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New treatment option for RAS Mutation
Official title ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC
ClinicalTrials.gov ID: NCT06321081
What this study is testing
What is irinotecan, cetuximab, envafolimab?
irinotecan, cetuximab, envafolimab is an investigational medicine, being studied as a potential treatment for ras mutation.
Also referred to as CPT-11, PD-L1 inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a non-profit phase II, open, clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit (complete or partial response) from both of them, no matter whether they had treated by any PD-1 inhibitor before.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management.
- Male or female people aged ≥ 18 years. Histologically proven diagnosis of colorectal adenocarcinoma. Diagnosis of metastatic disease. RAS (NRAS and...
- More than 2 months since the last dose of cetuximab administered in first line treatment before randomization.
- Measurable disease according to RECIST criteria v1.1. ECOG PS of 0 to 1 at trial entry. Estimated life expectancy of more than 12 weeks. Adequate...
- Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and alanine aminotransferase (ALT)...
You likely can't join if
- Any contraindication to cetuximab and/or envafolimab. Past or current history of malignancies other than colorectal carcinoma, except for curatively...
- Pregnancy. Breastfeeding. Participation in a clinical study or experimental drug treatment within 30 days before enrollment.
- people receiving immunosuppressive agents (such as steroids) for any reason, should be tapered off these drugs before initiation of the trial...
- people with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to ≤ 10 mg prednisone daily...
- Significant acute or chronic infections including, among others:
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
See the full eligibility criteria
Who can join
- Signed written informed consent before any trial-related procedure is undertaken that is not part of the standard patient management.
- Male or female people aged ≥ 18 years. Histologically proven diagnosis of colorectal adenocarcinoma. Diagnosis of metastatic disease. RAS (NRAS and KRAS exon 2,3 and 4) and BRAF wild-type in liquid biopsy at screening...
- More than 2 months since the last dose of cetuximab administered in first line treatment before randomization.
- Measurable disease according to RECIST criteria v1.1. ECOG PS of 0 to 1 at trial entry. Estimated life expectancy of more than 12 weeks. Adequate hematological function defined by white blood cell (WBC) count ≥ 2.5 ×...
- Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and alanine aminotransferase (ALT) levels ≤ 2.5 × ULN for all people or AST and ALT levels ≤ 5 x ULN...
- Adequate renal function defined by an estimated creatinine clearance \> 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).
- Effective contraception for both male and female people throughout the study and for at least 2 months after last study treatment administration if the risk of conception exists (Note: The effects of the trial drug on...
What rules you out
- Any contraindication to cetuximab and/or envafolimab. Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ...
- Pregnancy. Breastfeeding. Participation in a clinical study or experimental drug treatment within 30 days before enrollment.
- people receiving immunosuppressive agents (such as steroids) for any reason, should be tapered off these drugs before initiation of the trial treatment, with the exception of:
- people with adrenal insufficiency, who may continue corticosteroids at physiologic replacement dose, equivalent to ≤ 10 mg prednisone daily Intranasal, inhaled, topical steroids, Local steroid injection (e.g...
- Significant acute or chronic infections including, among others:
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
- people with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
- people requiring hormone replacement with corticosteroids are eligible if steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or equivalent prednisone per day.
- Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are acceptable.
- Active infection requiring systemic therapy. Previous or ongoing administration of systemic steroids for the management of an acute allergic phenomenon is acceptable as long as it is anticipated that the administration...
- Known severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v 5 Grade ≥ 3), any history of...
- History of hypersensitivity to Polysorbate 80 that led to unacceptable toxicity requiring treatment cessation.
- Persisting toxicity related to prior therapy of Grade \> 1 NCI- CTCAE v 5.0. Known alcohol or drug abuse. Clinically significant (that is active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months...
- History of keratitis, ulcerative keratitis or severe dry eye. Since contact lent use is also a risk factor for keratitis and ulceration, it is not recommended.
- Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active...
- Legal incapacity or limited legal capacity.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.