A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3)
Key facts
- Where
- Budapest VIII, Budapest XII, Debrecen, Gyula, Kecskemét és Zalaegerszeg, MagyarországSee the 6 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How many different drug treatment plans (such as chemotherapy) have you had for cancer that has spread?
- Has a test of your tumour shown a change (mutation) in the KRAS, NRAS or BRAF genes?
- Has a test shown that your tumour is 'MSI-high' or 'dMMR'?
- Which best describes how well you can look after yourself and be active?
Where in Magyarország
- Semmelweis UniversityBudapest VIII, MagyarországTaking people
- Orszagos Onkologiai IntezetBudapest XII, MagyarországTaking people
- University of DebrecenDebrecen, MagyarországTaking people
- Bekes Varmegyei Koezponti KorhazGyula, MagyarországTaking people
- Bacs-Kiskun Varmegyei OktatokorhazKecskemét, MagyarországTaking people
- Zala Varmegyei Szent Rafael KorhazZalaegerszeg, MagyarországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Summit Therapeutics Inc.
- Trial code
- EU 2025-521587-35-00
- Record updated
- 2026. október 16.
- Original description
To compare the progression-free survival (PFS) as assessed by blinded Independent Radiological Review Committee (IRRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, of ivonescimab in combination with modified 5 FU, oxaliplatin, and leucovorin (mFOLFOX6) to bevacizumab in combination with mFOLFOX6.Read full original descriptionShow less
To compare the progression-free survival (PFS) as assessed by blinded Independent Radiological Review Committee (IRRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, of ivonescimab in combination with modified 5 FU, oxaliplatin, and leucovorin (mFOLFOX6) to bevacizumab in combination with mFOLFOX6.
Inclusion: Histologically or cytologically confirmed mCRC, not amenable to curative resection; An Eastern Cooperative Oncology Organization Group (ECOG) performance status score of 0 or 1; No prior systemic therapy for mCRC. NOTE:- If patients have received systemic therapy or radiotherapy for early-stage disease, >12 months must have elapsed since completion of neoadjuvant therapy and/or adjuvant therapy (including adjuvant oxaliplatin or radiotherapy) and prior to diagnosis of recurrent or metastatic disease; At least one measurable tumor lesion according to RECIST v1.1 that is amenable to repeated accurate measurements. NOTE:- Brain metastases cannot be selected as target lesions and lesions that have received radiotherapy in the past cannot be selected as target lesions unless they have progressed following radiation; Known BRAF, KRAS and NRAS (extended RAS) mutation status from existing reports, or determined by testing tumor tissue utilizing a clinical assay.
Exclusion: Known BRAF V600E mutation status. known DPD deficiency (refer to local fluorouracil label or local clinical guidance for DPD status recommendation prior to starting treatment); Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and any other therapy based on the mechanism of action of tumor immunity or angiogenesis; Symptomatic central nervous system (CNS) metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease. NOTE:- Patients who have stopped corticosteroids or on stable corticosteroid therapy (prednisone ≤ 10 mg daily or equivalent) are allowed; Resectable oligometastastic-only disease with multidisciplinary plan for complete resection of all disease; Patients with known MSI-H/dMMR disease as determined by a health authority approved assay (eg, FDA for United States, CE-IVD marked for Europe, PMDA for Japan, and NMPA for China) conducted at a local clinical laboratory or at the central laboratory; Ascites requiring paracentesis within last 30 days.