Rectal NeoplasmsPhase 1/2R-IMMUNENCT03127007
Safety and Efficacy of Atezolizumab Combined to Preoperative Radio-chemotherapy in Localized Rectal Cancer
A Phase 1/2 study testing Atezolizumab and 5-FU based radio-chemotherapy in people with Rectal Neoplasms, run by Grand Hôpital de Charleroi at 5 sites in Belgium.
Trial summary
The study has a phase Ib and a phase II part. The phase Ib part of the study aims to determine the safety and tolerance of administration at a fixed dosing of 1200 mg / 3 weeks, concomitantly to the standard preoperative radio-chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Atezolizumab and 5-FU based radio-chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 5 sitesBelgium
- Study dates
- 27 Apr 2017to 15 Oct 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Written informed consent and any locally-required authorization are obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Male or female > 18 years at time of study entry
- Patients with previously untreated localized T3-T4 N0 or T any or N1-2, M0 rectal adenocarcinoma requiring preoperative radiotherapy
- Availability of protocol required screening tumor and blood samples
- ECOG performance status of 0 or 1
- Adequate normal organ and marrow function:
Show all 13Show fewer
- haemoglobin ≥ 9.0 g/dL, absolute neutrophil count (ANC) ≥ 1.5 x 109/L (> 1500 per mm3), platelet count ≥ 100 x 109/L (>100,000 per mm3).
- Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit
- Serum creatinine CL > 30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
- For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of < 1% per year, during the treatment period and for at least 6 months after the last dose of atezolizumab / radio-chemotherapy
- Patients who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Who cannot join
- Patient has locally recurrent or metastatic RC
- Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current rectal cancer disease
- Patients not requiring preoperative radio-chemotherapy
- Participation in another clinical study with an investigational product for any other indication until 4 weeks before study participation
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤ 21 days prior to the first dose of study drug
- Any previous treatment with a PD1 or PD-L1 inhibitor, including atezolizumab
Show all 26Show fewer
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ
- Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
- Current or prior use of immunosuppressive medication within 28 days before the first dose of atezolizumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
- Treatment with systemic immunostimulatory agents (including but not limited to interferons or IL-2) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to randomization
- Receipt of live attenuated vaccination within 30 days prior first atezolizumab planned administration (i.e. at week 3 after study entry) or within 5 months of receiving atezolizumab or anticipation that such a live attenuated vaccine will be required during the study. Influenza vaccination (inactivated forms only but not live attenuated forms) should be given during influenza season only (approximately October to March).
- Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia's Correction
- Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study
- Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
- History of primary immunodeficiency
- History of allogeneic organ transplant
- History of hypersensitivity to atezolizumab or any excipient
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
- Subjects with uncontrolled seizures.
- Known history of active tuberculosis
- Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing or willing to employ an effective method of birth control
- Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
Institut Jules Bordet
Brussels, 1000
Hôpital Erasme
Brussels, 1070
Cliniques universitaires St Luc
Brussels, 1320
GHdC
Charleroi, Hainaut, 6000
Katholiek universiteit Leuven
Leuven, Vlaams Brabant, 3000
About this study
Official title: A Phase Ib/II Study to Evaluate Safety and Efficacy of Atezolizumab Combined With Radio-chemotherapy in a Preoperative Setting for Patients With Localized Rectal Cancer
The study has a phase Ib and a phase II part. The phase Ib part of the study aims to determine the safety and tolerance of administration at a fixed dosing of 1200 mg / 3 weeks, concomitantly to the standard preoperative radio-chemotherapy.
The phase II part of the study aims to explore efficacy of atezolizumab in combination with the standard preoperative chemo/radiotherapy in stage II and III rectal cancers.
- Conditions
- Rectal Neoplasms
- Being tested
- Atezolizumab, 5-FU based radio-chemotherapy
- Keywords
- immunotherapy, anti-PD-L1
- 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 Tecentriq, MPDL3280a
Atezolizumab is given on day 1 of week 3, 6, 9 and 12 at 1200 mg IV.
5-FU based radio-chemotherapyDrug
IV protracted 5-FU given at 225mg/m2 over 24h 5 days/week for 5 weeks associated to radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Protracted IV 5-FU 225 mg/m2 is given from day 1 to 5 in parallel with radiotherapy 1.8 to 2 Gy from day 1 to 5 during 5 consecutive weeks.
