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Active, Not Recruiting

NCT Number: NCT04017455

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Marieke van de Belt

Amsterdam, North Holland, 1066CX, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atezolizumab

Drug

3 cycles of atezolizumab 840 mg

Other names: MPDL3280A

Bevacizumab

Drug

3 cycles of bevacizumab 5mg/kg

Other names: HCA 185 ,Avastin

Primary outcomes

  1. clinical complete and near-complete response rate

    Time frame: 12 weeks post-radiotherapy

    response rate will be assessed by MRI and endoscopy

Secondary outcomes

  1. 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

  2. local recurrence rate at 1 year follow-up

    Time frame: 1 year post-radiotherapy

    recurrence will be assessed by MRI and CT scans

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Acronym: TARZAN

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 12, 2019
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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