Study of Intratumoral (IT) MK-1454 in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002)

STATUS

Recruiting
participants needed

200
sponsor

Merck Sharp & Dohme Corp.

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Updated on 19 February 2024

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HIV Infection

measurable disease

solid tumour

pembrolizumab

squamous cell carcinoma of head and neck

squamous cell carcinoma

antiretroviral therapy

carcinoma

biomarker analysis

systemic therapy

immunodeficiency

hiv test

recurrent head and neck squamous cell carcinoma

Summary

The purpose of this study is to assess the efficacy and safety of intratumoral (IT) MK-1454 in PLUS pembrolizumab (MK-3475) compared to pembrolizumab alone as a first line treatment of adults with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

The primary study hypotheses are that IT MK-1454 in combination with pembrolizumab results in a superior Objective Response Rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), compared to pembrolizumab alone:

in participants with a tumor that has a programmed cell death-ligand 1 (PD-L1) Combined Positive Scoring (CPS) 1, and
in participants with a tumor that has a PD-L1 CPS 20.

Details

Condition	Head and Neck Squamous Cell Carcinoma (HNSCC)
Age	18-100 years
Treatment	Pembrolizumab, MK-1454
Clinical Study Identifier	NCT04220866
Sponsor	Merck Sharp & Dohme Corp.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Has histologically or cytologically confirmed diagnosis of metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) that is considered incurable by local therapies
	Has tumor PD-L1 expression of CPS 1. Tumor tissue must be provided for PD-L1 biomarker analysis
	Has not had prior systemic therapy administered in the recurrent or metastatic setting
	Has at least 1 measurable lesion which is amenable to injection
	Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
	Demonstrates adequate organ function within 7 days prior to treatment initiation
	Male participants of reproductive potential must agree to use a highly effective method of contraception during sexual contact with females of childbearing potential starting with the first dose of study treatment through 120 days after the last dose of study treatment
	Female participants of childbearing potential must be willing to use a highly effective method of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after last dose of study treatment
	Human immunodeficiency virus (HIV)-infected participants must meet these additional
	criteria
	Has HIV-1 infection documented by using any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry (Day 1)
	Has well-controlled HIV on anti-retroviral therapy (ART)
Exclusion Criteria
	Has disease that is suitable for local therapy administered with curative intent
	Has progressive disease (PD) within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC
	Has had chemotherapy or biological cancer therapy in the recurrent or metastatic setting for the treatment of HNSCC
	Has had radiation therapy (or other non-systemic therapy) within 2 weeks prior to randomization or participant has not fully recovered from adverse events (AEs) due to a previously administered treatment
	Is expected to require any other form of antineoplastic therapy while on study
	Has a history of a second malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for at least 2 years
	Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis
	Has an active autoimmune disease that has required systemic treatment in the past 2 years
	Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
	Has had an allogenic tissue/solid organ transplant
	Has a history of vasculitis
	Has a history of interstitial lung disease
	Has an active infection requiring systemic therapy
	Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
	Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
	Has had a severe hypersensitivity reaction to treatment a monoclonal antibody/components of the study treatment
	Has known Hepatitis B virus or Hepatitis C virus infections
	Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or if the participant has previously participated in Merck MK-3475 clinical trials
	HIV infected participant who has had an HIV-related opportunistic infection within 6 months
	HIV infected participants who have a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
	Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
	Has not fully recovered from any effects of major surgery without significant detectable infection
	Has a history of re-irradiation for HNSCC at the projected injection site in the head and neck
	Has received a live-virus vaccine within 30 days of planned study treatment start
	Has been treated with a stimulator of interferon genes (STING) agonist (e.g. MK-1454, ADU-S100)
	Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy, or used an investigational device, any of which occurred within 4 weeks of the first dose of study treatment

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Study Definition

Wikipedia

Study of Intratumoral (IT) MK-1454 in Combination With Intravenous (IV) Pembrolizumab (MK-3475) Compared to IV Pembrolizumab Alone as the First Line Treatment of Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) (MK-1454-002)