Status:
TERMINATED
Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer
Lead Sponsor:
Institut de Recherches Internationales Servier
Collaborating Sponsors:
ADIR, a Servier Group company
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized phase III study with a safety lead-in part in patients with KRAS/ NRAS and BRAF Wild Type metastatic colorectal cancer who have previously received treatment with oxaliplatin, iri...
Eligibility Criteria
Inclusion
- 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 ≥ 4 months
- Estimated life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate haematological, renal and hepatic function
Exclusion
- Pregnancy, possibility of becoming pregnant during the study, breastfeeding woman
- Patients currently receiving or having received anticancer therapies within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part).
- Major surgery within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 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 (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 (Phase 3 part)
- Prior radiotherapy if completed less than 4 weeks before the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part)
- Patients with other malignancies
Key Trial Info
Start Date :
April 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05223673
Start Date
April 21 2022
End Date
June 21 2023
Last Update
August 20 2024
Active Locations (15)
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1
University of Michigan Oncology Clinic | Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
2
Cleveland Clinic Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, United States, 44195
3
UZA Edegem
Edegem, Belgium, 2650
4
UZ Leuven Campus Gasthuisberg
Leuven, Belgium, 3000