Atezolizumab is given on day 1 of week 3, 6, 9 and 12 at 1200 mg IV. Rectal surgery is planned during week 15 Receives: Drug: Atezolizumab; Drug: 5-FU based radio-chemotherapy |
| Arm B | Active comparator | Protracted IV 5-FU 225 mg/m2 is given from day 1 to 5 in parallel with radiotherapy 1.8 to 2 Gy from day 1 to 5 during 5 consecutive weeks.
Rectal surgery is planned during week 15 Receives: Drug: 5-FU based radio-chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events
Evaluation of adverse events use CTCAE v4.0 terminology
Measured: 74 weeks
Rate of complete pathological response
Evaluation by central pathological review of rectal tumor resected after the preoperative treatment
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start27 Apr 2017
- Primary completion22 Feb 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grand Hôpital de Charleroi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Carrasco, MD, PhD, Principal investigator, GHdCMarc Van den Eynde, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127007
- Sponsor's protocol ID
- ONCOGHdC2015_02
- Acronym
- R-IMMUNE
- Status last verified
- Jan 2025
- First submitted
- 11 Apr 2017
- Last updated
- 22 Jan 2025
- 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Study to Evaluate Safety and Efficacy of Atezolizumab Combined With Radio-chemotherapy in a Preoperative Setting for Patients With Localized Rectal Cancer
- ClinicalTrials.gov ID
- NCT03127007
- Acronym / sponsor ID
- R-IMMUNE / ONCOGHdC2015_02
- Conditions
- Rectal Neoplasms
- Keywords
- immunotherapy, anti-PD-L1
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Grand Hôpital de CharleroiUniversity, hospital or other
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 25 Apr 2017 (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.
The study has a phase Ib and a phase II part. The phase Ib part of the study aims to determine the safety and tolerance of administration at a fixed dosing of 1200 mg / 3 weeks, concomitantly to the standard preoperative radio-chemotherapy.
The phase II part of the study aims to explore efficacy of atezolizumab in combination with the standard preoperative chemo/radiotherapy in stage II and III rectal cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Atezolizumab, Drug: 5-FU based radio-chemotherapyProtracted IV 5-FU 225 mg/m2 is given from day 1 to 5 in parallel with radiotherapy 1.8 to 2 Gy from day 1 to 5 during 5 consecutive weeks. Atezolizumab is given on day 1 of week 3, 6, 9 and 12 at 1200 mg IV. Rectal surgery is planned during week 15 |
| Arm B | Active comparator | Drug: 5-FU based radio-chemotherapyProtracted IV 5-FU 225 mg/m2 is given from day 1 to 5 in parallel with radiotherapy 1.8 to 2 Gy from day 1 to 5 during 5 consecutive weeks. Rectal surgery is planned during week 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent and any locally-required authorization are obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
- Male or female > 18 years at time of study entry
- Patients with previously untreated localized T3-T4 N0 or T any or N1-2, M0 rectal adenocarcinoma requiring preoperative radiotherapy
- Availability of protocol required screening tumor and blood samples
- ECOG performance status of 0 or 1
Key exclusion criteria (26 listed)
- Patient has locally recurrent or metastatic RC
- Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current rectal cancer disease
- Patients not requiring preoperative radio-chemotherapy
- Participation in another clinical study with an investigational product for any other indication until 4 weeks before study participation
- Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) ≤ 21 days prior to the first dose of study drug
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: Tecentriq, MPDL3280aAtezolizumab is given on day 1 of week 3, 6, 9 and 12 at 1200 mg IV. | Drug | Arm A |
| 5-FU based radio-chemotherapyIV protracted 5-FU given at 225mg/m2 over 24h 5 days/week for 5 weeks associated to radiotherapy. | Drug | Arm A, Arm B |
Primary outcome
Rate of adverse events
Time frame: 74 weeks
Evaluation of adverse events use CTCAE v4.0 terminology
Rate of complete pathological response
Time frame: 15 weeks
Evaluation by central pathological review of rectal tumor resected after the preoperative treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Rectal Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Javier Carrasco, MD, PhD principal investigator
GHdC
Marc Van den Eynde, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Atezolizumab and 5-FU based radio-chemotherapy in people with Rectal Neoplasms, run by Grand Hôpital de Charleroi at 5 sites in Belgium.
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 13 inclusion and 26 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: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of adverse events (time frame: 74 weeks). The study lists 2 primary outcomes in all. 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 22 Jan 2025.