Gastro-Oesophageal CancerPhase 3INTEGRATEIIbNCT04879368
RegoNivo vs Standard of Care Chemotherapy in AGOC
A Phase 3 study testing Regorafenib, Nivolumab and Docetaxel in people with Gastro-Oesophageal Cancer, run by Australasian Gastro-Intestinal Trials Group at 94 sites in 9 countries.
Trial summary
To determine if the regorafenib and nivolumab combination (RegoNivo) improves overall survival compared with current standard chemotherapy options in refractory AGOC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-Oesophageal Cancer
- What is being tested?
- Regorafenib, Nivolumab and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- 94 sitesin 9 countries
- Study dates
- 5 May 2021to 30 Apr 2025
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
94 sites in 9 countries.
94 sites in 9 countries
Australia24 sites
The Queen Elizabeth Hospital
Adelaide, South Australia, 5011
Flinders Medical Centre
Bedford Park, South Australia, 5042
Monash Health
Clayton, Victoria, 3168
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, 2450
Concord Repatriation General Hospital
Concord, New South Wales, 2139
St Vincent's Public Hospital
Darlinghurst, New South Wales, 2010
The Townsville Hospital
Douglas, Queensland, 4814
Border Medical Oncology Research Unit
East Albury, New South Wales, 2640
Gosford Hospital
Gosford, New South Wales, 2250
Royal Brisbane and Womens Hospital
Herston, Queensland, 4029
Royal Hobart Hospital
Hobart, Tasmania, 700
St George Hospital
Kogarah, New South Wales, 2217
Austin Health
Melbourne, Victoria, 3084
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Newcastle Private Hospital
New Lambton Heights, New South Wales, 2035
Port Macquarie Base Hospital
Port Macquarie, New South Wales, 2444
Prince of Wales Hospital
Randwick, New South Wales, 2031
St John of God Hospital Subiaco
Subiaco, Western Australia, 6008
Sunshine Coast University Hospital
Sunshine Coast, Queensland, 4560
Royal North Shore Private Hospital
Sydney, New South Wales, 2065
Royal Darwin Hospital
Tiwi, Northern Territory, 0810
The Tweed Hospital
Tweed Heads, New South Wales, 2485
Ballarat Oncology and Haematology Services
Wendouree, New South Wales, 3355
Westmead Hospital
Westmead, New South Wales, 2145
Germany22 sites
Helios Bad Saarow
Bad Saarow
Klinikum Bayreuth
Bayreuth
Charité Universitätsmedizin Berlin
Berlin
Universitätsklinikum Bonn
Bonn
Kliniken der Stadt Köln
Cologne
KEM/Evang. Kliniken Essen Mitte gGmbH
Essen
Institut für Klinisch Onkol Forschung am Krankenhaus Nordwest
Frankfurt
Universitätsklinikum Greifswald
Greifswald
Evang. Klinikum Bethel Bielefeld
Gütersloh, North Rhine-Westphalia
Norddeutsches Studienzentrum für Innovative Onkologie (NIO)
Hamburg
Universitätsklinikum Heidelberg
Heidelberg
Universitätsklinikum Jena
Jena
Universitätsklinikum Leipzig
Leipzig
Klinikum Leverkusen gGmbH
Leverkusen
Klinikum Ludwigburg
Ludwigsburg
Klinikum Magdeburg gGmbH
Magdeburg
Universitätsklinikum Mainz
Mainz
Philipps-Universitat Marburg
Marburg
Klinikum rechts der Isar der TU München
München
Studienzentrum Onkologie Ravensburg
Ravensburg
Caritas Klinikum Saarbrücken St. Theresia
Saarbrücken
Universitätsklinikum Ulm
Ulm
South Korea18 sites
Hallym University Sacred Heart Hospital
Anyang
Dong-A University Hospital
Busan
Haeundae Paik Hospital
Busan
Chungbuk National University Hospital
Cheongju-si
Jeonbuk National University Hospital
Jeonju
Gyeongsang National University Hospital
Jinju
Asan Medical Centre
Seoul
Chung-Ang University Hospital
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Seoul National University Bundang Hospital
Seoul
