Solid TumorsPhase 2AcSéNCT02304809
Phase 2 Study Assessing Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations
A Phase 2 study testing Vemurafenib in people with Solid Tumors and Hematologic Cancers, run by UNICANCER at 1 site in France.
Trial summary
Patients with metastatic or unresectable locally advanced malignancies harboring BRAF genomic alterations, the biological target of vemurafenib, and who are no more amenable to curative treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Hematologic Cancers, Metastatic Cancers
- What is being tested?
- Vemurafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2014to 13 Oct 2027
- 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
- Male and female ≥ 8 years of age
- Unresectable locally advanced or metastatic histologically confirmed malignancy (excluding melanoma V600 mutation) resistant or refractory to standard therapy or for which standard therapy does not exist or is not considered appropriate by the Investigator and are not eligible to an appropriate ongoing clinical trial. For Hairy Cell Leukemia: .patients must have relapsed and/or be refractory HCL candidate for treatment after 2 lines of purine analogues treatment.
- Patient with BRAF V600 mutation determined by the INCa platforms on the primary and/or metastatic lesion in the following pathologies:
- NSCLC
- Ovarian cancer
- Cholangiocarcinoma
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- Thyroid cancer
- Prostatic cancer
- Bladder cancer
- Sarcoma/GIST
- Multiple myeloma
- Chronic Lymphocytic Leukemia (CLL)
- Hairy cell leukaemia (HCL) (this excludes Hairy Cell Leukemia variant types, marginal zone splenic lymphoma (MZL), splenic red pulp lymphoma (SRPL) patients).
- Or patient with the same or another pre-listed pathology harboring any type of activating BRAF alteration determined from outside the INCa platforms network.
- Measurable disease according to RECIST 1.1 guidelines for solid tumors with target lesion of at least 10 mm and presence of at least one RECIST-measurable lesion outside of a previously radiated field or potential palliative irradiation fields, International Myeloma Working group Response Criteria for myeloma, IWCLL Chronic Lymphocytic Leukemia and clinical/biological parameters for Hairy cell leukaemia (Serum M-protein >0.5 g/dL; Urine M-protein >200 mg per 24 hours; Involved FLC level >10 mg/dL (>100 mg/L) provided serum FLC ratio is abnormal).
- Patients who had received any previous systemic anticancer treatment and/or radiotherapy should have recovered from any treatment related toxicity, i.e. ≤ grade1, with a mandatory free interval of at least 3 weeks for systemic or radiotherapy treatments and at least 5 half-lives for targeted drugs.
- Patients who had received any investigational drug are eligible after a 4-week wash-out period or a wash-out period equivalent to 5 half-lives of the product, depending on the longest period
- Adequate hematologic*, renal* and liver function*, as defined by the following laboratory values; test performed within 7 days prior to the first dose of vemurafenib:
- Hemoglobin ≥9 g/dL
- Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L
- Platelet count ≥100 x 10⁹/L
- Serum creatinine ≤1.5 times upper limit of normal (ULN) or creatine clearance (CrCl) >50 mL/min by Cockroft-Gault formula
- Aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) ≤2.5 times ULN (≤5 times ULN if considered due to primary or metastatic liver involvement)
- Serum bilirubin ≤1.5 times ULN
- Alkaline phosphatase ≤2.5 times ULN (≤5 times ULN if considered due to tumor) * not applicable if biological abnormality(ies) is (are) fully related to the malignant disease itself.
- Normal values for calcium, magnesium and potassium levels
- Patients able to swallow and retain oral medication (tablet size: 19 mm. Can not be chewed or crushed)
- ECOG Performance Status of 0 to 2, or Karnofsky scale >50 %
- Life expectancy ≥3 months
- Potentially reproductive patients must agree to use an effective contraceptive method, practice adequate methods of birth control or practice complete abstinence while on treatment, beginning 2 weeks before the first dose of investigational product and for at least 6 months after the last dose of study drug
- Women of childbearing potential must have a negative serum pregnancy test within 14 days of enrollment and/or urine pregnancy test 72 hours prior to the administration of the study drug
- Women who are breastfeeding should discontinue nursing prior to the first day of study drug and permanently after the last dose
- Patients must be affiliated to a Social Security System.
- Patient information and written informed consent form signed.
Who cannot join
- V600 BRAF mutated melanoma patients or colorectal cancer patients
- Patient eligible to a clinical trial with an anticancer drug (including vemurafenib) targeting the same BRAF molecular alteration in the same type/localization as the patient's cancer presentation open to accrual in France. Patient not eligible in this trial are still eligible for the AcSé study.
