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METIMMOX-2: Oxaliplatin Chemotherapy and Immunotherapy to Patients with the Common pMMR/MSS Type of Large Bowel Cancer Spread to Other Organs
EU CTIS ID: 2022-500027-76-00
What this study is testing
To determine progression-free survival (PFS) of repeat sequential treatment with oxaliplatin-based chemotherapy (the Nordic FLOX regimen) and an immune checkpoint inhibitor (nivolumab) in previously untreated unresectable metastatic pMMR/MSS colorectal cancer (CRC).
- 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
- Patient has histologically verified CRC adenocarcinoma.
- Patient has radiologically measurable metastatic disease.
- Patient has not had previous systemic cytotoxic therapy for the metastatic disease, except for previous neoadjuvant treatment.
- Patient is eligible for the Nordic FLOX chemotherapy regimen.
You likely can't join if
- Patient has initially resectable metastatic disease for which systemic therapy is deemed superfluous.
- Patient has Eastern Cooperative Oncology Group (ECOG) performance status 2 or worse.
- Patient has serum/plasma C-reactive protein (CRP) of 60 mg/L or higher.
- Patient does not meet the following requirements at baseline: adequate bone marrow function without current use of colony-stimulating factors (minimum values of neutrophils 1.5 x10e9/L, platelets 100 x10e9/L, hemoglobin 10 g/dL), adequate liver function (maximum values of AST/ALT 5 xULN and bilirubin 2 xULN; albumin value of 30 g/L or higher; INR within normal level), adequate renal function (maximum creatinine value of 1.5 xULN), protein in urine less than 2+ by dipstick (within 14 days prior to initiation of study treatment).
- Patient has any other reason, in the opinion of Clinical Investigator, not to participate in the study.
- Patient does not present any infradiaphragmatic metastatic manifestation.
See the full eligibility criteria
- Patient has histologically verified CRC adenocarcinoma.
- Patient has radiologically measurable metastatic disease.
- Patient has not had previous systemic cytotoxic therapy for the metastatic disease, except for previous neoadjuvant treatment.
- Patient is eligible for the Nordic FLOX chemotherapy regimen.
- Patient has initially resectable metastatic disease for which systemic therapy is deemed superfluous.
- Patient has Eastern Cooperative Oncology Group (ECOG) performance status 2 or worse.
- Patient has serum/plasma C-reactive protein (CRP) of 60 mg/L or higher.
- Patient does not meet the following requirements at baseline: adequate bone marrow function without current use of colony-stimulating factors (minimum values of neutrophils 1.5 x10e9/L, platelets 100 x10e9/L, hemoglobin 10 g/dL), adequate liver function (maximum values of AST/ALT 5 xULN and bilirubin 2 xULN; albumin value of 30 g/L or higher; INR within normal level), adequate renal function (maximum creatinine value of 1.5 xULN), protein in urine less than 2+ by dipstick (within 14 days prior to initiation of study treatment).
- Patient has any other reason, in the opinion of Clinical Investigator, not to participate in the study.
- Patient does not present any infradiaphragmatic metastatic manifestation.
- Patient has untreated or symptomatic brain metastasis (patient must be symptom-free without the use of corticosteroids).
- Patient experiences a period of less than 6 months since discontinuation of neoadjuvant or adjuvant oxaliplatin-containing chemotherapy.
- Patient is ineligible for full (100%) chemotherapy doses at first treatment cycle.
- Patient has had radiation therapy against the only measurable lesion within 4 weeks of start of study treatment.
- Patient has a nervous system disorder worse than grade 1 of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
- Patient has any medical condition or has undergone any treatment within 4 weeks of start of study treatment that will preclude him/her from cancer immune therapy.
- Patient has any medical condition that will preclude him/her from receiving a component of the FLOX regimen.
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.