MelanomaPhase 1/2NCT03101254
LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma
A Phase 1/2 study testing LY3022855, Vemurafenib and Cobimetinib in people with Melanoma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is studying a combination of targeted therapies as a possible treatment for advanced melanoma that was found to have a BRAF V600E or BRAF V600K genetic mutation The interventions involved in this study are: LY3022855 Vemurafenib Cobimetinib Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- LY3022855, Vemurafenib and Cobimetinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2017to 11 Nov 2020
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For enrollment to the phase I portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective.
- For enrollment to the phase II portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) and cannot have received prior BRAF or MEK inhibitor therapy.
- Participants enrolling to the phase I portion of the trial must have evaluable or measurable disease (see Section 11 for definitions).
- Participants enrolling to the phase II portion of the trial must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
- Age ≥ 18 years. As no dosing or adverse event data are currently available in participants < 18 years of age, children are excluded from this study but will be eligible for future pediatric trials.
- ECOG performance status 0 - 1 (see APPENDIX A).
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- Participants must have normal organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1.5 K/uL
- Platelets ≥ 100 K/uL
- Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN
- Serum creatinine ≤ 1.5 × institutional ULN
- PT-INR ≤ 1.5 × institutional ULN (for participants on anticoagulation therapy, ≤ 1.5 × their baseline value)
- aPTT ≤ 1.5 × institutional ULN (for participants on anticoagulation therapy, ≤ 1.5 × their baseline value)
- Participants must have a left ventricular ejection fraction (LVEF) ≥ 50%.
- Participants must have a QTc of ≤ 470 msec on the screening EKG.
- The effects of LY3022855 on the developing human fetus are unknown. For this reason and because anti-cancer agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of LY3022855 administration.
- Ability to understand and the willingness to sign a written informed consent document.
- Participants must have archival tumor tissue available. Participants without archival tissue may be enrolled at the discretion of the principal investigator.
Who cannot join
- Participants who have had chemotherapy, radiotherapy, biologic therapy, major surgery, or another investigational agent within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
- Participants who have not recovered to ≤ CTCAE grade 1 or baseline from toxicity as a result of previous cancer treatment prior to entering the study (with the exception of alopecia and peripheral neuropathy which can be ≤ grade 2).
- For enrollment to the phase II portion: participants who have received prior BRAF or MEK inhibitor therapy.
- Participants with known untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Participants with a history of brain metastases that have been treated, are no longer taking corticosteroids, and have been stable on imaging for ≥ 4 weeks following the last date of treatment are permitted.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to LY3022855, vemurafenib, or cobimetinib.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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- Pregnant women are excluded from this study because LY3022855 is an anti-cancer agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LY3022855, breastfeeding should be discontinued if the mother is treated with LY3022855. These potential risks may also apply to the other agents used in this study.
- Participants with a known history of HIV are ineligible because of the potential for pharmacokinetic interactions with LY3022855, vemurafenib, and cobimetinib with antiretroviral agents. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
- Participants with a personal or family history of long QT syndrome.
- Participants with a history of a second primary malignancy. Exceptions include: patients with a history of malignancies that were treated curatively and have not recurred within 3 years prior to study entry; resected basal and squamous cell carcinomas of the skin, and completely resected carcinoma in situ of any type.
- Participants with impairment of GI function or GI disease that may significantly alter the absorption of vemurafenib and cobimetinib in the opinion of the treating investigator (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection).
- Participants who are unable to swallow or retain oral medication.
- Participants that require co-administration of strong or moderate CYP3A inhibitors, as these medications may alter vemurafenib and cobimetinib concentrations.
- Participants who require treatment with medications that are strong or moderate CYP3A inducers, as these medications may alter the concentration of cobimetinib.
- Participants with evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Phase I/II Study of LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma
This research study is studying a combination of targeted therapies as a possible treatment for advanced melanoma that was found to have a BRAF V600E or BRAF V600K genetic mutation
The interventions involved in this study are:
- LY3022855
- Vemurafenib
- Cobimetinib
Read the detailed description
This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved LY3022855 as a treatment for any disease.
The FDA has approved vemurafenib and cobimetinib as treatment options for this disease.
LY3022855 is a colony-stimulating factor-1 receptor (CSF-1R) inhibitor. It is a human monoclonal antibody. A monoclonal antibody is a type of protein made in the laboratory that can locate and bind to substances in the body, including tumor cells. By binding to the tumor cells, the antibody might prevent the tumor cell from growing and spreading. LY3022855 is being developed as a treatment for patients with advanced cancer.
Vemurafenib and cobimetinib attack different proteins that promote the growth of cancerous cells. Vemurafenib is a BRAF inhibitor that works by blocking altered BRAF proteins from stimulating the growth of melanoma cancer cells. Cobimetinib works by blocking a protein called MEK that has been known to promote melanoma growth. In order to participate in the study, participant's disease needs to be tested positive for a mutation (a permanent change in the DNA sequence of a gene) of the BRAF gene that belongs to a class of genes known as oncogenes. When mutated, oncogenes have the potential to cause normal cells to become cancerous. Once the BRAF gene is mutated, the normal functioning of the BRAF protein may be changed.
In this research study, the investigators are combining LY3022855 with vemurafenib and cobimetinib in the hopes that the LY3022855 will enhance how your cancer responds to vemurafenib and cobimetinib.
