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

Carcinoma, Squamous Cell of Head and Neck Clinical Trial

Official title:
A Randomized Phase II Study on the OPTimization of IMmunotherapy in Squamous Carcinoma of the Head and Neck

Clinical Trial 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.

Clinical Trial Description

This is a randomized, open-label, multicenter, phase II trial. Patients with recurrent or metastatic squamous cell carcinoma of the head and neck will be enrolled in this trial will initiate palliative systemic treatment with nivolumab monotherapy (240 mg fixed dose Q2W). Tumor response will be assessed after 4, 8, 12, 18 and 24 weeks to capture early progressors. Patients with (radiologic) tumor progression during the first 6 months of NIVO mono will be randomized (1:1) to receive either docetaxel (75 mg/m2 Q3W) or nivolumab+ipilimumab combination (Nivolumab 3mg/kg Q2W + Ipilimumab 1mg/kg Q6W) until progressive disease [PD] or death. Patients without PD within 6 months NIVO monotherapy continue treatment under study surveillance for a maximum of 12 months measured from first dose of NIVO or until documented disease progression. ;

Study Design

Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Squamous Cell
  • Carcinoma, Squamous Cell of Head and Neck
  • Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
  • Squamous Cell Carcinoma of Head and Neck
Clinical Trial Details
NCT number NCT03620123
Study type Interventional
Source AIO-Studien-gGmbH
Contact
Status Completed
Phase Phase 2
Start date July 16, 2018
Completion date June 19, 2022
View Details
See also
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