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)

NCT06099782 | Active Not Recruiting Phase 2 Results FDA Drug

• 5 other identifiers: 3475A-F112023-506017-22-00U1111-1293-0814MK-3475A-F11jRCT2051230147
• Study Type: interventional
• Target: 147
• Locations: 10 countries
• Sites: 45

Brief Summary

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

Non-Small Cell Lung Cancer; Renal Cell Carcinoma; Melanoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Prefer Pembrolizumab Plus Berahyaluronidase Alfa Subcutaneous (SC) As Assessed By Patient Preference Questionnaire (PPQ) Question 1

  The PPQ is an instrument that has been developed from participant interviews and includes questions to evaluate directly from participants their preference regarding mode of administration, as well as the strength of the preference, and the reason for the preference. The PPQ does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the PPQ evaluates participants' preferred method of administration with response options of IV, SC or "no preference". As pre-specified by the protocol, the percentage of participants who preferred SC administration (participant preference rate \[PPR\]) was reported out of all randomized participants who received all 3 doses of Pembrolizumab IV and Pembrolizumab SC during treatment crossover period and answered at least question 1 of the PPQ on Cycle 6 Day 1 (Day 106).

  Day 106

Secondary Outcomes (6)

• Percentage of Participants Who Preferred SC Administration According to Most Frequent Reasons of Preference As Assessed by PPQ Question 3

  Day 106

• Percentage of Participants That Were Satisfied or Dissatisfied With the SC Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) Question 1

  Up to approximately Day 106

• Percentage of Participants That Were Satisfied or Dissatisfied With the IV Method of Administration According to Level of Satisfaction, As Assessed by Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) Question 1

  Up to approximately Day 106

• Percentage of Participants Who Chose Pembrolizumab (+) Berahyaluronidase Alfa SC or Pembrolizumab IV for the Treatment Continuation Period on the Participant Choice Questionnaire

  Day 106

• Number of Participants Who Experience an Adverse Event (AE)

  Up to ~27 months

Study Arms (2)

Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV

EXPERIMENTAL

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).

Biological: Pembrolizumab (+) Berahyaluronidase alfa; Biological: Pembrolizumab

Arm B: Pembrolizumab IV→pembrolizumab (+) berahyaluronidase alfa SC

ACTIVE COMPARATOR

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).

Biological: Pembrolizumab (+) Berahyaluronidase alfa; Biological: Pembrolizumab

Interventions

Pembrolizumab (+) Berahyaluronidase alfa BIOLOGICAL

Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.

Also known as: MK-3475A

Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV; Arm B: Pembrolizumab IV→pembrolizumab (+) berahyaluronidase alfa SC

Pembrolizumab BIOLOGICAL

Administered via IV infusion

Also known as: MK-3475, KEYTRUDA®

Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV; Arm B: Pembrolizumab IV→pembrolizumab (+) berahyaluronidase alfa SC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (45)

Russell Medical ( Site 0160)

Alexander City, Alabama, 35010, United States

Location

Alaska Oncology and Hematology ( Site 0121)

Anchorage, Alaska, 99508, United States

Location

Highlands Oncology Group-Research Department ( Site 0133)

Springdale, Arkansas, 72762, United States

Location

Marin Cancer Care ( Site 0148)

Greenbrae, California, 94904, United States

Location

Holy Cross Hospital-Clinical Research ( Site 0159)

Fort Lauderdale, Florida, 33308, United States

Location

Mid Florida Hematology and Oncology Center ( Site 0113)

Orange City, Florida, 32763, United States

Location

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112)

Marietta, Georgia, 30060, United States

Location

Kadlec Clinic Hematology and Oncology ( Site 0103)

Kennewick, Washington, 99336, United States

Location

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

Location

Fundación Respirar ( Site 0302)

Buenos Aires, Buenos Aires F.D., C1426ABP, Argentina

Location

Instituto San Marcos ( Site 0305)

