Breast Cancer Clinical Trial

RegoNivo vs Standard of Care Chemotherapy in AGOC

Summary

To determine if the regorafenib and nivolumab combination (RegoNivo) improves overall survival compared with current standard chemotherapy options in refractory AGOC.

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Full Description

The purpose of this international study is to determine if the combination of regorafenib and nivolumab is more effective than standard chemotherapy in prolonging overall survival in a broad group of participants with AGOC, who have progressed after treatment with standard anti-cancer therapy.

In the INTEGRATE study, regorafenib alone was shown to be effective in prolonging the progression-free period in people with AGOC following standard anti-cancer therapy (i.e. it delayed tumour growth), and demonstrated a potential benefit on long term survival. Recent research has shown the early results from this combination of regorafenib & nivolumab may improve outcomes for cancer patients. INTEGRATE IIb will investigate this effect further in a larger group of participants with AGOC.

The study aims to determine:

i. Whether the combination of regorafenib/nivolumab is likely to help patients with AGOC live longer; ii. The effects of this treatment on progression-free survival; iii. The numbers of participants responding to the treatment iv. The effects of this treatment on quality of life v. The side effects and tolerability of this treatment vi. Molecular differences (e.g. variations in genes or proteins) that may account for the effects of this treatment vii. Differences in the costs of care for people on this treatment.

The Investigators plan to enrol 450 participants in the study from, but not limited to; Australia, New Zealand, South Korea, Japan, Taiwan, Canada, USA, Germany, Belgium, Spain, France, Switzerland, Netherlands and Italy.

View Eligibility Criteria

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. Note: Neoadjuvant or adjuvant chemotherapy or chemoradiotherapy will be considered as first line treatment where people have relapsed or progressed within 6 months of completing treatment; Radiosensitising chemotherapy given solely for this purpose concurrent with palliative radiation will not be considered as a line of treatment. Ramucirumab monotherapy, or immunotherapy with a checkpoint inhibitor, will be considered a line of treatment.
HER2-positive participants must have received trastuzumab
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix 1).
Ability to swallow oral medication.
Adequate bone marrow function (Platelets ≥100x109/L; Absolute Neutrophil Count (ANC) ≥1.5x109/L and Haemoglobin ≥ 9.0g/dL).
Adequate renal function (Creatinine clearance >50 ml/min) based on either the Cockcroft-Gault formula (Appendix 2), 24-hour urine or Glomerular Filtration Rate (GFR) scan; and serum creatinine ≤1.5 x Upper Limit of Normal (ULN).

Adequate liver function (Serum total bilirubin ≤1.5 x ULN, and INR ≤ 1.5 x ULN, and Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ≤2.5 x ULN (≤ 5 x ULN for participants with liver metastases)).

Participants being treated with an anti-coagulant, such as warfarin or heparin, will be allowed to participate provided that no prior evidence of an underlying abnormality in these parameters exists.

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 (note: subjects randomised on a Friday should commence treatment no earlier than the following Monday)
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 (systolic blood pressure >140mmHg or diastolic pressure> 90mmHg despite optimal medical management).
Participants with known, uncontrolled malabsorption syndromes
Any prior anti-VEGF targeted therapy using small molecule VEGF TKIs (e.g. apatinib). Prior anti-VEGF targeted monoclonal antibody therapies (e.g. bevacizumab and ramucirumab) are permitted.
Any prior use of more than one immune checkpoint inhibitor
Treatment with any previous drug therapy within 2 weeks prior to first dose of study treatment. This includes any investigational therapy.
Use of biological response modifiers, such as granulocyte colony stimulating factor (G-CSF), within 3 weeks prior to randomisation.
Concurrent treatment with strong CYP3A4 inhibitors or inducers.
Palliative radiotherapy, unless more than 14 days have elapsed between completion of radiation and the date of registration, and adverse events resulting from radiation have resolved to < Grade 2 according to CTCAE V5.0
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization
Arterial thrombotic or ischaemic events, such as cerebrovascular accident, within 6 months prior to randomization.
Venous thrombotic events and pulmonary embolism within 3 months prior to randomization
Any haemorrhage or bleeding event ≥ Grade 3 according to CTCAE v5.0 within 4 weeks prior to randomization.
Non-healing wound, ulcer, or bone fracture.
Interstitial lung disease with ongoing signs and symptoms
Clinical hyperthyroidism or hypothyroidism. Note: non-clinically significant abnormal TFTs (abnormal TSH and abnormal T3 and/or abnormal T4) considered to be due to sick euthyroid syndrome is allowed.
Persistent proteinuria of ≥ Grade 3 according to CTCAE v5.0 (equivalent to > 3.5g of protein over 24 hour measured on either a random specimen or 24 hour collection.
Uncontrolled metastatic disease to the central nervous system. To be eligible, known CNS metastases should have been treated with surgery and/or radiotherapy and the patient should have been receiving a stable dose of steroids for at least 2 weeks prior to randomization, with no deterioration in neurological symptoms during this time.

