History of Changes for Study: NCT06099782

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)

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Study Record Versions

Version	Submitted Date	Changes
1	October 19, 2023	None (earliest Version on record)
2	November 21, 2023	Recruitment Status, Study Status and Contacts/Locations
3	November 28, 2023	References and Study Status
4	January 8, 2024	Study Status and Contacts/Locations
5	January 18, 2024	Study Status, Contacts/Locations and Study Identification
6	February 5, 2024	Study Status and Contacts/Locations
7	February 14, 2024	Contacts/Locations and Study Status
8	March 7, 2024	Contacts/Locations and Study Status
9	March 13, 2024	Contacts/Locations and Study Status
10	April 4, 2024	Study Status and Contacts/Locations
11	April 19, 2024	Contacts/Locations and Study Status
12	April 25, 2024	Contacts/Locations and Study Status
13	May 9, 2024	Study Status and Contacts/Locations
14	May 21, 2024	Contacts/Locations and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	3475A-F11
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)
Secondary IDs:	2023-506017-22 [Registry Identifier: EU CT] U1111-1293-0814 [UTN] MK-3475A-F11 [Merck]

Study Status


Record Verification:	October 2023
Overall Status:	Not yet recruiting
Study Start:	November 17, 2023
Primary Completion:	March 3, 2025 [Anticipated]
Study Completion:	November 16, 2026 [Anticipated]

First Submitted:	October 19, 2023
First Submitted that Met QC Criteria:	October 19, 2023
First Posted:	October 25, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	October 19, 2023
Last Update Posted:	October 25, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Merck Sharp & Dohme LLC
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description


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:

Conditions


Conditions:	Non-Small Cell Lung Cancer Renal Cell Carcinoma Melanoma
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Crossover Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	144 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

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®

Outcome Measures


Primary Outcome Measures:
1.	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.
Secondary Outcome Measures:
1.	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.
2.	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.
3.	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.
4.	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.
5.	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.
6.	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.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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.

Contacts/Locations


Study Officials:	Medical Director Study Director Merck Sharp & Dohme LLC
Locations:

IPDSharing


Plan to Share IPD:	Yes http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
	Supporting Information:
	Time Frame:
	Access Criteria:
	URL: http://engagezone.msd.com/ds_documentation.php

References


Citations:
Links:	URL: https://www.merckclinicaltrials.com/ Description: Merck Clinical Trials Information
Available IPD/Information: