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Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer

Program Status

Recruiting

Phase

Phase 3

Immunotherapy-centered Trial

No

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

Futuximab/modotuximab, Trifluridine/Tipiracil

Tags

MSS/ pMMR

Comments

Phase 3. Only for patients with KRAS/ NRAS and BRAF Wild type mCRC, who already had 2 lines of systemic chemotherapy, and and anti EGFR. Patients receive 3rd line therapy, trifluridine/tipiracil (Lonsurf) plus Futuximab/modotuximab, and anti-EGFR/HER1 therapeutic antibody, with the aim to overcome acquired resistance to anti EGFRs.

Location Location Status
United States
University of Michigan Oncology Clinic | Rogel Cancer Center
Ann Arbor, Michigan 48109
Not yet recruiting
Cleveland Clinic Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio 44195
Not yet recruiting
Belgium
UZA Edegem
Edegem 2650
Recruiting
UZ Leuven Campus Gasthuisberg
Leuven 3000
Recruiting
CHUUCL Namur site Godinne
Yvoir 5530
Not yet recruiting
Denmark
Rigshospitalet
Copenhagen 2100
Not yet recruiting
Herning Regional Hospital (Regionhospitalet Godstrup)
Herning 7400
Not yet recruiting
Odense Universitetshospital
Odense 5000
Not yet recruiting
Finland
Docrates cancer center
Helsinki 00180
Recruiting
TAYS (Tampere University Hospital)
Tampere 33520
Not yet recruiting
Japan
National Cancer Center Hospital East
Chiba 277-8577
Recruiting

Contacts

Institut de Recherches Internationales Servier, Clinical Studies Department
Contact
+33 1 55 72 43 66 scientificinformation@servier.com

Inclusion Criteria

Inclusion Criteria:

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 Criteria

Exclusion Criteria:

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

NCT ID

NCT05223673

Date Trial Added

2022-02-04

Updated Date

2022-07-08