INTEGRATE IIb
  • INTEGRATE IIb
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Trial Status

Open

Cancer Type

Stomach Cancer, Oesophageal Cancer

If you think this trial is relevant to your situation, please contact your Cancer Specialist to discuss further.

Protocol Title

INTEGRATE II: Randomised Phase III Controlled Trials of Regorafenib containing regimens versus standard care in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)

Purpose of the Study

Advanced Gastro-oesophageal Carcinoma (AGOC) has a poor prognosis, and there is no established standard treatment following failure of first- and second-line chemotherapy. Regorafenib is an investigational oral multi-targeted inhibitor. Regorafenib was shown to prolong progression free survival in INTEGRATE.  The INTEGRATE II trial is currently a randomised phase III, controlled trial aiming to determine if regorafenib improves overall survival in refractory AGOC.

With the shift in practice in AGOC resulting in use of multiple lines of therapy, the use of new immunotherapy agents, and the promising activity of RegoNivo, this amended trial is proposed to compare the effectiveness of RegoNivo in pre-treated patients with AGOC to the current standard therapy.

The aim of INTEGRATE IIb is to determine if the regorafenib and nivolumab combination (RegoNivo) improves overall survival compared with current standard chemotherapy options in refractory AGOC.

Eligibility Criteria

Inclusion Criteria

  • Adults (18 years or over) with metastatic or locally recurrent gastro-oesophageal cancer which:
    • has arisen in any primary gastro-oesophageal site (oesophago-gastric junction (GOJ) or stomach); and
    • is of adenocarcinoma or undifferentiated carcinoma histology; and
    • is evaluable according to Response Evaluation Criteria in Solid Tumours (RECIST Version 1.1) by computed tomography (CT) scan performed within 21 days prior to randomisation. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrolment; and
    • has failed or been intolerant to a minimum of 2 lines of prior anti-cancer therapy for recurrent/metastatic disease which must have included at least one platinum agent and one fluoropyrimidine analogue.
    • HER2-positive participants must have received trastuzumab
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Ability to swallow oral medication.
  • Adequate bone marrow function
  • Adequate renal function
  • Willing and able to comply with all study requirements, including treatment, timing, and/or nature of required assessments and follow-up.
  • Study treatment both planned and able to start within 7 days after randomisation
  • Signed, written informed consent.

Exclusion Criteria

  • Known allergy to the investigational product drug class or excipients in the regorafenib and/or nivolumab
  • Poorly-controlled hypertension
  • Participants with known, uncontrolled malabsorption syndromes
  • Treatment with any previous drug therapy within 2 weeks prior to first dose of study treatment. This includes any investigational therapy.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization
  • Interstitial lung disease with ongoing signs and symptoms
  • Any significant active infection, including chronic active hepatitis B, hepatitis C, or HIV.
  • Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease
  • Patients with a seizure disorder who require pharmacotherapy
  • Serious medical or psychiatric condition(s) that might limit the ability of the patient to comply with the protocol.
  • Pregnancy, lactation, or inadequate contraception.

Study Chairs

Professor Nick Pavlakis
Professor Kohei Shitara
Professor David Goldstein

DETAILED INFORMATION AVAILABLE

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) please click here

Funding

Bayer HealthCare Pharmaceuticals Inc

Patients Recruited

Click here to access the table and view recruitment data on all AGITG open trials:

Open Trial Recruitment Table

Participating Centres

Northern Territory
Royal Darwin Hospital
New South Wales
Prince of Wales Hospital
Border Medical Oncology
Westmead Hospital
The Tweed Hospital
St Vincent’s Public Hospital, Sydney
St George Hospital
Royal North Shore Hospital
Port Macquarie Base Hospital/NCCI
NCCI – Coffs Harbour Health Campus
Newcastle Private Hospital
Gosford Hospital
Concord Repatriation General Hospital
Queensland
Sunshine Coast University Hospital
Townsville Hospital
Royal Brisbane and Womens Hospital
South Australia
Queen Elizabeth Hospital
Flinders Medical Centre
Tasmania
Royal Hobart Hospital
Victoria
Monash Medical Centre
Ballarat Oncology & Haematology Services
Austin Health
Western Australia
St John of God Hospital, Subiaco
Sir Charles Gairdner Hospital
Korea
Jeonbuk National University Hospital
The Catholic Uni of Korea – Seoul St. Mary’s Hospital
The Catholic Uni of Korea – Yeouido St. Mary’s Hospital
Yonsei University Health System – Gangnam Severance Hospital
Seoul National University Bundang Hospital
Kangbuk Samsung Hospital
Haeundae Paik Hospital
Dong-A University Hospital
Chungbuk National University Hospital
Asan Medical Centre
Gyeongsang University Hospital
Chung-Ang University Hospital
Hallym University Sacred Heart Hospital
Korea University Guro Hospital
SMG-SNU Boramae Medical Center
Korea University Anam Hospital
Yonsei University Health System-Severence Hospital
Seoul National University Hospital
Taiwan
National Cheng Kung University Hospital (NCKUH)
China Medical University Hospital (CMUH)
Kaohsiung Medical University Chung-Ho Memorial Hospital
National Taiwan University Hospital (NTUH)
Japan
Shikoku Cancer Center
Saitama Cancer Centre
Shizuoka Cancer Centre
Kyushu Cancer Centre
Hokkaido University Hospital
National Cancer Centre Hospital East
USA
Fred Hutchinson Cancer Research Centre – South Lake Union Clinic
Monument Health Rapid City Hospital
Siouxland Regional Cancer Center
St Elizabeth Healthcare
Mayo Clinic Arizona
USC Norris
Germany
Klinikum Ludwigburg
Kliniken der Stadt Köln
Evang. Klinikum Bethel Bielefeld
Klinikum Leverkusen gGmbH
Caritas Klinikum Saarbrücken St. Theresia
Charité Universitätsmedizin Berlin
Norddeutsches Studienzentrum für Innovative Onkologie (NIO)
KEM/Evang. Kliniken Essen Mitte gGmbH
Klinikum Bayreuth
Universitätsklinikum Heidelberg
Philipps-Universitat Marburg
Universitätsklinikum Mainz
Institut für Klinisch Onkol Forschung am Krankenhaus Nordwest
Studienzentrum Onkologie Ravensburg
Klinikum rechts der Isar der TU München
Universitätsklinikum Ulm
Klinikum Magdeburg gGmbH
Helios Bad Saarow
Universitätsklinikum Jena
Universitätsklinikum Leipzig
Universitätsklinikum Bonn
Austria
Ordensklinikum Linz
Klinikum Klagenfurt am Wörthersee
Universitätsklinikum Wien
Spain
Hospital General Universitari Vall Hebron Barcelona
Hospital Clínico de Valencia
Hospital Universitario de Navarra
Italy
Ospedale San Camillo Forlanini
Azienda USL-IRCCS Di Reggio Emilia
Istituto Nazionale Tumori di Napoli-IRCCSFondazione G.Pascale
U.D.C. Oncologia San Giovanni Rotondo

