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Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma

Open-Label, Randomized Phase 2 Trial of Ramucirumab in Combination With Pembrolizumab Versus Pembrolizumab Alone as First-Line Treatment of PD-L1 Positive, Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma (RM-HNSCC)

NCT05980000•Washington University School of Medicine

View on ClinicalTrials.gov

Summary

This is a phase 2 study investigating the efficacy of ramucirumab in combination with pembrolizumab compared to pembrolizumab monotherapy. Ramucirumab is a VEGFR-2 inhibitor believed to potentially enhance the efficacy of PD-1 inhibitors such as pembrolizumab.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Incurable RM-HNSCC, defined as RM disease or second or subsequent primary HNSCC not amenable to cure by surgery and/or radiation therapy or patient declines or is ineligible for curative therapy. Eligible primary tumor sub-sites include oral cavity, oropharynx, larynx and hypopharynx only.
•PD-L1 positive (CPS ≥1) disease, based on local IHC assay using 22C3 antibody.
•Measurable disease per RECIST 1.1.
•No prior systemic therapy for RM-HNSCC. RM disease developing within 6 months of completion of either a) systemic platinum or cetuximab therapy given as a component of a curative-intent multi-modality regimen or b) radiation therapy and/or surgery is eligible.
•At least 18 years of age.
•ECOG performance status 0-1.
•Normal bone marrow and organ function as defined below:
•* Absolute neutrophil count ≥ 1.5 K/cumm
•* Platelets ≥ 100 K/cumm
•* Hemoglobin ≥ 9.0 g/dL
+20 more criteria

Exclusion Criteria

•PD-L1 negative (CPS 0) disease, based on local IHC assay using 22C3 antibody.
•Cutaneous or nasopharynx SCC.
•Major surgery within 28 days prior to C1D1, minor surgery or subcutaneous venous access device placement within 7 days prior to C1D1, history of significant tumor site bleeding within 14 days prior to C1D1, or elective or planned major surgery to be performed during the course of the clinical trial.
•Palliative radiation therapy within 2 weeks of C1D1.
•Serious or non-healing, non-malignant wound, ulcer, or bone fracture within 28 days prior to C1D1.
•A history of other malignancy ≤ 1 year previous with the exception of completely resected skin carcinoma or other cancers with a low risk (\<10%) of recurrence over the next 2 years.
•Cirrhosis at a level of Child-Pugh B (or worse). Cirrhosis of any degree with a history of hepatic encephalopathy or clinically meaningful ascites (from cirrhosis requiring diuretics or paracentesis).
•Currently receiving any other investigational agents.
•Ongoing toxicity attributed to prior anti-cancer therapy that is \> grade 1, except alopecia, anemia, lymphopenia, xerostomia, fatigue or rash.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

October 27, 2023

Primary Completion Date

June 30, 2027

Completion Date

June 30, 2030

Last Updated

February 6, 2026

Enrollment

ACTUAL participants

Conditions

Recurrent Head and Neck CancerRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Head and Neck CarcinomaMetastatic Head-and-neck Squamous-cell CarcinomaMetastatic Head and Neck CancerHNSCC

Interventions

Ramucirumab

DRUG

Pembrolizumab

DRUG

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

NCT06980038

Head and Neck Squamous Cell CarcinomaHypopharyngeal Squamous Cell Carcinoma+20 more

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Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Human Papillomavirus-Related Neck Squamous Cell Carcinoma of Unknown Primary+20 more

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: February 6, 2026Data 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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Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

Testing Whether Cemiplimab (REGN2810) Plus CDX-1140 Given Prior to Surgery Are Better Than Cemiplimab (REGN2810) Alone in Patients With Stage III-IV Head and Neck Cancer

Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial

Combining Immunotherapy Salvage Surgery & IORT Tx Persistent/Recurrent Head & Neck Cancer

A Study of ASP-1929 Photoimmunotherapy in Combination With Pembrolizumab in First-line Treatment of Locoregional Recurrent Squamous Cell Carcinoma of the Head and Neck With No Distant Metastases

Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer

Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery