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

  • STATUS
    Recruiting
  • End date
    Aug 28, 2026
  • participants needed
    500
  • sponsor
    Institut de Recherches Internationales Servier
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Updated on 4 October 2022
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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, 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) (Double negative [DN].

Details
Condition Metastatic Colorectal Cancer
Treatment Trifluridine/Tipiracil, Futuximab/modotuximab
Clinical Study IdentifierNCT05223673
SponsorInstitut de Recherches Internationales Servier
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

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

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
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