HPV-16 Vaccination and Pembrolizumab Plus Cisplatin for "Intermediate Risk" HPV-16-associated Head and Neck Squamous Cell Carcinoma

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Dan Zandberg
Study ID
NCT04369937
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMRT (Intensity Modulated Radiotherapy) — RADIATION
    Radiation therapy
  • Pembrolizumab — DRUG
    A potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between programmed cell death protein 1 (PD-1) and its ligands, PD-L1 and PD-L2.
  • Cisplatin — DRUG
    Chemotherapy
  • ISA101b — BIOLOGICAL
    ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16.

Study Details

This clinical trial will evaluate a new combination of pembrolizumab, HPV-16 E6/E7 specific therapeutic vaccination (ISA101b) and cisplatin-based chemoradiotherapy for patients with newly diagnosed, local-regionally advanced, intermediate risk HPV-associated head and neck squamous cell carcinoma.

Key Dates

Start date
Jul 6, 2020
Status verified
Apr 2026
Primary completion
Mar 12, 2025
Completion
Mar 9, 2026

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IMRT + Pembrolizumab + Cisplatin + ISA101b
    IMRT (Intensity Modulated Radiotherapy) of 70 Gy in 35 fractions over 7 weeks (5 fractions per week). Pembrolizumab will be administered at 200 mg (fixed dose) IV every 3 weeks (+/- 3 days), beginning beginning one week (week -1) prior to concurrent cisplatin-IMRT. Cisplatin will be administered at 100 mg/m2 IV on days 1(Week 0) and 22 (Week 3). ISA101b will be administered as three rounds of vaccination 3-4 weeks apart via two SC injections per vaccination round at 100ug/peptide, before pembrolizumab treatment. Vaccination #1 will be administered 1 week before pembrolizumab.

Primary Outcome Measure

Progression-free Survival (PFS) at 2 Years [ Time Frame: At 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-

Related coverage on Hipa.ai

Find similar trials in Pittsburgh, PA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

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