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Pembrolizumab for Head and Neck Squamous Cell Carcinoma

Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 913.0 days
Awards & highlights

Study Summary

This trial will test whether adding ulevostinag to pembrolizumab helps people with head and neck squamous cell carcinoma.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 913.0 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 913.0 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Secondary outcome measures
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Number of Participants Discontinuing Study Treatment Due to an AE
Number of Participants Who Experienced an Adverse Event (AE)
+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ulevostinag+PembrolizumabExperimental Treatment2 Interventions
Participants receive ulevostinag 540 ug via intratumoral (IT) injection on Day 1 of every week for two 3-week cycles (Cycles 1-2), then on Day 1 of each 3-week cycle for up 33 cycles (Cycles 3-35), for a total of 35 cycles PLUS pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment is up to approximately 2 years.
Group II: PembrolizumabActive Control1 Intervention
Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 cycles. The total duration of treatment is up to approximately 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-1454
Not yet FDA approved
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,810 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,535 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,468 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
NatureJournal
A Kinase-cgas Cascade to Synthesize a Therapeutic STING Activator
McIntosh, John A., Zhijian Liu, Brian M. Andresen, Nastaran Salehi Marzijarani, Jeffrey C. Moore, Nicholas M. Marshall, Margie Borra-Garske, et al.. 2022. “A Kinase-cgas Cascade to Synthesize a Therapeutic STING Activator”. Nature. Springer Science and Business Media LLC. doi:10.1038/s41586-022-04422-9.
clinicaltrials.govStudy
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)
2020. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04220866.
~4 spots leftby Apr 2025
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