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)
NCT ID: NCT06099782
Last Updated: 2025-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
147 participants
INTERVENTIONAL
2023-12-26
2026-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV
In the treatment crossover period, participants will receive pembrolizumab (+) berahyaluronidase alfa SC followed by pembrolizumab IV. After completion of the treatment crossover period, participants will enter the treatment continuation period, where they will receive their preferred intervention for up to \~1 year for renal cell carcinoma (RCC) and melanoma and for up to \~2 years for non-small cell lung cancer (NSCLC).
Pembrolizumab (+) Berahyaluronidase alfa
Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.
Pembrolizumab
Administered via IV infusion
Arm B: Pembrolizumab IV→pembrolizumab (+) berahyaluronidase alfa SC
In the treatment crossover period, participants will receive pembrolizumab IV followed by pembrolizumab (+) berahyaluronidase alfa SC. After completion of the treatment crossover period, participants will enter the treatment continuation period, where they will receive their preferred intervention for up to \~1 year for RCC and melanoma and for up to \~2 years for NSCLC.
Pembrolizumab (+) Berahyaluronidase alfa
Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.
Pembrolizumab
Administered via IV infusion
Interventions
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Pembrolizumab (+) Berahyaluronidase alfa
Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.
Pembrolizumab
Administered via IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Russell Medical ( Site 0160)
Alexander City, Alabama, United States
Alaska Oncology and Hematology ( Site 0121)
Anchorage, Alaska, United States
Highlands Oncology Group-Research Department ( Site 0133)
Springdale, Arkansas, United States
Marin Cancer Care ( Site 0148)
Greenbrae, California, United States
Holy Cross Hospital-Clinical Research ( Site 0159)
Fort Lauderdale, Florida, United States
Mid Florida Hematology and Oncology Center ( Site 0113)
Orange City, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112)
Marietta, Georgia, United States
Kadlec Clinic Hematology and Oncology ( Site 0103)
Kennewick, Washington, United States
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
Mar del Plata, Buenos Aires, Argentina
Fundación Respirar ( Site 0302)
Buenos Aires, Buenos Aires F.D., Argentina
Instituto San Marcos ( Site 0305)
San Juan, , Argentina
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001)
Port Macquarie, New South Wales, Australia
Frankston Hospital-Oncology and Haematology ( Site 1007)
Frankston, Victoria, Australia
Clínica Puerto Montt ( Site 0404)
Port Montt, Los Lagos Region, Chile
FALP-UIDO ( Site 0401)
Santiago, Region M. de Santiago, Chile
Oncovida ( Site 0403)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0407)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 0402)
Santiago, Region M. de Santiago, Chile
Centro Investigacion Cancer James Lind ( Site 0408)
Temuco, Región de la Araucanía, Chile
ONCOCENTRO APYS-ACEREY ( Site 0400)
Viña del Mar, Región de Valparaíso, Chile
CENTRE LEON BERARD-onco dermatology ( Site 0600)
Lyon Cedex08, Auvergne-Rhône-Alpes, France
Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0604)
Caen, Calvados, France
Clinique Francois Chenieux ( Site 0603)
Limoges, Haute-Vienne, France
HIA Sainte Anne-Pneumology ( Site 0601)
Toulon, Var, France
Hôpital Bichat - Claude-Bernard ( Site 0605)
Paris, Île-de-France Region, France
Bell Land General Hospital ( Site 1101)
Sakai, Osaka, Japan
Tokyo Women's Medical University ( Site 1100)
Tokyo, , Japan
Auckland City Hospital-Cancer & Blood Research ( Site 1051)
Auckland, , New Zealand
Bowen Hospital ( Site 1050)
Wellington, , New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
Warsaw, Masovian Voivodeship, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702)
Koszalin, West Pomeranian Voivodeship, Poland
Zachodniopomorskie Centrum Onkologii ( Site 0703)
Szczecin, West Pomeranian Voivodeship, Poland
Cancer Care Langenhoven Drive Oncology Centre ( Site 0808)
Port Elizabeth, Eastern Cape, South Africa
Medical Oncology Centre of Rosebank ( Site 0805)
Johannesburg, Gauteng, South Africa
Nosworthy Oncology ( Site 0807)
Johannesburg, Gauteng, South Africa
Steve Biko Academic Hospital-Medical Oncology ( Site 0804)
Pretoria, Gauteng, South Africa
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0800)
Pretoria, Gauteng, South Africa
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0801)
Sandton, Gauteng, South Africa
Cape Town Oncology Trials ( Site 0802)
Cape Town, Western Cape, South Africa
CANCERCARE RONDEBOSCH ONCOLOGY-Cancercare Rondebosch Oncology ( Site 0806)
Cape Town, Western Cape, South Africa
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 0903)
Adana, , Turkey (Türkiye)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0900)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0901)
Ankara, , Turkey (Türkiye)
Ege Universitesi Hastanesi ( Site 0902)
Izmir, , Turkey (Türkiye)
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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2023-506017-22
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1293-0814
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-3475A-F11
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2051230147
Identifier Type: REGISTRY
Identifier Source: secondary_id
3475A-F11
Identifier Type: -
Identifier Source: org_study_id
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