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Testing Ivonescimab in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancers Without Liver Metastases

ConditionMetastatic Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER

About this trial

The goal of this clinical trial is to evaluate the superiority of ivonescimab combined with FOLFIRI over FOLFIRI + bevacizumab as second-line treatment of non resectable pMMR/MSS BRAFwt mCRC patients without liver metastases in terms of PFS. The main questions it aims to answer are:

Does FOLFIRI + ivonescimab improve progression-free survival compared to FOLFIRI + bevacizumab?

Participants will:

Take FOLFIRI + ivonescimab or FOLFIRI + bevacizumab every 2 weeks for a maximum of 24 months Visit the clinic once every 2 weeks for checkups and tests, and have imaging done every 8 weeks Complete some quality of life questionnaires every 8 weeks

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed a written informed consent form prior to any trial specific procedures. Note: If the patient is physically unable to provide their written consent, a trusted person of their choice, independent of the Investigator or the Sponsor, can confirm the patients consent in writing.

Histologically confirmed diagnosis of non resectable pMMR (by IHC) and MSS (by molecular biology) and BRAFwt metastatic colorectal cancer with no liver metastasis.

Must have previously received 1st-line treatment with FOLFOX +/- anti-VEGF (Vascular endothelial growth factor) or EGFR (Epithelial Growth Factor Receptor) therapy (including recurrence within 6 months after adjuvant FOLFOX for localized CRC and adjuvant/perioperative FOLFOX for mCRC, as well as progressive disease under maintenance treatment for mCRC) OR 1st-line treatment with FOLFIRINOX (Oxaliplatin, Irinotecan, 5FU, Folinic acid) (under the following condition: no progression under triplet-chemotherapy, progression under LV5FU2 (Folinic acid + 5FU) maintenance, irinotecan stopped for at least 3 months for a reason other than progression)

Presence of at least one measurable lesion as assessed by the investigator according to RECIST v1.1.

Disqualifiers

Presence of liver metastases by CT-scan or MRI. Note: Patients with prior definitively treated liver metastases (surgical resection, microwave or radiofrequency ablation, or stereotactic body radiation therapy) are eligible if no evidence of metastatic disease in the liver on subsequent imaging).

History of Gilbert's syndrome

Other current or previous malignancy within the past 3 years (with the exception of squamous cell carcinoma of the skin or in situ tumour treated by surgery).

Patients with high microsatellite instability (MSI-H), mismatched repair disease (dMMR) and/or BRAF V600E mutated tumor.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ivonescimab

    Drug

    Ivonescimab 20 mg/kg by intravenous infusion (IV) once every 2 weeks (Q2W)

  • Bevacizumab

    Drug

    Bevacizumab 5 mg/kg by intravenous infusion (IV) once every 2 weeks (Q2W)

  • FOLFIRI Protocol

    Drug

    FOLFIRI chemotherapy (irinotecan 180 mg/m2 IV, folinic acid 400 mg/m2 IV (or L-folinic acid 200 mg/m²), and fluorouracil (5-FU) 400 mg/m² IV bolus; followed by 5 FU 2400 mg/m2 as a 46 hour continuous IV infusion), every two weeks

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Ivonescimab + FOLFIRIExperimental treatment 2 interventions
Group B: Bevacizumab + FOLFIRIActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

The primary objective is to evaluate the superiority of ivonescimab combined with FOLFIRI over FOLFIRI + bevacizumab as second-line treatment of non resectable pMMR/MSS BRAFwt mCRC patients without liver metastases in terms of Progression-Free Survival (PFS).

Time frame
Time from the date of randomization until the date of first documented disease progression as assessed by the investigator according to RECIST1.1, or death from any cause, whichever came first, assessed up to 72 months.

Secondary outcomes

1

PFS as per iRECIST

To evaluate the efficacy of ivonescimab in combination with FOLFIRI in terms of PFS as per iRECIST

Time frame
The time from the date of randomization to the date of first documentation of disease progression as assessed by the investigator according to iRECIST, or death from any cause, whichever came first, assessed up to 72 months.
2

Overall Response Rate (ORR) as per RECIST v1.1

To evaluate the efficacy of ivonescimab in combination with FOLFIRI in terms of Overall Response Rate (ORR) as per RECIST v1.1. The proportion of patients achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST v1.1.

Time frame
Imagery will be done within 28 days before first study treatment, and every 8 weeks until the date of the first documented disease progression.
3

Duration of Response (DOR) as per RECIST v1.1

To evaluate the efficacy of ivonescimab in combination with FOLFIRI in terms of Duration of Response (DOR) as per RECIST v1.1.

Time frame
The time from first documented PR or CR (compared to baseline measurement done within 28 days before first study treatment) until the date of PD (Imagery done every 8 weeks), or death from any cause.
4

Overall Survival (OS)

To evaluate the efficacy of ivonescimab in combination with FOLFIRI in terms of Overall Survival (OS). The time from randomization to death from any cause. Patients who are alive at the data-cutoff date will be censored on the last known alive date.

Time frame
From date of randomization until the date of death from any cause, whichever came first, assessed up to 72 months.

Other outcomes

Sponsors and contacts

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

UNICANCER

Lead sponsor

Summit Therapeutics

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: