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 (R-IMMUNE)

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 (R-IMMUNE) - R-IMMUNE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004526-41-BE

Enrollment

Registered

2016-11-24

Start date

2017-03-23

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectum cancer

Interventions

Product Name: Atezolizumab Pharmaceutical Form: Solution for infusion INN or Proposed INN: ATEZOLIZUMAB CAS Number: SUB178312 Current Sponsor code: Roche Other descriptive name: Roche Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patient has T3-T4 N0 or T any N1-2, M0, rectal adenocarcinoma • EGOG performance status 0 or 1 • Patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active using an acceptable method of contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16

Exclusion criteria

Exclusion criteria: • Patient has locally recurrent or metastatic disease • Patient has received any systemic therapy (e.g. chemotherapy, targeted therapy, immunotherapy) or radiotherapy for current rectal cancer disease

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): Phase II: ORR based on pelvis MRI assessment pre- and post-neoadjuvant treatment Nature frequency and severity of AEs based on physical examinations, vital signs including blood pressure, pulse, electrocardiograms, and laboratory findings including clinical chemistry, hematology and urinalysis;Timepoint(s) of evaluation of this end point: January 2021	—

Primary

Measure	Time frame
Main Objective: Phase Ib and II: To evaluate the safety and tolerability of atezolizumab associated to radio-chemotherapy in a neoadjuvant setting for early RC Phase 2: To explore the efficacy of atezolizumab associated to preoperative radio-chemotherapy for locally advanced RC ;Secondary Objective: To explore the efficacy of atezolizumab associated to preoperative radio-chemotherapy for locally advanced RC To evaluate the safety and tolerability of atezolizumab associated to radio-chemotherapy in a neoadjuvant setting for locally advanced RC ;Primary end point(s): Phase Ib and II: Nature, frequency and severity of AEs based on physical examinations, vital signs including blood pressure, pulse, electrocardiograms, and laboratory findings (CTCAE version 4.03) including clinical chemistry, hematology and urinalysis. Phase II: pCR on resected tumor (4.5.5) ;Timepoint(s) of evaluation of this end point: January 2018	—

Measure

Time frame

Main Objective: Phase Ib and II: To evaluate the safety and tolerability of atezolizumab associated to radio-chemotherapy in a neoadjuvant setting for early RC Phase 2: To explore the efficacy of atezolizumab associated to preoperative radio-chemotherapy for locally advanced RC ;Secondary Objective: To explore the efficacy of atezolizumab associated to preoperative radio-chemotherapy for locally advanced RC To evaluate the safety and tolerability of atezolizumab associated to radio-chemotherapy in a neoadjuvant setting for locally advanced RC ;Primary end point(s): Phase Ib and II: Nature, frequency and severity of AEs based on physical examinations, vital signs including blood pressure, pulse, electrocardiograms, and laboratory findings (CTCAE version 4.03) including clinical chemistry, hematology and urinalysis. Phase II: pCR on resected tumor (4.5.5) ;Timepoint(s) of evaluation of this end point: January 2018

—

Countries

Belgium

Contacts

Public ContactDr Javier CARRASCO

Grand Hôpital de Charleroi

r-immunetrial_support@oncobase.net003271104701

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026