Trial Status

Open

Cancer Type

Stomach Cancer, Oesophageal Cancer

If you think this clinical trial may be relevant to your patient or to discuss further, please contact the Clinical Trial team.

Participating Centres

Northern Territory
Royal Darwin Hospital
New South Wales
Prince of Wales Hospital
Border Medical Oncology
Westmead Hospital
The Tweed Hospital
St Vincent’s Public Hospital, Sydney
St George Hospital
Royal North Shore Hospital
Port Macquarie Base Hospital/NCCI
NCCI – Coffs Harbour Health Campus
Newcastle Private Hospital
Gosford Hospital
Concord Repatriation General Hospital
Queensland
Sunshine Coast University Hospital
Townsville Hospital
Royal Brisbane and Womens Hospital
South Australia
Queen Elizabeth Hospital
Flinders Medical Centre
Tasmania
Royal Hobart Hospital
Victoria
Monash Medical Centre
Ballarat Oncology & Haematology Services
Austin Health
Western Australia
St John of God Hospital, Subiaco
Sir Charles Gairdner Hospital
Korea
Jeonbuk National University Hospital
The Catholic Uni of Korea – Seoul St. Mary’s Hospital
The Catholic Uni of Korea – Yeouido St. Mary’s Hospital
Yonsei University Health System – Gangnam Severance Hospital
Seoul National University Bundang Hospital
Kangbuk Samsung Hospital
Haeundae Paik Hospital
Dong-A University Hospital
Chungbuk National University Hospital
Asan Medical Centre
Gyeongsang University Hospital
Chung-Ang University Hospital
Hallym University Sacred Heart Hospital
Korea University Guro Hospital
SMG-SNU Boramae Medical Center
Korea University Anam Hospital
Yonsei University Health System-Severence Hospital
Seoul National University Hospital
Taiwan
National Cheng Kung University Hospital (NCKUH)
China Medical University Hospital (CMUH)
Kaohsiung Medical University Chung-Ho Memorial Hospital
National Taiwan University Hospital (NTUH)
Japan
Shikoku Cancer Center
Saitama Cancer Centre
Shizuoka Cancer Centre
Kyushu Cancer Centre
Hokkaido University Hospital
National Cancer Centre Hospital East
USA
Fred Hutchinson Cancer Research Centre – South Lake Union Clinic
Monument Health Rapid City Hospital
Siouxland Regional Cancer Center
St Elizabeth Healthcare
Mayo Clinic Arizona
USC Norris
Germany
Klinikum Ludwigburg
Kliniken der Stadt Köln
Evang. Klinikum Bethel Bielefeld
Klinikum Leverkusen gGmbH
Caritas Klinikum Saarbrücken St. Theresia
Charité Universitätsmedizin Berlin
Norddeutsches Studienzentrum für Innovative Onkologie (NIO)
KEM/Evang. Kliniken Essen Mitte gGmbH
Klinikum Bayreuth
Universitätsklinikum Heidelberg
Philipps-Universitat Marburg
Universitätsklinikum Mainz
Institut für Klinisch Onkol Forschung am Krankenhaus Nordwest
Studienzentrum Onkologie Ravensburg
Klinikum rechts der Isar der TU München
Universitätsklinikum Ulm
Klinikum Magdeburg gGmbH
Helios Bad Saarow
Universitätsklinikum Jena
Universitätsklinikum Leipzig
Universitätsklinikum Bonn
Austria
Ordensklinikum Linz
Klinikum Klagenfurt am Wörthersee
Universitätsklinikum Wien
Spain
Hospital General Universitari Vall Hebron Barcelona
Hospital Clínico de Valencia
Hospital Universitario de Navarra
Italy
Ospedale San Camillo Forlanini
Azienda USL-IRCCS Di Reggio Emilia
Istituto Nazionale Tumori di Napoli-IRCCSFondazione G.Pascale
U.D.C. Oncologia San Giovanni Rotondo