METIMMOX-2: Oxaliplatin Chemotherapy and Immunotherapy to Patients with the Common pMMR/MSS Type of Large Bowel Cancer Spread to Other Organs

Phase 1

Recruiting

• Conditions: Colorectal cancer; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-500027-76-00
• Lead Sponsor: Akershus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-20
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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).;Secondary Objective: To determine safety and tolerability of the repeat sequential treatment., To monitor quality-of-life alterations during the therapy course.;Primary end point(s): PFS: radiologic assessment following every 2 cycles each of FLOX and nivolumab, according to RECIST v1.1 and iRECIST

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Safety: incidence of adverse events, as reported according to CTCAE v5.0, recorded on onboing basis and summarized at every visit.;Secondary end point(s):Tolerability: adverse event grading, as assessed by CTCAE v5.0, recorded on onboing basis and summarized at every visit.;Secondary end point(s):Objective response rate: the percentage of patients with a confirmed complete or partial response.;Secondary end point(s):Duration of response: the time from the first documentation of a complete or partial response to disease progression on active therapy.;Secondary end point(s):Secondary surgical curative-intent resection rate: the percentage of patients with a confirmed resection of metastatic disease with microscopically free margin (R0).;Secondary end point(s):Overall survival: the time from study enrollment to death of any cause.