Clinical Trials Logo
  1. Home
  2. Cancer of Esophagus
  3. NCT04984733

Temozolomide + Nivolumab in MGMT Methylated Oesophagogastric Cancer — ELEVATE  

Cancer of Esophagus Clinical Trial

Official title:
An Open Label Single Arm Phase II Trial in Patients With Advanced Unresectable Previously Treated Oesophagogastric Adenocarcinoma Which is MGMT Deficient

Clinical Trial Summary

An open label single arm phase II trial in patients with advanced unresectable previously treated oesophagogastric adenocarcinoma which is MGMT deficient.

Clinical Trial Description

The aim of the ELEVATE trial is to determine the activity and safety of 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04984733
Study type Interventional
Source University of Southampton
Contact Elizabeth Smyth
Phone 023 81205773
Email elizabeth.smyth2@nhs.net
Status Recruiting
Phase Phase 2
Start date September 28, 2021
Completion date July 2026
View Details
See also
  Status Clinical Trial Phase
Completed NCT05088304 - GLIM-defined Malnutrition Criteria for Postoperative Outcomes in Patients With Esophagogastric Cancer
Completed NCT04046601 - Impedance Spectroscopy in Esophageal Cancer N/A
Recruiting NCT05179824 - Tempus Priority Study: A Pan-tumor Observational Study
Terminated NCT03108885 - Measuring Cell Free DNA During the Course of Treatment for Esophageal Cancer as a Marker of Response and Recurrence
Recruiting NCT04886635 - Surgery As Needed for Oesophageal Cancer - 2
Recruiting NCT03301493 - Genomic Testing and Resulting Medical Decisions
Completed NCT03032224 - Analysis of Body Composition in Relation to Outcome After Surgery in a Cohort of Patients With Esophageal Cancer
Recruiting NCT03896958 - The PIONEER Initiative: Precision Insights On N-of-1 Ex Vivo Effectiveness Research Based on Individual Tumor Ownership (Precision Oncology)
Recruiting NCT02017002 - Comparison of Ivor Lewis and Tri-incision Approaches for Patients With Esophageal Cancer N/A
Recruiting NCT03274349 - Whole Body Electromyostimulation and Nutritional Therapy for Patients With Esophageal and Bronchial Carcinoma N/A
Recruiting NCT05830097 - A Study of Bi-Ligand-Drug Conjugate CBP-1019 in Patients With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03619317 - Impact of Cancer Therapy on Myocardial Function in Patients With Esophagus Cancer
Withdrawn NCT02843750 - Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery N/A
Not yet recruiting NCT05041335 - Wet Heparinized Suction for Abdominal Cancer N/A
Recruiting NCT04258813 - Onco-primary Care Networking to Support TEAM-based Care N/A
Completed NCT03541629 - Audit of the Spanish EURECCA Esophagogastric Cancer Registry
Completed NCT03102229 - Real-time Activity Monitoring to Prevent Admissions During RadioTherapy N/A
Recruiting NCT00193817 - Three Field Radical Esophagectomy Versus Two Field Esophagectomy - a Prospective Trial Phase 3
Completed NCT00318903 - Irinotecan and Taxotere With Radiotherapy as Preoperative Treatment in Resectable Esophageal Cancer Phase 2
Completed NCT03719716 - Early Support in Primary Care for People Starting Treatment for Cancer N/A