A study of futuximab/modotuximab in combination with trifluridine/tipiracil in participants with previously treated colorectal cancer that has spread (metastatic)
- Conditions
- Metastatic colorectal cancerMedDRA version: 21.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-003151-41-DK
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 500
- Histologically or cytologically confirmed adenocarcinoma of metastatic colorectal cancer (mCRC), not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumour
Without RAS (KRAS and NRAS) and BRAF V600E mutations based on Circulating tumour DNA (ctDNA) screening blood test analysis
- Participants with measurable or non-measurable lesion
- Participants must have received at least 2 prior regimens of standard chemotherapy for mCRC and had demonstrated progressive disease or intolerance to their last regimen
- Participants should have received previous treatment with commercially available anti-EGFR mAbs for = 16 weeks.
- Estimated life expectancy = 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate haematological function
- Adequate renal function
- Adequate hepatic function
- Serum potassium, serum phosphates, serum magnesium within normal limits
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 275
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 225
- Pregnancy, possibility of becoming pregnant during the study, breast-feeding woman
- Patients currently receiving or having received anticancer therapies within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Randomised part)
- Major surgery within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Randomised part) or participants who have not recovered from side effects of the surgery
- Participants with serious/active/uncontrolled infection
- Known clinically significant cardiovascular disease or condition
- Significant gastrointestinal abnormality
- Skin rash of Grade > 1 from prior anti-EGFR at the time of inclusion (Safety Lead-in part) or randomization (Randomised Phase 3 part), or any other skin toxicity precluding participation in the study according to investigator's discretion
- Treatment with systemic immunosuppressive therapy within 4 weeks prior to inclusion (Safety Lead-in part) or randomization (Randomised part)
- Prior radiotherapy if completed less than 4 weeks before the inclusion visit (Safety Lead-in part) or randomization visit (Randomised part)
- Patients with other malignancies
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method