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A Randomized Phase II Study on the Optimization of Immunotherapy in Squamous Carcinoma of the Head and Neck

NCT03620123 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-11-18

No results posted yet for this study

Summary

AIO-KHT-0117 (OPTIM) is a phase II, open-label randomized, multicenter study of nivolumab and ipilimumab on the optimization of immunotherapy in squamous carcinoma of the head and neck after prior platinum-based therapy.

Conditions

  • Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
  • Carcinoma, Squamous Cell of Head and Neck

Interventions

DRUG

Nivolumab and Ipilimumab

Nivolumab 3 mg/kg of body weight intravenous infusion every two weeks and ipilimumab 1 mg/kg of body weight intravenous infusion every six weeks

DRUG

Docetaxel

docetaxel 75 mg/m² intravenous infusion every three weeks

Sponsors & Collaborators

Principal Investigators

  • Viktor Grünwald, Prof. Dr. · Essen University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2021-06-20
Completion
2022-06-19

Countries

  • Germany

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 NCT03620123 on ClinicalTrials.gov