METIMMOX-2: Metastatic pMMR/MSS Colorectal Cancer – Shaping Anti-Tumor Immunity by Oxaliplatin

Conditions

Colorectal cancer

Brief summary

PFS: radiologic assessment following every 2 cycles each of FLOX and nivolumab, according to RECIST v1.1 and iRECIST

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGAdrenalin Aguettant 1 mg/ml injeksjonsvæske

DRUGoppløsning i ferdigfylt sprøyte

DRUGKalsiumfolinat Pfizer 10 mg/ml injeksjonsvæske

DRUGoppløsning

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGDexamethasone Krka 4 mg tabletter

DRUGSolu-Cortef 250 mg pulver og væske til injeksjonsvæske

DRUGoppløsning i tokammerhetteglass

DRUGFluorouracil Accord 50 mg/ml injeksjons-/infusjonsvæske

DRUGOndansetron Bluefish 8 mg tabletter

DRUGfilmdrasjerte

DRUGParacet 1 g tabletter

DRUGMetoclopramide Accord 10 mg tabletter

DRUGOxaliplatin Fresenius Kabi 5 mg/ml konsentrat til infusjonsvæske

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS: radiologic assessment following every 2 cycles each of FLOX and nivolumab, according to RECIST v1.1 and iRECIST	—

Secondary

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

Measure

Time frame

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

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Countries

Norway

Outcome results

None listed