Multiple Myeloma, NeoplasmsPhase 2NCT01524978
A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
A Phase 2 study testing cetuximab and vemurafenib in people with Multiple Myeloma, Neoplasms, run by Hoffmann-La Roche at 34 sites in 6 countries.
Trial summary
This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Multiple Myeloma, Neoplasms
- What is being tested?
- cetuximab and vemurafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 34 sitesin 6 countries
- Study dates
- 12 Apr 2012to 28 Oct 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Must have recovered from all side effects of their most recent systemic or local treatment
- Adequate hematological, renal and liver function
- For solid tumors only:
- Histologically confirmed cancers (excluding melanoma and papillary thyroid cancer) with a BRAF V600 mutation and that are resistant to standard therapy or for which standard or curative therapy does not exist
- Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
Show all 11Show fewer
- For multiple myeloma only:
- Confirmed diagnosis of multiple myeloma with a BRAF V600 mutation
- Must have received at least one prior systemic therapy for the treatment of multiple myeloma
- Treated with local radiotherapy
- Must have relapsed and/or refractory multiple myeloma with measurable disease
Who cannot join
- Melanoma, papillary thyroid cancer or hematological malignancies (with the exception of multiple myeloma)
- Uncontrolled concurrent malignancy
- Multiple myeloma: solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
- Active or untreated central nervous system (CNS) metastases
- History of or known carcinomatous meningitis
- Concurrent administration of any anti-cancer therapies other than those administered in this study
- Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that would, in the investigator's opinion, contraindicate participation in this study
Trial locations and contacts
34 sites in 6 countries.
34 sites in 6 countries
United States11 sites
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012
Massachusetts General Hospital;Oncology
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Karmanos Cancer Institute
Detroit, Michigan, 48201
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Vanderbilt
Nashville, Tennessee, 37232
Memorial Sloan-Kettering Cancer Center
New York, New York
Washington University
St Louis, Missouri, 63110
Arizona Oncology
Tucson, Arizona, 85704
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902
France8 sites
Institut Bergonie; Oncologie
Bordeaux, 33076
Centre Francois Baclesse; Oncologie
Caen, 14076
Centre Georges François Leclerc
Dijon, 21000
Centre Leon Berard; Departement Oncologie Medicale
Lyon, 69373
Institut Paoli-Calmettes; Oncologie Medicale 1
Marseille, 13273
Centre Rene Gauducheau
Saint-Herblain, 44805
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, 31059
Institut Gustave Roussy; Sitep
Villejuif, 94805
Spain8 sites
Hospital del Mar; Servicio de Oncologia
Barcelona, 08003
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Barcelona, 08035
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007
Fundacion Jimenez Diaz; Servicio de Oncologia
Madrid, 28040
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica
Madrid, 28050
Hospital Univ. Central de Asturias; Servicio de Oncologia
Oviedo, Principality of Asturias, 33011
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Salamanca, 37007
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010
Germany3 sites
Klinik der Uni zu Koeln; Klinik I für Innere Medizin; Onkologie
Cologne, 50937
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
Essen, 45122
Universitätsklinikum Mannheim, Tagestherapiezentrum, Interdisziplinäres Tumorzentrum
Mannheim, 68167
United Kingdom3 sites
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
The Royal Marsden Hospital; Dept of Medicine
London, SW3 5PT
The Royal Marsden Hospital
Sutton, SM2 5PT
About this study
Official title: An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers
This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed.
- Conditions
- Multiple Myeloma, Neoplasms
- Being tested
- cetuximab, vemurafenib
- Medical subject headings
- Multiple Myeloma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximabDrug
Escalating doses administered on Day 1 and then once weekly by intravenous infusion.