History of another malignancy within 2 years prior to randomization. Participants with the following are eligible for this study:

curatively treated cervical carcinoma in situ,
non-melanomatous carcinoma of the skin,
superficial bladder tumours (T1a [Non-invasive tumour], and Tis [Carcinoma in situ]),
treated thyroid papillary cancer
Any significant active infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated. Participants with known Hepatitis B/C infection will be allowed to participate providing evidence of viral suppression has been documented and the patient remains on appropriate anti-viral therapy.
Patients with acute coronary syndrome (including myocardial infarction and unstable angina), and with a history of coronary angioplasty or stent placement performed within 6 months before enrolment
Patients with a ≥ grade 3 active infection according to CTCAE version 5.0
Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease
Patients who require systemic corticosteroids (excluding temporary usage for tests, prophylactic administration for allergic reactions, or to alleviate swelling associated with radiotherapy; if used as replacement therapy e.g. ≤ 10 mg prednisolone or dexamethasone ≤ 2 mg per day) or immunosuppressants, or who have received such a therapy < 14 days prior to randomisation
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. Women must be post-menopausal infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to randomization. Men must have been surgically sterilized or use a barrier method of contraception.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

450

Study ID:

NCT04879368

Recruitment Status:

Recruiting

Sponsor:

Australasian Gastro-Intestinal Trials Group

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There are 30 Locations for this study

