Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer
Stopped early · Phase 3
Conditions studied: Metastatic Colorectal Cancer
In brief
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, irinotecan, fluoropyrimidines, anti-VEGF agents and anti-EGFR antibodies. The main objective of the safety lead-in part is to assess safety and tolerability of futuximab/modotuximab in combination with trifluridine/tipiracil. The primary objective of the phase III part is to compare Overall Survival of futuximab/modotuximab in combination with trifluridine/tipiracil vs trifluridine/tipiracil monotherapy in patients with tumours that are KRAS/NRAS and BRAF wild-type (WT).
Key facts
- Study ID
- NCT05223673
- Run by
- Institut de Recherches Internationales Servier
- People needed
- 7
- Starts
- 2022-04-21
- Expected to finish
- 2023-06-21
- Last updated by the study team
- 2024-08-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Michigan Oncology Clinic | Rogel Cancer Center — Ann Arbor, Michigan, United States
- Cleveland Clinic Cleveland Clinic Lerner College of Medicine — Cleveland, Ohio, United States
- UZA Edegem — Edegem, Belgium
- UZ Leuven Campus Gasthuisberg — Leuven, Belgium
- CHUUCL Namur site Godinne — Yvoir, Belgium
- Rigshospitalet — Copenhagen, Denmark
- Herning Regional Hospital (Regionhospitalet Godstrup) — Herning, Denmark
- Odense Universitetshospital — Odense, Denmark
- Docrates cancer center — Helsinki, Finland
- TAYS (Tampere University Hospital) — Tampere, Finland
- Magyar Honvédség Egészségügyi Központ Onkológiai Osztály — Budapest, Hungary
- Debreceni Egyetem, Klinikai Központ Onkológiai Klinika — Debrecen, Hungary
- Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudomáyi Kar Oktatókórháza — Kecskemét, Hungary
- Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Onkoterápiás Klinika — Szeged, Hungary
- National Cancer Center Hospital East — Chiba, Japan
Full record on ClinicalTrials.gov
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