vemurafenibDrug
Also called Zelboraf
Escalating doses given orally twice a day starting on Day 2
vemurafenibDrug
Also called Zelboraf
960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - vemurafenib | Experimental | Participants with NSCLC will be treated with vemurafenib monotherapy. Receives: Drug: vemurafenib |
| Cohort 2: Ovarian Cancer - vemurafenib | Experimental | Participants with ovarian cancer will be treated with vemurafenib monotherapy. Receives: Drug: vemurafenib |
| Cohort 3a: Colorectal Cancer - vemurafenib | Experimental | Participants with colorectal cancer will be treated with vemurafenib monotherapy. Receives: Drug: vemurafenib |
| Cohort 3b: Colorectal Cancer - vemurafenib + cetuximab | Experimental | Participants with colorectal cancer will be treated with vemurafenib and cetuximab combination therapy. Receives: Drug: cetuximab; Drug: vemurafenib |
| Cohort 4: Cholangiocarcinoma - vemurafenib | Experimental | Participants with cholangiocarcinoma will be treated with vemurafenib monotherapy. Receives: Drug: vemurafenib |
| Cohort 6: Multiple Myeloma - vemurafenib | Experimental | Participants with multiple myeloma will be treated with vemurafenib monotherapy. Receives: Drug: vemurafenib |
| Cohort 7: Other Solid Tumors - vemurafenib | Experimental | Participants with Erdheim-Chester disease (ECD), Langerhans cell histiocytosis (LCH), anaplastic thyroid cancer, advanced stage astrocytoma, early stage astrocytoma and other BRAF V600-positive tumors will be treated with vemurafenib monotherapy. Subcohorts will be analyzed separately if 7 or more participants are enrolled for each indication. Receives: Drug: vemurafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Best Overall Response Rate (BORR)
Confirmed BORR: percentage of participants with an objective response (OR) (complete response [CR], partial response [PR], stringent CR [sCR] or very good PR [VGPR]) on 2 occasions >/= 4 weeks apart as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. or International Myeloma Working Group (IMWG) criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: >/= 30% decrease in the sum of diameters of target lesions. IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow; PR: >/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >/= 90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour; sCR: CR plus normal free light chain (FLC) ratio and no clonal cells in bone marrow.
Measured: Up to approximately 3 years
Secondary outcomes (10)
Percentage of Participants With Confirmed Clinical Benefit
Included were participants with confirmed PR or CR or Stable Disease (SD) that had lasted at least 6 months according to RECIST v1.1 or confirmed CR, PR, VGPR, sCR or SD for at least 6 months according to IMWG criteria. RECIST v1.1: PR: >/= 30% decrease in the sum of diameters of target lesions; CR: disappearance of all target lesions; SD: not meeting criteria for CR, PR or progressive disease (PD). IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow; PR: >/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >/= 90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow; SD: not meeting criteria for CR, VGPR, PR or PD.
Measured: Up to approximately 3 years
Overall Response Rate (ORR)
ORR: percentage of participants with an objective response (OR) (CR, PR, sCR or VGPR) on 2 occasions >/= 4 weeks apart as assessed by the Investigator using RECIST v1.1. or IMWG criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: >/= 30% decrease in the sum of diameters of target lesions. IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow; PR: >/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >/= 90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow.
Measured: Up to approximately 3 years
Duration of Response (DOR)
DOR was defined as the period from the date of initial PR or CR for solid tumors according to RECISTv1.1 and CR, PR, VGPR or sCR for multiple myeloma according to IMWG criteria, until the date of PD or death from any cause. RECIST v1.1: PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG: PD: increase of >/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas.
Measured: Up to approximately 3 years
Time to Response
Time to response was defined as the time from the first day of study treatment to the date of first CR, or PR for solid tumors according to RECISTv1.1 and CR, PR, VGPR or sCR for multiple myeloma according to IMWG criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: at least a 30% decrease in the sum of diameters of target lesions. IMWG criteria: CR: negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow; PR: >/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >/= 90% or to < 200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour; sCR: CR plus normal FLC ratio and no clonal cells in bone marrow.
Measured: Up to approximately 3 years
Time to Tumor Progression (TTP)
TTP was defined as time from the first day of study treatment to the first occurrence of progressive disease (PD). RECIST v1.1: PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG: PD: increase of >/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas.
Measured: Up to approximately 3 years
Progression Free Survival (PFS)
PFS was defined as the time from the first day of study treatment, until the first documented PD or death from any cause, whichever occurs first. RECIST v1.1: PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. IMWG criteria: PD: increase of >/= 25% from lowest response value in serum or urine M-protein or bone marrow plasma cell percentage or development of new or increase in size of bone lesions or soft tissue plasmacytomas.
Measured: Up to approximately 3 years
Overall Survival (OS)
OS was defined as time between the first day of study treatment and date of death of any cause.
Measured: Up to approximately 3 years
Maximum Tolerated Dose for Vemurafenib in Combination With Cetuximab
Cohort 3b included participants with colorectal cancer treated with escalating doses of vemurafenib and cetuximab. The escalating doses were as follows: Dose Level 1: 720 milligrams (mg) of vemurafenib orally twice daily starting on Day 2 of Cycle 1 and 300 milligrams per square meter (mg/m^2) loading dose of cetuximab by infusion and then 200 mg/m^2 weekly; Dose Level 2: 720 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly; Dose Level 3: 960 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly. Reported here are the maximum tolerated doses for each vemurafenib and cetuximab.
