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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting. - Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting - Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1 - Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations - Other protocol defined inclusion criteria may apply

Exclusion Criteria

  • If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0 - Participant has a history of additional malignancy within 3 years before randomization - Participants with known brain metastases - Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization - Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments - Other protocol defined exclusion criteria may apply

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1: Precemtabart tocentecan (Precem-TcT) Monotherapy
  • Drug: Precemtabart tocentecan
    Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.
    Other names:
    • Precem-TcT
Experimental
Arm 2: Precem-TcT plus Bevacizumab
  • Drug: Precemtabart tocentecan
    Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.
    Other names:
    • Precem-TcT
  • 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.
Active Comparator
Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus Bevacizumab
  • 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.

Recruiting Locations

Profound Research LLC at Cancer and Leukemia Center
Troy, Michigan 48098

More Details

Status
Recruiting
Sponsor
EMD Serono Research & Development Institute, Inc.

Study Contact

US Medical Information
888-275-7376
eMediUSA@emdserono.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.