INTEGRATE IIb
  • INTEGRATE IIb
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Trial Status

Open

Cancer Type

Oesophageal Cancer, Stomach 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

New South Wales
NCCI – Coffs Harbour Health Campus
St George Hospital
Newcastle Private Hospital
Royal North Shore Hospital
Prince of Wales Hospital
St Vincent’s Public Hospital, Sydney
Port Macquarie Base Hospital/NCCI
Gosford Hospital
Border Medical Oncology
Westmead Hospital
The Tweed Hospital
Northern Territory
Royal Darwin Hospital
Queensland
Royal Brisbane and Womens Hospital
Sunshine Coast University Hospital
South Australia
Flinders Medical Centre
Queen Elizabeth Hospital
Tasmania
Royal Hobart Hospital
Victoria
Monash Medical Centre
Austin Health
Ballarat Oncology & Haematology Services
Western Australia
St John of God Hospital, Subiaco
Japan
National Cancer Centre Hospital East
Kyushu Cancer Centre
Hokkaido University Hospital
Shizuoka Cancer Centre
Saitama Cancer Centre
Korea
Yonsei University Health System-Severence Hospital
Hallym University Sacred Heart Hospital
Kangbuk Samsung Hospital
Yonsei University Health System – Gangnam Severance Hospital
The Catholic University of Korea-Seoul St Marys Hospital
Korea University Guro Hospital
Gyeongsang University Hospital
Haeundae Paik Hospital
SMG-SNU Boramae Medical Center
Chungbuk National University Hospital
Chonbuk National University Hospital
Seoul National University Bundang Hospital
Dong-A University Hospital
Korea University Anam Hospital
Chung-Ang University Hospital
Taiwan
National Taiwan University Hospital (NTUH)
Taipei Veterans General Hospital (NCKUH)
National Cheng Kung University Hospital (NCKUH)
Kaohsiung Medical University Chung-Ho Memorial Hospital
China Medical University Hospital (CMUH)

Trial Status

Open

Cancer Type

Oesophageal Cancer, Stomach 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

New South Wales
NCCI – Coffs Harbour Health Campus
St George Hospital
Newcastle Private Hospital
Royal North Shore Hospital
Prince of Wales Hospital
St Vincent’s Public Hospital, Sydney
Port Macquarie Base Hospital/NCCI
Gosford Hospital
Border Medical Oncology
Westmead Hospital
The Tweed Hospital
Northern Territory
Royal Darwin Hospital
Queensland
Royal Brisbane and Womens Hospital
Sunshine Coast University Hospital
South Australia
Flinders Medical Centre
Queen Elizabeth Hospital
Tasmania
Royal Hobart Hospital
Victoria
Monash Medical Centre
Austin Health
Ballarat Oncology & Haematology Services
Western Australia
St John of God Hospital, Subiaco
Japan
National Cancer Centre Hospital East
Kyushu Cancer Centre
Hokkaido University Hospital
Shizuoka Cancer Centre
Saitama Cancer Centre
Korea
Yonsei University Health System-Severence Hospital
Hallym University Sacred Heart Hospital
Kangbuk Samsung Hospital
Yonsei University Health System – Gangnam Severance Hospital
The Catholic University of Korea-Seoul St Marys Hospital
Korea University Guro Hospital
Gyeongsang University Hospital
Haeundae Paik Hospital
SMG-SNU Boramae Medical Center
Chungbuk National University Hospital
Chonbuk National University Hospital
Seoul National University Bundang Hospital
Dong-A University Hospital
Korea University Anam Hospital
Chung-Ang University Hospital
Taiwan
National Taiwan University Hospital (NTUH)
Taipei Veterans General Hospital (NCKUH)
National Cheng Kung University Hospital (NCKUH)
Kaohsiung Medical University Chung-Ho Memorial Hospital
China Medical University Hospital (CMUH)