MS914001_0002 (PROCEADE-CRC-03)
Research type
Research Study
Full title
A randomized, open label, 3-arm Phase 3 study of precemtabart tocentecan with or without bevacizumab compared to trifluridine/tipiracil plus bevacizumab in participants with previously treated metastatic colorectal cancer (PROCEADE-CRC-03)
IRAS ID
1013976
Contact name
Communication Center Merck Healthcare KGaA
Contact email
Sponsor organisation
Merck Healthcare KGaA
Clinicaltrials.gov Identifier
Research summary
This is a large global clinical study looking at new treatment options for people with metastatic colorectal cancer (mCRC) whose cancer has continued to grow or who can no longer tolerate standard treatments.
The study will compare two ways of giving a new treatment called Precem‑TcT (either on its own or together with another medicine called bevacizumab) against an existing treatment combination called trifluridine/tipiracil (FTD‑TPI) plus bevacizumab.
What is the purpose of the study?
The main aim is to find out whether Precem‑TcT, either alone or with bevacizumab, can help people live longer than those receiving the current standard treatment (FTD‑TPI plus bevacizumab).
The study will also look at safety, to understand how well people tolerate each treatment.
Who can take part?
People with metastatic colorectal cancer who have already received standard chemotherapy drugs (irinotecan, oxaliplatin, fluoropyrimidines) and bevacizumab, and whose cancer has worsened despite this treatment.
How long will participation last?
Around 19 months for those in the Precem‑TcT groups
Around 14 months for those in the FTD‑TPI plus bevacizumab group
This includes screening, treatment, and follow‑up.
How often are study visits?
Every 3 weeks for participants receiving Precem‑TcT (Arms 1 and 2)
Every 2 weeks for participants receiving FTD‑TPI plus bevacizumab (Arm 3)
How many people will join the study?
About 1,020 participants worldwide.
How are participants assigned to treatment?
Participants who qualify will be randomly placed into one of three groups, with equal chances of being assigned to any group:
Precem‑TcT alone
Precem‑TcT + bevacizumab
FTD‑TPI + bevacizumab (current treatment option)
This randomisation ensures each treatment group is fairly balanced.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
26/EM/0095
Date of REC Opinion
1 Jul 2026
REC opinion
Further Information Favourable Opinion