BridgeMD
New treatment option for Neoplasms
Official title A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT06978400
What this study is testing
What is mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy?
mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the efficacy and toxicity of FOLFOX regimen with dabrafenib and cetuximab/panitumumab in the first line of therapy for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mutation in the BRAF gene and MSS. Participants in this study will receive one of the following study treatments: These participants will receive FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy This study is currently enrolling participants who will receive either FOLFOX regimen with dabrafenib and cetuximab or panitumumab in the first line of therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed colorectal adenocarcinoma that contains MSS and BRAF V600E mutation
- Metastatic inoperable colorectal cancer
- Adequate function of hematopoiesis and basic indicators of internal organs
- Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
- Lacking antitumor systemic treatment for colorectal cancer.
You likely can't join if
- Participants having more than 2 lines of treatment (a progression of disease within 12 months of the completion of adjuvant and/or perioperative...
- Presence of any other malignancy, except radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years prior to...
- Pregnant and breastfeeding women.
- Male and female patients with preserved reproductive potential who refused to use adequate contraception throughout the study.
- HIV-infected patients.
- Patients with a life expectancy of less than 3 months.
See the full eligibility criteria
- Histologically confirmed colorectal adenocarcinoma that contains MSS and BRAF V600E mutation
- Metastatic inoperable colorectal cancer
- Adequate function of hematopoiesis and basic indicators of internal organs
- Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
- Lacking antitumor systemic treatment for colorectal cancer.
- Patients with progression after adjuvant chemotherapy may be included if progression is recorded no earlier than 12 months after the last course of chemotherapy.
- The primary tumor is removed or asymptomatic.
- Absence of grade 2 or higher neuropathy.
- Absence of tumor MSI or dMMR.
- ECOG PS 0-2
- Participants having more than 2 lines of treatment (a progression of disease within 12 months of the completion of adjuvant and/or perioperative chemotherapy with oxaliplatin and fluoropyrimidines is acceptable).
- Presence of any other malignancy, except radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years prior to enrolment.
- Pregnant and breastfeeding women.
- Male and female patients with preserved reproductive potential who refused to use adequate contraception throughout the study.
- HIV-infected patients.
- Patients with a life expectancy of less than 3 months.
- The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.