> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-precemtabart-tocentecan-with-or-without-21c5d54c-43a5-4347-a5d0-44bb5990e16c > Record changed: 2026-10-13 # 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) NCT07549412 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) Participants 1,020 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) Lead sponsor EMD Serono Research & Development Institute, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) Start date 2026-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) Number of sites 34 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Short title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) ## Dates **Completion date** 2029-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **First posted** 2026-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Registry last updated** 2026-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Primary completion date** 2029-10-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Start date** 2026-05-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) ## Size and sites **Participants** 1,020 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Planned participants** 1,020 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Number of sites** 34 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Lead sponsor** EMD Serono Research & Development Institute, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) ## Identifiers **Registry ID** NCT07549412 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **ClinicalTrials.gov ID** NCT07549412 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) ## Outcomes ### Primary outcomes 1. Arm 1, 2 and 3: Overall Survival Timeframe: 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 Timeframe: Time from date of randomization to death, assessed approximately up to average of 19 months 2. Progression Free Survival (PFS) Timeframe: 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 Timeframe: Up to average of 19 months 4. Duration of Response as Assessed by Investigator Timeframe: Time from first documentation of objective response to PD or death (assessed up to average of 19 months) 5. Number of Participants with Adverse Events (AEs) and Treatment Related Adverse Events Timeframe: Up to average of 19 months 6. Observed Concentration at End of Infusion (CEOI) Period Timeframe: At end of infusion on Cycle 1 Day 1 and Cycle 3 Day 1 (Arm 1 and Arm 2 only; each cycle is for 21 days) 7. Concentration Observed at the end of a Dosing Interval Immediately Before next Dosing (Ctrough) Timeframe: At end of dosing interval on Cycle1Day1,Cycle2Day1,Cycle3Day1,Cycle4Day1, Cycle5Day1,Cycle6Day1,Cycle7Day1 until treatment discontinuation(assessed up to average of 19months (Arm 1 and Arm 2 only; each cycle is for 21 days) 8. Number of Participants with Anti-Drug Antibody as measured by ADA assay Timeframe: Predose(-4to0 hours)on Cycle1Day1,Cycle2 Day1,Cycle 3Day1,Cycle4Day1, Cycle8Day1;thereafter every 4cycles until treatment discontinuation(assessed up to average of 19 months) (Arm 1 and Arm 2 only; each cycle is for 21 days) 9. Change from Baseline in Global Health Status, Physical, and Role Functioning Subscale Scores of European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) Timeframe: Baseline, Cycle 1 Day 1 and Day 1 of every new cycle until treatment discontinuation (assessed up to average of 19 months). EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) ## Sites - Rocky Mountain Cancer Centers, LLP- AuroraLone Tree, United StatesRecruiting - Florida Cancer Specialists-BroadwayFort Myers, United StatesRecruiting - Florida Cancer Specialists - St. Petersburg BayfrontSt. Petersburg, United StatesRecruiting - Florida Cancer Specialists East - FCS EAST - West Palm BeachWest Palm Beach, United StatesRecruiting - Illinois Cancer SpecialistsArlington Heights, United StatesRecruiting - Illinois CancerCare PCPeoria, United StatesRecruiting - Springfield ClinicSpringfield, United StatesRecruiting - Profound Research LLC at Cancer and Leukemia CenterSterling Heights, United StatesRecruiting - Minnesota Oncology Hematology, P.A.Saint Louis Park, United StatesRecruiting - Missouri Cancer Associates - 150518964Columbia, United StatesRecruiting - SCRI Oncology PartnersNashville, United StatesRecruiting - Texas Oncology, P.A. - Abilene - 300210366Abilene, United StatesRecruiting - Texas Oncology-South AustinAustin, United StatesRecruiting - Texas Oncology DFWBedford, United StatesRecruiting - Texas Oncology- San AntonioSan Antonio, United StatesRecruiting - Texas Oncology, P.A. - TylerTyler, United StatesRecruiting - Virginia Oncology AssociatesNewport News, United StatesRecruiting - Blue Ridge Cancer Care - 300202915Roanoke, United StatesRecruiting - GenesisCare North Shore (Oncology)St Leonards, AustraliaRecruiting - Icon Cancer Centre ChermsideChermside, AustraliaRecruiting - Mater Misericordiae Ltd - PARENTSouth Brisbane, AustraliaRecruiting - Flinders Medical CentreBedford Park, AustraliaRecruiting - University Health Network - Princess Margaret Cancer CentreToronto, CanadaRecruiting - Sun Yat-sen University Cancer CenterGuangzhou, ChinaRecruiting - Sichuan Cancer HospitalChengdu, ChinaRecruiting And 9 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) ## References - Related resource (clinicaltrials.emdgroup.com) Source: [clinicaltrials.emdgroup.com](https://clinicaltrials.emdgroup.com/en) - Related resource (medical.emdserono.com) Source: [medical.emdserono.com](https://medical.emdserono.com/en%5FUS/home.html) ### Other registry identifiers (4) - 2025 - 2025-524648-37-00 - jRCT2031260267 - CTR20262356 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07549412) ## Related records ### Drugs (4) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Precemtabart tocentecan](https://trialight.com/data/asset/precemtabart-tocentecan-495d685d-7437-43fd-a725-f1fc70394bbf.md) - [Tipiracil hydrochloride](https://trialight.com/data/asset/tipiracil-hydrochloride-c5072dfa-12fa-4ccc-9e35-c488a67c9673.md) - [Trifluridine](https://trialight.com/data/asset/trifluridine-cf1f965b-3efb-4c26-a766-cb4c7c73675f.md) ### Collaborators (1) - Merck KGaA, Darmstadt, Germany ### Lead sponsors (1) - [EMD Serono Research & Development Institute, Inc.](https://trialight.com/data/company/emd-serono-research-development-institute-inc-e77dadd3-e500-4922-8f75-5f886ee22b12.md) ### Conditions (2) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Primary condition - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) ### Targets (2) - [TYMP](https://trialight.com/data/target/tymp-d3e9f860-719a-5bf3-88de-e36378c4ce8c.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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