A Randomized Phase 2 Study of Cemiplimab ± ISA101b in HPV16-Positive OPC

Part of paid clinical trials in Duarte, California.

Sponsor
ISA Pharmaceuticals
Study ID
NCT03669718
Phase
PHASE2
Status
Unknown

Conditions

  • HPV16 Positive
  • Squamous Cell Carcinoma of the Oropharynx

Eligibility Criteria

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

Interventions

  • ISA101b — BIOLOGICAL
    Every 3 weeks for a total of 3 times
  • Cemiplimab — DRUG
    Every 3 weeks for up to 24 months
  • Placebo — OTHER
    Every 3 weeks for a total of 3 times

Study Details

This will be a blinded, placebo-controlled, randomized, phase 2 study in which subjects will be randomly assigned 1:1 to cemiplimab plus placebo or cemiplimab plus ISA101b.

Key Dates

Start date
Nov 30, 2018
Status verified
Dec 2023
Primary completion
Sep 30, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
194 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active ISA101b and cemiplimab.
    ISA101b 3 times plus cemiplimab every 3 weeks for up to 24 months
  • Placebo Comparator: Placebo and cemiplimab
    Placebo 3 times plus cemiplimab every 3 weeks for up to 24 months

Primary Outcome Measure

Overall Response Rate [ Time Frame: 25months ]

Locations (10)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Moores Cancer Center at the UC San Diego HealthSan DiegoCalifornia92093-
University of California San FranciscoSan FranciscoCalifornia94115-
Robert H. Lurie Comprehensive Cancer CenterChicagoIllinois60208-
Washington University School of MedicineSt LouisMissouri63110-
ICAHN School of Medicine at Mount SinaiNew YorkNew York10029-
University of Cincinnati Cancer InstituteCincinnatiOhio45069-
Providence Portland Medical CenterPortlandOregon97213-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
M. D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAMoores Cancer Center at the UC San Diego Health· San Diego, CAUniversity of California San Francisco· San Francisco, CARobert H. Lurie Comprehensive Cancer Center· Chicago, ILWashington University School of Medicine· St Louis, MOICAHN School of Medicine at Mount Sinai· New York, NY

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