Seoul National University Hospital
Seoul
SMG-SNU Boramae Medical Center
Seoul
The Catholic University of Korea - Seoul St. Mary's Hospital
Seoul
The Catholic University of Korea - Yeouido St. Mary's Hospital
Seoul
Yonsei University Health System - Gangnam Severance Hospital
Seoul
Yonsei University Health System - Severance Hospital
Seoul
United States6 sites
St Elizabeth Healthcare
Edgewood, Kentucky, 41017
USC Norris
Los Angeles, California, 90001
Monument Health Rapid City Hospital
Rapid City, South Dakota, 57701
Mayo Clinic Arizona
Scottsdale, Arizona, 85054
Fred Hutchinson Cancer Research Centre - South Lake Union Clinic
Seattle, Washington, 98109
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101
Italy6 sites
Istituto Nazionale Tumori di Napoli-IRCCS Fondazione G. Pascale
Naples
Universitae degli studi della Campania "Luigi Vanvitelli"
Naples
Azienda USL-IRCCS Di Reggio Emilia
Reggio Emilia
San Camillo Forlanini Hospitals
Roma
Universita Cattolica del Sacro Cuore, University Hospital Gemelli
Roma
IRCCS Fondazione Casa Sollievo della Sofferenza
San Giovanni Rotondo
Japan6 sites
National Cancer Centre Hospital East
Chiba, Kashiwa
Kyushu Cancer Center
Fukuoka
Shikoku Cancer Center
Matsuyama
Saitama Cancer Center
Saitama
Hokkaido University Hospital
Sapporo, Kita
Shizuoka Cancer Center
Shizuoka
Taiwan5 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
China Medical University Hospital (CMUH)
Taichung
National Cheng Kung University Hospital
Taipei
National Taiwan University Hospital (NTUH)
Taipei
Taipei Veterans General Hospital (TPVGH)
Taipei
Austria4 sites
Landeskrankenanstalten-Betriebsgesellschaft-KABEG
Klagenfurt
Ordensklinikum Linz GmbH Barmherzige schwestern
Linz
Medizinische Universitaet Wien
Vienna
Landesklinikum Wiener Neustadt
Wiener Neustadt
Spain3 sites
Vall d'Hebron University Hospital
Barcelona
Hospital Universitario de Navarra
Pamplona
Hospital Clinico Universitario De Valencia
Valencia
About this study
Official title: A Randomised Phase III Open Label Study of Regorafenib + Nivolumab vs Standard Chemotherapy in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)
To determine if the regorafenib and nivolumab combination (RegoNivo) improves overall survival compared with current standard chemotherapy options in refractory AGOC.
Read the detailed 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:
- 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 460 participants in the study from, but not limited to; Australia, South Korea, Japan, Taiwan, USA, Germany, Austria, Spain, and Italy.
- Conditions
- Gastro-Oesophageal Cancer
- Being tested
- Regorafenib, Nivolumab, Docetaxel, Paclitaxel, Irinotecan
- Keywords
- Metastatic, Locally recurrent, Oesophago-gastric junction, Stomach, Adenocarcinoma, Undifferentiated carcinoma, RegoNivo
- Medical subject headings
- Neoplasm Metastasis, Adenocarcinoma, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegorafenibDrug
Also called Stivarga
Oral multi-targeted tyrosine kinase inhibitor (TKI) which targets angiogenic (VEGF, TIE-2), stromal (PDGF-β), and oncogenic (RAF, RET and KIT) receptor tyrosine kinases
NivolumabBiological
Also called Opdivo
human IgG4 monoclonal antibody inhibitor of PD-1
DocetaxelDrug
Also called Taxotere
Docetaxel is taxane-derivative chemotherapy drug, used in the treatment of early, locally advanced and metastatic breast cancer. It is an anti-microtubule agent. Other uses are in the treatment of non-small cell lung cancer, advanced stomach cancer, head and neck cancers, soft tissue sarcoma, ovarian cancer, metastatic prostate cancer, etc.
