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

• Register: EUCTR
• Last refreshed on: 7 February 2022
• Main ID: EUCTR2014-001017-61-IT
• Date of registration: 11/09/2014
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: A clinical trial evaluating tumour marker-driven treatment choices for advanced colorectal cancer.
• Scientific title: A MULTI-CENTRE RANDOMISED CLINICAL TRIAL OF BIOMARKER-DRIVEN MAINTENANCE TREATMENT FOR FIRST-LINE METASTATIC COLORECTAL CANCER (MODUL) - MODUL
• Date of first enrolment: 08/11/2014
• Target sample size: 1442
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001017-61
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
- Male and female patients >/= 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status of - At least 16 weeks of life expectancy at time of entry into the study
- Histologically confirmed metastatic colorectal cancer (CRC)
- Measureable, unresectable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1
- No prior chemotherapy for CRC in the metastatic setting
- Archival tumor formalin-fixed paraffin-embedded tissue block from the primary tumor obtained at the time of the initial diagnosis is available
- Adequate hematological, liver and renal function
- Agreement to use highly effective measures 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 721
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 721

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

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

Intervention(s)

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 Sponsor code: RO4876646
Other descriptive name: rhuMAb VEGF, anti-VEGF
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Product Name: MPDL3280A
Product Code: RO5541267/F03
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: n.a.
CAS Number: n.a.
Current Sponsor code: RO5541267
Other descriptive name: MPDL3280A; 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Vemurafenib
CAS Number: 918504-65-1
Current Sponsor code: RO5185426
Other descriptive name: VEMURAFENIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 240-

Trade Name: Erbitux®
Product Code: Ro 546-9926
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923-56-4
Current Sponsor code: RO5469926
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-

Primary Outcome(s)

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

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

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)

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)

Secondary Outcome(s)

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)

Secondary ID(s)

MO29112

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd

Ethics review

Status: Approved
Approval date: 26/09/2014
Contact:

Results

• Results available: Yes
• Date Posted: 12/06/2020
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-001017-61/results