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Title:
ELEVATE: Temozolomide + nivolumab in MGMT methylated oesophagogastric cancer
Rationale:
In MGMT methylated oesophagogastric adenocarcinoma, temozolomide will induce a hypermutated state and increase sensitivity to nivolumab.
Description:
The aim of the trial is to determine the activity and safety maintenance TMZ dosing followed by nivolumab treatment to evaluate the potential for a future randomised trial against a standard of care control arm. The rationale to continue TMZ for 3 months or until PD is to evaluate the emergence of mismatch repair deficiency both with and without radiological PD, as clinically relevant MMRd may emerge before radiological progression. This will also reduce the number of patients who drop out due to symptomatic progressive disease.
Objectives:
Primary Objectives:
- To determine the anti-tumour activity of nivolumab, when given after temozolomide in patients with previously treated advanced oesophagogastric adenocarcinomawith MGMT methylation.
Secondary Objectives:
- To determine the effect of TMZ priming followed by nivolumab on disease control rates, progression-free and overall survival of patients with previously treated advanced oesophagogastric adenocarcinoma which is MGMT methylated.
- To assess the safety and toxicity of TMZ priming followed by nivolumab in oesophagogastric cancer patients.
- To describe the quality of life of patients on TMZ and/or nivolumab.
Trial Design:
An open label single arm phase II trial in patients with advanced unresectable previously treated oesophagogastric adenocarcinoma which is MGMT methylated.
Trial Status:
Open to recruitment
Population:
Patients with advanced, previously treated oesophagogastric cancer
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This trial is supported by the National Institute for Health and Care Research
Senior Trial Manager:
Kelly Cozens
Trial Manager:
Sam Goode
Data Manager:
Charlotte Stuart
Clinical Data Coordinator:
Alex Allen
Clinical Trial Monitor:
Parys Hatchard
Contact Information:
Email: [email protected]
Phone: 023 8120 5154
SAE Reporting:
Email: [email protected]
Investigator Site File Documents:
000 ELEVATE - Investigator Site File Index v1 11-Jan-2021
1.5 ELEVATE - Randomisation Service Note to File v1 02-Feb-2021
1.6 ELEVATE - Unblinding Service Note to File v1 02-Feb-2021
2.1 ELEVATE - Master Patient List v1 02-Feb-2021
2.2 ELEVATE - Screening Log Stage 1 v1 25-Jun-2021
2.2 ELEVATE - Screening Log Stage 2 v3 08-Mar-2022
3.1 ELEVATE - Site Delegation Log v1 14-Jan-2021
3.3 ELEVATE - Site Training Log Template v1 02-Feb-2021
4.1 ELEVATE - Protocol v8 22-Jan-2024
4.3 ELEVATE Patient Information Sheet Stage 2 v6 26-JUL-2023
4.3 ELEVATE Patient Information Sheet Tumour Sample - Screening v1 13-MAY-2021
4.4 ELEVATE Informed Consent Form Tumour Sample - Screening v1 13-MAY-2021
4.4 Elevate_Informed Consent Form Stage 2 v6 29-Aug-2023
4.5 Elevate GP Letter v1 10-DEC-2020
4.7 ELEVATE - Patient Questionnaire OG25
4.7 ELEVATE - Patient Questionnaire QLQ-C30
4.7 ELEVATE - Patient Questionnaire EQ-5D-5L
5.1 ELEVATE - Instructions for Adverse and Serious Adverse Event Reporting v1 02-Feb-2021
