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Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab.

ConditionsColorectal CarcinomaColorectal NeoplasmsColorectal TumorColorectal AdenocarcinomaColorectal Cancer (CRC)Colorectal CancerColon CancerColon AdenocarcinomaColon CarcinomaColon Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

The aim of this study is to determine the activity of encorafenib plus cetuximab in combination with FOLFIRI in patients with BRAF V600E mutated metastatic colorectal cancer progressing on encorafenib plus cetuximab administered in second line.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

written informed consent to study procedures;

age ≥ 18 years;

histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma;

radiological evidence of metastatic disease;

Disqualifiers

patients experiencing PD as best response to EC;

patients with specific BRAFi/AntiEGFR contraindications;

patients with specific irinotecan or fluoropyrimidines contraindications;

patients with DPYD deficiency;

Trial design

Design model

Single group

Treatments tested in this trial

  • encorafenib + cetuximab + FOLFIRI

    Drug

    encorafenib plus cetuximab beyond progression in combination with irinotecan-based doublet chemoterapy (FOLFIRI) as follows: * encorafenib 300 mg (75 mgx4 hard capsules) orally once daily; * cetuximab 500 mg/sqm iv every 14 days; * FOLFIRI iv every 14 days (Irinotecan 180 mg/sqm, Folinic Acid 400 mg/sqm, 5Fluorouracil 400 mg/sqm iv bolus and 2400 mg/sqm iv continuous infusion over 46-48 hours).

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: encorafenib+cetuximab+FOLFIRIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

6-month Progression Free Survival rate

The proportion of patients alive and progression-free by the 6-month time point from start of investigational treatment (encorafenib plus cetuximab beyond progression in combination with FOLFIRI). Progression free survival is defined as the time elapsed between start of investigational treatment and the date of first event (progression or death, whichever occurs first).

Time frame
6 months after the enrollment of the last patient.

Secondary outcomes

1

Progression Free Survival (PFS)

Time elapsed from start of investigational treatment to the documentation of investigator-assessed disease progression, according to RECIST 1.1, or death due to any cause, whichever occurs first.

Time frame
6 months after the enrollment of the last patient.
2

Overall Survival (OS)

Time elapsed from start of investigational treatment to the date of death due to any cause.

Time frame
6 months after the enrollment of the last patient.
3

Duration of response (DOR)

Time from response, in patients who achieve partial response (PR) or complete response (CR), to disease progression or death.

Time frame
6 months after the enrollment of the last patient.
4

Overall Response Rate (ORR)

Percentage of patients who achieve PR or CR as measured by RECIST 1.1 criteria.

Time frame
6 months after the enrollment of the last patient.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Pierre Fabre Pharma GmbH

Collaborator

Source ClinicalTrials.gov
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