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A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma

NCT03978689 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-22

No results posted yet for this study

Summary

This is a multi-center, open-label, phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and immunogenicity of CUE-101 as monotherapy treatment in second line or CUE-101 Combination Therapy with Pembrolizumab in first line patients with HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Conditions

Interventions

DRUG

CUE-101

CUE-101 is a novel biologic to treat HPV - driven recurrent / metastatic head and neck cancer given as monotherapy in parts A\&B and in combination in Parts C\&D according to the schedule described in the protocol.

DRUG

KEYTRUDA®, Pembrolizumab

KEYTRUDA® is first-line therapy in HPV16 and HLA A\*0201-positive recurrent and/or metastatic HNSCC patients given in combination with CUE-101 in Parts C\&D according to the schedule described in the protocol.

Sponsors & Collaborators

Principal Investigators

  • Matteo Levisetti, MD · Cue Biopharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2026-01-04
Completion
2026-01-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT03978689 on ClinicalTrials.gov