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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)
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
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
Intervention code [1] 0 0
Other interventions
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
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Argentina
State/province [7] 0 0
Buenos Aires
Country [8] 0 0
Argentina
State/province [8] 0 0
San Juan
Country [9] 0 0
Chile
State/province [9] 0 0
Araucania
Country [10] 0 0
Chile
State/province [10] 0 0
Los Lagos
Country [11] 0 0
Chile
State/province [11] 0 0
Region M. De Santiago
Country [12] 0 0
Chile
State/province [12] 0 0
Valparaiso
Country [13] 0 0
France
State/province [13] 0 0
Calvados
Country [14] 0 0
France
State/province [14] 0 0
Haute-Vienne
Country [15] 0 0
France
State/province [15] 0 0
Ile-de-France
Country [16] 0 0
France
State/province [16] 0 0
Rhone-Alpes
Country [17] 0 0
France
State/province [17] 0 0
Var
Country [18] 0 0
Japan
State/province [18] 0 0
Osaka
Country [19] 0 0
Japan
State/province [19] 0 0
Tokyo
Country [20] 0 0
New Zealand
State/province [20] 0 0
Auckland
Country [21] 0 0
New Zealand
State/province [21] 0 0
Wellington
Country [22] 0 0
Poland
State/province [22] 0 0
Kujawsko-pomorskie
Country [23] 0 0
Poland
State/province [23] 0 0
Mazowieckie
Country [24] 0 0
Poland
State/province [24] 0 0
Zachodniopomorskie
Country [25] 0 0
South Africa
State/province [25] 0 0
Gauteng
Country [26] 0 0
South Africa
State/province [26] 0 0
Western Cape
Country [27] 0 0
Turkey
State/province [27] 0 0
Adana
Country [28] 0 0
Turkey
State/province [28] 0 0
Ankara
Country [29] 0 0
Turkey
State/province [29] 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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06099782
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@merck.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06099782