See Locations Near You

Mayo Clinic Arizona
Scottsdale Arizona, 85054, United States More Info
Mohamad B. Sonbol
Principal Investigator
USC Norris
Los Angeles California, 90001, United States More Info
Syma Iqbal
Principal Investigator
Siouxland Regional Cancer Center
Sioux City Iowa, 51101, United States More Info
Donald Wender
Principal Investigator
St Elizabeth Healthcare
Edgewood Kentucky, 41017, United States More Info
Minsig Choi
Principal Investigator
Monument Health Rapid City Hospital
Rapid City South Dakota, 57701, United States More Info
Abdel-Ghani Azzouqa
Principal Investigator
Fred Hutchinson Cancer Research Centre - South Lake Union Clinic
Seattle Washington, 98109, United States More Info
David Zhen
Principal Investigator
Coffs Harbour Health Campus
Coffs Harbour New South Wales, 2450, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Karen Briscoe
Principal Investigator
Concord Repatriation General Hospital
Concord New South Wales, 2139, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Kim Tam Bui
Principal Investigator
St Vincent's Public Hospital
Darlinghurst New South Wales, 2010, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Hao-Wen Sim
Principal Investigator
Border Medical Oncology Research Unit
East Albury New South Wales, 2640, Australia More Info
Craig Underhill
Contact
+61 2956 25000
[email protected]
Craig Underhill
Principal Investigator
Gosford Hospital
Gosford New South Wales, 2250, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Matthew Wong
Principal Investigator
St George Hospital
Kogarah New South Wales, 2217, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Katrin Sjoquist
Principal Investigator
Newcastle Private Hospital
New Lambton Heights New South Wales, 2035, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Antonino Bonaventura
Principal Investigator
Port Macquarie Base Hospital
Port Macquarie New South Wales, 2444, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Stephen Begbie
Principal Investigator
Prince of Wales Hospital
Randwick New South Wales, 2031, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
David Goldstein
Principal Investigator
Royal North Shore Private Hospital
Sydney New South Wales, 2065, Australia More Info
Trial Coordinator
Contact
+6129565000
[email protected]
Nick Pavlakis
Principal Investigator
The Tweed Hospital
Tweed Heads New South Wales, 2485, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Sumit Lumba
Principal Investigator
Ballarat Oncology and Haematology Services
Wendouree New South Wales, 3355, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
George Kannourakis
Principal Investigator
Westmead Hospital
Westmead New South Wales, 2145, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Adnan Nagrial
Principal Investigator
Royal Darwin Hospital
Tiwi Northern Territory, 0810, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Narayan Karanth
Principal Investigator
The Townsville Hospital
Douglas Queensland, 4814, Australia More Info
INTEGRATE II Coordinator
Contact
+61 2 9562 5000
[email protected]
Nathan Bain
Principal Investigator
Royal Brisbane and Womens Hospital
Herston Queensland, 4029, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Matthew Burge
Principal Investigator
Sunshine Coast University Hospital
Sunshine Coast Queensland, 4560, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Alessandra Francesconi
Principal Investigator
The Queen Elizabeth Hospital
Adelaide South Australia, 5011, Australia More Info
Trial Coordinator
Contact
+612956 5000
[email protected]
Timothy Price
Principal Investigator
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Chris Karapetis
Principal Investigator
Royal Hobart Hospital
Hobart Tasmania, 700, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Monash Health
Clayton Victoria, 3168, Australia More Info
Trial Coordinator
Contact
+61 2956 5000
[email protected]
Andrew Strickland
Principal Investigator
Austin Health
Melbourne Victoria, 3084, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Niall Tebbutt
Principal Investigator
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Kevin Jasas
Principal Investigator
St John of God Hospital Subiaco
Subiaco Western Australia, 6008, Australia More Info
Trial Coordinator
Contact
+61 2 9562 5000
[email protected]
Tom Van Hagen
Principal Investigator
Landeskrankenanstalten-Betriebsgesellschaft-KABEG
Klagenfurt , , Austria More Info
Wolfgang Eisterer
Principal Investigator
Ordensklinikum Linz GmbH Barmherzige schwestern
Linz , , Austria More Info
Holger Florian Rumpold
Principal Investigator
Medizinische Universitaet Wien
Vienna , , Austria More Info
Ayseguel Ilhan-Mutlu
Principal Investigator
Landesklinikum Wiener Neustadt
Wiener Neustadt , , Austria More Info
Birgit Gruenberger
Principal Investigator
Evang. Klinikum Bethel Bielefeld
Gütersloh Nordrhein-Westfalen, , Germany More Info
Kambiz Taghizadeh
Principal Investigator
Helios Bad Saarow
Bad Saarow , , Germany More Info
Daniel Pink
Principal Investigator
Klinikum Bayreuth
Bayreuth , , Germany More Info
Alexander Kiani
Principal Investigator
Charité Universitätsmedizin Berlin
Berlin , , Germany More Info
Peter Thuss-Patience
