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)

• ClinicalTrials.gov Identifier: NCT06099782
• Recruitment Status: Recruiting
• First Posted: October 25, 2023
• Last Update Posted: May 10, 2024
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

Tracking Information

• First Submitted Date: October 19, 2023
• First Posted Date: October 25, 2023
• Last Update Posted Date: May 10, 2024
• Actual Study Start Date: December 26, 2023
• Estimated Primary Completion Date: March 3, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 19, 2023)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 19, 2023)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• Official Title: 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)
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

• Biological: Pembrolizumab co-formulated with hyaluronidase
  Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.
  Other Name: MK-3475A
• Biological: Pembrolizumab
  Administered via IV infusion
  Other Name: MK-3475, KEYTRUDA®

Study Arms

• 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).
  Interventions:

  • Biological: Pembrolizumab co-formulated with hyaluronidase
  • Biological: Pembrolizumab
• 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.
  Interventions:

  • Biological: Pembrolizumab co-formulated with hyaluronidase
  • Biological: Pembrolizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 19, 2023): 144
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 16, 2026
• Estimated Primary Completion Date: March 3, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Toll Free Number; 1-888-577-8839; Trialsites@merck.com

• Listed Location Countries: Argentina, Australia, Chile, France, Japan, New Zealand, Poland, South Africa, Turkey, United States

Administrative Information

• NCT Number: NCT06099782
• 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) )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
• URL: http://engagezone.msd.com/ds_documentation.php

• Current Responsible Party: Merck Sharp & Dohme LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Merck Sharp & Dohme LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Merck Sharp & Dohme LLC
• Verification Date: May 2024