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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06099782




Registration number
NCT06099782
Ethics application status
Date submitted
19/10/2023
Date registered
25/10/2023

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)
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)
Secondary ID [1] 0 0
2023-506017-22
Secondary ID [2] 0 0
3475A-F11
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Renal Cell Carcinoma 0 0
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab co-formulated with hyaluronidase
Treatment: Other - 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.


Treatment: Other: Pembrolizumab co-formulated with hyaluronidase
Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.

Treatment: Other: Pembrolizumab
Administered via IV infusion
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Prefer MK-3475A Subcutaneous (SC) on Patient Preference Questionnaire (PPQ) Question 1
Timepoint [1] 0 0
~Day 106
Secondary outcome [1] 0 0
Percentage of Responses From Participants to the Two Main Reasons for Their Preferred Method of Administration as Assessed on PPQ Question 3
Timepoint [1] 0 0
~Day 106
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to ~Day 106
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Up to ~Day 106
Secondary outcome [4] 0 0
Percentage of Participants Who Choose MK-3475A SC for the Study Treatment Continuation Period
Timepoint [4] 0 0
~Day 106
Secondary outcome [5] 0 0
Number of Participants Who Experience an Adverse Event (AE)
Timepoint [5] 0 0
Up to ~27 months
Secondary outcome [6] 0 0
Number of participants who discontinue study drug due to an AE
Timepoint [6] 0 0
Up to ~24 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
16/11/2026
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001) - Port Macquarie
Recruitment hospital [2] 0 0
Frankston Hospital-Oncology and Haematology ( Site 1007) - Frankston
Recruitment postcode(s) [1] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Argentina
State/province [8] 0 0
Buenos Aires
Country [9] 0 0
Argentina
State/province [9] 0 0
Caba
Country [10] 0 0
Argentina
State/province [10] 0 0
San Juan
Country [11] 0 0
Chile
State/province [11] 0 0
Araucania
Country [12] 0 0
Chile
State/province [12] 0 0
Los Lagos
Country [13] 0 0
Chile
State/province [13] 0 0
Region M. De Santiago
Country [14] 0 0
Chile
State/province [14] 0 0
Valparaiso
Country [15] 0 0
France
State/province [15] 0 0
Calvados
Country [16] 0 0
France
State/province [16] 0 0
Haute-Vienne
Country [17] 0 0
France
State/province [17] 0 0
Ile-de-France
Country [18] 0 0
France
State/province [18] 0 0
Rhone-Alpes
Country [19] 0 0
France
State/province [19] 0 0
Var
Country [20] 0 0
Japan
State/province [20] 0 0
Osaka
Country [21] 0 0
Japan
State/province [21] 0 0
Tokyo
Country [22] 0 0
New Zealand
State/province [22] 0 0
Auckland
Country [23] 0 0
New Zealand
State/province [23] 0 0
Wellington
Country [24] 0 0
Poland
State/province [24] 0 0
Kujawsko-pomorskie
Country [25] 0 0
Poland
State/province [25] 0 0
Mazowieckie
Country [26] 0 0
Poland
State/province [26] 0 0
Zachodniopomorskie
Country [27] 0 0
South Africa
State/province [27] 0 0
Eastern Cape
Country [28] 0 0
South Africa
State/province [28] 0 0
Gauteng
Country [29] 0 0
South Africa
State/province [29] 0 0
Western Cape
Country [30] 0 0
Turkey
State/province [30] 0 0
Adana
Country [31] 0 0
Turkey
State/province [31] 0 0
Ankara
Country [32] 0 0
Turkey
State/province [32] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@msd.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06099782