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

NCT ID: NCT04017455

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-22

Study Completion Date

2025-08-31

Brief Summary

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In this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab

Detailed Description

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

Conditions

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Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single group, open label
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bevacizumab and atezolizumab

1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy

Group Type EXPERIMENTAL

Atezolizumab

Intervention Type DRUG

3 cycles of atezolizumab 840 mg

Bevacizumab

Intervention Type DRUG

3 cycles of bevacizumab 5mg/kg

Interventions

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Atezolizumab

3 cycles of atezolizumab 840 mg

Intervention Type DRUG

Bevacizumab

3 cycles of bevacizumab 5mg/kg

Intervention Type DRUG

Other Intervention Names

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MPDL3280A HCA 185 ,Avastin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Myriam Chalabi, MD

Role: PRINCIPAL_INVESTIGATOR

Antoni van Leeuwenhoek

Locations

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Marieke van de Belt

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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N18TRZ

Identifier Type: -

Identifier Source: org_study_id

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