- Prior treatment with a BRAF or MEK inhibitor
- Major surgery or tumor embolization within 4 weeks and minor surgery within 2 weeks prior to the initiation of the study drug
- Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to:
- Any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, or cerebrovascular accident including transient ischemic attack. Ongoing congestive heart failure.
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- Pulmonary embolism within 30 days prior to first vemurafenib administration
- Hypertension not adequately controlled by current medications within 30 days prior to first vemurafenib administration
- Congenital long QT syndrome
- Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, uncontrolled atrial fibrillation of any grade, or machine-read ECG with QTc interval >460 msec
- Spinal cord compression unless treated with the patient attaining good pain control and stable or recovered neurologic function
- Carcinomatous meningitis or leptomeningeal disease
- Any uncontrolled infection
- Other severe acute or chronic medical (including severe gastrointestinal conditions such as diarrhea or ulcer) or psychiatric conditions, or end stage renal disease on hemodialysis or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for study entry
- For MM, solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
- Known hypersensitivity to vemurafenib or another BRAF inhibitor
- Concurrent administration of any anti-cancer therapies (e.g., chemotherapy, other targeted therapy, experimental drug, etc.) other than those administered in this study
- Refractory nausea and vomiting, malabsorption, external biliary shunt or significant bowel resection that would preclude adequate absorption.
- Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Individual deprived of liberty or placed under the authority of a tutor.
- Unwillingness to practice effective birth control. Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations
Patients with metastatic or unresectable locally advanced malignancies harboring BRAF genomic alterations, the biological target of vemurafenib, and who are no more amenable to curative treatment.
To explore the efficacy of vemurafenib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the vemurafenib target gene, per cohort.
Read the detailed description
This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy and the safety of the targeted agent vemurafenib as a monotherapy in cohorts of patients with identified activating molecular alterations in BRAF gene. A cohort is defined by a pathology and a BRAF- alteration (eg ovarian cancer with BRAF V600 mutation).
To explore the efficacy of vemurafenib per pathology and per target. To assess the safety profile of vemurafenib. To explore whether molecularly driven, high quality multi-tumor screening phase II trials are feasible in the French multiinstitutional, multidisciplinary setting.
To investigate the additional molecular mechanisms in patients with tumor response versus patients without tumor response within the same cohort.
The study will include 11 cohorts of adult patients with the following cancers and alterations:
- NSCLC V600 mutated
- Ovarian cancer V600 mutated
- Cholangiocarcinoma V600 mutated
- Thyroid cancer V600 mutated
- Prostatic cancer V600 mutated
- Bladder cancer V600 mutated
- Sarcoma/GIST V600 mutated
- Multiple myeloma V600 mutated
- Chronic Lymphocytic Leukemia (CLL) V600 mutated
- Hairy cell leukaemia (HCL) V600 mutated (this excludes Hairy Cell Leukemia variant types, marginal zone splenic lymphoma (MZL), splenic red pulp lymphoma (SRPL) patients)
- Other pathology / other alteration than those pre-defined above.
The cohort named "Other" will include adult patients with tumor harboring BRAF genomic alterations only tested via emerging biomarkers programs or molecular pangenomic programs:
- with any other non-predefined pathology harboring a V600 mutation
- Same or other non-predefined pathology harboring non V600 activating mutations
- Same or other non-predefined pathology harboring BRAF amplifications.
- Conditions
- Solid Tumors, Hematologic Cancers, Metastatic Cancers
- Being tested
- Vemurafenib
- Keywords
- metastatic or unresectable locally advanced malignancies., genomic alterations, biological vemurafenib targets BRAF, genomic.
- Medical subject headings
- Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VemurafenibDrug
Also called Zelboraf
Vemurafenib is a low molecular weight, orally available, inhibitor of BRAF serine-threonine kinase. Mutations in the BRAF gene which substitute the valine at amino acid position 600 result in constitutively activated BRAF proteins, which can cause cell proliferation in the absence of growth factors that would normally be required for proliferation
| Study group | Role | What they receive |
|---|---|---|
| VEMURAFENIB | Experimental | all eligible patients entering the study will receive oral Vemurafenib as monotherapy.
