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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

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

NCT04220866•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of intratumoral (IT) ulevostinag 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 ulevostinag 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
+2 more criteria

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
+16 more criteria

Locations (34)

UCLA Hematology & Oncology ( Site 0005)

Los Angeles, California, United States

University of California at San Francisco ( Site 0006)

San Francisco, California, United States

Henry Ford Hospital ( Site 0012)

Detroit, Michigan, United States

Washington University ( Site 0021)

St Louis, Missouri, United States

Sanford Cancer Center Oncology Clinic ( Site 0014)

Sioux Falls, South Dakota, United States

Huntsman Cancer Institute ( Site 0004)

Salt Lake City, Utah, United States

Chris OBrien Lifehouse ( Site 0040)

Camperdown, New South Wales, Australia

Calvary Central Districts Hospital ( Site 0042)

Elizabeth Vale, South Australia, Australia

Monash Health-Monash Medical Centre ( Site 0041)

Clayton, Victoria, Australia

Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 0051)

Linz, Upper Austria, Austria

Key Dates

Start Date

March 4, 2020

Primary Completion Date

September 30, 2022

Completion Date

September 30, 2022

Last Updated

October 29, 2025

Enrollment

ACTUAL participants

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

Ulevostinag

DRUG

Pembrolizumab

BIOLOGICAL

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

NCT04080804

Head and Neck Squamous Cell Carcinoma (HNSCC)

View study

RECRUITINGNA

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

NCT06630780

Head and Neck Squamous Cell Carcinoma (HNSCC)

View study

RECRUITINGPHASE1/PHASE2

AK129 Combination Therapy for Advanced Solid Tumors

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

AK129 Combination Therapy for Advanced Solid Tumors

A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

Study of AB598 Monotherapy and Combination Therapy in Participants With Advanced Cancers

A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer