A clinical trial evaluating tumour marker-driven treatment choices for advanced colorectal cancer.

A MULTI-CENTRE RANDOMISED CLINICAL TRIAL OF BIOMARKER-DRIVEN MAINTENANCE TREATMENT FOR FIRST-LINE METASTATIC COLORECTAL CANCER (MODUL) - MODUL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001017-61-IT

Enrollment

1442

Registered

2014-09-11

Start date

2014-11-08

Completion date

Unknown

Last updated

2022-02-07

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

Conditions

METASTATIC COLORECTAL CANCER MedDRA version: 17.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864

Interventions

Trade Name: Avastin Product Name: Bevacizumab Product Code: RO4876646/F02 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Current Sp

Anti-PDL1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60- Trade Name: Zelboraf 240 mg Film-coated Tablets Product Code: RO5185426/F17 Pharmaceuti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male and female patients >/= 18 years of age - Eastern Cooperative Oncology Group (ECOG) performance status of =65 years) yes F.1.3.1 Number of subjects for this age range 721

Exclusion criteria

Exclusion criteria: - Positive test for human immunodeficiency virus (HIV) - Active hepatitis B or hepatitis C at Screening - Active tuberculosis - Administration of a live, attenuated vaccine within four weeks prior to start of maintenance treatment or anticipation that such a live attenuated vaccine will be required during the remainder of the study - Prior treatment with CD137 agonists, anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents - Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within four weeks or five half-lives of the drug, whichever is shorter, prior to start of maintenance treatment - Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to start of maintenance treatment, or anticipated requirement for systemic immunosuppressive medications during the remainder of the study. The use of inhaled corticosteroids and mineralocorticoids is allowed.

Design outcomes

Primary

Measure	Time frame
Main Objective: • Assessing early efficacy during the Maintenance Treatment Phase based on a 20% reduction in tumour size after 2 months of treatment • Evaluating PFS ;Secondary Objective: • OS • ORR • Disease control rate (DCR) • Time to treatment response (TTR) • Duration of response (DoR) • ECOG performance status • Incidence, nature and severity of adverse events (AEs);Primary end point(s): 1) Proportion of patients with a 20% reduction in tumor size in the Maintenance Treatment Phase after 2 months of treatment 2) Progression-free survival (PFS) ;Timepoint(s) of evaluation of this end point: 1) After two months of maintenance therapy 2) From randomization until disease progression ordeath from any cause	—

Measure

Time frame

Main Objective: • Assessing early efficacy during the Maintenance Treatment Phase based on a 20% reduction in tumour size after 2 months of treatment • Evaluating PFS ;Secondary Objective: • OS • ORR • Disease control rate (DCR) • Time to treatment response (TTR) • Duration of response (DoR) • ECOG performance status • Incidence, nature and severity of adverse events (AEs);Primary end point(s): 1) Proportion of patients with a 20% reduction in tumor size in the Maintenance Treatment Phase after 2 months of treatment 2) Progression-free survival (PFS) ;Timepoint(s) of evaluation of this end point: 1) After two months of maintenance therapy 2) From randomization until disease progression ordeath from any cause

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Overall survival 2) Overall response rate, calculated as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) determined according to RECIST 1.1 3) Disease control rate (DCR), calculated as the proportion of patients with a best overall response of CR, PR or stable disesase (SD) as determined according to RECIST 1.1 4) Time to treatment response (TTR), calculated as the time from randomization to the first occurrence of a documented objective response (CR or PR) determined according to RECIST 1.1 5) Duration of response (DoR), , defined as the time from the first assessment of CR or PR until disease progression or death from any cause, whichever occurs first 6) Change in ECOG performance status 7) Incidence of adverse events (AEs);Timepoint(s) of evaluation of this end point: 1) From randomization until death from any cause 2) From randomization until disease progression 3) From randomization until disease progression 4) From randomization until disease progression or death from any cause 5) From randomization until disease progression or death from any cause 6) From baseline until end of study (up to 6 years) 7) From baseline until end of study (up to 6 years)	—

Measure

Time frame

Secondary end point(s): 1) Overall survival 2) Overall response rate, calculated as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) determined according to RECIST 1.1 3) Disease control rate (DCR), calculated as the proportion of patients with a best overall response of CR, PR or stable disesase (SD) as determined according to RECIST 1.1 4) Time to treatment response (TTR), calculated as the time from randomization to the first occurrence of a documented objective response (CR or PR) determined according to RECIST 1.1 5) Duration of response (DoR), , defined as the time from the first assessment of CR or PR until disease progression or death from any cause, whichever occurs first 6) Change in ECOG performance status 7) Incidence of adverse events (AEs);Timepoint(s) of evaluation of this end point: 1) From randomization until death from any cause 2) From randomization until disease progression 3) From randomization until disease progression 4) From randomization until disease progression or death from any cause 5) From randomization until disease progression or death from any cause 6) From baseline until end of study (up to 6 years) 7) From baseline until end of study (up to 6 years)

—

Countries

Algeria, Argentina, Austria, Belgium, Brazil, China, Cyprus, Denmark, Egypt, France, Germany, Greece, Italy, Macedonia, the former Yugoslav Republic of, Mexico, Netherlands, Poland, Portugal, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, United Kingdom

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com

Outcome results

None listed

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