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Adenocarcinoma of the ColonPhase 2NCT04554836

MoLiMoR - A Study With FOLFIRI-based First-line Therapy With or Without Intermittent Cetuximab

A Phase 2 study testing Cetuximab and FOLFIRI in people with Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, run by TheraOp at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, prospective, randomized, multicenter phase II trial that will evaluate the efficacy and safety of intermittent addition of cetuximab to a FOLFIRI-based first line therapy to patients with RAS (Rat sarcoma)-mutant mCRC (Metastatic colorectal cancer) diagnosis who convert to RAS wild-type using… Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Cetuximab and FOLFIRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
4 sitesGermany
Study dates
29 Dec 2020to 11 Jun 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed, UICC stage IV adenocarcinoma of the left-sided colon or rectum with metastases (metastatic colorectal cancer), primarily non-resectable, confirmed RAS mutations proven in the primary tumor or metastasis (KRAS ans NRAS exon 2, 3, 4)
  • Age ≥ 18 years on day of signing informed consent
  • No previous chemotherapy for metastatic disease (1- 2 cycles FOLFIRI or mFOLFIRI are permitted before enrolment until RAS status is determined)
  • Patients suitable for chemotherapy administration
  • ECOG (Eastern Cooperative Oncology Group) status 0-1
  • Consent to liquid biopsy and mutation analysis
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  • Estimated life expectancy > 3 months
  • Presence of at least one measurable reference lesion according to the RECIST 1.1 criteria (chest CT and abdominal CT 4 weeks or less before enrollment)
  • Adequate bone marrow function defined as: Leukocytes 3.0 x 10 9/L with neutrophils 1.5 x 10 9/L, Thrombocytes 100 x 10 9/L, Hemoglobin 9 g/dL
  • Adequate hepatic function defined as: Serum bilirubin 1.5 x ULN (Upper limit of normal), ALAT (Alanine-aminotransferase (= SGPT = serum glutamate pyruvate transaminase) and ASAT (aspartate-aminotransferase (= SGOT = serum glutamate oxalacetate transaminase) 2.5 x ULN (Upper limit of normal) (in the presence of hepatic metastases, ALAT and ASAT 5 x ULN)
  • Adequate renal function: Creatinine clearance ≥ 50 mL/min
  • Adequate cardiac function defined as Normal ECG and echocardiogram with a left ventricular ejection fraction (LVEF) of 55%
  • INR (International normalized ratio) < 1.5 and aPTT (activated Partial thromboplastin time) < 1.5 x ULN (patients without anticoagulation). Therapeutic anticoagulation is allowed if INR and aPTT have remained stable within the therapeutic range for at least 2 weeks.
  • Time interval of at least 6 months since last administration of any previous neoadjuvant/adjuvant chemotherapy or radiochemotherapy of the primary tumor in curative treatment intention to start of 1st line treatment
  • Any relevant toxicities of prior treatments must have resolved to grade ≤ 1 according to the CTCAE (version 5), except alopecia
  • Women of childbearing potential (WOCBP) should have a negative urine pregnancy test within 72 hours prior to receiving the first dose of study medication.
  • Highly effective contraception for both male and female patients throughout the study and for at least 3 months after last dose of study medication administration if the risk of conception exists. Highly effective contraception has to be in line with the definition of the CTFG (Clinical Trial Facilitation Group) recommendation
  • Signed written informed consent and capacity of understanding the informed consent

Who cannot join

  • Right sided mCRC
  • Primarily resectable metastases
  • Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study (1- 2 cycles FOLFIRI or mFOLFIRI are permitted before enrolment)
  • Patients with known brain metastases
  • Symptomatic peritoneal carcinosis
  • Progressive disease before randomization
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  • History of acute or subacute intestinal occlusion, inflammatory bowel disease, immune colitis or chronic diarrhea
  • Grade II heart failure (NYHA classification), Myocardial infarction, balloon angioplasty (PTCA) with or without stenting, and cerebral vascular accident/stroke within the past 12 months before enrollment, unstable angina pectoris, serious cardiac arrhythmia according to investigator's judgment requiring medication
  • Active infection with hepatitis B or C
  • Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study
  • Additional cancer; Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy without evidence of recurrence
  • Uncontrolled hypertension
  • Marked proteinuria (nephrotic syndrome)
  • Arterial thromboembolism or severe hemorrhage within 6 months prior to randomization (with the exception of tumor bleeding before tumor resection surgery)
  • Hemorrhagic diathesis or tendency towards thrombosis
  • Participation in a clinical study or experimental drug treatment within 30 days prior to study
  • Known hypersensitivity or allergic reaction to any of the study medications
  • Severe, non-healing wounds, ulcers, bone fractures or an infection requiring systemic therapy
  • Known history of alcohol or drug abuse
  • Complete dihydropyrimidine dehydrogenase (DPD) deficiency (phenotype and/or genotype test) (Patients with partial DPD deficiency may be included in this clinical trial at the discretion of the investigator and should receive a reduced starting 5-FU dose)
  • Known glucuronidation deficiency (Gilbert's syndrome) (specific screening not required)
  • Absent or restricted legal capacity
  • For female patients only: Pregnancy (absence to be confirmed by ß-HCG test) or lactating

