Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )

NCT02633800 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: U31287-A-U2032015-002222-40
• Study Type: interventional
• Target: 87
• Locations: 7 countries
• Sites: 34

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.

Conditions

Head and Neck Neoplasms

Keywords

Squamous cell cancer of the head and neck; Squamous cell carcinoma; Head and neck cancer; Neoplasms by site

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) in the Heregulin (HRG)-High Expression Population

  PFS is defined as the time from the date of randomization to the date of the first radiographic disease progression or death due to any cause, whichever comes first. Median PFS is from Kaplan-Meier analysis. Confidence interval (CI) for median was computed using Brookmeyer-Crowley method.

  from Day 0 to end of active study (study termination) - within 12 months

Secondary Outcomes (2)

• Median Overall Survival

  at approximately 25 months

• Percentage of Participants With Best Overall Response

  at approximately 22 months

Study Arms (2)

Patritumab

EXPERIMENTAL

All participants receive patritumab with cetuximab plus platinum-based therapy (cisplatin or carboplatin)

Drug: Patritumab; Drug: Cetuximab; Drug: Cisplatin; Drug: Carboplatin

Placebo

PLACEBO COMPARATOR

All participants receive placebo with cetuximab plus platinum-based therapy (cisplatin or carboplatin)

Drug: Cetuximab; Drug: Cisplatin; Drug: Carboplatin; Drug: Placebo

Interventions

Patritumab DRUG

Patritumab initial loading dose is 18 mg/kg IV over 60 minutes followed by a maintenance dose of 9 mg/kg IV over 60 minutes (± 10 minutes) every three weeks

Also known as: U3-1287

Patritumab

Cetuximab DRUG

Cetuximab 400 mg/mg/m\^2 IV loading dose, followed by 250 mg/m\^2 weekly

Patritumab; Placebo

Cisplatin DRUG

Cisplatin at 100 mg/m\^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles

Also known as: Platinum-based therapy

Patritumab; Placebo

Carboplatin DRUG

Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles

Also known as: Platinum-based therapy

Patritumab; Placebo

Placebo DRUG

Placebo to match patritumab

Placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (34)

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Univeristair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Institut Curie

Paris, Cedex, 75248, France

Location

Institut de Cancerologie de l'Ouest

Angers, 49055, France

Location

Centre Hospitalier de Bordeaux - Hôpital Saint André

Bordeaux, 33075, France

Location

Hopital Croix-Rousse

Lyon, 69004, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

CHU Hopital de la Timone

Marseille, 13005, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Centre de Cancerologie du Grand Montpellier

Montpellier, 34070, France

Location

Institut de Cancerologie de l'Ouest

Saint-Herblain, 44805, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Charite Universitatsmedizin Berlin

Berlin, 12200/12203, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Klinikum der Universitat Munchen

München, 81377, Germany

Location

Orszagos Onkologiai Intezet

Budapest, 1122, Hungary

Location

Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum

Debrecen, 4032, Hungary

Location

Bacs-Kiskun Megyei Korhaz

Kecskemét, 6000, Hungary

Location

Borsod Abauj Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

Miskolc, 3526, Hungary

Location

Josa Andras Oktatokorhaz

Nyíregyháza, 4400, Hungary

Location

Centrum Onkologii im. Prof. Franciszka Lukaszczyka w Bydgoszczy

Bydgoszcz, 85-796, Poland

Location

Przychodnia Lekarska "KOMED"

Konin, 62-500, Poland

Location

Regionalny Osrodek Onkologiczny Szpital im. M. Kopernika w Lodzi

Lodz, 93-513, Poland

Location

Medisprof SRL

Cluj-Napoca, 400058, Romania

Location

Centrul de Oncologie Sfantul Nectarie

Craiova, 200347, Romania

Location

Institutul Regional de Oncologie Iasi

Iași, 700483, Romania

Location

University College London Hospitals NHS Foundation Trust - University College Hospital

London, NW1 2PG, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

Weston Park Hospital

Sheffield, S10 2SJ, United Kingdom

Location

The Shrewsbury and Telford Hospital NHS Trust

Shrewsbury, SY3 8XQ, United Kingdom

Location

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (2)

• Barber PR, Mustapha R, Flores-Borja F, Alfano G, Ng K, Weitsman G, Dolcetti L, Suwaidan AA, Wong F, Vicencio JM, Galazi M, Opzoomer JW, Arnold JN, Thavaraj S, Kordasti S, Doyle J, Greenberg J, Dillon MT, Harrington KJ, Forster M, Coolen ACC, Ng T. Predicting progression-free survival after systemic therapy in advanced head and neck cancer: Bayesian regression and model development. Elife. 2022 Dec 23;11:e73288. doi: 10.7554/eLife.73288.

  PMID: 36562609 DERIVED

• 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.

  PMID: 31648099 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Carcinoma, Squamous Cell; Neoplasms by Site

Interventions

patritumab; Cetuximab; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Global Clinical Leader
• Organization: Daiichi Sankyo, Inc.

CTRinfo@DSI.com

9089926400

Study Officials

• Kevin Harrington, Prof, MD

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 17, 2015
• Study Start: December 22, 2015
• Primary Completion: January 11, 2018
• Study Completion: February 21, 2018
• Last Updated: January 7, 2019
• Results First Posted: January 7, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Studies for which the medicine and indication have received EU and US marketing approval on or after 01 January 2014 or by the US or EU Health Authorities when regulatory submissions in both regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States and the European Union from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

HU (5); PL (3); DE (3); FR (10); GB (7); RO (3); BE (3)