Study of Intratumoral (IT) Ulevostinag (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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 not had prior systemic therapy administered in the recurrent or metastatic setting
Has tumor PD-L1 expression of CPS ≥1. Tumor tissue must be provided for PD-L1 biomarker analysis
Has measurable disease per RECIST 1.1, as assessed by BICR
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 refrain from donating sperm and use a male condom plus partner use of an additional contraceptive method during sexual contact with females of childbearing potential during the intervention period with ulevostinag and for at least 120 days after the last dose of ulevostinag
Female participants of childbearing potential who are not pregnant or breastfeeding must be willing to use a highly effective method of birth control or be surgically sterile or abstain from heterosexual activity during the intervention period and for at least 120 days after the last dose of study intervention, and agree not to donate eggs (ova, oocytes) to others or freeze/store for personal use
Human immunodeficiency virus (HIV)-infected participants must meet these additional criteria:
1. 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)
2. Has well-controlled HIV on anti-retroviral therapy (ART)
You may not be if
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 Sharp \& Dohme (MSD) 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. ulevostinag, 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
