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Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Oesophageal Cancer

NCT02735239 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2024-03-22

Study results available
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Summary

This is an open-label, Phase 1/2 study to evaluate the safety of durvalumab (MEDI4736) in combination with oxaliplatin/capecitabine chemotherapy in metastatic/locally advanced oesophageal cancer (OC) and with neoadjuvant chemo(radio)therapy before surgery in operable OC. The immunotherapy will be given for a 4-week period before starting the standard chemo(radio)therapy, continuing durvalumab treatment once the chemotherapy starts. The study will include 2 phases, a safety run-in Phase 1 (Cohorts A1 and A2) and an expansion Phase 2 (Cohorts B, C, C-FLOT, D/D2).

Conditions

  • Esophageal Cancer

Interventions

DRUG

Durvalumab

Anti PD-L1 antibody

DRUG

Tremelimumab

Anti CTLA-4 antibody

DRUG

Oxaliplatin

IV administered chemotherapy

DRUG

Capecitabine

orally-administered chemotherapy

RADIATION

Radiotherapy

DRUG

Paclitaxel

IV administered chemotherapy

DRUG

Carboplatin

IV administered Chemotherapy

DRUG

5-fluorouracil (5-FU)

IV administered chemotherapy

DRUG

Leucovorin

chemo-protective agent

DRUG

Docetaxel

IV administered chemotherapy

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Ludwig Institute for Cancer Research

    lead OTHER

Principal Investigators

  • Mark Middleton · University of Oxford, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-24
Primary Completion
2022-06-16
Completion
2022-06-16

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02735239 on ClinicalTrials.gov