Vemurafenib ZELBORAF 240 mg tablets Per OS 960 mg twice daily, to a total daily dose of 1,920 mg Cycles are defined in 28-day periods Disease response will be assessed every 8 weeks Safety will be assessed continuously
Treatment will be pursed until disease progression, unacceptable toxicity, intercurrent conditions that preclude continuation of treatment, or patient refusal. Receives: Drug: Vemurafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective response rate (ORR) will be defined as the proportion of patients with a complete response (CR) or a partial response (PR) as best overall response during the study
RECIST for solid tumors, International Myeloma Working Group Response Criteria for myeloma, IWCLL for CLL, clinical exam, blood tests (blood count) and bone marrow exam for Hairy Cell Leukemia.
Measured: Determined after 8 weeks (2 cycles) of treatment
Secondary outcomes (1)
Safety profile of Vemurafenib (frequency of adverse events coded using the common toxicity criteria (CTC-V4.0) grade)
The assessment of safety will be based mainly on the frequency of adverse events coded using the common toxicity criteria (CTC-V4.0) grade.
Measured: Determined after 8 weeks (2 cycles) of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study start13 Oct 2014
- Primary completion7 May 2019
- Study completion13 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies 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
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Fondation ARC, Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Jean-Yves PI Blay, MD, Principal investigator, CCLC LEON BERARD LYON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304809
- Sponsor's protocol ID
- UC-0105/1401
- Other IDs
- 2014 001225 33, 2014
- Acronym
- AcSé
- Status last verified
- Jun 2025
- First submitted
- 26 Nov 2014
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mazieres J, Cropet C, Montane L, Barlesi F, Souquet PJ, Quantin X, Dubos-Arvis C, Otto J, Favier L, Avrillon V, Cadranel J, Moro-Sibilot D, Monnet I, Westeel V, Le Treut J, Brain E, Tredaniel J, Jaffro M, Collot S, Ferretti GR, Tiffon C, Mahier-Ait Oukhatar C, Blay JY. Vemurafenib in non-small-cell lung cancer patients with BRAFV600 and BRAFnonV600 mutations. Ann Oncol. 2020 Feb;31(2):289-294. doi: 10.1016/j.annonc.2019.10.022. Epub 2020 Jan 3.
PubMed 31959346
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations
- ClinicalTrials.gov ID
- NCT02304809
- Acronym / sponsor ID
- AcSé / UC-0105/1401
- Conditions
- Solid Tumors, Hematologic Cancers, Metastatic Cancers
- Keywords
- metastatic or unresectable locally advanced malignancies., genomic alterations, biological vemurafenib targets BRAF, genomic.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Fondation ARC, Hoffmann-La Roche
- Study start
- 13 Oct 2014 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 13 Oct 2027 (estimated)
- First posted
- 2 Dec 2014 (estimated)
- 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.
Patients with metastatic or unresectable locally advanced malignancies harboring BRAF genomic alterations, the biological target of vemurafenib, and who are no more amenable to curative treatment.
To explore the efficacy of vemurafenib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the vemurafenib target gene, per cohort.
Detailed description
This is a biology driven, trans-tumoral, multicentric phase II trial assessing the efficacy and the safety of the targeted agent vemurafenib as a monotherapy in cohorts of patients with identified activating molecular alterations in BRAF gene. A cohort is defined by a pathology and a BRAF- alteration (eg ovarian cancer with BRAF V600 mutation).
To explore the efficacy of vemurafenib per pathology and per target. To assess the safety profile of vemurafenib. To explore whether molecularly driven, high quality multi-tumor screening phase II trials are feasible in the French multiinstitutional, multidisciplinary setting.
To investigate the additional molecular mechanisms in patients with tumor response versus patients without tumor response within the same cohort.
The study will include 11 cohorts of adult patients with the following cancers and alterations:
- NSCLC V600 mutated
- Ovarian cancer V600 mutated
- Cholangiocarcinoma V600 mutated
- Thyroid cancer V600 mutated
- Prostatic cancer V600 mutated
- Bladder cancer V600 mutated
- Sarcoma/GIST V600 mutated
- Multiple myeloma V600 mutated
- Chronic Lymphocytic Leukemia (CLL) V600 mutated
- Hairy cell leukaemia (HCL) V600 mutated (this excludes Hairy Cell Leukemia variant types, marginal zone splenic lymphoma (MZL), splenic red pulp lymphoma (SRPL) patients)
- Other pathology / other alteration than those pre-defined above.
