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Checkpoint Inhibitor
RegoNivo vs Chemotherapy for Gastroesophageal Cancer (INTEGRATEIIb Trial)
Phase 3
Recruiting
Research Sponsored by Australasian Gastro-Intestinal Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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. 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, 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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
INTEGRATEIIb Trial Summary
This trial will compare the effects of the RegoNivo combination with standard chemotherapy in people with AGOC that has continued to grow despite prior treatment.
Who is the study for?
Adults over 18 with advanced gastroesophageal cancer that's worsened after at least two treatments, including platinum and fluoropyrimidine drugs. They must be in good physical condition (ECOG 0 or 1), able to swallow pills, and have proper organ function. Excluded are those with allergies to trial drugs, uncontrolled blood pressure or malabsorption syndromes, recent use of certain medications or therapies, significant bleeding events or surgeries within a month prior to the trial, active infections like hepatitis B/C unless controlled by therapy.Check my eligibility
What is being tested?
The study is testing whether a combination of Regorafenib and Nivolumab (RegoNivo) can extend life more effectively than standard chemotherapy options for patients with refractory AGOC. Patients will be randomly assigned to receive either the new drug combo or one of several standard chemo drugs like Docetaxel.See study design
What are the potential side effects?
Possible side effects include high blood pressure; hand-foot skin reactions; fatigue; diarrhea; decreased appetite; infection risk increase due to immune system effects from Nivolumab. Each patient may experience side effects differently.
INTEGRATEIIb Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowINTEGRATEIIb Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
O/S
Secondary outcome measures
Determine the effect of RegoNivo on; OTRR
Determine the effect of RegoNivo on; PFS
Determine the effect of RegoNivo on; QoL - EORTC Quality of Life Questionnaire
+6 moreOther outcome measures
Prognostic biomarker identification for AGOC
Regorafenib levels and correlation to treatment
Regorafenib max plasma concentration level assessment (Cmax) across geographical regions
Side effects data
From 2019 Phase 1 & 2 trial • 495 Patients • NCT0202460782%
Diarrhoea
76%
Nausea
71%
Fatigue
57%
Vomiting
53%
Abdominal pain
30%
Neuropathy peripheral
27%
Dyspnoea
25%
Anaemia
23%
Neutrophil count decreased
23%
Constipation
22%
Weight decreased
21%
Hypokalaemia
20%
Oedema peripheral
18%
Dehydration
17%
Cough
17%
Neutropenia
17%
Pyrexia
17%
Peripheral sensory neuropathy
16%
Thrombocytopenia
15%
Platelet count decreased
15%
Back pain
13%
Mucosal inflammation
13%
Temperature intolerance
13%
Dysgeusia
13%
Chromaturia
12%
White blood cell count decreased
12%
Urinary tract infection
11%
Dizziness
11%
Depression
10%
Hyponatraemia
10%
Stomatitis
10%
Ascites
10%
Dysphagia
10%
Anxiety
9%
Headache
9%
Abdominal distension
9%
Insomnia
8%
Arthralgia
8%
Asthenia
8%
Pain in extremity
8%
Alopecia
7%
Urine ketone body present
7%
Blood alkaline phosphatase increased
7%
Pulmonary embolism
6%
Lymphopenia
6%
Leukopenia
6%
Blood bilirubin increased
6%
Dyspepsia
5%
Sepsis
5%
Palmar-plantar erythrodysaesthesia syndrome
5%
Hypertension
5%
Urine leukocyte esterase positive
5%
Abdominal pain upper
5%
Gastrooesophageal reflux disease
5%
Proteinuria
5%
Rash
4%
Flatulence
4%
Chills
3%
Dry mouth
3%
Myalgia
3%
Epistaxis
3%
Muscle spasms
2%
Pneumonia
2%
pelvic fracture
2%
Haematemesis
2%
Disease progression
2%
Pleural effusion
2%
Confusional state
2%
Mental status changes
2%
malignant neoplasm progression
1%
Lung abscess
1%
Oesophagitis
1%
Large intestine perforation
1%
pancreatic carcinoma
1%
embolism
1%
fall
1%
Death
1%
Haemorrhage intranial
1%
Atrial fibrillation
1%
Colitis
1%
Enterocutaneous fistula
1%
Gastrointestinal haemorrhage
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
somnolence
1%
syncope
1%
Febrile neutropenia
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Hypoxia
1%
Pneumonia aspiration
1%
Clostridium difficile colitis
1%
Influenza
1%
Perirectal abscess
1%
Salmonella sepsis
1%
Septic shock
1%
hip fracture
1%
deep vein thrombosis
1%
haematoma
1%
pelvic venous thrombosis
1%
Cholangitis
1%
Ischaemic cerebral infarction
1%
Hyperglycaemia
1%
subdural haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Napabucasin Plus FOLFOX6
Napabucasin Plus FOLFOX6 Plus Bevacizumab
Napabucasin Plus FOLFIRI Plus Bevacizumab
Napabucasin Plus Regorafenib
Napabucasin Plus FOLFIRI
Napabucasin Plus Irinotecan
Napabucasin Plus CAPOX
INTEGRATEIIb Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RegoNivoExperimental Treatment2 Interventions
Participants in the RegoNivo arm will;
self-administer 90mg (3x30mg) of regorafenib days 1-21 of each 28-day treatment cycle and;
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.
Group II: Standard of CareActive Control4 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
2014
Completed Phase 2
~1580
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Syneos HealthOTHER
172 Previous Clinical Trials
68,004 Total Patients Enrolled
Frankfurter Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestUNKNOWN
Australasian Gastro-Intestinal Trials GroupLead Sponsor
22 Previous Clinical Trials
7,303 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: RegoNivo
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the other areas of research where Regorafenib has been used in the past?
"There are currently 2133 clinical trials underway for the investigational drug Regorafenib. 449 of those trials are in Phase 3, meaning that they are testing the efficacy of the drug. The majority of these trials are taking place in Mexico City and Maryland, but there are 100739 locations around the world where these studies are happening."
Answered by AI
Given the risks, why would anyone take Regorafenib?
"There is evidence from previous trials to support the safety of Regorafenib, so it received a score of 3."
Answered by AI
What is Regorafenib used to treat most frequently?
"Regorafenib is the go-to medication for treating head conditions. In addition, Regorafenib has been shown to be effective at treating other conditions like neoplasm metastasis, metastatic ureter urothelial carcinoma, and metastatic hepatocellular carcinoma."
Answered by AI
Are we currently able to enroll patients in this clinical trial?
"Yes, the most recent update on clinicaltrials.gov shows that this study is still looking for patients. The listing was first put up on 6/1/2021, with the most recent change happening on 1/11/2022. They need 450 patients total, which will be drawn from 4 different hospitals or clinics."
Answered by AI
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