Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy

NCT01417936 | Completed Phase 2 Results DMC

• 2 other identifiers: Sym004-022011-000902-24
• Study Type: interventional
• Target: 26
• Locations: 3 countries
• Sites: 10

Brief Summary

The trial is designed as a multi-center, open label Phase 2 trial that investigates the efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to that therapy. It is believed that Sym004 has the potential to induce tumor responses and provide a superior treatment option to subjects with advanced SCCHN. Symphogen was the sponsor for planning/conducting and reporting results for this trial.

Conditions

Carcinoma, Squamous Cell of Head and Neck

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) Time

  The PFS time was defined as the time from first infusion of Sym004 until progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. or death. PD was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on trial. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The unequivocal progression of existing non-target lesions and the appearance of one or more lesions was also considered progression. Subjects who died without confirmed PD were considered as progressed. Subjects who died or showed PD more than 21 days after last treatment were censored (that is, were considered alive without progression on Day 21 after last treatment). Evaluation was done using Kaplan-Meier estimates.

  Time from the first infusion of Sym004 until progressive disease or death, assessed up to 24 weeks

Secondary Outcomes (15)

• Objective Tumor Response and Derived Endpoints (Objective Response Rate and Disease Control Rate)

  Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months

• Duration of Overall Response

  Time from first infusion of Sym004 until disease progression or death, assessed up to 18 months

• Time to Progression (TTP)

  Time from first infusion of Sym04 until disease progression, assessed up to 18 months

• Overall Survival Time

  Time from first infusion of Sym004 until death, assessed up to 18 months

• Number of Subjects With Detectable Biomarkers at Any Visit

  Weeks 0 and 4; and 4 weeks after last dose

Study Arms (1)

Sym004

EXPERIMENTAL

Drug: Sym004

Interventions

Sym004 DRUG

Sym004 will be administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.

Sym004

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis initially or at relapse of SCCHN of the oral cavity, oropharynx, hypopharynx or larynx
• Recurrent and/or metastatic SCCHN not amenable to curative treatment with surgery and/or (chemo)radiation
• Previous treatment with an anti-EGFR monoclonal antibody (mAb) in the palliative setting either as monotherapy or in combination with chemotherapy or radiotherapy and showing:
• Documented clinical benefit or response for at least 8 weeks (PR, CR or SD) on the anti-EGFR mAb-based therapy and
• Documented disease progression (verified by computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\] according to RECIST (1.1) during or within 12 weeks following the last administration of anti-EGFR mAb
• Accessible tumor for biopsy and subject acceptance of repeat tumor biopsies

You may not qualify if:

• More than 2 lines of prior chemotherapy in the palliative setting
• Expected survival \<12 weeks
• Subjects with known brain metastases
• Chemotherapy or radiation therapy within 21 days prior to Visit 2 at the exception of palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given on target lesions
• Anti-EGFR mAbs within 14 days prior to Visit 2
• Major surgery within 4 weeks prior to Visit 2 and subjects must have recovered from effects of major surgery

Sponsors & Collaborators

• Symphogen A/S: lead

Study Sites (10)

3203; Antwerp University Hospital; Department of Medical Oncology

Antwerp, Edegem, 2650, Belgium

Location

3202; Jules Bordet Institute; Clinique d'Oncologie Médicale

Brussels, 1000, Belgium

Location

3201; Cliniques Universitaires St-Luc; Centre du Cancer

Brussels, 1200, Belgium

Location

3303; Centre Alexis Vautrin; Département d'Oncologie Médicale

Nancy, Vandoeuvre Les Nancy, 54111, France

Location

4905; Charité Campus Benjamin Franklin; Hematology, Oncology and Transfusion Medicine

Berlin, 12200, Germany

Location

4901; Universitätsklinikum Essen

Essen, 45122, Germany

Location

4904; Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

4906; University Medical Center Hamburg Eppendorf; Department of Otorhinolaryngology and Head and Neck Surgery

Hamburg, 20246, Germany

Location

4907; University Hospital Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, 6912, Germany

Location

4902; University of Leipzig

Leipzig, 04103, Germany

Location

Related Publications (1)

• Machiels JP, Specenier P, Krauss J, Dietz A, Kaminsky MC, Lalami Y, Henke M, Keilholz U, Knecht R, Skartved NJ, Horak ID, Pamperin P, Braun S, Gauler TC. A proof of concept trial of the anti-EGFR antibody mixture Sym004 in patients with squamous cell carcinoma of the head and neck. Cancer Chemother Pharmacol. 2015 Jul;76(1):13-20. doi: 10.1007/s00280-015-2761-4. Epub 2015 May 8.

  PMID: 25952795 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

futuximab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Symphogen A/S

info@symphogen.com

+45 8838 2600

Study Officials

• Ivan Horak, MD, FACP

  Symphogen A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2011
• First Posted: August 16, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 15, 2018
• Results First Posted: February 2, 2016

Record last verified: 2018-09

Locations

BE (3); FR (1); DE (6)