Measured: Up to approximately 3 years
Number of Dose-limiting Toxicities of Vemurafenib in Combination With Cetuximab
Cohort 3b included participants with colorectal cancer treated with escalating doses of vemurafenib and cetuximab. The escalating doses were as follows: Dose Level 1: 720 milligrams (mg) of vemurafenib orally twice daily starting on Day 2 of Cycle 1 and 300 milligrams per square meter (mg/m^2) loading dose of cetuximab by infusion and then 200 mg/m^2 weekly; Dose Level 2: 720 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly; Dose Level 3: 960 mg of vemurafenib twice daily starting on Day 2 of Cycle 1 and 400 mg/m^2 loading dose of cetuximab and then 250 mg/m^2 weekly. Reported here are type and number of dose limited toxicities observed.
Measured: Up to 28 days
Safety: Percentage of Participants With Adverse Event
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study start12 Apr 2012
- Primary completion28 Oct 2016
- Study completion28 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma, NeoplasmsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524978
- Sponsor's protocol ID
- MO28072
- Other IDs
- 2011-004426-10
- Status last verified
- Oct 2017
- First submitted
- 27 Jan 2012
- Last updated
- 20 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7.
PubMed 37934000Kaley T, Touat M, Subbiah V, Hollebecque A, Rodon J, Lockhart AC, Keedy V, Bielle F, Hofheinz RD, Joly F, Blay JY, Chau I, Puzanov I, Raje NS, Wolf J, DeAngelis LM, Makrutzki M, Riehl T, Pitcher B, Baselga J, Hyman DM. BRAF Inhibition in BRAFV600-Mutant Gliomas: Results From the VE-BASKET Study. J Clin Oncol. 2018 Dec 10;36(35):3477-3484. doi: 10.1200/JCO.2018.78.9990. Epub 2018 Oct 23.
PubMed 30351999Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations. N Engl J Med. 2015 Aug 20;373(8):726-36. doi: 10.1056/NEJMoa1502309.
PubMed 26287849
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers
- ClinicalTrials.gov ID
- NCT01524978
- Acronym / sponsor ID
- MO28072
- Conditions
- Multiple Myeloma, Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2012 (actual)
- Primary completion
- 28 Oct 2016 (actual)
- Study completion
- 28 Oct 2016 (actual)
- First posted
- 2 Feb 2012 (estimated)
- Results
- Posted 20 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label, multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers (solid tumors and multiple myeloma, except melanoma and papillary thyroid cancer) and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator. Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression, unacceptable toxicity, or withdrawal of consent. The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - vemurafenib | Experimental | Drug: vemurafenibParticipants with NSCLC will be treated with vemurafenib monotherapy. |
| Cohort 2: Ovarian Cancer - vemurafenib | Experimental | Drug: vemurafenibParticipants with ovarian cancer will be treated with vemurafenib monotherapy. |
| Cohort 3a: Colorectal Cancer - vemurafenib | Experimental | Drug: vemurafenibParticipants with colorectal cancer will be treated with vemurafenib monotherapy. |
| Cohort 3b: Colorectal Cancer - vemurafenib + cetuximab | Experimental | Drug: cetuximab, Drug: vemurafenibParticipants with colorectal cancer will be treated with vemurafenib and cetuximab combination therapy. |
| Cohort 4: Cholangiocarcinoma - vemurafenib | Experimental | Drug: vemurafenibParticipants with cholangiocarcinoma will be treated with vemurafenib monotherapy. |
| Cohort 6: Multiple Myeloma - vemurafenib | Experimental | Drug: vemurafenibParticipants with multiple myeloma will be treated with vemurafenib monotherapy. |
| Cohort 7: Other Solid Tumors - vemurafenib | Experimental | Drug: vemurafenibParticipants with Erdheim-Chester disease (ECD), Langerhans cell histiocytosis (LCH), anaplastic thyroid cancer, advanced stage astrocytoma, early stage astrocytoma and other BRAF V600-positive tumors will be treated with vemurafenib monotherapy. Subcohorts will be analyzed separately if 7 or more participants are enrolled for each indication. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Must have recovered from all side effects of their most recent systemic or local treatment
- Adequate hematological, renal and liver function
- Histologically confirmed cancers (excluding melanoma and papillary thyroid cancer) with a BRAF V600 mutation and that are resistant to standard therapy or for which standard or curative therapy does not exist
- Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
Key exclusion criteria (7 listed)
