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

Phase 2

• Conditions: Rectal Cancer
• Interventions: Drug: Atezolizumab; Drug: Bevacizumab

• Registration Number: NCT04017455
• Lead Sponsor: The Netherlands Cancer Institute

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.

Study Timeline

• Study First Submitted: 2019-07-10
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-12
• Study Start: 2019-10-22
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-04-20
• Primary Completion: 2023-08-30
• Study Completion: 2024-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bevacizumab and atezolizumab	Bevacizumab	1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy
bevacizumab and atezolizumab	Atezolizumab	1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy

Primary Outcome Measures

Name	Time	Method
clinical complete and near-complete response rate	12 weeks post-radiotherapy	response rate will be assessed by MRI and endoscopy

Secondary Outcome Measures

Name	Time	Method
local recurrence rate at 1 year follow-up	1 year post-radiotherapy	recurrence will be assessed by MRI and CT scans
incidence of adverse events following treatment (safety)	untill 100 days after last patient last study drug	adverse events will be assessed (according tot CTC-AE v5) during treatment

Trial Locations

Locations (1)

Marieke van de Belt; 🇳🇱 Amsterdam, Noord-Holland, Netherlands