Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab | Biological | Pembrolizumab | ALIAS |
| Pembrolizumab (+) Berahyaluronidase alfa | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV
- description
- In the Treatment Crossover Period: participants will first receive pembrolizumab (+) berahyaluronidase alfa SC for three 21-day cycles, followed by pembrolizumab IV for three 21-day cycles. After completion of the Treatment Crossover Period, participants will enter the Treatment Continuation Period where they will receive their preferred intervention for up to 17 21-day cycles (up to \~1 year) for renal cell carcinoma (RCC) and melanoma, and for up to 35 21-day cycles (up to \~2 years) for non-small cell lung cancer (NSCLC).
- interventionNames
- Biological: Pembrolizumab (+) Berahyaluronidase alfa
- Biological: Pembrolizumab
- type
- ACTIVE_COMPARATOR
- label
- Arm B: Pembrolizumab IV→pembrolizumab (+) berahyaluronidase alfa SC
- description
- In the Treatment Crossover Period: participants will first receive pembrolizumab IV for three 21-day cycles, followed by pembrolizumab (+) berahyaluronidase alfa SC for three 21-day cycles. After completion of the Treatment Crossover Period, participants will enter the Treatment Continuation Period where they will receive their preferred intervention for up to 17 21-day cycles (up to \~1 year) for renal cell carcinoma (RCC) and melanoma, and for up to 35 21-day cycles (up to \~2 years) for non-small cell lung cancer (NSCLC).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDCasarini IA, Kowalski DM, Caglevic C, Karaca Yayla B, Sumbul AT, Yanez Weber P, Yanzi Castilla AN, Bylicki O, Takagi T, McQuarrie K, Saraf S, Arunachalam A, Bhagwati N, Cohen G. Participant-Reported Preference for Pembrolizumab Administered Subcutaneously or Intravenously: A Randomized, Open-Label, Phase II Study. JCO Oncol Pract. 2026 Jun 3:OP2501248. doi: 10.1200/OP-25-01248. Online ahead of print. PMID 42234938