Rectal Cancer
Conditions
Keywords
short term immunotherapy, atezolizumab, bevacizumab, radiotherapy
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.
Interventions
DRUGAtezolizumab
3 cycles of atezolizumab 840 mg
DRUGBevacizumab
3 cycles of bevacizumab 5mg/kg
Sponsors
Hoffmann-La Roche
The Netherlands Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single group, open label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical complete and near-complete response rate | 12 weeks post-radiotherapy | response rate will be assessed by MRI and endoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Netherlands
Outcome results
None listed