Health Trials

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)

ConditionMetastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEMD Serono Research & Development Institute, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Precemtabart tocentecan

    Drug

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

  • Bevacizumab

    Drug

    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.

  • Trifluridine/Tipiracil (FTD-TPI)

    Drug

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

Treatment groups

1,020 Participants
are divided into 3 treatment groups
Group A: Arm 1: Precemtabart tocentecan (Precem-TcT) MonotherapyExperimental treatment 1 intervention
Group B: Arm 2: Precem-TcT plus BevacizumabExperimental treatment 2 interventions
Group C: Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus BevacizumabActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Arm 1, 2 and 3: Overall Survival

Time frame
Time from date of randomization to death, assessed approximately up to average of 19 months

Secondary outcomes

1

Arm 1 and Arm 2: Overall Survival

Time frame
Time from date of randomization to death, assessed approximately up to average of 19 months
2

Progression Free Survival (PFS)

Time frame
Time from randomization to the first occurrence of disease progression or death, whichever occurs first (assessed up to average of 19 months)
3

Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator

Time frame
Up to average of 19 months
4

Duration of Response as Assessed by Investigator

Time frame
Time from first documentation of objective response to PD or death (assessed up to average of 19 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EMD Serono Research & Development Institute, Inc.

Lead sponsor

Merck KGaA, Darmstadt, Germany

Collaborator

Source ClinicalTrials.gov
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