department ( Site 0133)
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SpringdaleUnited StatesUnknown status
Cape Town Oncology Trials ( Site 0802)
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Cape TownSouth AfricaUnknown status
CANCERCARE RONDEBOSCH ONCOLOGY-Cancercare Rondebosch Oncology ( Site 0806)
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Cape TownSouth AfricaUnknown status
Nosworthy Oncology ( Site 0807)
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JohannesburgSouth AfricaUnknown status
Medical Oncology Centre of Rosebank ( Site 0805)
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JohannesburgSouth AfricaUnknown status
Cancer Care Langenhoven Drive Oncology Centre ( Site 0808)
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Port ElizabethSouth AfricaUnknown status
Steve Biko Academic Hospital-Medical Oncology ( Site 0804)
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PretoriaSouth AfricaUnknown status
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0800)
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PretoriaSouth AfricaUnknown status
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0801)
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SandtonSouth AfricaUnknown status
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 0903)
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AdanaTurkey (Türkiye)Unknown status
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0900)
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AnkaraTurkey (Türkiye)Unknown status
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0901)
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AnkaraTurkey (Türkiye)Unknown status
Ege Universitesi Hastanesi ( Site 0902)
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IzmirTurkey (Türkiye)Unknown status

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This page is information, not medical advice. Discuss any trial with your doctor.