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)

Part of paid clinical trials in Alexander City, Alabama.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06099782
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab (+) Berahyaluronidase alfa — BIOLOGICAL
    Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.
  • Pembrolizumab — BIOLOGICAL
    Administered via IV infusion

Study Details

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.

Key Dates

Start date
Dec 26, 2023
Status verified
Mar 2026
Primary completion
Apr 9, 2025
Completion
Feb 15, 2027

Study Design

Enrollment
147 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV
    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).
  • Active Comparator: Arm B: Pembrolizumab IV→pembrolizumab (+) berahyaluronidase alfa SC
    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).

Primary Outcome Measure

Percentage of Participants Who Prefer Pembrolizumab Plus Berahyaluronidase Alfa Subcutaneous (SC) As Assessed By Patient Preference Questionnaire (PPQ) Question 1 [ Time Frame: Day 106 ]

Locations (8)

FacilityCityStateZIP
Russell Medical ( Site 0160)Alexander CityAlabama35010
Alaska Oncology and Hematology ( Site 0121)AnchorageAlaska99508
Highlands Oncology Group-Research Department ( Site 0133)SpringdaleArkansas72762
Marin Cancer Care ( Site 0148)GreenbraeCalifornia94904
Holy Cross Hospital-Clinical Research ( Site 0159)Fort LauderdaleFlorida33308
Mid Florida Hematology and Oncology Center ( Site 0113)Orange CityFlorida32763
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112)MariettaGeorgia30060
Kadlec Clinic Hematology and Oncology ( Site 0103)KennewickWashington99336

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By research site
Russell Medical ( Site 0160)· Alexander City, ALAlaska Oncology and Hematology ( Site 0121)· Anchorage, AKHighlands Oncology Group-Research Department ( Site 0133)· Springdale, ARMarin Cancer Care ( Site 0148)· Greenbrae, CAHoly Cross Hospital-Clinical Research ( Site 0159)· Fort Lauderdale, FLMid Florida Hematology and Oncology Center ( Site 0113)· Orange City, FL

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