Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
estimated completion

Description

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: 1. in participants with a tumor that has a programmed cell death-ligand 1 (PD-L1) Combined Positive Scoring (CPS) ≥ 1, and 2. in participants with a tumor that has a PD-L1 CPS ≥ 20.

Official Title

A Phase 2 Study in First Line Metastatic or Unresectable, Recurrent Head and Neck Squamous Cell Carcinoma to Evaluate Intratumoral MK-1454 in Combination With IV Pembrolizumab vs IV Pembrolizumab Monotherapy

Keywords

Head and Neck Squamous Cell Carcinoma (HNSCC) Programmed Cell Death-1 (PD1, PD-1) Programmed Death-Ligand 1 (PDL1, PD-L1) intratumoral (IT) metastatic unresectable recurrent MK-1454 pembrolizumab Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck MK-1454+Pembrolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 MK-1454 and for at least 120 days after the last dose of MK-1454
  • 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:
  • 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)

You CAN'T join 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 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

Locations

  • UCLA Hematology & Oncology ( Site 0005) accepting new patients
    Los Angeles California 90095 United States
  • University of California at San Francisco ( Site 0006) accepting new patients
    San Francisco California 94158 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme Corp.
ID
NCT04220866
Phase
Phase 2
Study Type
Interventional
Last Updated