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Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer

ConditionMetastatic Colorectal Cancer (CRC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSummit Therapeutics

About this trial

A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer(HARMONi-GI3)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ECOG performance status score of 0 or 1

Expected life expectancy ≥ 6 months

Patients with histologically or cytologically confirmed metastatic CRC

No prior systemic therapy for metastatic CRC

Disqualifiers

Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease

Known BRAF V600E mutant status

Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction

Ascites requiring paracentesis within last 30 days

Trial design

Design model

Parallel

Treatments tested in this trial

  • Drug: Ivonescimab Injection

    Drug

    Subjects will receive Ivonescimab Plus mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) via intravenous infusion (IV) Q2W, up to 8 cycles. Afterward, Ivonescimab plus Leucovorin and 5-Fluorouracil will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) for up to 2 years.

  • Drug: Bevacizumab Injection

    Drug

    Subjects will receive bevacizumab Plus mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) via intravenous infusion (IV) Q2W, up to 8 cycles in treatment periods per the randomization schedule. Afterward, bevacizumab Plus 5-FU and Leucovorin will be used for maintenance treatment (administered on Day 1 of each cycle, Q2W) up to 2 years.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Arm A: Ivonescimab in combination with mFOLFOX6Experimental treatment 1 intervention
Group B: Arm B: Bevacizumab in combination with mFOLFOX6Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

PFS by IRRC based on RECIST v1.1

Progression-free survival (PFS) assessed by IRRC per RECIST v1.1

Time frame
Up to approximately 2.5 years

Secondary outcomes

1

Overall Survival (OS) in the population

Overall Survival (OS) in the mCRC population

Time frame
Up to approximately 4 years
2

ORR

Efficacy measures such as overall response rate (ORR), which is the proportion of subjects with CR or PR by IRRC based on RECIST v1.1

Time frame
Up to approximately 2.5 years
3

Adverse Events (AE)

incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results \[From the time subject signs the ICF to 30 days (AE) and 90 days (SAE related to ivonescimab/bevacizumab) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first\]

Time frame
Up to approximately 4 years
4

DoR

Efficacy measures such as duration of response (DoR), which is the proportion of subjects with CR or PR by IRRC based on RECIST v1.1

Time frame
up to approximately 2.5 years

Other outcomes

Sponsors and contacts

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

Summit Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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