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

NCT03669718 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2023-12-29

No results posted yet for this study

Summary

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.

Conditions

  • Squamous Cell Carcinoma of the Oropharynx
  • HPV16 Positive

Interventions

BIOLOGICAL

ISA101b

Every 3 weeks for a total of 3 times

DRUG

Cemiplimab

Every 3 weeks for up to 24 months

OTHER

Placebo

Every 3 weeks for a total of 3 times

Sponsors & Collaborators

Principal Investigators

  • Bonnie S. Glisson, MD, BS · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2024-09-30
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT03669718 on ClinicalTrials.gov