Patient Preference Study of SC Pembrolizumab versus IV Pembrolizumab with hyaluronidase (MK-3475A) in multiple cancer types

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

16 Feb 2024 → ongoing

Decision date (initial)

2024-01-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-506017-22-00

WHO UTN

U1111-1293-0814

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

To evaluate participant preference for MK-3475A SC

Secondary objectives 4

1. To evaluate the reasons for preference for MK-3475A SC
2. To evaluate participant satisfaction with route of administration of MK-3475A SC and pembrolizumab IV
3. To evaluate participants choice of administration for the study treatment Continuation Period
4. To evaluate the safety and tolerability of MK-3475A SC and pembrolizumab IV

Conditions and MedDRA coding

Melanoma, Renal Cell Carcinoma, Non-small cell lung cancer

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 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.
2. Has a life expectancy of at least 3 months.
3. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
4. 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.
5. 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.
6. 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 22

1. Non-small cell lung cancer (NSCLC) participants with a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
2. Melanoma participants with ocular, mucosal, or conjunctival melanoma
3. Renal Cell Carcinoma (RCC) participants who have had major surgery, other than nephrectomy, within 12 weeks before randomization
4. Has received prior radiotherapy for RCC
5. RCC participants who have residual thrombus post nephrectomy in the vena renalis or vena cava
6. 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)
7. Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
8. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
9. Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids
10. 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.
11. Received radiation therapy to the lung that is >30 Gray within 6 months of start of study intervention.
12. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
13. 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
14. Has known additional malignancy that is progressing or has required active treatment within the past 3 years
15. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
16. Has active autoimmune disease that has required systemic treatment in the past 2 years
17. Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
18. Has active infection requiring systemic therapy
19. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
20. Has history of allogeneic tissue/solid organ transplant
21. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
22. Has not adequately recovered from major surgery or have ongoing surgical complications

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Percentage of Participants Who Prefer MK-3475A Subcutaneous (SC) on Patient Preference Questionnaire (PPQ) Question 1

Secondary endpoints 6

1. Percentage of Responses From Participants to the Two Main Reasons for Their Preferred Method of Administration as Assessed on PPQ Question 3
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
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
4. Percentage of Participants Who Choose MK-3475A SC for the Study Treatment Continuation Period
5. Number of Participants Who Experience an Adverse Event (AE)
6. Number of Participants Who Discontinue Study Treatment Due to an AE

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Niyati Bhagwati

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Niyati Bhagwati

Third parties 3

Locations

2 EU/EEA countries · 8 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications