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

NCT05980000 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

  • Recurrent Head and Neck Cancer
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Recurrent Head and Neck Carcinoma
  • Metastatic Head-and-neck Squamous-cell Carcinoma
  • Metastatic Head and Neck Cancer
  • HNSCC

Interventions

DRUG

Ramucirumab

Ramucirumab is administered at a dose of 10 mg/kg over 60 minutes.

DRUG

Pembrolizumab

Pembrolizumab is administered at a flat dose of 200 mg over 30 minutes.

Sponsors & Collaborators

Principal Investigators

  • Douglas R Adkins, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-27
Primary Completion
2027-06-30
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05980000 on ClinicalTrials.gov