MelanomaPhase 3NCT02427893
Trial of Vemurafenib and Cobimetinib in Patients With Advanced BRAFV600 Mutant Melanoma
A Phase 3 study testing Cobimetinib and Vemurafenib in people with Melanoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This trial explores the immunologic effects of vemurafenib (BRAF inhibitor) and cobimetinib (MEK inhibitor), administered alone and in combination, to patients with advanced BRAF V600E/K mutant melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Cobimetinib and Vemurafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Nov 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Signed informed consent
- Signed HIV testing consent
- Life expectancy ≥ 12 weeks
- Able to swallow pills
- ECOG performance status 2 or less
- Adequate bone marrow function
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- Adequate renal function
- Adequate liver function
- Negative urine pregnancy test within 7 days prior to commencement of dosing in premenopausal women
- Histological diagnosis of unresectable AJCC stage III or stage IV, BRAFV600E/K mutant melanoma
- Measurable disease
- Accessible tumor that can be biopsied
- Naive to targeted therapy (Prior immune-based therapy in the adjuvant setting or for advanced disease will be allowed if >2 weeks from study entry)
Who cannot join
- Active systemic infection
- Active autoimmune disease or history of known or suspected autoimmune disease
- Active brain metastases or leptomeningeal metastases
- Treatment with any immunomodulatory medication within 4 weeks of initiation of study therapy.
- Positive test for hepatitis B virus
- Positive test for hepatitis C virus
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- Positive test for human immunodeficiency virus (HIV)
- Pregnant, lactating or breast feeding women
- Localized radiation therapy within the last 14 days
- History of malabsorption
- No consumption of the following within 7 days prior to start of treatment:
- St. John's wort or hyperforin (potent cytochrome P450 CYP3A4 enzyme inducer)
- Grapefruit juice (potent cytochrome P450 CYP3A4 enzyme inhibitor
- History or evidence of cardiovascular risk
- History or evidence of retinal pathology
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
About this study
Official title: An Exploratory Study of the Immunological Effects of Vemurafenib and Cobimetinib, Administered Alone and in Combination, in Subjects With Advanced BRAF V600E/K Mutant Melanoma
This trial explores the immunologic effects of vemurafenib (BRAF inhibitor) and cobimetinib (MEK inhibitor), administered alone and in combination, to patients with advanced BRAF V600E/K mutant melanoma.
- Conditions
- Melanoma
- Being tested
- Cobimetinib, Vemurafenib
- Keywords
- immunotherapy, Vemurafenib, Cobimetinib
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CobimetinibDrug
Also called GDC-0973, XL518
A potent and highly selective inhibitor of MEK1 and MEK2, central components of the RAS/RAF pathway.
VemurafenibDrug
Also called RO5185426, PLX4032, or RG7204
A low molecular weight, orally available inhibitor of the activated form of the BRAF serine-threonine kinase enzyme, which is commonly found in melanoma
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | Ten patients begin Vemurafenib monotherapy, after 10 days, begin combination therapy by adding Cobimetinib. Receives: Drug: Cobimetinib; Drug: Vemurafenib |
| Cohort 2 | Active comparator | Ten patients begin Cobimetinib monotherapy, after 10 days, begin combination therapy by adding Vemurafenib. Receives: Drug: Cobimetinib; Drug: Vemurafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of cobimetinib monotherapy and combination vemurafenib/cobimetinib in subjects with advanced melanoma.
compare immunologic changes described above with the development of study treatment-related adverse events. For example, severity or extent of rash from cobimetinib (a well-described dermatologic toxicity of MEK inhibitors) may be compared to levels of intratumoral immune activation assessed by one or more of the parameters.
Measured: 2 years
Secondary outcomes (1)
Anti-tumor activity of cobimetinib monotherapy and combination vemurafenib/cobimetinib in subjects with advanced melanoma.
compare immunologic changes described above with therapeutic outcomes, including CR, PR, SD, and PD measured by RECIST 1.1. For example, tumor regression may be correlated with levels of intratumoral immune activation or expression of immune checkpoints assessed by one or more of the parameters
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: no patients were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Evan J Lipson, MD, Principal investigator, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427893
- Sponsor's protocol ID
- J1517
- Other IDs
- IRB00051085
- Status last verified
- Nov 2016
- First submitted
- 27 Mar 2015
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of the Immunological Effects of Vemurafenib and Cobimetinib, Administered Alone and in Combination, in Subjects With Advanced BRAF V600E/K Mutant Melanoma
- ClinicalTrials.gov ID
- NCT02427893
- Acronym / sponsor ID
- J1517
- Conditions
- Melanoma
- Keywords
- immunotherapy, Vemurafenib, Cobimetinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patients were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 28 Apr 2015 (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.
This trial explores the immunologic effects of vemurafenib (BRAF inhibitor) and cobimetinib (MEK inhibitor), administered alone and in combination, to patients with advanced BRAF V600E/K mutant melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: Cobimetinib, Drug: VemurafenibTen patients begin Vemurafenib monotherapy, after 10 days, begin combination therapy by adding Cobimetinib. |
| Cohort 2 | Active comparator | Drug: Cobimetinib, Drug: VemurafenibTen patients begin Cobimetinib monotherapy, after 10 days, begin combination therapy by adding Vemurafenib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed informed consent
- Signed HIV testing consent
- Life expectancy ≥ 12 weeks
- Able to swallow pills
- ECOG performance status 2 or less
Key exclusion criteria (15 listed)
- Active systemic infection
- Active autoimmune disease or history of known or suspected autoimmune disease
- Active brain metastases or leptomeningeal metastases
- Treatment with any immunomodulatory medication within 4 weeks of initiation of study therapy.
- Positive test for hepatitis B virus
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 |
|---|---|---|
| CobimetinibAlso: GDC-0973, XL518A potent and highly selective inhibitor of MEK1 and MEK2, central components of the RAS/RAF pathway. | Drug | Cohort 1, Cohort 2 |
| VemurafenibAlso: RO5185426, PLX4032, or RG7204A low molecular weight, orally available inhibitor of the activated form of the BRAF serine-threonine kinase enzyme, which is commonly found in melanoma | Drug | Cohort 1, Cohort 2 |
Primary outcome
Safety and tolerability of cobimetinib monotherapy and combination vemurafenib/cobimetinib in subjects with advanced melanoma.
Time frame: 2 years
compare immunologic changes described above with the development of study treatment-related adverse events. For example, severity or extent of rash from cobimetinib (a well-described dermatologic toxicity of MEK inhibitors) may be compared to levels of intratumoral immune activation assessed by one or more of the parameters.
1 secondary outcome
Anti-tumor activity of cobimetinib monotherapy and combination vemurafenib/cobimetinib in subjects with advanced melanoma.
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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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.
Evan J Lipson, MD principal investigator
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cobimetinib and Vemurafenib in people with Melanoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
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 13 inclusion and 15 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: withdrawn, as of the sponsor's last update on 15 Nov 2016. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety and tolerability of cobimetinib monotherapy and combination vemurafenib/cobimetinib in subjects with advanced melanoma. (time frame: 2 years). 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 15 Nov 2016.