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

Sponsor

The Netherlands Cancer Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04017455

Collaborator

Hoffmann-La Roche (Industry)

Enrollment

Location

Arm

58.3

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Drug: Atezolizumab Drug: Bevacizumab	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

single group, open labelsingle group, open label

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 22, 2019

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bevacizumab and atezolizumab 1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy	Drug: Atezolizumab 3 cycles of atezolizumab 840 mg Other Names: MPDL3280A Drug: Bevacizumab 3 cycles of bevacizumab 5mg/kg Other Names: HCA 185 ,Avastin

Arm

Intervention/Treatment

Experimental: bevacizumab and atezolizumab

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

Drug: Atezolizumab

3 cycles of atezolizumab 840 mg

Other Names:

MPDL3280A

Drug: Bevacizumab

3 cycles of bevacizumab 5mg/kg

Other Names:

HCA 185 ,Avastin

Outcome Measures

Primary Outcome Measures

clinical complete and near-complete response rate [12 weeks post-radiotherapy]
response rate will be assessed by MRI and endoscopy

Secondary Outcome Measures

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
local recurrence rate at 1 year follow-up [1 year post-radiotherapy]
recurrence will be assessed by MRI and CT scans

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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