Rectal CancerPhase 2TARZANNCT04017455
Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)
A Phase 2 study testing Atezolizumab and Bevacizumab in people with Rectal Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
In this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Atezolizumab and Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Oct 2019to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
In this study, patients with resectable rectal cancer will receive radiotherapy, followed by neoadjuvant bevacizumab and atezolizumab
Read the detailed description
38 patients with resectable rectal cancer will be enrolled. All patients will be treated with radiotherapy followed by bevacizumab and atezolizumab.
- Conditions
- Rectal Cancer
- Being tested
- Atezolizumab, Bevacizumab
- Keywords
- short term immunotherapy, atezolizumab, bevacizumab, radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called MPDL3280A
3 cycles of atezolizumab 840 mg
BevacizumabDrug
Also called HCA 185 ,Avastin
3 cycles of bevacizumab 5mg/kg
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab and atezolizumab | Experimental | 1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy Receives: Drug: Atezolizumab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical complete and near-complete response rate
response rate will be assessed by MRI and endoscopy
Measured: 12 weeks post-radiotherapy
Secondary outcomes (2)
incidence of adverse events following treatment (safety)
adverse events will be assessed (according tot CTC-AE v5) during treatment
Measured: untill 100 days after last patient last study drug
local recurrence rate at 1 year follow-up
recurrence will be assessed by MRI and CT scans
Measured: 1 year post-radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start22 Oct 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single group, open label
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Myriam Chalabi, MD, Principal investigator, Antoni van Leeuwenhoek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017455
- Sponsor's protocol ID
- N18TRZ
- Acronym
- TARZAN
- Status last verified
- Sep 2026
- First submitted
- 10 Jul 2019
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment in Rectal Cancer With Radiotherapy Followed by Atezolizumab and Bevacizumab (TARZAN)
- ClinicalTrials.gov ID
- NCT04017455
- Acronym / sponsor ID
- TARZAN / N18TRZ
- Conditions
- Rectal Cancer
- Keywords
- short term immunotherapy, atezolizumab, bevacizumab, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single group, open label
| Arm | Type | Receives |
|---|---|---|
| bevacizumab and atezolizumab | Experimental | Drug: Atezolizumab, Drug: Bevacizumab1 cycle of bevacizumab monotherapy, followed by 2 cycles of bevacizumab combined with atezolizumab, followed by 1 cycle of atezolizumab monotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtezolizumabAlso: MPDL3280A3 cycles of atezolizumab 840 mg | Drug | bevacizumab and atezolizumab |
| BevacizumabAlso: HCA 185 ,Avastin3 cycles of bevacizumab 5mg/kg | Drug | bevacizumab and atezolizumab |
Primary outcome
clinical complete and near-complete response rate
Time frame: 12 weeks post-radiotherapy
response rate will be assessed by MRI and endoscopy
2 secondary outcomes
incidence of adverse events following treatment (safety)
Time frame: untill 100 days after last patient last study drug
local recurrence rate at 1 year follow-up
Time frame: 1 year post-radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myriam Chalabi, MD principal investigator
Antoni van Leeuwenhoek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab and Bevacizumab in people with Rectal Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical complete and near-complete response rate (time frame: 12 weeks post-radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.