Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN) (TARZAN)
Primary Purpose
Rectal Cancer
Status
Recruiting
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Atezolizumab
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring short term immunotherapy, atezolizumab, bevacizumab, radiotherapy
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
Sites / Locations
- Marieke van de BeltRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
bevacizumab and atezolizumab
Arm Description
1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy
Outcomes
Primary Outcome Measures
clinical complete and near-complete response rate
response rate will be assessed by MRI and endoscopy
Secondary Outcome Measures
incidence of adverse events following treatment (safety)
adverse events will be assessed (according tot CTC-AE v5) during treatment
local recurrence rate at 1 year follow-up
recurrence will be assessed by MRI and CT scans
Full Information
NCT ID
NCT04017455
First Posted
July 10, 2019
Last Updated
April 19, 2021
Sponsor
The Netherlands Cancer Institute
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT04017455
Brief Title
Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)
Acronym
TARZAN
Official Title
Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2019 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute
Collaborators
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
short term immunotherapy, atezolizumab, bevacizumab, radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
single group, open label
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bevacizumab and atezolizumab
Arm Type
Experimental
Arm Description
1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
MPDL3280A
Intervention Description
3 cycles of atezolizumab 840 mg
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
HCA 185 ,Avastin
Intervention Description
3 cycles of bevacizumab 5mg/kg
Primary Outcome Measure Information:
Title
clinical complete and near-complete response rate
Description
response rate will be assessed by MRI and endoscopy
Time Frame
12 weeks post-radiotherapy
Secondary Outcome Measure Information:
Title
incidence of adverse events following treatment (safety)
Description
adverse events will be assessed (according tot CTC-AE v5) during treatment
Time Frame
untill 100 days after last patient last study drug
Title
local recurrence rate at 1 year follow-up
Description
recurrence will be assessed by MRI and CT scans
Time Frame
1 year post-radiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marieke van de Belt
Phone
+3120512
Ext
1926
Email
m.vd.belt@nki.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myriam Chalabi, MD
Organizational Affiliation
Antoni van Leeuwenhoek
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marieke van de Belt
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1066CX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marieke van de Belt
Phone
+3120512
Ext
1926
Email
m.vd.belt@nki.nl
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)
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