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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 (COLSTAR)

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Servier Protocol Code: CL3-95026-001 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT05223673 EudraCT Number: 2021-003151-41

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How to participate to the study?
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you don’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 15 locations

Study description

This study was done to test a new cancer drug called futuximab/modotuximab in participants with colorectal cancer that has spread to other parts of the body. When a cancer spreads to other parts of the body, it is called metastatic cancer. Colorectal cancer means a cancer is in a part of the gut (colon or rectum).

Futuximab/modotuximab is a combination of two drugs that target a specific protein (called EGFR) found on cancer cells.

Trifluridine/tipiracil is a combination of two cancer drugs put together in the same pill. It is available to treat metastatic colorectal cancer when standard treatments are no longer effective in the United States of America, Europe, and other countries.

It is hoped that by combining futuximab/modotuximab with trifluridine/tipiracil, their actions on the cancer cells may be more effective.

Two parts were planned in the study. The main goal of the first part was to look at the safety of futuximab/modotuximab in combination with trifluridine/tipiracil. The main goal of second part was to test if futuximab/modotuximab in combination with trifluridine/tipiracil worked better than trifluridine/tipiracil alone in patients with metastatic colorectal cancer.

Official title: A Randomised, Open-label, Multi-centre, Two-arm Phase 3 Study Comparing Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil to Trifluridine/Tipiracil Single Agent With a Safety Lead-In Part in Participants With KRAS/NRAS and BRAF Wild Type Metastatic Colorectal Cancer Previously Treated With Standard Treatment and Anti-EGFR Therapy
Conditions
Metastatic Colorectal Cancer
Interventions / Treatments
  • Futuximab/modotuximab
  • Trifluridine/Tipiracil
Other study id numbers
  • CL3-95026-001

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sexes

Male/Female

Accepts Healthy Volunteers

No

To take part, participants had to:

  • Be at least 18 years of age.
  • Have metastatic colorectal cancer that cannot be removed by surgery.
  • Be without specific changes in genes (hereditary material).
  • Be resistant (not respond) to at least 2 previous treatments for metastatic colorectal cancer.

Participants could not take part in the study if:

  • They had major heart disease.
  • Their cancer had spread to the brain or spinal cord and had not been treated.
  • They had received treatment with drugs that suppress the immune system or radiation in the 4 weeks before starting the study.

 

How is the study designed?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
Experimental: Futuximab/modotuximab combined with trifluridine/tipiracil (Safety Lead-In and Phase III parts)
Intervention / Treatment
Biological: Futuximab/modotuximab

Participants received futuximab/modotuximab through an IV (injection given slowly) into a vein once a week in each cycle. Each cycle lasted up to 28 days.

Drug: Trifluridine/Tipiracil

Participants took trifluridine/tipiracil tablets orally before receiving futuximab/modotuximab. They took the tablets twice a day for 5 days on and 2 days off, over 14 days, followed by a 14-day rest. This treatment cycle was repeated every 28 days.

Participant Group / Arm
Active Comparator: Trifluridine/tipiracil (Phase III part)
Intervention / Treatment
Drug: Trifluridine/Tipiracil

Participants took trifluridine/tipiracil tablets orally twice a day. They took the tablets for 5 days, then had 2 days off, over a period of 14 days, followed by a 14-day rest. This treatment cycle was repeated every 28 days.

Keywords

Provided by Servier
Futuximab/modotuximab Trifluridine/tipiracil Phase III Safety Lead-In part S95026 Sym004 Adult Metastatic Colorectal Colorectal Cancer EGFR
Additional Relevant MeSH Terms Glioma
Colorectal Neoplasms Neoplasm Metastasis