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

NCT04017455 | Active Not Recruiting Phase 2

• 1 other identifier: N18TRZ
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rectal Cancer

Keywords

short term immunotherapy; atezolizumab; bevacizumab; radiotherapy

Outcome Measures

Primary Outcomes (1)

• clinical complete and near-complete response rate

  response rate will be assessed by MRI and endoscopy

  12 weeks post-radiotherapy

Secondary Outcomes (2)

• incidence of adverse events following treatment (safety)

  untill 100 days after last patient last study drug

• local recurrence rate at 1 year follow-up

  1 year post-radiotherapy

Study Arms (1)

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

Atezolizumab DRUG

3 cycles of atezolizumab 840 mg

Also known as: MPDL3280A

bevacizumab and atezolizumab

Bevacizumab DRUG

3 cycles of bevacizumab 5mg/kg

Also known as: HCA 185 ,Avastin

bevacizumab and atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Marieke van de Belt

Amsterdam, North Holland, 1066CX, Netherlands

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

atezolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Myriam Chalabi, MD

  Antoni van Leeuwenhoek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single group, open label

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 12, 2019
• Study Start: October 22, 2019
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)