microtubules, and simultaneously promotes assembly and inhibits disassembly of them
PaclitaxelDrug
Also called Abraxane
Paclitaxel is one of several cytoskeletal drugs that target tubulin. Paclitaxel-treated cells have defects in mitotic spindle assembly, chromosome segregation, and cell division. Unlike other tubulin-targeting drugs, such as colchicine, that inhibit microtubule assembly, paclitaxel stabilizes the microtubule polymer and protects it from disassembly. Chromosomes are thus unable to achieve a metaphase spindle configuration. This blocks the progression of mitosis and prolonged activation of the mitotic checkpoint triggers apoptosis or reversion to the G0-phase of the cell cycle without cell division
IrinotecanDrug
Also called Camptosar
Camptothecin, one of the four major structural classifications of plant-derived anti-cancerous compounds, is a cytotoxic alkaloid which consists of a pentacyclic ring structure containing a pyrrole (3, 4 β) quinoline moiety, an S-configured lactone form, and a carboxylate form. Irinotecan is activated by hydrolysis to SN-38, an inhibitor of topoisomerase I. This is then inactivated by glucuronidation by uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1). The inhibition of topoisomerase I by the active metabolite SN-38 eventually leads to inhibition of both DNA replication and transcription.
Trifluridine/TipracilDrug
Also called Lonsurf
The drug consists of the cytotoxin trifluridine and the thymidine phosphorylase inhibitor (TPI) tipiracil. Trifluridine is incorporated into DNA during DNA synthesis and inhibits tumor cell growth. Trifluridine (TFT) is incorporated into DNA by phosphorylation by thymidylate kinase (TK) to TF-TMP; TF-TMP then covalently binds to tyrosine 146 of the active site of thymidylate synthase (TS) inhibiting the enzyme's activity. TS is vital to the synthesis of DNA because it is an enzyme involved in the synthesis of the deoxynucleotide, thymidine triphosphate (dTTP). Inhibition of TS depletes the cell of dTTP and causes accumulation of deoxyuridine monophosphate (dUMP), which increases the likelihood that uracil gets misincorporated into the DNA.
| Study group | Role | What they receive |
|---|---|---|
| RegoNivo | Experimental | Participants in the RegoNivo arm will;
1. self-administer 90mg (3x30mg) of regorafenib days 1-21 of each 28-day treatment cycle and;
2. receive intravenous nivolumab 240 mg day 1 of each 14 day cycle until disease progression or prohibitive adverse events as per protocol, given in hospital by infusion.
After 2 months, patients whose disease is controlled may have nivolumab administered 480 mg every 28 days. Receives: Drug: Regorafenib; Biological: Nivolumab |
| Standard of Care | Active comparator | Participants in the control arm will receive investigator choice chemotherapy with any of the following agents
* taxane (paclitaxel or docetaxel)
* irinotecan or
* oral trifluridine/tipiracil (TAS102)
All treatment groups will receive Best Supportive Care (BSC). Receives: Drug: Docetaxel; Drug: Paclitaxel; Drug: Irinotecan; Drug: Trifluridine/Tipracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
O/S
To determine the effect of RegoNivo on overall survival (OS) (death from any cause) in the overall study population and in the Asian sub-population. Overall survival is defined as the interval from the date of randomisation to date of death from any cause, or the date last known alive.
Measured: From the date of randomisation to date of death from any cause or the date last known alive, assessed up to approximately 44 months.
Secondary outcomes (5)
Determine the Effect of RegoNivo on; PFS
A PFS (Progressive free survival) event is defined as the first occasion that either RECIST criteria and iRECIST for disease progression are met, a patient is judged to have progressed by the responsible investigator (in the event that no RECIST assessment is available) or death occurs.
Progression is defined using RECIST v1.1 and iRECIST, as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum of diameters recorded in the study (including baseline) and an absolute increase of at least 5mm. The appearance of one or more new lesions is also considered progression. In exceptional circumstances, unequivocal progression of non-target disease was accepted as evidence of disease progression, where the overall tumour burden has increased sufficiently to merit discontinuation of treatment or where the tumour burden appears to have increased by at least 73% in volume.
Measured: From the date of randomisation to the date of first evidence of disease progression or death, whichever occurs first, assessed up to approximately 44 months.
