BridgeMD
Study to evaluate the efficacy and safety of cetuximab plus irinotecan compared to investigator's choice therapy in patients with metastatic colorectal cancer.
EU CTIS ID: 2024-518728-59-00
What this study is testing
The primary objective of the study is to evaluate the efficacy, in terms of overall response rate (ORR), of a rechallenge strategy with cetuximab and irinotecan in comparison to investigator's choice of treatment, excluding anti-EGFR therapy, as third-line treatment in patients with RAS, BRAF and EGFR-ECD wild-type mCRC genomically selected by liquid biopsy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent before any study procedure is performed.
- ECOG performance status of 0-1
- Adequate bone marrow (hemoglobin ≥9.0 g/dL, neutrophil count > 1.0 x 109/L and platelet > 50 x 109/L), renal (serum creatinine <2 x upper limit of normal [ULN] and/or bilirubin <2.5 x UNL) and hepatic function (ALT and AST < 2.5 x ULN, ≤ 5 x ULN if liver metastases are present).
- Absence of any psychological, familial, sociological or geographical circumstance potentially hampering compliance with the study protocol.
- Life expectancy >12 weeks, as determined by the investigator.
- Men and women aged 18 years or older.
You likely can't join if
- Patients who decline or are unable to understand, provide or are unwilling to sign an informed consent form.
- Unable or unwilling to complete all required screening and/or follow-up assessments.
- Patients under ongoing treatment with an investigational medication or medical device or participation in another investigational study within the previous 4 weeks.
- Patients with active alcohol or drug addiction or any other condition that, in the investigator's opinion, would interfere with their ability to comply with the study requirements.
- Patients with any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
- Failure to perform screening examinations.
See the full eligibility criteria
Who can join
- Written informed consent before any study procedure is performed.
- ECOG performance status of 0-1
- Adequate bone marrow (hemoglobin ≥9.0 g/dL, neutrophil count > 1.0 x 109/L and platelet > 50 x 109/L), renal (serum creatinine <2 x upper limit of normal [ULN] and/or bilirubin <2.5 x UNL) and hepatic function (ALT and AST < 2.5 x ULN, ≤ 5 x ULN if liver metastases are present).
- Absence of any psychological, familial, sociological or geographical circumstance potentially hampering compliance with the study protocol.
- Life expectancy >12 weeks, as determined by the investigator.
- Men and women aged 18 years or older.
- Histologically confirmed mCRC.
- RAS wild-type (KRAS and NRAS exon 2,3,4) status in a tissue-based test determined by a local assay before starting first-line treatment.
- Patients must have received two prior regimens of standard chemotherapy for mCRC and must have been refractory to or failed (includes intolerance) to those regimens. ▪ Prior standard chemotherapy may not have included TAS-102 or regorafenib, but must have included all of the following agents: ▪ AntiEGFR monoclonal antibodies (cetuximab or panitumumab) in the firstline setting ▪ Fluoropyrimidines, irinotecan and oxaliplatin (+/- an anti-VEGF pathway inhibitor approved for treatment of mCRC). Reintroduction of a chemotherapeutic regimen will not be considered as a new line of treatment.
- Patients with “acquired” resistance to antiEGFR monoclonal antibodies (cetuximab or panitumumab), defined as: ▪ Response to first-line antiEGFR-based treatment (defined as CR, PR or SD lasting ≥16 weeks). ▪ Documented progression to first-line antiEGFR-based treatment within 4 weeks after the last administration of cetuximab or panitumumab.
- Recovery of any toxicity related to second-line treatment to grade ≤1 according to NCICTCAE version 5.0 at screening, with the exception of grade 2 alopecia or grade 2 neuropathy.
- Triple negative mutation status defined as no detection of clonal mutations in extended RAS (KRAS and NRAS exon 2,3,4), BRAF V600E and EGFR-ECD (V441, S464, G465 and S492) as assessed in liquid biopsy testing for screening before third-line treatment initiation assessed by the central laboratory. Note: A centralized genomic analysis will be performed. For this purpose, peripheral blood will be collected and sent to the central laboratory for detecting RAS, BRAF V600E, and EGFR-ECD mutations on ctDNA by Oncomine CRC NGS analysis.
- At least one measurable lesion, defined as one or more target lesions according to RECIST, version 1.1.
What rules you out
- Patients who decline or are unable to understand, provide or are unwilling to sign an informed consent form.
- Unable or unwilling to complete all required screening and/or follow-up assessments.
- Patients under ongoing treatment with an investigational medication or medical device or participation in another investigational study within the previous 4 weeks.
- Patients with active alcohol or drug addiction or any other condition that, in the investigator's opinion, would interfere with their ability to comply with the study requirements.
- Patients with any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
- Failure to perform screening examinations.
- Second-line treatment with anti-EGFR therapy.
- Pregnant or nursing (lactating) women; women of childbearing potential (premenopausal or less than 12 months of amenorrhea post-menopause) who have not undergone surgical sterilization and who are sexually active that are unwilling to use adequate contraception (such as oral contraceptives, intrauterine contraceptive device or barrier method with spermicide or surgical sterilization) during the study and until 3 months after last dose of study treatment administration.
- Previous or concurrent second malignancy with exception of basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other solid tumors with no evidence of recurrence in the last 5 years.
- Patients with known, untreated central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression; patients with any of these metastases not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required.
- Patients with MSI-high (MSI-H) tumors.
- Suspected or known allergy or intolerance to any components of the study treatment.
- History of grade 3/4 infusion reactions to cetuximab or panitumumab monoclonal antibodies.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.