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

  • Universitätsklinikum Knappschaftskrankenhaus

    Bochum

  • Onkologisches Zentrum (Dachau II)

    Dachau

  • Kliniken-Essen-Mitte Evang. Huyssens-Stiftung

    Essen

  • Evangelisches Krankenhaus Hamm

    Hamm

Other trials in Germany

About this study

Official title: Modulation of the FOLFIRI-based Standard First-line Therapy With Cetuximab, Controlled by Monitoring the RAS (Rat Sarcoma) Mutation Load by Liquid Biopsy in RAS-mutated mCRC (Metastatic Colorectal Cancer): A Randomized Phase II Study With FOLFIRI-based First-line Therapy With or Without Intermittent Cetuximab (MoLiMoR)

This is an open-label, prospective, randomized, multicenter phase II trial that will evaluate the efficacy and safety of intermittent addition of cetuximab to a FOLFIRI-based first line therapy to patients with RAS (Rat sarcoma)-mutant mCRC (Metastatic colorectal cancer) diagnosis who convert to RAS wild-type using monitoring of the RAS mutation status by liquid biopsy.

Being tested
Cetuximab, FOLFIRI
Keywords
Left sided Adenocarcinoma of the Colon, RAS mutated
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CetuximabDrug

    Patients in Arm A will receive FOLFIRI +cetuximab.

  • FOLFIRIOther

    Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)

Study groups in NCT04554836
Study groupRoleWhat they receive
FOLFIRI + cetuximabExperimentalPatients in Arm A will receive FOLFIRI + cetuximab until progressive disease (PD), unacceptable toxicity, withdrawal of informed consent or death, whatever occurs first. The recurrence of RAS-mutation without PD to switch back to FOLFIRI. In case of repeated conversion to RAS wild-type without PD, treatment will shift to FOLFIRI + cetuximab again, and so on. Switches of treatment will proceed until progressive disease (PD), unacceptable toxicity, withdrawal of informed consent or death, whatever occurs first. [FOLFIRI = Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)]
Receives: Drug: Cetuximab; Other: FOLFIRI
FOLFIRIOtherPatients in Arm B will continue therapy with FOLFIRI until PD, unacceptable toxicity, withdrawal of informed consent or death, whatever occurs first.
Receives: Other: FOLFIRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Evaluation of efficacy in terms of progression free survival (PFS)

    Measured: From date of randomization up to 24 months

Secondary outcomes (9)

  1. Overall Survival (OS)

    In experimental and control arms

    Measured: From date of randomization up to 24 months.

  2. Time to Failure of Treatment Strategy (TFTS)

    In experimental and control arms

    Measured: After randomization up to 24 months.

  3. PFS (Progression Free Survival) Rate

    In experimental and control arms

    Measured: 1 year after date of randomization

  4. Depth of Response

    In terms of reduction of tumor mass in experimental and control arms

    Measured: From the start of the first line treatment in the study up to 24 months.

  5. Metastasis Resections.

    In experimental and control arms.

    Measured: From the start of the first line treatment in the study up to 24 months.

  6. Objective Response Rate (ORR)

    Defined as patients with partial or complete response (CR or PR) in experimental and control arms

    Measured: From the start of the first line treatment in the study up to 24 months.

  7. Safety Profile

    According to CTCAE (Common Terminology Criteria of Adverse Events), Version 5.0 criteria in experimental and control arms.

    Measured: From the date of signature of Informed Consent to 24 months.

  8. Identification of Driver Mutations.

    In patients with progressive disease (PD) under cetuximab therapy who remain RAS (Rat sarcoma) wild-type in liquid biopsy.

    Measured: From the start of the first line treatment in the study up to 24 months.

  9. Comparison the Efficacy in Terms of Progression Free Survival (PFS)

    In patients with conversion to RAS (RAt sarcoma) wild-type in both ddPCR (Droplet Digital PCR) BEAMing with those patients showing conversion to RAS wild-type in ddPCR but not in BEAMing.

    Measured: From the start of the first line treatment in the study up to 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2020
  2. Study start29 Dec 2020
  3. Primary completion11 Jun 2024
  4. Study completion11 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04554836
Sponsor's protocol ID
4213000
Status last verified
Jun 2025
First submitted
7 Sep 2020
Last updated
8 Jun 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Klein-Scory S, Wahner I, Maslova M, Al-Sewaidi Y, Pohl M, Mika T, Ladigan S, Schroers R, Baraniskin A. Evolution of RAS Mutational Status in Liquid Biopsies During First-Line Chemotherapy for Metastatic Colorectal Cancer. Front Oncol. 2020 Jul 16;10:1115. doi: 10.3389/fonc.2020.01115. eCollection 2020.

    PubMed 32766143

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab and FOLFIRI in people with Adenocarcinoma of the Colon and Adenocarcinoma of the Rectum, run by TheraOp at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From date of randomization up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04554836, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.

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