NeoplasmsPhase 2NCT06978400
A Study of Dabrafenib Plus Cetuximab/Panitumumab With FOLFOX in the First Line of Therapy in People With Metastatic Colorectal Cancer
A Phase 2 study testing mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy in people with Neoplasms, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2025to 10 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- The primary tumor is removed or asymptomatic.
- Absence of grade 2 or higher neuropathy.
- Absence of tumor MSI or dMMR.
- ECOG PS 0-2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Blokhin's Russian Cancer Research Center
Moscow, 115193
Evgenia Kuzmina, 89824012681, kuz011@mail.ru
Mikhail Fedyanin MD, +7 905 704-33-18, fedianinmu@mail.ru
About this study
Official title: Non-randomised, Multicentre, Prospective, Single-arm, Phase II Study of the Efficacy and Toxicity of a Combination of FOLFOX With Dabrafenib and Cetuximab/Panitumumab in the First Line of Therapy of Patients With Metastatic BRAF V600E- Mutated MSS Colorectal Cancer
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:
Read more
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.
The study team will monitor how each participant responds to the study treatment for up to about 3 years.
Read the detailed description
The purpose of the study is to evaluate the efficacy and toxicity of first-line FOLFOX with dabrafenib and cetuximab or panitumumab in patients with previously untreated metastatic inoperable colorectal cancer who have MSS and BRAF mutation.
- Conditions
- Neoplasms
- Being tested
- mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy
- Keywords
- metastatic colorectal cancer, BRAF V600E- mutated, first line, MSS, treatment
- Medical subject headings
- Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapyDrug
Dabrafenib 150 mg twice orally daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks, Сalcium folinate 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy | Experimental | mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy Dabrafenib 150 mg twice orally daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks, Сalcium folinate 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks.
In the first-line setting, 8 courses are administered, and if disease control is achieved, dabrafenib, cetuximab or panitumumab therapy is continued until disease progression or intolerable toxicity. Receives: Drug: mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
From date of enrollment until the date of first documented objective response
Measured: assessed at 8 and 16 weeks
Secondary outcomes (3)
Progression-free survival
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
Measured: assessed up to 24 months
Time to objective response
Time from start of treatment to objective response to treatment
Measured: assessed up to 12 months
Overall survival
From the time of enrolment until the death from any cause
Measured: assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Mar 2025
- Primary completion10 Nov 2027 (estimated)
- Study completion10 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- * Drug: Dabrafenib * Drug: Cetuximab * Drug: Рanitumumab * Drug: Oxaliplatin * Drug: Irinotecan * Drug: Leucovorin * Drug: 5-FU
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- City Clinical Oncology Hospital No 1, Moscow City Oncology Hospital No. 62, The Loginov MCSC MHD, Moscow Multidisciplinary Clinical Center "Kommunarka"
- Responsible party
- Sponsor
- Investigators
- Mikhail Fedyanin MD, Principal investigator, Blokhin's Russian Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978400
- Sponsor's protocol ID
- 05202500303
- Status last verified
- May 2025
- First submitted
- 3 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-randomised, Multicentre, Prospective, Single-arm, Phase II Study of the Efficacy and Toxicity of a Combination of FOLFOX With Dabrafenib and Cetuximab/Panitumumab in the First Line of Therapy of Patients With Metastatic BRAF V600E- Mutated MSS Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06978400
- Acronym / sponsor ID
- 05202500303
- Conditions
- Neoplasms
- Keywords
- metastatic colorectal cancer, BRAF V600E- mutated, first line, MSS, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Collaborators
- City Clinical Oncology Hospital No 1, Moscow City Oncology Hospital No. 62, The Loginov MCSC MHD, Moscow Multidisciplinary Clinical Center "Kommunarka"
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 10 Nov 2027 (estimated)
- Study completion
- 10 Jul 2028 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The study team will monitor how each participant responds to the study treatment for up to about 3 years.
Detailed description
The purpose of the study is to evaluate the efficacy and toxicity of first-line FOLFOX with dabrafenib and cetuximab or panitumumab in patients with previously untreated metastatic inoperable colorectal cancer who have MSS and BRAF mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- * Drug: Dabrafenib * Drug: Cetuximab * Drug: Рanitumumab * Drug: Oxaliplatin * Drug: Irinotecan * Drug: Leucovorin * Drug: 5-FU
| Arm | Type | Receives |
|---|---|---|
| mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy | Experimental | Drug: mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapymFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy Dabrafenib 150 mg twice orally daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks, Сalcium folinate 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks. In the first-line setting, 8 courses are administered, and if disease control is achieved, dabrafenib, cetuximab or panitumumab therapy is continued until disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapyDabrafenib 150 mg twice orally daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks, Сalcium folinate 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks. | Drug | mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy |
Primary outcome
Objective Response Rate
Time frame: assessed at 8 and 16 weeks
From date of enrollment until the date of first documented objective response
3 secondary outcomes
Progression-free survival
Time frame: assessed up to 24 months
Time to objective response
Time frame: assessed up to 12 months
Overall survival
Time frame: assessed up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mikhail Fedyanin MD principal investigator
Blokhin's Russian Cancer Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing mFOLFOX6 + dabrafenib and cetuximab or panitumumab in the first line of therapy in people with Neoplasms, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
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 10 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikhail Fedyanin MD (+7 905 704-33-18, fedianinmu@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: assessed at 8 and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2025.