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

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Cetuximab

Fluorouracil

Cisplatin

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Immunological

60 mg/day 0, 930 mg/day 1, followed by 720 mg i.v. weekly administration

CetuGEX™

400 mg/sqm body surface area (BSA) on day 1, followed by 250 mg/sqm BSA i.v. weekly administration

Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)

Chemotherapy

Ulrich Keilholz, Prof

The aim of the study is to evaluate the efficacy of CetuGEX™ for the treatment of patients with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in combination with platinum-based chemotherapy) in terms of progression-free survival (PFS).

Indication: First line systemic treatment for stage III/IV recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN)

Primary Objective:

To evaluate the efficacy of CetuGEX™ for the treatment of patients with stage III/IV recurrent and/or metastatic SCCHN as compared to cetuximab (both in combination with platinum-based chemotherapy) in terms of progression-free survival (PFS).

Secondary Objectives:

To evaluate further efficacy criteria, safety and quality of life (QoL) of patients with stage III/IV recurrent and/or metastatic SCCHN treated with CetuGEX™ as compared to cetuximab (both in combination with platinum-based chemotherapy).

To assess pharmacokinetic (PK) parameters and profiles of CetuGEX™. To assess efficacy and safety based on genetic markers for immune response (Fc-gamma receptor \[FcγR\] allotypes) and biomarkers (exploratory only).

CetuGEX™ in Comparison to Cetuximab for the Treatment of Patients With Head and Neck Cancer

Randomized, Controlled, Open Label, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of CetuGEX™ Plus CT in Comparison to Cetuximab Plus CT in Patients With Stage III/IV Recurrent and/or Metastatic SCCHN

The primary efficacy endpoint was PFS as assessed by the investigator. Date of disease progression was defined as the date of imaging (based on computed tomography (CT) scans or magnetic resonance imaging (MRI)) showing disease progression, as assessed by the investigator according to adapted immune-related RECIST 1.1 (modified irRC). Disease progression was defined as a 20% increase in tumor burden, taking as reference the smallest tumor burden recorded since the treatment started; confirmation by a second scan was not required. The PFS time was censored at the time of the last tumor assessment if the patient was alive and without progression at the last time of observation.

Objective response rate is the percentage of patients with a tumor size reduction of a predefined amount for a minimum time period and it is defined as the sum of complete responses (CR) and partial responses (PR).

CR: Disappearance of all non-nodal target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.

Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\< 10 mm short axis).

PR: At least a 30% decrease in the tumor burden (sum of the longest lesion diameter (LD) of target lesions (including the short axes of any target lymph nodes plus measurable new lesions), taking as reference the baseline sum diameters.

The clinical benefit rate is the percentage of patients with an objective response or stable disease (SD). SD is defined as not meeting criteria of complete response and partial response, in absence of meeting criteria for disease progression. Follow-up measurements must have met the SD criteria at least once after randomization at a minimum interval of 8 weeks.

Time to treatment failure is defined as the time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death.

The overall survival is defined as the duration of time from randomization to the time of death.

Quality of Life (QoL) scores as assessed by European Oncology Research Trials Committee (EORTC) QoL questionnaires (QLQ) EORTC-QLQ-C30.

Scores are on a scale of 0 to 100, where 100 represents the highest possible QoL.Time to first deterioration of at least 10 points.

Glycotope GmbH

CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly

CetuGEX

Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA.

720 mg weekly administration

CetuGEX™: 60 mg/day 0, 930 mg/day 1, followed by 720 mg i.v. weekly administration

Chemotherapy: Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)

CetuGEX™ Plus Chemotherapy

250 mg/m2 weekly administration

Cetuximab: 400 mg/sqm body surface area (BSA) on day 1, followed by 250 mg/sqm BSA i.v. weekly administration

Chemotherapy: Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)

Cetuximab Plus Chemotherapy

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Romania

Belgium

Poland

Italy

France

Germany

Spain

Region of Enrollment

The intention-to-treat (ITT) population consisted of all randomized patients. The ITT population was the primary population for the efficacy analysis. The safety population included all patients who received at least 1 dose of trial medication (N=237). This population was used for safety analyses (adverse events).

Senior Director Clinical Department

Progression-free Survival (PFS)

CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly.

Objective Response Rate (ORR)

Clinical Benefit Rate

Time to Treatment Failure

Overall Survival

CetuGEX™ was administered as infusion to all patients randomized to the CetuGEX™ arm, once weekly. The initial dose was 990 mg and subsequent doses were 720 mg once weekly. Chemotherapy consisted of 5-FU (1000 mg/m2/d, day 1-4) and cisplatin (100 mg/m2, on day 1).Treatment cycles were scheduled to be repeated every 3 weeks for a maximum of 6 cycles, and followed by a weekly single-agent maintenance therapy of CetuGEX.

CetuGEX in Combination With Chemotherapy

Cetuximab was administered once weekly as infusion to all patients randomized to the cetuximab arm.The initial dose was 400 mg/m2 body surface area (BSA) and each subsequent dose was 250 mg/m2 BSA. Chemotherapy consisted of 5-FU (1000 mg/m2/d, day 1-4) and cisplatin (100 mg/m2, on day 1).Treatment cycles were scheduled to be repeated every 3 weeks for a maximum of 6 cycles, and followed by a weekly single-agent maintenance therapy of cetuximab.

Cetuximab in Combination With Chemotherapy

Intent-to treat population. 158 patients were evaluable for this Outcome Measure.

Spots Global Cancer Trial Database for tomuzotuximab