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

Primary Purpose

Rectal Cancer

Status

Recruiting

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Atezolizumab

Bevacizumab

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring short term immunotherapy, atezolizumab, bevacizumab, radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Marieke van de BeltRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bevacizumab and atezolizumab

Arm Description

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

Outcomes

Primary Outcome Measures

clinical complete and near-complete response rate

response rate will be assessed by MRI and endoscopy

Secondary Outcome Measures

incidence of adverse events following treatment (safety)

adverse events will be assessed (according tot CTC-AE v5) during treatment

local recurrence rate at 1 year follow-up

recurrence will be assessed by MRI and CT scans

Full Information

NCT ID

NCT04017455

First Posted

July 10, 2019

Last Updated

April 19, 2021

Sponsor

The Netherlands Cancer Institute

Collaborators

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT04017455

Brief Title

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

Acronym

TARZAN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Recruiting

Study Start Date

October 22, 2019 (Actual)

Primary Completion Date

August 30, 2023 (Anticipated)

Study Completion Date

August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Netherlands Cancer Institute

Collaborators

Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rectal Cancer

Keywords

short term immunotherapy, atezolizumab, bevacizumab, radiotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

single group, open label

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

bevacizumab and atezolizumab

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Atezolizumab

Other Intervention Name(s)

MPDL3280A

Intervention Description

3 cycles of atezolizumab 840 mg

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

HCA 185 ,Avastin

Intervention Description

3 cycles of bevacizumab 5mg/kg

Primary Outcome Measure Information:

Title

clinical complete and near-complete response rate

Description

response rate will be assessed by MRI and endoscopy

Time Frame

12 weeks post-radiotherapy

Secondary Outcome Measure Information:

Title

incidence of adverse events following treatment (safety)

Description

adverse events will be assessed (according tot CTC-AE v5) during treatment

Time Frame

untill 100 days after last patient last study drug

Title

local recurrence rate at 1 year follow-up

Description

recurrence will be assessed by MRI and CT scans

Time Frame

1 year post-radiotherapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marieke van de Belt

Phone

+3120512

Ext

1926

m.vd.belt@nki.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Myriam Chalabi, MD

Organizational Affiliation

Antoni van Leeuwenhoek

Official's Role

Principal Investigator

Facility Information:

Facility Name

Marieke van de Belt

City

Amsterdam

State/Province

Noord-Holland

ZIP/Postal Code

1066CX

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marieke van de Belt

Phone

+3120512

Ext

1926

m.vd.belt@nki.nl

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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