Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Carcinoma, Squamous Cell

Recurrence

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Carboplatin

Cetuximab

Cisplatin

Immunoglobulins

Antineoplastic Agents, Immunological

All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin) in Period 1 - Initial phase of the trial.

Participants deriving clinical benefit enter Period 2 - Extension phase, during which they continue to receive patritumab with cetuximab, but not platinum-based therapy.

Patritumab initial loading dose is 18 mg/kg IV over 60 minutes, followed in Cycle 2 and beyond with a maintenance dose of 9 mg/kg IV over 60 minutes (+/- 10 minutes) every 3 weeks. Infusion time can be extended to a maximum of 120 minutes for participants unable to tolerate the 60-minute infusion.

Patritumab

Cetuximab initial dose at 400 mg/m2 IV as a 2-hour infusion, followed by 250 mg/m2 IV over 60 minutes weekly.

Cisplatin is given as an IV infusion, over 1 hour, 1 hour after the cetuximab infusion, every 3 weeks up to a maximum of 6 cycles (with standard pre- or post-treatment therapies at the investigator's discretion).

Carboplatin is given as an IV-bolus, over 30-60 minutes, every 3 weeks, for a maximum of 6 cycles (with standard pre- or post-treatment therapies at the investigator's discretion).

Global Team Leader

The purpose of this study is to test a study drug called patritumab. Patritumab may work when combined with other medications that are approved in the UK for treating Squamous Cell Carcinoma of the Head and Neck (SCCHN), called cetuximab, cisplatin or carboplatin. It is hoped that patritumab may have some benefit in treating patients with cancer. This study will help identify how much patritumab can be given in combination with cetuximab, and cisplatin or carboplatin. This study will show how safe and how well tolerated patritumab is when these medications are given together.

The trial will be performed in two "phases" (Periods):

Period 1: Initial phase in which the recommended phase 2 dose (RP2D) is determined

Period 2: Extension phase in which participants who are deriving benefit (stable disease or better) will have the opportunity to continue treatment at the discretion of the Investigator

Patritumab With Cetuximab and a Platinum Containing Therapy for Patients With Head and Neck Cancer

An Open Label, Phase 1B Safety Evaluation of Patritumab (U31287) in Combination With Cetuximab Plus Platinum Containing Therapy In Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

DLTs are used to determine the maximum tolerated dose.

A titer is a way of expressing concentration. Titer testing employs serial dilution to obtain approximate quantitative information from an analytical procedure that inherently only evaluates as positive or negative. The titer corresponds to the highest dilution factor that still yields a positive reading.

Daiichi Sankyo

Docetaxel

Immunomodulating Agents

Nivolumab

Ipilimumab

Tubulin Modulators

Antimitotic Agents

Immune Checkpoint Inhibitors

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 75 mg/m² intravenous infusion every three weeks

Nivolumab and Ipilimumab

Viktor Grünwald, Prof. Dr.

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.

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patritumab With Cetuximab and a Platinum Containing Therapy for Patients With Head and Neck Cancer	NCT02350712	Squamous Cell C...	Patritumab Cetuximab Cisplatin Carboplatin	18 Years -	Daiichi Sankyo
A Randomized Phase II Study on the Optimization of Immunotherapy in Squamous Carcinoma of the Head and Neck	NCT03620123	Recurrent or Me... Carcinoma, Squa...	Nivolumab and I... Docetaxel	18 Years -	AIO-Studien-gGmbH
A Randomized Phase II Study on the Optimization of Immunotherapy in Squamous Carcinoma of the Head and Neck	NCT03620123	Recurrent or Me... Carcinoma, Squa...	Nivolumab and I... Docetaxel	18 Years -	AIO-Studien-gGmbH

Spots Global Cancer Trial Database for recurrent or metastatic squamous cell carcinoma of the head and neck