5.2 ELEVATE - SAE-SUSAR Form v2 15-Mar-2021
5.6 ELEVATE - Unblinding Service Note to File v1 02-Feb-2021
5.7 ELEVATE - Pregnancy Reporting Form
6.1 ELEVATE - BMS Nivolumab IB v22 03-Jul-2023
6.1 ELEVATE - BMS Nivolumab IB Addendum 01 for v20 02-Jul-2021
6.1 ELEVATE - Temozolomide (Temodal) Capsules - SmPC - 26-Aug-2021
6.3 ELEVATE - Nivolumab 100mg Accountability Log v1 02-Feb-2021
6.4 ELEVATE - Nivolumab Dispensing Log v1 02-Feb-2021
6.4 ELEVATE - TMZ Dispensing Log v1 02-Feb-2021
8.1 ELEVATE - Sample Collection, Processing and Storage Note to File v1 24-Jun-2021
8.2 ELEVATE - Plasma and ctDNA Samples Dispatch Log v1 28-Jun-2021
8.2 ELEVATE - Tissue Samples Dispatch Log v1 28-Jun-2021
8.3 ELEVATE - Sample Manifest v1 28-Jun-2021
8.4 ELEVATE - Central Lab Information v1 24-Jun-2021
8.5 ELEVATE - Lab Manual v3 26-Oct-2021
9.1 ELEVATE - 282284 21EE0017 FIFO 15-Mar-2021
9.1 ELEVATE - IRAS 282284 Letter of HRA Approval 15-Mar-2021
9.2 ELEVATE - IRAS 282284 Favourable Opinion of a Substantial Amendment
9.4 ELEVATE - ARSAC Licence Approval v1 02-Feb-2021
10.1 ELEVATE - IRAS 282284 Favourable Opinion of a Substantial Amendment
11.1 ELEVATE - SSI Form v1 25-Jun-2021
11.2 ELEVATE - R&D Approvals v1 25-Jun-2021
12.1 ELEVATE - CTA Acceptance of Amendment Request
12.2 ELEVATE - Application Form Amendment 1 Elevate 19-May-2021
12.2 ELEVATE - Notice of Acceptance of Amendment
13.2 ELEVATE - iMedidata Contact Sheet v1 02-Feb 2021
14.2 ELEVATE - Site Visit Log v1 02-Feb-2021
ELEVATE - SIV Presentation v3 15-Sep-2023
Pharmacy File Documents:
000 ELEVATE - Pharmacy File Index v1 25-Jan-2021
3.1 ELEVATE - Site Delegation Log v1 14-Jan-2021
3.3 ELEVATE - Site Training Log Template v1 02-Feb-2021
4.2 ELEVATE - Pharmacy Manual v6 28-Sep-2023
5.1 ELEVATE - BMS Nivolumab IB v22 03-Jul-2023
5.1 ELEVATE - BMS Nivolumab IB Addendum 01 for v19 29-Jun-2020
5.1 ELEVATE - Temozolomide (Temodal) Capsules - SmPC - 26-Aug-2021
5.12 ELEVATE - Unblinding Reports Note to File v1 02-Feb-2021
5.2 ELEVATE - Nivolumab 100mg Accountability Log v1 02-Feb-2021
5.3 ELEVATE - Nivolumab Dispensing Log v1 02-Feb-2021
5.3 ELEVATE - TMZ Dispensing Log v1 02-Feb-2021
5.4 ELEVATE - BMS Clinigen Drug Order Form Template_CA209-7K8-ELEVATE_v2_2021
5.9 ELEVATE - Nivolumab Master Label 01_Carton_Picture
5.9 ELEVATE - Nivolumab Master Label 02_Vial_Picture
6.1 ELEVATE - 282284 21EE0017 FIFO 15-Mar-2021
6.1 ELEVATE - IRAS 282284 Letter of HRA Approval 15-Mar-2021
6.2 ELEVATE - IRAS 282284 Favourable Opinion of a Substantial Amendment
9.1 ELEVATE - Application Form 21-Jan-2021
9.1 ELEVATE - CTA Acceptance of Amended Request
9.2 ELEVATE - Application Form Amendment 1 Elevate 19-May-2021
9.2 ELEVATE - Notice of Acceptance of Amendment
10.2 ELEVATE - Site Visit Log v1 02-Feb-2021
ELEVATE – evaluating Temozolomide and Nivolumab in patients with advanced unresectable previously treated oesophagogastric adenocarcinoma with MGMT methylation: study protocol for a single arm phase II trial. E.Smyth, et al. BMC Cancer, Sept 2022
Press releases, video clips and other external websites:
(University of Southampton cannot accept responsibility for external websites)
ELEVATE trial opening, September 2021
Watch our infographic explainer video on the ELEVATE trial