Regarding colorectal cancer, it is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.
Today, we have a rundown of six, ongoing clinical trials focusing on colorectal cancer, currently recruiting or soon to be recruiting in the United States. The ranges of anticipated primary completion dates range from May 2028 through March 2030. The trials are arranged in order of their start date.
Quick View Table of Colorectal Cancer Clinical Trials
| Study Title | Recruiting? | Phase | Estimated Enrollment | Start Date | Anticipated Primary Completion |
|---|---|---|---|---|---|
| A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) | Yes | 3 | 477 | July 2025 | March 2029 |
| Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer (HARMONi-GI3) | Yes | 3 | 600 | November 2025 | May 2028 |
| A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer | Yes | 2,3 | 990 | December 2025 | February 2030 |
| Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer | Yes | 3 | 800 | December 2025 | March 2030 |
| A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer | Yes | 3 | 700 | March 2026 | December 2028 |
| 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) | Not Yet | 3 | 1020 | May 2026 | December 2028 |
Featured Ongoing Colorectal Cancer Clinical Trials
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
- Sponsor: Merck Sharp & Dohme LLC
- Goal: The goals of this study are to learn: About the safety of calderasib with cetuximab and mFOLFOX6 and if people tolerate the treatments and If people who receive calderasib with cetuximab and mFOLFOX6 live longer without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.
- Interventions: Calderasib, Oxaliplatin, leucovorin/levofolinate calcium, 5-Fluorouracil, cetuximab, bevacizumab, bevacizumab biosimilar
- Primary Outcome Measures: Number of Participants Experiencing Dose-Limiting Toxicity (DLT); Part 1: Number of Participants Who Experience an Adverse Event (AE); Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE; Progression Free Survival (PFS).
- Time Frame: Up to approximately 28 days; Up to approximately 44 months; Up to approximately 44 months; Up to approximately 44 months.
- Study Details
- Source
Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer (HARMONi-GI3)
- Sponsor: Summit Therapeutics
- Goal: Performed as a Phase 3, randomized, active-controlled, double-blind, multiregional study comparing Ivonescimab in combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in combination with mFOLFOX6 in patients with metastatic colorectal cancer who have not previously received systemic therapy for metastatic disease.
- Interventions: Ivonescimab injection, Bevacizumab injection
- Primary Outcome Measure: PFS by IRRC based on RECIST v1.1.
- Time Frame: Up to approximately 2.5 years.
- Study Details
- Source
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
- Sponsor: Bristol-Myers Squibb
- Goal: To evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer.
- Interventions: Pumitamig, FOLFOX, FOLFIRI, bevacizumab, CAPOX
- Primary Outcome Measures: Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment; Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR).
- Time Frame: Up to five years; Up to five years.
- Study Details
- Source
Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer
- Sponsor: Pfizer
- Goal: To understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.
- Interventions: PF-08634404, bevacizumab, chemotherapy
- Primary Outcome Measures: Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR); Overall survival (OS).
- Time Frames: Approximately four years; Approximately four years.
- Study Details
- Source
A Study to Evaluate the Efficacy and Safety of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
- Sponsor: Incyte Corporation
- Goal: To evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.
- Interventions: INCA33890, placebo, bevacizumab, FOLFOX
- Primary Outcome Measures: Progression-Free Survival (PFS).
- Time Frame: Up to three years.
- Study Details
- Source
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.
- Goal: 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.
- Interventions: Precemtabart tocentecan, bevacizumab, trifluridine/tipiracil (FTD-TPI)
- Primary Outcome Measure: Arm 1, 2 and 3: Overall Survival.
- Time Frame: Time from date of randomization to death, assessed approximately up to average of 19 months.
- Study Details
- Source
Related Guidelines:
- Early Detection of Colorectal Cancer
- American Society of Clinical Oncology (ASCO), February 2019
- Colorectal Cancer Screening for Average‐Risk Adults
- American Cancer Society (ACS), May 2018
- Role of Endoscopy in the Staging and Management of Colorectal Cancer
- American Society for Gastrointestinal Endoscopy (ASGE), May 2013
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