NeoplasmsPhase 2NCT06967155
A Study of Irinotecan With Dabrafenib Plus Trametinib and Anti-EGFR in the Second Line of Therapy in People With Metastatic Colorectal Cancer
A Phase 2 study testing • Drug: Dabrafenib • Drug: Trametinib • Drug: Cetuximab • Drug: Рanitumumab • Drug: Oxaliplatin • Drug: Irinotecan • Drug: Leucovorin • Drug: 5-FU 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 irinotecan with dabrafenib, cetuximab/panitumumab in the second line of treatment for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mutation in the BRAF gene. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasms
- What is being tested?
- • Drug: Dabrafenib • Drug: Trametinib • Drug: Cetuximab • Drug: Рanitumumab • Drug: Oxaliplatin • Drug: Irinotecan • Drug: Leucovorin • Drug: 5-FU
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2025to 10 Jun 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically confirmed metastatic inoperable colorectal adenocarcinoma
- The tumour has a BRAF mutation
- 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).
- Absence of grade 2 or higher toxicity from previous line of treatment.
- It is possible to include patients with MSI or dMMR if they have received first-line immune checkpoint therapy.
- ECOG PS 0-1
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.
About this study
Official title: Non-randomised, Multicentre, Prospective, Single-arm, Phase II Study of the Efficacy and Toxicity of a Combination of Irinotecan With Dabrafenib and Trametinib, Anti-EGFR in the Second Line of Treatment of Patients With Metastatic BRAF V600E- Mutated Colorectal Cancer.
The purpose of this study is to evaluate the efficacy and toxicity of irinotecan with dabrafenib, cetuximab/panitumumab in the second line of treatment for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mutation in the BRAF gene.
Participants in this study will receive one of the following study treatments:
Read more
These participants will receive in the second line is irinotecan, dabrafenib + trametinib, cetuximab or panitumumab.
This trial is currently enrolling participants who will receive either irinotecan and dabrafenib plus cetuximab or panitumumab in the second 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 irinotecan in combination with dabrafenib + trametinib and cetuximab or panitumumab in second-line treatment of patients with metastatic inoperable colorectal cancer who have a BRAF mutation.
- Conditions
- Neoplasms
- Being tested
- • Drug: Dabrafenib • Drug: Trametinib • Drug: Cetuximab • Drug: Рanitumumab • Drug: Oxaliplatin • Drug: Irinotecan • Drug: Leucovorin • Drug: 5-FU
- Keywords
- metastatic colorectal cancer, BRAF V600E- mutated, 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.
• Drug: Dabrafenib • Drug: Trametinib • Drug: Cetuximab • Drug: Рanitumumab • Drug: Oxaliplatin • Drug: Irinotecan • Drug: Leucovorin • Drug: 5-FUDrug
Irinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy Dabrafenib 150 mg twice orally daily Trametinib 2 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Irinotecan 90 mg/m2 (90-minute IV infusion) weekly.
Second-line treatment is administered until disease progression or intolerable toxicity. It may be possible to switch to a regimen of dabrafenib, trametinib, cetuximab or panitumumab if irinotecan is intolerable.
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy | Experimental | Irinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy Dabrafenib 150 mg twice orally daily Trametinib 2 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Irinotecan 90 mg/m2 (90-minute IV infusion) weekly.
Second-line treatment is administered until disease progression or intolerable toxicity. It may be possible to switch to a regimen of dabrafenib, trametinib, cetuximab or panitumumab if irinotecan is intolerable. Receives: Drug: • Drug: Dabrafenib • Drug: Trametinib • Drug: Cetuximab • Drug: Рanitumumab • Drug: Oxaliplatin • Drug: Irinotecan • Drug: Leucovorin • Drug: 5-FU |
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 progression
Measured: assessed up to 12 months
Secondary outcomes (8)
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 6 months
Duration of response
Calculated from achieving objective response to progression or death from any cause
Measured: assessed up to 12 months
Disease control rate
Measured: Percentage of patients who achieved a complete response, partial response or disease stabilisation? through study completion, an average of 1 year
Overall survival
From the time of enrolment until the death from any cause
Measured: assessed up to 36 months
Incidence of adverse events
Measured: Proportion of patients with adverse events out of all patients (NCI CTCAE 5.0)
Incidence of adverse events grade 3-4
Measured: Proportion of patients with adverse events grade 3-4 out of all patients (NCI CTCAE 5.0)
Reduction of dose reductions and drug withdrawals
Measured: Proportion of patients with dose reductions and drug withdrawals in the total number of patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Mar 2025
- Primary completion10 Nov 2027 (estimated)
- Study completion10 Jun 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: Trametinib * Drug: Cetuximab * Drug: Рanitumumab * Drug: Oxaliplatin * Drug: Irinotecan * Drug: Leucovorin * Drug: 5-FU
- Masking
- None (open label)
- Enrolment
- 23 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
- NCT06967155
- Sponsor's protocol ID
- 05202500302
- Status last verified
- Sep 2025
- First submitted
- 25 Apr 2025
- Last updated
- 2 Oct 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 2 Oct 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 Irinotecan With Dabrafenib and Trametinib, Anti-EGFR in the Second Line of Treatment of Patients With Metastatic BRAF V600E- Mutated Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT06967155
- Acronym / sponsor ID
- 05202500302
- Conditions
- Neoplasms
- Keywords
- metastatic colorectal cancer, BRAF V600E- mutated, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 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 Jun 2028 (estimated)
- First posted
- 13 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 irinotecan with dabrafenib, cetuximab/panitumumab in the second line of treatment for the potential treatment of colorectal cancer that: has a metastatic, inoperable; has a mutation in the BRAF gene.
