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

NCT05504252 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 2022-500027-76-00
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

Hypothesis: Patients with metastatic colorectal cancer with DNA mismatch repair-proficient (pMMR) function / microsatellite-stable (MSS) phenotype harbor a non-immunogenic disease that can be transformed into an immunogenic condition by short-course oxaliplatin-based therapy, and may achieve durable disease control or even tumor eradication by the addition of immune checkpoint blockade therapy to the standard-of-care oxaliplatin-based treatment.

Conditions

Colorectal Adenocarcinoma; Mucinous Adenocarcinoma; Signet Ring Cell Adenocarcinoma

Keywords

Immune checkpoint inhibitor (nivolumab); Oxaliplatin

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  To determine PFS, in terms of continuation of treatment strategy, of repeat sequential treatment with the Nordic FLOX regimen and nivolumab in patients with previously untreated unresectable metastatic pMMR/MSS colorectal cancer reaching 10% or higher target lesion reduction at the first radiologic restaging.

  From date of the first FLOX cycle until the date of disease progression on ongoing therapy or death, whichever occurs first, assessed up to 60 months

Secondary Outcomes (6)

• Incidence of adverse events

  From date of the first FLOX cycle until 100 days following discontinuation of the study treatment, assessed up to 60 months

• Grading of adverse events

  From date of the first FLOX cycle until 100 days following discontinuation of the study treatment, assessed up to 60 months

• Objective response rate

  Through study completion, an average of 18 months

• Duration of response

  From date of the best overall response until the date of disease progression, assessed up to 60 months

• Secondary surgical curative-intent resection rate

  Through study completion, an average of 18 months

Study Arms (1)

Experimental Arm

EXPERIMENTAL

The study has a start-up single-arm design consisting of 2 cycles of the Nordic FLOX regimen followed by 2 cycles of nivolumab for a total of 4 individual cycles before radiologic response assessment and patient stratification to continued therapy or not. Patients who present less than 10% target lesion reduction at the first radiologic response assessment will proceed to standard-of-care treatment at the Clinical Investigator's discretion. Patients who present 10% or higher target lesion reduction at the first radiologic response assessment will continue with alternating 2 cycles of the Nordic FLOX regimen and 2 cycles of nivolumab in a go-and-stop schedule until progressive disease on ongoing therapy (defining PFS), intolerable toxicity, withdrawal of consent, or death, whichever occurs first.

Drug: Nivolumab; Drug: Oxaliplatin

Interventions

Nivolumab DRUG

Q2W Nivolumab: 240 mg fixed dose over 30 minutes, IV administration every 2 weeks

Also known as: Opdivo

Experimental Arm

Oxaliplatin DRUG

FLOX, Q2W

Also known as: 5-fluorouracil, folinic acid

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has histologically verified pMMR/MSS colorectal adenocarcinoma (also comprising the mucinous adenocarcinoma and signet-ring cell carcinoma entities).
• Patient is ambulatory with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Patient is at least 18 years of age.
• Patient has radiologically measurable metastatic disease.
• Patient has an infradiaphragmatic metastatic lesion that can be biopsied.
• Patient has not had previous systemic cytotoxic therapy for the metastatic disease, except for previous neoadjuvant treatment.
• Patient is eligible for the Nordic FLOX regimen when it would be the preferred treatment option for first-line therapy in routine practice.
• Patient has the following laboratory values, as measured in serum/plasma within 14 days prior to study entry, indicative of adequate organ function:
• Hemoglobin at least 10.0 g/dL
• Neutrophils at least 1.5 x10(9)/L (without current use of colony-stimulating factors).
• Platelets at least 100 x10(9)/L. - C-reactive protein less than 60 mg/L
• AST/ALT no higher than 2xULN when patient does not have metastatic disease in the liver or no higher than 5xULN when patient has metastatic disease in the liver. o Bilirubin no higher than 1.5xULN when patient does not have metastatic disease in the liver or no higher than 2xULN when patient has metastatic disease in the liver
• Albumin no lower than 30 g/L. - INR within normal level
• Creatinine no higher than 1.5xULN
• Woman of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug

You may not qualify if:

• Patient has metastatic dMMR/MSI colorectal cancer.
• Patient has initially resectable metastatic disease for which neoadjuvant therapy is deemed superfluous.
• Patient has supradiaphragmatic metastatic disease as the sole site(s).
• Patient has untreated or symptomatic brain metastasis (patient must be symptom-free without the use of corticosteroids).
• Patient has experienced a period of less than 6 months since discontinuation of neoadjuvant or adjuvant oxaliplatincontaining chemotherapy.
• Patient is ineligible for full (100%) chemotherapy doses at first treatment cycle.
• Patient has partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency.
• Patient has had radiation therapy against the only measurable lesion within 4 weeks of start of study treatment.
• Patient has a medical condition treated with anticoagulant medication that cannot be replaced by low molecular weight heparin or a direct oral anticoagulant during active study treatment.
• Patient has a nervous system disorder worse than CTCAE grade 1.
• Patient has any medical condition that will preclude him/her from immune checkpoint blockade therapy, such as:
• Active or chronic hepatitis B or hepatitis C. - Known history of human immunodeficiency virus or acquired immunodeficiency-related illnesses.
• Diagnosis of immunodeficiency or medical condition requiring systemic steroids or other forms of immunosuppressive therapy.
• Autoimmune disease that has required systemic therapy within the past 2 years.
• Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving study therapy.

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Oslo University Hospital: collaborator
• St. Olavs Hospital: collaborator

Study Sites (3)

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

Location

Oslo University Hospital

Oslo, Akershus, 0424, Norway

Location

St Olavs Hospital

Trondheim, Trøndelag, 7006, Norway

Location

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MeSH Terms

Conditions

Adenocarcinoma, Mucinous; Carcinoma, Signet Ring Cell

Interventions

Nivolumab; Oxaliplatin; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Christian Kersten, MD, PhD

  University Hospital, Akershus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 17, 2022
• Study Start: October 5, 2022
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 2022-2047
• Access Criteria: The listed study information can be made available from the Principal Investigator on reasonable request and in accordance with the General Data Protection Regulation of the European Union.

Locations

NO (3)