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Combination of Targeted and Immunotherapy for Advanced Biliary Tract and Esophagogastric Gastric Cancer

NCT03818997 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-02-05

No results posted yet for this study

Summary

In this study, non-operable esophagogastric adenocarcinoma cancer patients or non-operable biliary cancer patients whose cancer progressed/spread/got worse after first line treatment will be treated with or without immunotherapy and chemotherapy. This study will take place in several countries across Europe. One hundred twenty-three (123) patients will be invited to participate in this study

Biliary tract cancer (BTC), is a form of cancer that start in your bile ducts, a series of tubes that runs from the liver to the small intestines. It is not know yet the exact cause of BTC. For patients who have advanced or metastatic BTC (where surgery is not possible), chemotherapy is the first option for treatment. Chemotherapy with cisplatin and gemcitabine (CisGem) is the current standard of care.

Esophagogastric cancer (EGC) is cancer that occurs in the esophagus, a long hollow tube that runs from your throat to your stomach. The accumulating abnormal cells form a tumor in the esophagus that can grow to invade nearby structures and spread to other parts of the body. It's thought that chronic irritation of your esophagus may contribute to the changes that cause esophageal cancer.

The purpose of this study is to look at the risks and benefits of combining DKN-01 and atezolizumab (humanized monoclonal antibody) with or without paclitaxel (chemotherapy). Immune therapy boosts the body's natural defenses to fight cancer. It uses specific products made either by participants' body or in a laboratory to improve, target or restore immune system function and control or stop cancer. Atezolizumab is such an "immunotherapy" drug. DKN-01 is another new type of drug (humanized monoclonal antibody) in development as anticancer agent. Paclitaxel is a commonly-used chemotherapy drug of the class of taxanes used to treat a number of cancer types, it stimulates the cell to die or to stop the cell from dividing into two new cells.The idea behind combining these drugs is linked to targeting the immune system to attack the tumor. Combining immune and chemotherapy has already demonstrated clinical activity in relapsed (return of the disease)/refractory (not responding to treatment) esophagogastric cancer patients.

Conditions

Interventions

DRUG

DKN-01

Patient will receive DKN-01 300 mg IV every 2 weeks

DRUG

Atezolizumab

Patient will receive Atezolizumab 840 mg IV every 2 weeks until PD

DRUG

Paclitaxel

Patient will receive Paclitaxel 80 mg/m2 IV on day 1, 8 and 15 of a 28 day cycle until PD

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Leap Therapeutics, Inc.

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Markus Moehler · Universitaetsmedizin - Mainz University Medical Center, Mainz, Germany

  • Maria Alsina · Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-31
Primary Completion
2021-04-30
Completion
2022-04-30
FDA Drug
Yes

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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 NCT03818997 on ClinicalTrials.gov