EMD 1201081 + 5-FU + Cisplatin + Cetuximab in Subjects With Recurrent / Metastatic Squamous Cell Carcinoma of the Head and Neck

Merck KGaA (EMD Serono)

Status and phase: Terminated; Phase 1

Conditions: Squamous Cell Carcinoma of the Head and Neck

Treatments: Drug: EMD 1201081 + 5-FU + Cisplatin + Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01360827

EMR 200068-007

Details and patient eligibility

About

The primary purpose of this trial is to assess the safety and tolerability of EMD 1201081, a novel immunomodulatory agent that is an agonist of TLR9, in combination with 5-FU/cisplatin and cetuximab in first line treatment of patients with recurrent/metastatic squamous cell carcinoma of the head and neck, and to determine the maximum tolerated dose (MTD) among the dose levels.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the head and neck (SCCHN).
• Recurrent and/or metastatic SCCHN, not suitable for local therapy.
• At least 1 measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI) (according to RECIST 1.0).
• Karnofsky performance status (KPS) of ≥ 70 / Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at trial entry.

Exclusion criteria

• Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease which was completed more than 2 months prior to trial entry.
• Nasopharyngeal carcinoma.
• Medical history of diagnosed interstitial lung disease.
• Known hypersensitivity against any of the components of the trial treatment.
• Previous treatment with experimental or non-approved epidermal growth factor receptor (EGFR) targeting therapy or experimental or nonapproved EGFR signal transduction inhibitors (prior treatment with cetuximab is allowed).
• Relevant cardiovascular co-morbidities.
• Concomitant chronic systemic immune therapy, or hormonal therapy as cancer therapy, steroid use ≥ 10 mg prednisone equivalent.
• Known human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Arm 1 (Part 1)

Experimental group

Treatment:

Drug: EMD 1201081 + 5-FU + Cisplatin + Cetuximab

Drug: EMD 1201081 + 5-FU + Cisplatin + Cetuximab

Arm 2 (Expansion cohorts -Part 2 and Part 2a)

Experimental group

Treatment:

Drug: EMD 1201081 + 5-FU + Cisplatin + Cetuximab

Drug: EMD 1201081 + 5-FU + Cisplatin + Cetuximab