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RECRUITING
NCT07549412
PHASE3

A 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)

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

Summary

This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluoride/tipiracil (FTD-TPI) plus bevacizumab.

Official 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1020

Start Date

2026-05-06

Completion Date

2029-10-16

Last Updated

2026-07-24

Healthy Volunteers

No

Interventions

DRUG

Precemtabart tocentecan

Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.

DRUG

Bevacizumab

Bevacizumab, administered intravenously every 3 weeks on Day 1 of each 21-day cycle or every 2 weeks on Day 1 and Day 15 of each 28-day cycle.

DRUG

Trifluridine/Tipiracil (FTD-TPI)

FTD-TPI, tablet, administered orally twice daily, on Days 1 to 5 and Days 8 to 12 of each 28-day cycle.

Locations (21)

Rocky Mountain Cancer Centers, LLP- Aurora

Lone Tree, Colorado, United States

Illinois Cancer Specialists

Arlington Heights, Illinois, United States

Illinois CancerCare PC

Peoria, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Profound Research LLC at Cancer and Leukemia Center

Sterling Heights, Michigan, United States

Minnesota Oncology Hematology, P.A.

Saint Louis Park, Minnesota, United States

Missouri Cancer Associates - 150518964

Columbia, Missouri, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Texas Oncology, P.A. - Abilene - 300210366

Abilene, Texas, United States

Texas Oncology-South Austin

Austin, Texas, United States

Texas Oncology DFW

Bedford, Texas, United States

Texas Oncology- San Antonio

San Antonio, Texas, United States

Texas Oncology, P.A. - Tyler

Tyler, Texas, United States

Virginia Oncology Associates

Newport News, Virginia, United States

Blue Ridge Cancer Care - 300202915

Roanoke, Virginia, United States

GenesisCare North Shore (Oncology)

St Leonards, New South Wales, Australia

Icon Cancer Centre Chermside

Chermside, Queensland, Australia

University Health Network - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

National Cancer Center Hospital

Chūōku, Tokyo-To, Japan

Samsung Medical Center

Seoul, South Korea

China Medical University Hospital

Taichung, Taiwan