Trial Outcomes & Findings for MoLiMoR - A Study With FOLFIRI-based First-line Therapy With or Without Intermittent Cetuximab (NCT NCT04554836)

NCT ID: NCT04554836

Last Updated: 2025-06-08

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

From date of randomization up to 24 months

Results posted on

2025-06-08

Participant Flow

Between September 2020 and July 2021 20 sites in Germany and 1 site in Austria screened patients. Of these, 4 sites randomized patients. 1. Onkologisches Zentrum Donauwörth, Onkologisches Zentrum, Dachau 2. Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für internistische Onkologie/Hämatologie, Essen 3. Universitätsklinikum Knappschaftskrankenhaus Bochum, Medizinische Klinik - Innere Medizin, Bochum 4. Evangelisches Krankenhaus Hamm, Innere Medizin II, Hamm

Participant milestones

Participant milestones
Measure	FOLFIRI + Cetuximab Patients 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. \[FOLFIRI = Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)\] Cetuximab: Patients in Arm A will receive FOLFIRI +cetuximab. FOLFIRI: Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)	FOLFIRI Patients in Arm B will continue therapy with FOLFIRI until PD, unacceptable toxicity, withdrawal of informed consent or death, whatever occurs first. FOLFIRI: Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)
Overall Study STARTED	4	2
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FOLFIRI + Cetuximab n=4 Participants Patients 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. \[FOLFIRI = Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)\] Cetuximab: Patients in Arm A will receive FOLFIRI +cetuximab. FOLFIRI: Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)	FOLFIRI n=2 Participants Patients in Arm B will continue therapy with FOLFIRI until PD, unacceptable toxicity, withdrawal of informed consent or death, whatever occurs first. FOLFIRI: Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants
Age, Continuous	68.5 years n=99 Participants	46 years n=107 Participants	61 years n=206 Participants
Sex: Female, Male Female	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Sex: Female, Male Male	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment Germany	4 participants n=99 Participants	2 participants n=107 Participants	6 participants n=206 Participants

PRIMARY outcome

Timeframe: From date of randomization up to 24 months

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

Outcome measures

Outcome measures
Measure	FOLFIRI + Cetuximab n=4 Participants Patients 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. \[FOLFIRI = Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)\] Cetuximab: Patients in Arm A will receive FOLFIRI +cetuximab. FOLFIRI: Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)	FOLFIRI n=2 Participants Patients in Arm B will continue therapy with FOLFIRI until PD, unacceptable toxicity, withdrawal of informed consent or death, whatever occurs first. FOLFIRI: Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)
Progression Free Survival (PFS)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From date of randomization up to 24 months.

In experimental and control arms

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After randomization up to 24 months.

In experimental and control arms

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year after date of randomization

In experimental and control arms

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

In experimental and control arms.

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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

Outcome measures

Outcome data not reported

SECONDARY outcome

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

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.

Outcome measures

Outcome data not reported

Adverse Events

FOLFIRI + Cetuximab

Serious events: 3 serious events

Other events: 4 other events

Deaths: 3 deaths

FOLFIRI

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	FOLFIRI + Cetuximab n=4 participants at risk Patients 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. \[FOLFIRI = Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)\] Cetuximab: Patients in Arm A will receive FOLFIRI +cetuximab. FOLFIRI: Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)	FOLFIRI n=2 participants at risk Patients in Arm B will continue therapy with FOLFIRI until PD, unacceptable toxicity, withdrawal of informed consent or death, whatever occurs first. FOLFIRI: Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	25.0% 1/4 • Number of events 1 • up to 37 months (Consent of FPI until 30 days after last dose of study treatment) Adverse events have to be reported after informed consent until 30 days after last dose of study treatment. Then only adverse events which are causally related to study treatment have to be reported	0.00% 0/2 • up to 37 months (Consent of FPI until 30 days after last dose of study treatment) Adverse events have to be reported after informed consent until 30 days after last dose of study treatment. Then only adverse events which are causally related to study treatment have to be reported
Hepatobiliary disorders Hepatobiliary procedural complication	25.0% 1/4 • Number of events 1 • up to 37 months (Consent of FPI until 30 days after last dose of study treatment) Adverse events have to be reported after informed consent until 30 days after last dose of study treatment. Then only adverse events which are causally related to study treatment have to be reported	0.00% 0/2 • up to 37 months (Consent of FPI until 30 days after last dose of study treatment) Adverse events have to be reported after informed consent until 30 days after last dose of study treatment. Then only adverse events which are causally related to study treatment have to be reported
Gastrointestinal disorders Ileus	25.0% 1/4 • Number of events 1 • up to 37 months (Consent of FPI until 30 days after last dose of study treatment) Adverse events have to be reported after informed consent until 30 days after last dose of study treatment. Then only adverse events which are causally related to study treatment have to be reported	0.00% 0/2 • up to 37 months (Consent of FPI until 30 days after last dose of study treatment) Adverse events have to be reported after informed consent until 30 days after last dose of study treatment. Then only adverse events which are causally related to study treatment have to be reported
Gastrointestinal disorders Gastric ulcer	25.0% 1/4 • Number of events 1 • up to 37 months (Consent of FPI until 30 days after last dose of study treatment) Adverse events have to be reported after informed consent until 30 days after last dose of study treatment. Then only adverse events which are causally related to study treatment have to be reported	0.00% 0/2 • up to 37 months (Consent of FPI until 30 days after last dose of study treatment) Adverse events have to be reported after informed consent until 30 days after last dose of study treatment. Then only adverse events which are causally related to study treatment have to be reported

Other adverse events

Additional Information

Prof. Dr. Alexander Baraniskin

Evangelisches Krankenhaus Hamm Werler Str. 110, 59063 Hamm

Phone: +49 (0) 2381 / 589 1863

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60