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

Sponsor
AIO-Studien-gGmbH
Study ID
NCT03620123
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

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

Interventions

  • Nivolumab and Ipilimumab — DRUG
    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
  • Docetaxel — DRUG
    docetaxel 75 mg/m² intravenous infusion every three weeks

Study Details

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.

Key Dates

Start date
Jul 16, 2018
Status verified
Nov 2022
Primary completion
Jun 20, 2021
Completion
Jun 19, 2022

Study Design

Enrollment
54 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Other: Docetaxel
    docetaxel 75 mg/m² intravenous infusion every three weeks

Primary Outcome Measure

objective response rate in all randomized subjects [ Time Frame: approx. 48 months ]

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