Participants in this study will receive one of the following study treatments:
These participants will receive in the second line is irinotecan, dabrafenib + trametinib, cetuximab or panitumumab.
This trial is currently enrolling participants who will receive either irinotecan and dabrafenib plus cetuximab or panitumumab in the second 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 irinotecan in combination with dabrafenib + trametinib and cetuximab or panitumumab in second-line treatment of patients with metastatic inoperable colorectal cancer who have a 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: Trametinib * Drug: Cetuximab * Drug: Рanitumumab * Drug: Oxaliplatin * Drug: Irinotecan * Drug: Leucovorin * Drug: 5-FU
| Arm | Type | Receives |
|---|---|---|
| Irinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy | Experimental | Drug: • Drug: Dabrafenib • Drug: Trametinib • Drug: Cetuximab • Drug: Рanitumumab • Drug: Oxaliplatin • Drug: Irinotecan • Drug: Leucovorin • Drug: 5-FUIrinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy Dabrafenib 150 mg twice orally daily Trametinib 2 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Irinotecan 90 mg/m2 (90-minute IV infusion) weekly. Second-line treatment is administered until disease progression or intolerable toxicity. It may be possible to switch to a regimen of dabrafenib, trametinib, cetuximab or panitumumab if irinotecan is intolerable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed metastatic inoperable colorectal adenocarcinoma
- The tumour has a BRAF mutation
- 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).
- Absence of grade 2 or higher toxicity from previous line of treatment.
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 |
|---|---|---|
| • Drug: Dabrafenib • Drug: Trametinib • Drug: Cetuximab • Drug: Рanitumumab • Drug: Oxaliplatin • Drug: Irinotecan • Drug: Leucovorin • Drug: 5-FUIrinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy Dabrafenib 150 mg twice orally daily Trametinib 2 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks or Panitumumab 6 mg/kg (60-minute IV infusion) every two weeks Irinotecan 90 mg/m2 (90-minute IV infusion) weekly. Second-line treatment is administered until disease progression or intolerable toxicity. It may be possible to switch to a regimen of dabrafenib, trametinib, cetuximab or panitumumab if irinotecan is intolerable. | Drug | Irinotecan + Dabrafenib + Trametinib and Cetuximab or Panitumumab in the second line of therapy |
Primary outcome
Objective Response Rate
Time frame: assessed up to 12 months
From date of enrollment until the date of first documented progression
8 secondary outcomes
Progression-free survival
Time frame: assessed up to 24 months
Time to objective response
Time frame: assessed up to 6 months
Duration of response
Time frame: assessed up to 12 months
Disease control rate
Time frame: Percentage of patients who achieved a complete response, partial response or disease stabilisation? through study completion, an average of 1 year
Overall survival
Time frame: assessed up to 36 months
Incidence of adverse events
Time frame: Proportion of patients with adverse events out of all patients (NCI CTCAE 5.0)
Incidence of adverse events grade 3-4
Time frame: Proportion of patients with adverse events grade 3-4 out of all patients (NCI CTCAE 5.0)
Reduction of dose reductions and drug withdrawals
Time frame: Proportion of patients with dose reductions and drug withdrawals in the total number of patients
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 2 Oct 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. This study is not recruiting at the moment.
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 • Drug: Dabrafenib • Drug: Trametinib • Drug: Cetuximab • Drug: Рanitumumab • Drug: Oxaliplatin • Drug: Irinotecan • Drug: Leucovorin • Drug: 5-FU 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 7 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 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?
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?
Objective Response Rate (time frame: assessed up to 12 months). 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 2 Oct 2025.