Clinical trial NCT02633800: Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )
Official title: Randomized, Placebo-controlled, Double-blind Phase 2 Study of Patritumab (U3-1287) in Combination With Cetuximab Plus Platinum-based Therapy in First Line Setting in Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Keywords: Squamous cell cancer of the head and neck
Squamous cell carcinoma
Head and neck cancer
Neoplasms by site
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2015-12-17
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test an investigational study drug called patritumab. It is a 'randomized study' which means participants have an equal chance of being assigned to receive the experimental medication (patritumab) or a substance that looks like the experimental product, but is not (placebo). Patritumab may work when combined with other medications that are approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or carboplatin. All participants will receive the other medications approved for treatment of head and neck cancer, even if they do not receive the experimental product.

Detailed description: Main objective of the trial:

The main objective of the trial is to evaluate progression-free survival (PFS) in the heregulin (HRG) high expression population from subjects treated with patritumab + cetuximab + platinum-based therapy compared to placebo + cetuximab + platinum-based therapy.

Eligibility criteria: Inclusion Criteria:

* Has histologically confirmed recurrent disease or metastatic SCCHN tumor and/or from its lymph nodal metastases originating from the oral cavity, oropharynx, hypopharynx, and larynx
* Has or be willing to provide tumor tissue for testing
* Has measurable disease per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1
* Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Has adequate hematological function per protocol
* Has adequate renal function per protocol
* Has adequate hepatic function per protocol
* Agrees to use effective contraception while on the study and for 6-months after the end of the study
* Provides written informed consent(s)

Exclusion Criteria:

* Has left ventricular ejection fraction (LVEF) \<50%
* Had prior epidermal growth factor receptor (EGFR) targeted regimen
* Had prior anti-human epidermal growth factor receptor 3 (anti-HER3) therapy
* Had prior chemotherapy for recurrent/metastatic disease
* Had anti-cancer therapy between biopsy and submission of sample
* Has history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years
* Has known history of brain metastases or active brain metastases
* Has uncontrolled hypertension
* Has clinically significant electrocardiograph (ECG) findings
* Had myocardial infarction within 1 year before enrollment, symptomatic congestive heart failure, unstable angina, or arrhythmia requiring medication
* Had platinum-containing drug therapy with radiotherapy less than 6 months before study drug treatment
* Had therapeutic or palliative radiation therapy or major surgery within 4 weeks before study drug treatment

Primary outcomes:
measure: Progression Free Survival (PFS) in the Heregulin (HRG)-High Expression Population
timeFrame: from Day 0 to end of active study (study termination) - within 12 months
Secondary outcomes:
measure: Median Overall Survival
timeFrame: at approximately 25 months
measure: Percentage of Participants With Best Overall Response
timeFrame: at approximately 22 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Edegem
country: Belgium
facility: Univeristair Ziekenhuis Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven
city: Paris
country: France
facility: Institut Curie
state: Cedex
city: Angers cedex 02
country: France
facility: Institut de Cancerologie de l'Ouest
city: Bordeaux
country: France
facility: Centre Hospitalier de Bordeaux - Hôpital Saint André
city: Lyon
country: France
facility: Hopital Croix-Rousse
city: Lyon
country: France
facility: Centre Leon Berard
city: Marseille
country: France
facility: CHU Hopital de la Timone
city: Marseille
country: France
facility: Hopital Saint Joseph
city: Montpellier
country: France
facility: Centre de Cancerologie du Grand Montpellier
city: Saint-Herblain Cedex
country: France
facility: Institut de Cancerologie de l'Ouest
city: Villejuif
country: France
facility: Gustave Roussy
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: München
country: Germany
facility: Klinikum der Universitat Munchen
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz
city: Miskolc
country: Hungary
facility: Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
city: Nyíregyháza
country: Hungary
facility: Josa Andras Oktatokorhaz
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy
city: Konin
country: Poland
facility: Przychodnia Lekarska "KOMED"
city: Lodz
country: Poland
facility: Regionalny Osrodek Onkologiczny Szpital im. M. Kopernika w Lodzi
city: Cluj-Napoca
country: Romania
facility: Medisprof SRL
city: Craiova
country: Romania
facility: Centrul de Oncologie Sfantul Nectarie
city: Iasi
country: Romania
facility: Institutul Regional de Oncologie Iasi
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust - University College Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital
city: Shrewsbury
country: United Kingdom
facility: The Shrewsbury and Telford Hospital NHS Trust
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Kevin Harrington, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forster MD, Dillon MT, Kocsis J, Remenar E, Pajkos G, Rolland F, Greenberg J, Harrington KJ. Patritumab or placebo, with cetuximab plus platinum therapy in recurrent or metastatic squamous cell carcinoma of the head and neck: A randomised phase II study. Eur J Cancer. 2019 Dec;123:36-47. doi: 10.1016/j.ejca.2019.08.017. Epub 2019 Oct 21.