Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN) (TARZAN)

April 19, 2021 updated by: The Netherlands Cancer Institute
In this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

38 patients with resectable rectal cancer will be enrolled. All patients will be treated with radiotherapy followed by bevacizumab and atezolizumab.

Study Type

Interventional

Enrollment (Anticipated)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1066CX
        • Recruiting
        • Marieke van de Belt
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • signed informed consent
  • patients age 18 years and older
  • histologically confirmed adenocarcinoma of the rectum
  • intermediate risk rectal cancer or low risk distal rectal cancer

Exclusion Criteria:

  • evidence of metastatic disease
  • prior radiation therapy for disease under study
  • prior treatment with CD137 agonists or immune checkpoint blockade therapies
  • current or recent use of acetylsalicylic acid
  • history of clinically significant cardiac or pulmonary dysfunction pregnancy or breastfeeding
  • significant auto-immune disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bevacizumab and atezolizumab
1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy
Drug: Atezolizumab
3 cycles of atezolizumab 840 mg
Other Names:
  • MPDL3280A
Drug: Bevacizumab
3 cycles of bevacizumab 5mg/kg
Other Names:
  • HCA 185 ,Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical complete and near-complete response rate
Time Frame: 12 weeks post-radiotherapy
response rate will be assessed by MRI and endoscopy
12 weeks post-radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of adverse events following treatment (safety)
Time Frame: untill 100 days after last patient last study drug
adverse events will be assessed (according tot CTC-AE v5) during treatment
untill 100 days after last patient last study drug
local recurrence rate at 1 year follow-up
Time Frame: 1 year post-radiotherapy
recurrence will be assessed by MRI and CT scans
1 year post-radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Netherlands Cancer Institute

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: Myriam Chalabi, MD, Antoni van Leeuwenhoek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2019

Primary Completion (Anticipated)

August 30, 2023

Study Completion (Anticipated)

August 30, 2024

Study Registration Dates

First Submitted

July 10, 2019

First Submitted That Met QC Criteria

July 10, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N18TRZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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