San Juan, J5400EBB, Argentina

Location

Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001)

Port Macquarie, New South Wales, 2444, Australia

Location

Frankston Hospital-Oncology and Haematology ( Site 1007)

Frankston, Victoria, 3199, Australia

Location

Clínica Puerto Montt ( Site 0404)

Port Montt, Los Lagos Region, 5500243, Chile

Location

FALP-UIDO ( Site 0401)

Santiago, Region M. de Santiago, 7500921, Chile

Location

Oncovida ( Site 0403)

Santiago, Region M. de Santiago, 7500994, Chile

Location

Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0407)

Santiago, Region M. de Santiago, 8330032, Chile

Location

Bradfordhill-Clinical Area ( Site 0402)

Santiago, Region M. de Santiago, 8420383, Chile

Location

Centro Investigacion Cancer James Lind ( Site 0408)

Temuco, Región de la Araucanía, 4800827, Chile

Location

ONCOCENTRO APYS-ACEREY ( Site 0400)

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

CENTRE LEON BERARD-onco dermatology ( Site 0600)

Lyon Cedex08, Auvergne-Rhône-Alpes, 69373, France

Location

Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0604)

Caen, Calvados, 14000, France

Location

Clinique Francois Chenieux ( Site 0603)

Limoges, Haute-Vienne, 87039, France

Location

HIA Sainte Anne-Pneumology ( Site 0601)

Toulon, Var, 83800 Cedex 9, France

Location

Hôpital Bichat - Claude-Bernard ( Site 0605)

Paris, Île-de-France Region, 75018, France

Location

Bell Land General Hospital ( Site 1101)

Sakai, Osaka, 599-8247, Japan

Location

Tokyo Women's Medical University ( Site 1100)

Tokyo, 162-8666, Japan

Location

Auckland City Hospital-Cancer & Blood Research ( Site 1051)

Auckland, 1023, New Zealand

Location

Bowen Hospital ( Site 1050)

Wellington, 6035, New Zealand

Location

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702)

Koszalin, West Pomeranian Voivodeship, 75-581, Poland

Location

Zachodniopomorskie Centrum Onkologii ( Site 0703)

Szczecin, West Pomeranian Voivodeship, 71-730, Poland

Location

Cancer Care Langenhoven Drive Oncology Centre ( Site 0808)

Port Elizabeth, Eastern Cape, 6045, South Africa

Location

Medical Oncology Centre of Rosebank ( Site 0805)

Johannesburg, Gauteng, 2196, South Africa

Location

Nosworthy Oncology ( Site 0807)

Johannesburg, Gauteng, 2196, South Africa

Location

Steve Biko Academic Hospital-Medical Oncology ( Site 0804)

Pretoria, Gauteng, 0001, South Africa

Location

LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0800)

Pretoria, Gauteng, 0181, South Africa

Location

Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0801)

Sandton, Gauteng, 2196, South Africa

Location

Cape Town Oncology Trials ( Site 0802)

Cape Town, Western Cape, 7570, South Africa

Location

CANCERCARE RONDEBOSCH ONCOLOGY-Cancercare Rondebosch Oncology ( Site 0806)

Cape Town, Western Cape, 7700, South Africa

Location

Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 0903)

Adana, 01140, Turkey (Türkiye)

Location

Hacettepe Universite Hastaneleri-oncology hospital ( Site 0900)

Ankara, 06230, Turkey (Türkiye)

Location

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0901)

Ankara, 06800, Turkey (Türkiye)

Location

Ege Universitesi Hastanesi ( Site 0902)

Izmir, 35100, Turkey (Türkiye)

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Melanoma

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: December 26, 2023
• Primary Completion: April 9, 2025
• Study Completion (Estimated): February 15, 2027
• Last Updated: April 8, 2026
• Results First Posted: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

NZ (2); JP (2); US (8); ZA (8); AU (2); AR (3); FR (5); PL (4); CL (7); TU (4)