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Protocol # 19-374

Status

Recruiting

Description

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)

Condition

  • Head and Neck Cancer
  • HPV Positive Oropharyngeal Squamous Cell Carcinoma
  • HPV-Related Carcinoma

Interventions

  • CUE-101
  • Keytruda

Phase

Phase 1

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Dose Limiting Toxicity
  • Serum PK parameters for CUE-101
  • Serum PK parameters for CUE-101
  • Serum PK parameters for CUE-101

Secondary Outcome:

  • Overall response rate (ORR)

Enrollment

85

Study Start Date

July 30, 2019

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Cue Biopharma

Source

Cue Biopharma

Official title

A Phase1, First-in-Human, Open-Label, Dose Escalation and Expansion Study of CUE-101 Monotherapy in Second Line or CUE-101 Combination Therapy With Pembrolizumab in First Line Patients With HPV16+ Recurrent/Metastatic HNSCC KEYNOTE-A78

Clinicaltrials.gov Identifier

NCT03978689

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.