Principal Investigator
Universitätsklinikum Bonn
Bonn , , Germany More Info
Maria Gonzalez-Carmona
Principal Investigator
KEM/Evang. Kliniken Essen Mitte gGmbH
Essen , , Germany More Info
Christian Müller
Principal Investigator
Institut für Klinisch Onkol Forschung am Krankenhaus Nordwest
Frankfurt , , Germany More Info
Thorsten Goetze
Principal Investigator
Universitätsklinikum Greifswald
Greifswald , , Germany More Info
Ali Aghdassi
Principal Investigator
Norddeutsches Studienzentrum für Innovative Onkologie (NIO)
Hamburg , , Germany More Info
Eray Gökkurt
Principal Investigator
Universitätsklinikum Heidelberg
Heidelberg , , Germany More Info
Georg Martin Haag
Principal Investigator
Universitätsklinikum Jena
Jena , , Germany More Info
Udo Lindig
Principal Investigator
Kliniken der Stadt Köln
Koeln , , Germany More Info
Stefan Angermeier
Principal Investigator
Universitätsklinikum Leipzig
Leipzig , , Germany More Info
Gertraud Stocker
Principal Investigator
Klinikum Leverkusen gGmbH
Leverkusen , , Germany More Info
Andrea Heider
Principal Investigator
Klinikum Ludwigburg
Ludwigsburg , , Germany More Info
Bernhard Sibbing
Principal Investigator
Klinikum Magdeburg gGmbH
Magdeburg , , Germany More Info
Christoph Kahl
Principal Investigator
Universitätsklinikum Mainz
Mainz , , Germany More Info
Markus Möhler
Principal Investigator
Philipps-Universitat Marburg
Marburg , , Germany More Info
Jorge Riera Knorrenschild
Principal Investigator
Klinikum rechts der Isar der TU München
München , , Germany More Info
Sylvie Lorenzen
Principal Investigator
Studienzentrum Onkologie Ravensburg
Ravensburg , , Germany More Info
Tobais Dechow
Principal Investigator
Caritas Klinikum Saarbrücken St. Theresia
Saarbrücken , , Germany More Info
Manfred P. Lutz
Principal Investigator
Universitätsklinikum Ulm
Ulm , , Germany More Info
Thomas Ettrich
Principal Investigator
Istituto Nazionale Tumori di Napoli-IRCCS Fondazione G. Pascale
Napoli , , Italy More Info
Antonio Avallone
Principal Investigator
Universitae degli studi della Campania "Luigi Vanvitelli"
Napoli , , Italy More Info
Ferdinando De Vita
Principal Investigator
Azienda USL-IRCCS Di Reggio Emilia
Reggio Emilia , , Italy More Info
Angela Damato
Principal Investigator
San Camillo Forlanini Hospitals
Roma , , Italy More Info
Carlo Garufi
Principal Investigator
Universita Cattolica del Sacro Cuore, University Hospital Gemelli
Roma , , Italy More Info
Carmelo Pozzo
Principal Investigator
IRCCS Fondazione Casa Sollievo della Sofferenza
San Giovanni Rotondo , , Italy More Info
Evaristo Maiello
Principal Investigator
National Cancer Centre Hospital East
Chiba Kashiwa, , Japan
Hokkaido University Hospital
Sapporo Kita, , Japan
Kyushu Cancer Center
Fukuoka , , Japan
Shikoku Cancer Center
Matsuyama , , Japan
Saitama Cancer Center
Saitama , , Japan
Shizuoka Cancer Center
Shizuoka , , Japan
Hallym University Sacred Heart Hospital
Anyang , , Korea, Republic of
Dong-A University Hospital
Busan , , Korea, Republic of
Haeundae Paik Hospital
Busan , , Korea, Republic of
Chungbuk National University Hospital
Cheongju , , Korea, Republic of
Jeonbuk National University Hospital
Jeonju , , Korea, Republic of
Gyeongsang National University Hospital
Jinju , , Korea, Republic of
Asan Medical Centre
Seoul , , Korea, Republic of
Chung-Ang University Hospital
Seoul , , Korea, Republic of
Kangbuk Samsung Hospital
Seoul , , Korea, Republic of
Korea University Anam Hospital
Seoul , , Korea, Republic of
Korea University Guro Hospital
Seoul , , Korea, Republic of
Seoul National University Bundang Hospital
Seoul , , Korea, Republic of
Seoul National University Hospital
Seoul , , Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul , , Korea, Republic of
The Catholic University of Korea - Seoul St. Mary's Hospital
Seoul , , Korea, Republic of
The Catholic University of Korea - Yeouido St. Mary's Hospital
Seoul , , Korea, Republic of
Yonsei University Health System - Gangnam Severance Hospital
Seoul , , Korea, Republic of
Yonsei University Health System - Severance Hospital
Seoul , , Korea, Republic of
Vall d'Hebron University Hospital
Barcelona , , Spain More Info
Marc Diez
Principal Investigator
Hospital Universitario de Navarra
Pamplona , , Spain More Info
Maria Alsina
Principal Investigator
Hospital Clinico Universitario De Valencia
Valencia , , Spain More Info
Tania Fleitas
Principal Investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , , Taiwan More Info
Jaw-Yuan Wang
Principal Investigator
China Medical University Hospital (CMUH)
Taichung , , Taiwan More Info
Li-Yuan Bai
Principal Investigator
National Cheng Kung University Hospital
Taipei , , Taiwan More Info
Li-Tzong Chen
Principal Investigator
National Taiwan University Hospital (NTUH)
Taipei , , Taiwan More Info
Kun-Huei Yeh
Principal Investigator
Taipei Veterans General Hospital (TPVGH)
Taipei , , Taiwan More Info
Yi-Ping Hung
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

450

Study ID:

NCT04879368

Recruitment Status:

Recruiting

Sponsor:


Australasian Gastro-Intestinal Trials Group

How clear is this clinincal trial information?

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