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
- Diseases
- Kidney cancer, Melanoma, Lung cancer
- 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
Sites (44)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundación Respirar ( Site 0302) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300) Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Instituto San Marcos ( Site 0305) Coordinator of this site? Confirm its status | San Juan | Argentina | Unknown status |
| Frankston Hospital-Oncology and Haematology ( Site 1007) Coordinator of this site? Confirm its status | Frankston | Australia | Unknown status |
| Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001) Coordinator of this site? Confirm its status | Port Macquarie | Australia | Unknown status |
| Clínica Puerto Montt ( Site 0404) Coordinator of this site? Confirm its status | Port Montt | Chile | Unknown status |
| Oncovida ( Site 0403) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Bradfordhill-Clinical Area ( Site 0402) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0407) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| FALP-UIDO ( Site 0401) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Centro Investigacion Cancer James Lind ( Site 0408) Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| ONCOCENTRO APYS-ACEREY ( Site 0400) Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Completed |
| Polyclinique De Limoges Coordinator of this site? Confirm its status | Limoges Cedex I | France | Completed |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Completed |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 18 | France | Completed |
| HIA Sainte Anne Coordinator of this site? Confirm its status | Toulon Cedex 9 | France | Completed |
| Bell Land General Hospital ( Site 1101) Coordinator of this site? Confirm its status | Sakai | Japan | Unknown status |
| Tokyo Women's Medical University ( Site 1100) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Auckland City Hospital-Cancer & Blood Research ( Site 1051) Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Bowen Hospital ( Site 1050) Coordinator of this site? Confirm its status | Wellington | New Zealand | Unknown status |
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie Coordinator of this site? Confirm its status | Koszalin | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Russell Medical ( Site 0160) Coordinator of this site? Confirm its status | Alexander City | United States | Unknown status |
| Alaska Oncology and Hematology ( Site 0121) Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| Holy Cross Hospital-Clinical Research ( Site 0159) Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Marin Cancer Care ( Site 0148) Coordinator of this site? Confirm its status | Greenbrae | United States | Unknown status |
| Kadlec Clinic Hematology and Oncology ( Site 0103) Coordinator of this site? Confirm its status | Kennewick | United States | Unknown status |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112) Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Mid Florida Hematology and Oncology Center ( Site 0113) Coordinator of this site? Confirm its status | Orange City | United States | Unknown status |
| Highlands Oncology Group-Research Department ( Site 0133) Coordinator of this site? Confirm its status | Springdale | United States | Unknown status |
| Cape Town Oncology Trials ( Site 0802) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| CANCERCARE RONDEBOSCH ONCOLOGY-Cancercare Rondebosch Oncology ( Site 0806) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Nosworthy Oncology ( Site 0807) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Medical Oncology Centre of Rosebank ( Site 0805) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| Cancer Care Langenhoven Drive Oncology Centre ( Site 0808) Coordinator of this site? Confirm its status | Port Elizabeth | South Africa | Unknown status |
| Steve Biko Academic Hospital-Medical Oncology ( Site 0804) Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
| LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0800) Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
| Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0801) Coordinator of this site? Confirm its status | Sandton | South Africa | Unknown status |
| Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 0903) Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 0900) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0901) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ege Universitesi Hastanesi ( Site 0902) Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
Related publications
- Participant-Reported Preference for Pembrolizumab Administered Subcutaneously or Intravenously: A Randomized, Open-Label, Phase II Study.JCO Oncol Pract · 2026 · PMID 42234938
This page is information, not medical advice. Discuss any trial with your doctor.