Trial · NCT07359456
Testing Ivonescimab in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancers Without Liver Metastases
NCT07359456, Phase 2, Not yet recruiting, UNICANCER
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Testing Ivonescimab in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancers Without Liver Metastases. Trials, record NCT07359456. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07359456
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Testing Ivonescimab in Combination With Chemotherapy in Patients With Metastatic Colorectal Cancers Without Liver Metastases
- NCT number
- NCT07359456
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 130 participants, estimated
- Lead sponsor
- UNICANCER
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Ivonescimab, Bevacizumab, FOLFIRI Protocol
- First posted
- 2026-01-22
- Last updated
- 2026-05-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | 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. | 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). |
| Secondary | PFS as per iRECIST | 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. | To evaluate the efficacy of ivonescimab in combination with FOLFIRI in terms of PFS as per iRECIST |
| Secondary | Overall Response Rate (ORR) as per RECIST v1.1 | Imagery will be done within 28 days before first study treatment, and every 8 weeks until the date of the first documented disease progression. | 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. |
| Secondary | Duration of Response (DOR) as per RECIST v1.1 | 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. | To evaluate the efficacy of ivonescimab in combination with FOLFIRI in terms of Duration of Response (DOR) as per RECIST v1.1. |
| Secondary | Overall Survival (OS) | From date of randomization until the date of death from any cause, whichever came first, assessed up to 72 months. | 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. |
| Secondary | Safety and tolerability of treatment (NCI-CTCAE version 5.0) | At baseline within 14 days prior first study treatment, at day 1 of each visit during treatment (every 2 weeks), at the end of treatment (30 days after last study treatment), and at the two first follow-up (every 8 weeks after last administration). | Toxicity / Adverse events (AEs), occurrence of treatment-related AEs, treatment-related AEs (TRAEs) leading to dose reduction or discontinuation during treatment, serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs), iand tolerability of treatment (NCI-CTCAE version 5.0) |
| Secondary | The effect of treatments on Quality of Life (QoL) - QLQ-C30 | At baseline within 14 days prior first study treatment, every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 72 months | QoL is assessed using the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-C30 and EORTC QLQ-CR29 |
| Secondary | The effect of treatments on Quality of Life (QoL) - QLQ-CR29 | At baseline within 14 days prior first study treatment, every 8 weeks from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 72 months | QoL is assessed using the European Organisation for Research and Treatment of Cancer |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07359456
GET https://conductscience.org/api/trials/v1/NCT07359456/registered