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MULTICENTER RANDOMIZED PHASE II STUDY COMPARING THE EFFECTIVENESS AND TOLERANCE OF AVELUMAB VERSUS STANDARD 2nd LINE TREATMENT CHEMOTHERAPY IN PATIENTS WITH COLORECTAL METASTATIC CANCER WITH MICROSATELLITE INSTABILITY (MSI)
EU CTIS ID: 2024-517362-41-00
What this study is testing
Compare between the two arms PFS assessed by the investigator according to RECIST v1.1 criteria
- 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
- Histologically proven colorectal adenocarcinoma with metastasis(es) non-resectable
- WHO ≤ 2
- Life expectancy ≥ 3 months
- Patient failure (progression or unacceptable toxicity) of chemotherapy containing fluoropyrimidine (capecitabine or 5FU) +/- irinotecan +/- oxaliplatin with or without cetuximab, bevacizumab ,panitumumab or aflibercept (patients in progression during or within 6 months after discontinuation of adjuvant chemotherapy are eligible)
- PNN > 1500/mm3, platelets > 100 000/mm3, Hb > 9 g/dL
- Tumor block available
You likely can't join if
- patient eligible for curative therapy (surgical and/or percutaneous) after discussion in PCM
- Any known specific contraindication or allergy to the treatments used in the study (oxaliplatin, irinotecan, leucovorin, 5-fluorouracil and targeted therapy of choice [bevacuzimab, aflibercept, cetuximab or panitumumab]. In order to check the contraindications, please refer to the updated versions of the SmPCs presented in Appendix 8 of the protocol
- Peripheral sensory neuropathy with functional impairment
- Persistence of toxicities related to chemotherapy 1st line > 2 (NCI-CT v4.0) (except alopecia and neuropathy sequelae of oxaliplatin)
- Vaccination during the 4 weeks preceding the start of treatment
- QT/QTc interval > 450 msec for men and > 470 msec for women
See the full eligibility criteria
Who can join
- Histologically proven colorectal adenocarcinoma with metastasis(es) non-resectable
- WHO ≤ 2
- Life expectancy ≥ 3 months
- Patient failure (progression or unacceptable toxicity) of chemotherapy containing fluoropyrimidine (capecitabine or 5FU) +/- irinotecan +/- oxaliplatin with or without cetuximab, bevacizumab ,panitumumab or aflibercept (patients in progression during or within 6 months after discontinuation of adjuvant chemotherapy are eligible)
- PNN > 1500/mm3, platelets > 100 000/mm3, Hb > 9 g/dL
- Tumor block available
- Total bilirubin < 25 µmol/L, ASAT < 3 x LSN, ALAT < 3 x LSN (ASAT , ALAT < 5 x LSN in case of hepatic metastasis) , PT >60% , PAL<2.5 x LSN ( < 5 x LSN in case of hepatic metastasis)
- Creatinine clearance > 50 ml/min according to MDRD formula
- Patient belonging to a social security scheme
- Patient information and signature of the informed consent
- MSI-H determined by immunohistochemistry (loss of expression of MLH1, MSH2, MSH6 and/or PMS2) and by molecular biology
- At least one measurable target (primary tumour or metastasis) according to RECIST v1.1
- Mutational status RAS and BRAF
- Age ≥ 18
What rules you out
- patient eligible for curative therapy (surgical and/or percutaneous) after discussion in PCM
- Any known specific contraindication or allergy to the treatments used in the study (oxaliplatin, irinotecan, leucovorin, 5-fluorouracil and targeted therapy of choice [bevacuzimab, aflibercept, cetuximab or panitumumab]. In order to check the contraindications, please refer to the updated versions of the SmPCs presented in Appendix 8 of the protocol
- Peripheral sensory neuropathy with functional impairment
- Persistence of toxicities related to chemotherapy 1st line > 2 (NCI-CT v4.0) (except alopecia and neuropathy sequelae of oxaliplatin)
- Vaccination during the 4 weeks preceding the start of treatment
- QT/QTc interval > 450 msec for men and > 470 msec for women
- K+ < LIN, Mg2+ < LIN, Ca2+ < LIN
- Following alterations in the 6 months prior to inclusion: myocardial infarction, angina, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischemic attack
- Any progressive pathology not stabilised over the past 6 months: hepatic failure, renal failure, respiratory failure
- Patient with interstitial pneumonitis or pulmonary fibrosis or any other known severe respiratory insufficiency
- History of inflammatory bowel disease, or unresolved occlusion or sub-occlusion in symptomatic treatment
- Patient having progressed under 1st line treatment with FOLFIRINOX or FOLFOXIRI
- History of malignant pathologies during the past 5 years except basocellular skin carcinoma or in situ cervical carcinoma, properly treated
- Patient already included in another clinical trial with an experimental molecule for L2 or treatment during the last 4 weeks before inclusion
- Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age not having had a pregnancy test
- Persons deprived of freedom or under guardianship.
- Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons
- Active tuberculosis
- Partial or complete DPD deficiency (Uracilemia ≥ 16 ng/ml)
- Cerebral metastasis
- Previous treatment with anti-PD1 or anti-PDL1
- Autoimmune disease that might be aggravated during treatment with an immuno-stimulating agent (patients with type I diabetes, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible)
- Immunosuppressive long-term treatment. Patients necessitating hormone replacement corticosteroids are eligible if the steroids are administered to target hormone therapy and the dose < or = 10 mg or the equivalent of 10 mg of prednisone by daily administration of steroids by pathway resulting in minimal systemic exposure (local, intra-anal, intraocular or inhalation) are eligible
- Transplant patients (including stem cell transplants), HIV positive or other immune deficiency syndromes
- Active infection by HBV or HCV
- Known severe hypersensitivity to monoclonal antibodies or history of anaphylactic shock, or uncontrolled asthma
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, 18-64 years, 65+ 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.