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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06099782
Registration number
NCT06099782
Ethics application status
Date submitted
19/10/2023
Date registered
25/10/2023
Date last updated
22/05/2024
Titles & IDs
Public 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)
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Scientific 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)
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Secondary ID [1]
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2023-506017-22
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Secondary ID [2]
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3475A-F11
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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Renal Cell Carcinoma
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Melanoma
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Condition category
Condition code
Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Pembrolizumab co-formulated with hyaluronidase
Other interventions - Pembrolizumab
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).
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.
Other interventions: Pembrolizumab co-formulated with hyaluronidase
Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.
Other interventions: Pembrolizumab
Administered via IV infusion
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Prefer MK-3475A Subcutaneous (SC) on Patient Preference Questionnaire (PPQ) Question 1
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Assessment method [1]
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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.
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Timepoint [1]
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~Day 106
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Secondary outcome [1]
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Percentage of Responses From Participants to the Two Main Reasons for Their Preferred Method of Administration as Assessed on PPQ Question 3
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Assessment method [1]
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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.
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Timepoint [1]
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~Day 106
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Secondary outcome [2]
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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
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Assessment method [2]
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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.
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Timepoint [2]
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Up to ~Day 106
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Secondary outcome [3]
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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
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Assessment method [3]
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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.
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Timepoint [3]
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Up to ~Day 106
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Secondary outcome [4]
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Percentage of Participants Who Choose MK-3475A SC for the Study Treatment Continuation Period
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Assessment method [4]
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The percentage of participants who choose SC treatment for the continuation period in the study will be reported.
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Timepoint [4]
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~Day 106
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Secondary outcome [5]
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Number of Participants Who Experience an Adverse Event (AE)
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Assessment method [5]
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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.
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Timepoint [5]
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Up to ~27 months
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Secondary outcome [6]
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Number of participants who discontinue study drug due to an AE
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Assessment method [6]
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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.
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Timepoint [6]
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Up to ~24 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/12/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
16/11/2026
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Actual
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Sample size
Target
144
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001) - Port Macquarie
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Recruitment hospital [2]
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Frankston Hospital-Oncology and Haematology ( Site 1007) - Frankston
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Recruitment postcode(s) [1]
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2444 - Port Macquarie
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Recruitment postcode(s) [2]
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3199 - Frankston
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alaska
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Washington
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Argentina
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State/province [7]
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Buenos Aires
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Country [8]
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Argentina
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State/province [8]
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San Juan
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Chile
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Araucania
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Chile
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Los Lagos
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Chile
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Region M. De Santiago
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Chile
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Valparaiso
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France
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Calvados
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France
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Haute-Vienne
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France
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Ile-de-France
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France
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Rhone-Alpes
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France
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Var
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Japan
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Osaka
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Japan
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Tokyo
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New Zealand
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Auckland
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New Zealand
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Wellington
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Poland
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Kujawsko-pomorskie
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Poland
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Mazowieckie
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Poland
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Zachodniopomorskie
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South Africa
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Gauteng
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South Africa
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Western Cape
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Izmir
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06099782
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Email
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Contact person for public queries
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Toll Free Number
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Address
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Phone
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1-888-577-8839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06099782
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