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New combo injection shows promise for tough head and neck cancers

NCT ID NCT04220866

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug (MK-1454) injected directly into tumors, combined with the immunotherapy pembrolizumab, for people with advanced head and neck cancer that had not been treated before. The goal was to see if the combination worked better than pembrolizumab alone. 18 adults took part, and researchers measured tumor shrinkage and safety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

18 people

The number who actually took part.

Started

Mar 2020

Finished

Sep 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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) 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 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

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Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 head and neck squamous cell carcinoma Neoplasm Metastasis Recurrence Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck squamous cell carcinoma HNSCC

Contacts and locations

Locations

  • Allgemeines Krankenhaus der Stadt Wien ( Site 0049)

    Vienna/Wien, State of Vienna, 1090, Austria

  • Asan Medical Center ( Site 0104)

    Seoul, 05505, South Korea

  • Calvary Central Districts Hospital ( Site 0042)

    Elizabeth Vale, South Australia, 5112, Australia

  • Centre Antoine Lacassagne ( Site 0070)

    Nice, Alpes-Maritimes, 06189, France

  • Centre Leon Berard ( Site 0072)

    Lyon, Auvergne, 69373, France

  • Centre Oscar Lambret ( Site 0071)

    Lille, Nord, 59000, France

  • Centro Regional Integrado de Oncologia ( Site 0062)

    Fortaleza, Ceará, 60336-232, Brazil

  • Chaim Sheba Medical Center ( Site 0076)

    Ramat Gan, Tel Aviv, 5265601, Israel

  • Chris OBrien Lifehouse ( Site 0040)

    Camperdown, New South Wales, 2050, Australia

  • Gustave Roussy ( Site 0068)

    Villejuif, Val-de-Marne, 94800, France

  • H.U. Vall de Hebron ( Site 0112)

    Barcelona, 08035, Spain

  • Hadassah Medical Center. Ein Kerem ( Site 0078)

    Jerusalem, 9112001, Israel

  • Haukeland Universitetssykehus, Klinisk forskningspost voksne ( Site 0086)

    Bergen, Hordaland, 5021, Norway

  • Henry Ford Hospital ( Site 0012)

    Detroit, Michigan, 48202, United States

  • Hospital Clinico de Barcelona ( Site 0116)

    Barcelona, 08036, Spain

  • Hospital Universitario Ramon y Cajal ( Site 0115)

    Madrid, 28034, Spain

  • Hospital Universitario Virgen de la Victoria ( Site 0114)

    Málaga, 29010, Spain

  • Hospital de Caridade de Ijui ( Site 0061)

    Ijuí, Rio Grande do Sul, 98700-000, Brazil

  • Huntsman Cancer Institute ( Site 0004)

    Salt Lake City, Utah, 84112, United States

  • IUCT - Oncopole ( Site 0069)

    Toulouse, Haute-Garonne, 31059, France

  • Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0058)

    São Paulo, 01246-000, Brazil

  • Monash Health-Monash Medical Centre ( Site 0041)

    Clayton, Victoria, 3168, Australia

  • Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 0051)

    Linz, Upper Austria, 4010, Austria

  • Oslo Universitetssykehus Radiumhospitalet ( Site 0085)

    Oslo, 0379, Norway

  • Rambam Medical Center ( Site 0077)

    Haifa, 3109601, Israel

  • Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 0064)

    São Paulo, 01321-001, Brazil

  • Royal Marsden Hospital Sutton-Surrey ( Site 0032)

    Sutton, Surrey, SM2 5PT, United Kingdom

  • Royal Marsden NHS Foundation Trust ( Site 0031)

    London, London, City of, SW3 6JJ, United Kingdom

  • SCRI-CCCIT GesmbH ( Site 0050)

    Salzburg, 5020, Austria

  • Sanford Cancer Center Oncology Clinic ( Site 0014)

    Sioux Falls, South Dakota, 57104, United States

  • Severance Hospital ( Site 0103)

    Seoul, 03722, South Korea

  • UCLA Hematology & Oncology ( Site 0005)

    Los Angeles, California, 90095, United States

  • University of California at San Francisco ( Site 0006)

    San Francisco, California, 94158, United States

  • Washington University ( Site 0021)

    St Louis, Missouri, 63110, United States

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