Determine the Effect of RegoNivo on; OTRR
Number of participants achieving a Partial Response (PR) or Complete Response (CR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 and iRECIST.
Complete Response (CR):
Disappearance of all target and non-target lesions and normalisation of any specified tumour markers
Partial Response (PR):
>=30% decrease in the sum of diameters of target lesions (longest diameter for tumour lesions and short axis measure for target lymph nodes), taking as reference the baseline sum of diameters.
Measured: From randomisation until disease progression, with tumour assessments performed every 8 weeks (±7 days), assessed up to approximately 44 months.
Deterioration-Free Survival (DFS) Based on Physical Function (EORTC QLQ-C30)
Quality of life (scores from participant-completed questionnaires) of participants on study
EORTC QoL Questionnaire:
QLQ-C30: Q1 - Q28, Min 1 Max 4, Higher Score = Worse QLQ-C30: Q29 \& Q30 Min 1 Max 7, Higher = Better
Deterioration-Free Survival (DFS) rate based on Physical Function is defined as the percentage of participants who have not experienced deterioration, disease progression, death, or treatment discontinuation at the specified time point.
Deterioration is defined as a ≥10-point decrease from baseline in the Physical Function scale of the EORTC QLQ-C30, without a subsequent ≥10-point improvement compared with baseline.
Physical function is assessed using the EORTC QLQ-C30 Physical Function Scale to identify the percentage of participants who were deterioration-free at 6 months and 12 months.
Measured: 6 months and 12 months after randomisation.
Deterioration-Free Survival Rate Based on Global Health Status (EORTC QLQ-C30)
Quality of life (QoL)(scores from participant-completed questionnaires) of participants on study
EORTC Quality of Life Questionnaire:
EORTC QLQ-C30: Q1 - Q28, Min 1 Max 4, Higher Score = Worse EORTC QLQ-C30: Q29 \& Q30 Min 1 Max 7, Higher = Better
Deterioration-Free Survival (DFS) rate based on Global Health Status is defined as the percentage of participants who have not experienced any of the following events by the specified time point; A ≥10-point deterioration from baseline in the Global Health Status/QoL scale of the EORTC QLQ-C30, without a subsequent ≥10-point improvement, disease progression, death from any cause or treatment discontinuation.
Global Health Status is assessed using the EORTC QLQ-C30 Global Health Status to identify the percentage of participants who were deterioration free at 6 months and 12 months.
Measured: 6 months and 12 months after randomisation
Determine the Effect of RegoNivo on; Safety
Safety (rates of adverse events) of participants on study
Measured: From the first dose of study treatment until 30 days following the last dose of study treatment, up to approximately 44 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start5 May 2021
- Primary completion14 Jan 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastro-Oesophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australasian Gastro-Intestinal Trials Group
- Sponsor type
- Research network
- Collaborators
- Bayer, Bristol-Myers Squibb, University of Sydney, Academic and Community Cancer Research United, Taiwanese Cooperative Oncology Group, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest, National Cancer Center Hospital East, Syneos Health
- Responsible party
- Sponsor
- Investigators
- Nick Pavlakis, Prof, Study chair, AGITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879368
- Sponsor's protocol ID
- AG0315OG/CTC0140
- Other IDs
- 2020-004617-12
- Acronym
- INTEGRATEIIb
- Status last verified
- Jun 2026
- First submitted
- 24 Feb 2021
- Last updated
- 10 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Lam LL, Pavlakis N, Shitara K, Sjoquist KM, Martin AJ, Yip S, Kang YK, Bang YJ, Chen LT, Moehler M, Bekaii-Saab T, Alcindor T, O'Callaghan CJ, Tebbutt NC, Hague W, Chan H, Rha SY, Lee KW, Gebski V, Jaworski A, Zalcberg J, Price T, Simes J, Goldstein D. INTEGRATE II: randomised phase III controlled trials of regorafenib containing regimens versus standard of care in refractory Advanced Gastro-Oesophageal Cancer (AGOC): a study by the Australasian Gastro-Intestinal Trials Group (AGITG). BMC Cancer. 2023 Feb 22;23(1):180. doi: 10.1186/s12885-023-10642-7.
PubMed 36814222