- Melanoma, papillary thyroid cancer or hematological malignancies (with the exception of multiple myeloma)
- Uncontrolled concurrent malignancy
- Multiple myeloma: solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
- Active or untreated central nervous system (CNS) metastases
- History of or known carcinomatous meningitis
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 |
|---|---|---|
| cetuximabEscalating doses administered on Day 1 and then once weekly by intravenous infusion. | Drug | Cohort 3b: Colorectal Cancer - vemurafenib + cetuximab |
| vemurafenibAlso: ZelborafEscalating doses given orally twice a day starting on Day 2 | Drug | Cohort 3b: Colorectal Cancer - vemurafenib + cetuximab |
| vemurafenibAlso: Zelboraf960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent. | Drug | Cohort 1: Non-Small Cell Lung Cancer (NSCLC) - vemurafenib, Cohort 2: Ovarian Cancer - vemurafenib, Cohort 3a: Colorectal Cancer - vemurafenib, Cohort 4: Cholangiocarcinoma - vemurafenib, Cohort 6: Multiple Myeloma - vemurafenib, Cohort 7: Other Solid Tumors - vemurafenib |
Primary outcome
Confirmed Best Overall Response Rate (BORR)
Time frame: Up to approximately 3 years
Confirmed BORR: percentage of participants with an objective response (OR) (complete response [CR], partial response [PR], stringent CR [sCR] or very good PR [VGPR]) on 2 occasions >/= 4 weeks apart as assessed by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. or International Myeloma Working Group (IMWG) criteria. RECIST v1.1: CR: disappearance of all target lesions; PR: >/= 30% decrease in the sum of diameters of target lesions. IMWG: CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and </= 5% plasma cells in bone marrow; PR: >/= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >/= 90% or to <200 mg per 24 hours. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or >/= 90% reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hour; sCR: CR plus normal free light chain (FLC) ratio and no clonal cells in bone marrow.
10 secondary outcomes
Percentage of Participants With Confirmed Clinical Benefit
Time frame: Up to approximately 3 years
Overall Response Rate (ORR)
Time frame: Up to approximately 3 years
Duration of Response (DOR)
Time frame: Up to approximately 3 years
Time to Response
Time frame: Up to approximately 3 years
Time to Tumor Progression (TTP)
Time frame: Up to approximately 3 years
Progression Free Survival (PFS)
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Maximum Tolerated Dose for Vemurafenib in Combination With Cetuximab
Time frame: Up to approximately 3 years
Number of Dose-limiting Toxicities of Vemurafenib in Combination With Cetuximab
Time frame: Up to 28 days
Safety: Percentage of Participants With Adverse Event
Time frame: Up to approximately 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37934000Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7.
- Derived from this study: PubMed 30351999Kaley T, Touat M, Subbiah V, Hollebecque A, Rodon J, Lockhart AC, Keedy V, Bielle F, Hofheinz RD, Joly F, Blay JY, Chau I, Puzanov I, Raje NS, Wolf J, DeAngelis LM, Makrutzki M, Riehl T, Pitcher B, Baselga J, Hyman DM. BRAF Inhibition in BRAFV600-Mutant Gliomas: Results From the VE-BASKET Study. J Clin Oncol. 2018 Dec 10;36(35):3477-3484. doi: 10.1200/JCO.2018.78.9990. Epub 2018 Oct 23.
- Derived from this study: PubMed 26287849Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in Multiple Nonmelanoma Cancers with BRAF V600 Mutations. N Engl J Med. 2015 Aug 20;373(8):726-36. doi: 10.1056/NEJMoa1502309.
- Trialreach EntryLink provided by the sponsor.
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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.
Clinical Trials study director
Hoffmann-La Roche
34 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cetuximab and vemurafenib in people with Multiple Myeloma, Neoplasms, run by Hoffmann-La Roche at 34 sites in 6 countries.
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 11 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: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, France, Spain, Germany, United Kingdom and 1 more country. 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?
Yes. Results are posted in the registry (first posted 20 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Confirmed Best Overall Response Rate (BORR) (time frame: Up to approximately 3 years). 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 NCT01524978, which also lists 3 linked publications.
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 20 Nov 2017.