Neoadjuvant Treatment in Rectal Cancer With Radiotherapy... | NCT04017455

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

NCT04017455

Sponsor

The Netherlands Cancer Institute

Status

Active, not recruiting

Last Update Posted

Jun 8, 2025Actual

Enrollment

38Estimated

Phase

Phase 2

Conditions

Rectal Cancer

Interventions

Atezolizumab
Bevacizumab

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 22, 2019Actual

Primary Completion Date

Aug 31, 2025Estimated

Completion Date

Aug 31, 2025Estimated

First Submitted Date

Jul 10, 2019

First Submission Date that Met QC Criteria

Jul 10, 2019

First Posted Date

Jul 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2025

Last Update Posted Date

Jun 8, 2025Actual

Name	Class
Hoffmann-La Roche	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bevacizumab and atezolizumab	Experimental	1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy	Drug: Atezolizumab Drug: Bevacizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atezolizumab	Drug	3 cycles of atezolizumab 840 mg	bevacizumab and atezolizumab

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
incidence of adverse events following treatment (safety)	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Myriam Chalabi, MD	Antoni van Leeuwenhoek	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marieke van de Belt		Amsterdam	North Holland	1066CX	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000594389	atezolizumab
D000068258	Bevacizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided