A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)

March 13, 2024 updated by: Merck Sharp & Dohme LLC

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)

The purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab (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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Recruiting
        • Fundación Respirar ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +541151082017
      • San Juan, Argentina, J5400EBB
        • Recruiting
        • Instituto San Marcos ( Site 0305)
        • Contact:
          • Study Coordinator
          • Phone Number: +54 9 264 5017141
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, B7600FZO
        • Recruiting
        • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: +5492235937663
  • Australia
    • New South Wales
      • Port Macquarie, New South Wales, Australia, 2444
        • Recruiting
        • Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: 61265814053
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Frankston Hospital-Oncology and Haematology ( Site 1007)
        • Contact:
          • Study Coordinator
          • Phone Number: 0417129607
  • Chile
    • Los Lagos
      • Puerto Montt, Los Lagos, Chile, 5500243
        • Recruiting
        • Clínica Puerto Montt ( Site 0404)
        • Contact:
          • Study Coordinator
          • Phone Number: 56998634501
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: 56224457254
      • Santiago, Region M. De Santiago, Chile, 7510032
        • Recruiting
        • Oncovida ( Site 0403)
        • Contact:
          • Study Coordinator
          • Phone Number: 5624205100
      • Santiago, Region M. De Santiago, Chile, 8330032
        • Recruiting
        • Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0407)
        • Contact:
          • Study Coordinator
          • Phone Number: 56223546919
      • Santiago, Region M. De Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill-Clinical Area ( Site 0402)
        • Contact:
          • Study Coordinator
          • Phone Number: +56998744662
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • ONCOCENTRO APYS-ACEREY ( Site 0400)
        • Contact:
          • Study Coordinator
          • Phone Number: +56992369820
  • France
    • Calvados
      • Caen, Calvados, France, 14000
        • Recruiting
        • Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0604)
        • Contact:
          • Study Coordinator
          • Phone Number: 33231065227
    • Haute-Vienne
      • Limoges, Haute-Vienne, France, 87039
        • Recruiting
        • Clinique Francois Chenieux ( Site 0603)
        • Contact:
          • Study Coordinator
          • Phone Number: 33555454800
    • Ile-de-France
      • Paris, Ile-de-France, France, 75018
        • Recruiting
        • Hôpital Bichat - Claude-Bernard ( Site 0605)
        • Contact:
          • Study Coordinator
          • Phone Number: 33140257300
    • Rhone-Alpes
      • Lyon Cedex08, Rhone-Alpes, France, 69373
        • Recruiting
        • CENTRE LEON BERARD-onco dermatology ( Site 0600)
        • Contact:
          • Study Coordinator
          • Phone Number: +33478785996
  • Japan
      • Tokyo, Japan, 162-8666
        • Recruiting
        • Tokyo Women's Medical University ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3353-8111
    • Osaka
      • Sakai, Osaka, Japan, 599-8247
        • Recruiting
        • Bell Land General Hospital ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-72-234-2001
  • Poland
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
        • Contact:
          • Study Coordinator
          • Phone Number: 48225463066
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Oncology and Hematology ( Site 0121)
        • Contact:
          • Study Coordinator
          • Phone Number: 907-257-9851
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Recruiting
        • Highlands Oncology Group-Research Department ( Site 0133)
        • Contact:
          • Study Coordinator
          • Phone Number: 479-587-1700
    • Florida
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Mid Florida Hematology and Oncology Center ( Site 0113)
        • Contact:
          • Study Coordinator
          • Phone Number: 407-353-1915
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112)
        • Contact:
          • Study Coordinator
          • Phone Number: 770-281-5100
    • Washington
      • Kennewick, Washington, United States, 99336
        • Recruiting
        • Kadlec Clinic Hematology and Oncology ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: 509-942-2540

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: MK-3475A SC →Pembrolizumab IV
In the treatment crossover period, participants will receive MK-3475A 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).
Biological: Pembrolizumab co-formulated with hyaluronidase
Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.
Other Names:
  • MK-3475A
Biological: Pembrolizumab
Administered via IV infusion
Other Names:
  • MK-3475, KEYTRUDA®
Active Comparator: Arm B: Pembrolizumab IV→MK-3475A SC
In the treatment crossover period, participants will receive pembrolizumab IV followed by MK-3475A 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.
Biological: Pembrolizumab co-formulated with hyaluronidase
Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.
Other Names:
  • MK-3475A
Biological: Pembrolizumab
Administered via IV infusion
Other Names:
  • MK-3475, KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Prefer MK-3475A Subcutaneous (SC) on Patient Preference Questionnaire (PPQ) Question 1
Time Frame: ~Day 106
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. Question 1 in PPQ evaluates participants' preferred method of administration with response options of IV, SC or no preference. The percentage of participants who prefer SC will be reported.
~Day 106

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Responses From Participants to the Two Main Reasons for Their Preferred Method of Administration as Assessed on PPQ Question 3
Time Frame: ~Day 106
The PPQ is an instrument that has been developed from patient 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. Question 3 in PPQ evaluates two main reasons for participants' preference for one of the administration methods with response options of feels less emotionally distressing, requires less time in the clinic, lower level injection-site pain, among others. The percentage of responses from participants to the two main reasons for their preferred method of administration, as assessed on PPQ Question 3 will be reported.
~Day 106
Percentage of Participants by Their Level of Satisfaction With the SC Method of Administration as assessed on Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) Question 1
Time Frame: Up to ~Day 106
The TASQ SC is a 12-item questionnaire that asks questions regarding different aspects of participants' satisfaction with SC administration, experiences related to administration, convenience, time. Question 1 in TASQ SC evaluates participants' satisfaction or dissatisfaction with SC administration. The percentage of participants by their level of satisfaction with the SC method of administration as assessed on TASQ-SC Question 1 will be reported.
Up to ~Day 106
Percentage of Participants by Their Level of Satisfaction With the IV Method of Administration as assessed on Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) Question 1
Time Frame: Up to ~Day 106
The TASQ IV is a 12-item questionnaire that asks questions regarding different aspects of participants' satisfaction with IV administration, experiences related to administration, convenience, time. Question 1 in TASQ IV evaluates participants' satisfaction or dissatisfaction with IV administration. The percentage of participants by their level of satisfaction with the IV method of administration as assessed on TASQ-IV Question 1 will be reported.
Up to ~Day 106
Percentage of Participants Who Choose MK-3475A SC for the Study Treatment Continuation Period
Time Frame: ~Day 106
The percentage of participants who choose SC treatment for the continuation period in the study will be reported.
~Day 106
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to ~27 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~27 months
Number of participants who discontinue study drug due to an AE
Time Frame: Up to ~24 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to ~24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2023

Primary Completion (Estimated)

March 3, 2025

Study Completion (Estimated)

November 16, 2026

Study Registration Dates

First Submitted

October 19, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475A-F11
  • 2023-506017-22 (Registry Identifier: EU CT)
  • U1111-1293-0814 (Other Identifier: UTN)
  • MK-3475A-F11 (Other Identifier: Merck)
  • jRCT2051230147 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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