The cohort named "Other" will include adult patients with tumor harboring BRAF genomic alterations only tested via emerging biomarkers programs or molecular pangenomic programs:
- with any other non-predefined pathology harboring a V600 mutation
- Same or other non-predefined pathology harboring non V600 activating mutations
- Same or other non-predefined pathology harboring BRAF amplifications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VEMURAFENIB | Experimental | Drug: Vemurafeniball eligible patients entering the study will receive oral Vemurafenib as monotherapy. Vemurafenib ZELBORAF 240 mg tablets Per OS 960 mg twice daily, to a total daily dose of 1,920 mg Cycles are defined in 28-day periods Disease response will be assessed every 8 weeks Safety will be assessed continuously Treatment will be pursed until disease progression, unacceptable toxicity, intercurrent conditions that preclude continuation of treatment, or patient refusal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Male and female ≥ 8 years of age
- Unresectable locally advanced or metastatic histologically confirmed malignancy (excluding melanoma V600 mutation) resistant or refractory to standard therapy or for which standard therapy does not exist or is not considered appropriate by the Investigator and are not eligible to an appropriate ongoing clinical trial. For Hairy Cell Leukemia: .patients must have relapsed and/or be refractory HCL candidate for treatment after 2 lines of purine analogues treatment.
- Patient with BRAF V600 mutation determined by the INCa platforms on the primary and/or metastatic lesion in the following pathologies:
- Or patient with the same or another pre-listed pathology harboring any type of activating BRAF alteration determined from outside the INCa platforms network.
- Measurable disease according to RECIST 1.1 guidelines for solid tumors with target lesion of at least 10 mm and presence of at least one RECIST-measurable lesion outside of a previously radiated field or potential palliative irradiation fields, International Myeloma Working group Response Criteria for myeloma, IWCLL Chronic Lymphocytic Leukemia and clinical/biological parameters for Hairy cell leukaemia (Serum M-protein >0.5 g/dL; Urine M-protein >200 mg per 24 hours; Involved FLC level >10 mg/dL (>100 mg/L) provided serum FLC ratio is abnormal).
Key exclusion criteria (21 listed)
- V600 BRAF mutated melanoma patients or colorectal cancer patients
- Patient eligible to a clinical trial with an anticancer drug (including vemurafenib) targeting the same BRAF molecular alteration in the same type/localization as the patient's cancer presentation open to accrual in France. Patient not eligible in this trial are still eligible for the AcSé study.
- Prior treatment with a BRAF or MEK inhibitor
- Major surgery or tumor embolization within 4 weeks and minor surgery within 2 weeks prior to the initiation of the study drug
- Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to:
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 |
|---|---|---|
| VemurafenibAlso: ZelborafVemurafenib is a low molecular weight, orally available, inhibitor of BRAF serine-threonine kinase. Mutations in the BRAF gene which substitute the valine at amino acid position 600 result in constitutively activated BRAF proteins, which can cause cell proliferation in the absence of growth factors that would normally be required for proliferation | Drug | VEMURAFENIB |
Primary outcome
The objective response rate (ORR) will be defined as the proportion of patients with a complete response (CR) or a partial response (PR) as best overall response during the study
Time frame: Determined after 8 weeks (2 cycles) of treatment
RECIST for solid tumors, International Myeloma Working Group Response Criteria for myeloma, IWCLL for CLL, clinical exam, blood tests (blood count) and bone marrow exam for Hairy Cell Leukemia.
1 secondary outcome
Safety profile of Vemurafenib (frequency of adverse events coded using the common toxicity criteria (CTC-V4.0) grade)
Time frame: Determined after 8 weeks (2 cycles) of treatment
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 1 Aug 2025.
- Derived from this study: PubMed 31959346Mazieres J, Cropet C, Montane L, Barlesi F, Souquet PJ, Quantin X, Dubos-Arvis C, Otto J, Favier L, Avrillon V, Cadranel J, Moro-Sibilot D, Monnet I, Westeel V, Le Treut J, Brain E, Tredaniel J, Jaffro M, Collot S, Ferretti GR, Tiffon C, Mahier-Ait Oukhatar C, Blay JY. Vemurafenib in non-small-cell lung cancer patients with BRAFV600 and BRAFnonV600 mutations. Ann Oncol. 2020 Feb;31(2):289-294. doi: 10.1016/j.annonc.2019.10.022. Epub 2020 Jan 3.
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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.
Jean-Yves PI Blay, MD principal investigator
CCLC LEON BERARD LYON
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 Vemurafenib in people with Solid Tumors and Hematologic Cancers, run by UNICANCER at 1 site in France.
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 34 inclusion and 21 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 1 Aug 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 France. 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?
The objective response rate (ORR) will be defined as the proportion of patients with a complete response (CR) or a partial response (PR) as best overall response during the study (time frame: Determined after 8 weeks (2 cycles) of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02304809, which also lists 1 linked publication.
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 1 Aug 2025.