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The University of Southampton
Southampton Clinical Trials Unit

DECIPHER

Trial Overview

Trial Team

Essential Trial Documentation

Other media and videos

Title

A Single arm phase II trial of trastuzumab deruxtecan in patients with gastrooesophageal adenocarcinoma cancer who are ctDNA and HER2 positive.

Description

Gastrooesophageal (GOA) cancer is a common, global cancer. Those diagnosed early will generally have FLOT chemotherapy followed by surgery, followed by the same FLOT chemotherapy post-surgery.

Patients who are ctDNA positive (as confirmed by Natera’s Signatera assay) after chemotherapy and surgery are less likely to benefit from FLOT chemotherapy. Patients with pathologically documented GOA, with HER2 overexpression and who are ctDNA positive will be approached for DECIPHER.

DECIPHER aims to treat minimal residual disease in ctDNA patients with trastuzumab deruxtecan (T-DXd), a drug which has shown efficacy in advanced gastroesophageal adenocarcinoma, to reduce the chance of relapse. T-DXd is an antibody that targets HER2 cells. It attaches to the HER2 cells on the tumour and destroys them. All trial patients will be followed for up to 2 years to record their response to treatment.

DECIPHER aims to recruit 25 patients from 10-15 NHS Secondary Care Centres. Participants in the study will be treated with T-DXd at a dose of 6.4 mg/kg intravenously every 21 days for a maximum of 8 cycles. Treatment will cease when the patient either completes 8 cycles of treatment, disease recurrence, unacceptable toxicity, death or withdrawal from the study.

Objectives

Primary:

  • To assess the efficacy of T-DXd in reducing micrometastatic disease burden in HER2 positive GOA patients who are ctDNA positive after chemotherapy and surgery.

Secondary:

  • To assess the impact of T-DXd on ctDNA
  • To assess the efficacy of T-DXd in prolonging time of macroscopic disease recurrence
  • To assess the efficacy of T-DXd in prolonging survival
  • To assess impact of T-DXd on symptoms and quality of life
  • To assess the safety and tolerability of T-DXd

Tertiary:

  • To assess the effect of T-DXd on ctDNA dynamics
  • To assess the translational outcomes associated with sensitivity and resistance to T-DXd

Trial Design

A multicentre, open label, single stage, single arm A’Hern’s design.

Trial Status

Open to recruitment

Population

Patients with pathologically documented adenocarcinoma of the stomach (clinical stage before surgery of AJCC I-III), gastroesophageal junction, or oesophagus, with HER2 overexpression (IHC 3+ or IHC 2+/ISH+) based on local tissue testing results.

Funder

This trial is funded by Astra Zeneca

 

Senior Trial Manager:

Kelly Cozens

Trial Manager:

Daniel Griffiths

Trial Assistant:

Will Mitchell

Data Manager:

Zoe Konn

Clinical Data Coordinator:

Uroosha Ali Babul Hussain

 

Contact Information for trial queries

Email: decipher@soton.ac.uk

Phone: 023 8120 5154

 

SAE Reporting

Email: ctu@soton.ac.uk

 

Investigator Site Files

2.1 DECIPHER Master Patient List v1.0 03-May-2023

2.2 DECIPHER Stage 1 Screening Log v1.0 03-May-2023

2.3 DECIPHER Stage 2 Screening Log v1.0 03-May-2023

3.1 DECIPHER Site Delegation Log v1.0 03-May-2023

3.3 DECIPHER Site Training Log v1.0 03-May-2023

4.1 DECIPHER Protocol v3 26-Jul-2024

4.7 DECIPHER NHS Digital Patient Flagging Form v1.0 03-May-2023

4.7 DECIPHER Safesend Guide for Site v1.0 14-Jun-2023

4.7 Effective_UK (English) EQ-5D-5L Paper Self-Complete v1.2 2009

4.7 OG25 English

4.7 QLQ-C30 English

5.1 DECIPHER Instructions for Adverse and Serious Adverse Event Reporting v1.0 11-May-2023

5.2 DECIPHER SAE - SUSAR Follow-up Form v1.0 11-May-2023

5.2 DECIPHER Serious Adverse Event v1.0 11-May-2023

6.1 ib-trastuzumab-deruxtecan-edition-10

6.3 DECIPHER Accountability Log v1.0 03-May-2023

6.4 DECIPHER Dispensing Log v1.0 03-May-2023

8.3 DECIPHER Main Trial Sample Shipment Form v1 20-Dec-2023

8.3 DECIPHER Stage 1 Sample Shipment v2 25-Jul-2024

8.3 DECIPHER Translational Samples Dispatch Log v1 20-Dec-2023

8.5 DECIPHER Laboratory Manual v3 14-Aug-2024

13.1 DECIPHER - FORM 5239 eCRF Completion Guidance - v2 28-Feb-2024

14.2 DECIPHER - Site Visit Log v1 28-Nov-2023

 

Pharmacy Documents

5.4 DECIPHER Drug Request Form v2 20-Mar-2024

5.11 DECIPHER Temp Excursion Notification Form v1.0 03-May-2023

 

Natera Documents

CDC Letter 12-Jun-2024

DECIPHER - HER2 Tumour Tissue Sample WES Requisition Form FOR-0021332 Rev 02

DECIPHER - HER2 Whole Blood Sample ctDNA Requisition Form FOR-0021331 Rev 02

DECIPHER - HER2 Whole Blood Sample WES Requisition Form FOR-0021329 Rev 02

PRO-0021338 DECIPHER-HER2 Lab Manual Rev 01_Final

Press releases, video clips and other external websites:

(The University of Southampton cannot accept responsibility for external websites)

 

DECIPHER Infographic

 

Participant Information Video

Dr Lizzy Smyth, Chief Investigator of the DECIPHER trial, introduces the trial and explains what patients can expect if they decide to take part. This video should be watched in conjunction with reading the full Patient Information Sheet (PIS)

 

 
 
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