- Conditions
- Melanoma
- Being tested
- LY3022855, Vemurafenib, Cobimetinib
- Keywords
- Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3022855Drug
LY3022855 is a colony-stimulating factor-1 receptor (CSF-1R) inhibitor
VemurafenibDrug
Also called Zelboraf
Vemurafenib is a BRAF inhibitor that works by blocking altered BRAF proteins from stimulating the growth of melanoma cancer cells
CobimetinibDrug
Also called Cotellic
Cobimetinib works by blocking a protein called MEK that has been known to promote melanoma growth
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Dose Level 1: LY3022855 (50mg) + Vemurafenib + Cobimetinib | Experimental | * Starting dose level of LY3022855 50mg IV administered intravenously every week
* Vemurafenib 960 mg BID administered by mouth twice daily
* Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle Receives: Drug: LY3022855; Drug: Vemurafenib; Drug: Cobimetinib |
| Phase I: Dose Level 2: LY3022855 (75mg) + Vemurafenib + Cobimetinib | Experimental | * LY3022855 50mg IV administered intravenously every week
* Vemurafenib 960 mg BID administered by mouth twice daily
* Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle Receives: Drug: LY3022855; Drug: Vemurafenib; Drug: Cobimetinib |
| Phase I: Dose Level 3: LY3022855 (100mg) + Vemurafenib + Cobimetinib | Experimental | * LY3022855 100mg IV administered intravenously every week
* Vemurafenib 960 mg BID administered by mouth twice daily
* Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle Receives: Drug: LY3022855; Drug: Vemurafenib; Drug: Cobimetinib |
| Phase II: LY3022855 (MTD) + Vemurafenib + Cobimetinib | Experimental | * MTD of LY3022855 was not established
* Vemurafenib planned 960 mg BID administered by mouth twice daily
* Cobimetinib planned 60 mg administered by mouth once daily on days 1-21of each cycle Receives: Drug: LY3022855; Drug: Vemurafenib; Drug: Cobimetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT) [Phase I]
DLT is based on CTCAE v4.03. DLT refers to toxicities experienced during the first cycle of treatment that are possibly, probably, or definitely related to the study medication regimen, and grade or category outlined in protocol section 5.4.
Measured: Participants were assessed cycle 1 on day 1, 8, 15 and 22. The observation period for DLT evaluation was the first cycle (28 days).
LY3022855 Maximum Tolerated Dose (MTD) With Vemurafenib and Cobimetinib Combination [Phase I]
See previous primary outcome measure for the DLT defination. A conventional algorithm (3+3 design) will be used to identify the MTD, escalating on 0/3 or 1/6 DLTs, and de-escalating if two DLTs are encountered. The MTD will be the highest dose level at which ≤ 1/6 subjects experience a DLT. If dose level 1 is discovered to be intolerable (with 2/3 or ≥ 2/6 subjects experiencing a DLT), the trial will be discontinued.
Measured: Participants were assessed cycle 1 on day 1, 8, 15 and 22. The observation period is the first cycle (28 days).
Secondary outcomes (3)
Median Progression-Free Survival (PFS) [Phase I]
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria.
Measured: Disease was assessed radiologically at baseline and after treatment every 3-4 months. Median follow-up for survival was 202 days with maximum of 480 days.
Overall Response Rate (ORR) [Phase I]
The overall response rate (ORR) was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECISTv1.1 criteria.
Measured: Radiologic measurements is performed at Cycle 2 Day 28 and at the day 28 of every 2 cycles of treatment thereafter. Median treatment duration is 112 days (range 56 - 1008 days ).
Grade 3-5 Treatment-related Toxicity Rate [Phase II]
All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4.03 that are not resolved in accordance with treatment guidelines were counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.
Measured: AE evaluated on treatment on each cycle at day 1, 8, 15 and 22. Median treatment duration for this study cohort was 112 days (range 56 - 1008 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start6 Jun 2017
- Primary completion21 Oct 2020
- Study completion11 Nov 2020
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.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Elizabeth Buchbinder, MD, Dana-Farber Cancer Institute
- Investigators
- Elizabeth Buchbinder, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101254
- Sponsor's protocol ID
- 17-030
- Status last verified
- Jul 2024
- First submitted
- 30 Mar 2017
- Last updated
- 17 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma
- ClinicalTrials.gov ID
- NCT03101254
- Acronym / sponsor ID
- 17-030
- Conditions
- Melanoma
- Keywords
- Melanoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 21 Oct 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Posted 17 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is studying a combination of targeted therapies as a possible treatment for advanced melanoma that was found to have a BRAF V600E or BRAF V600K genetic mutation
The interventions involved in this study are:
- LY3022855
- Vemurafenib
- Cobimetinib
Detailed description
This is a Phase I/II clinical trial. A Phase I clinical trial tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved LY3022855 as a treatment for any disease.
The FDA has approved vemurafenib and cobimetinib as treatment options for this disease.
LY3022855 is a colony-stimulating factor-1 receptor (CSF-1R) inhibitor. It is a human monoclonal antibody. A monoclonal antibody is a type of protein made in the laboratory that can locate and bind to substances in the body, including tumor cells. By binding to the tumor cells, the antibody might prevent the tumor cell from growing and spreading. LY3022855 is being developed as a treatment for patients with advanced cancer.
Vemurafenib and cobimetinib attack different proteins that promote the growth of cancerous cells. Vemurafenib is a BRAF inhibitor that works by blocking altered BRAF proteins from stimulating the growth of melanoma cancer cells. Cobimetinib works by blocking a protein called MEK that has been known to promote melanoma growth. In order to participate in the study, participant's disease needs to be tested positive for a mutation (a permanent change in the DNA sequence of a gene) of the BRAF gene that belongs to a class of genes known as oncogenes. When mutated, oncogenes have the potential to cause normal cells to become cancerous. Once the BRAF gene is mutated, the normal functioning of the BRAF protein may be changed.
In this research study, the investigators are combining LY3022855 with vemurafenib and cobimetinib in the hopes that the LY3022855 will enhance how your cancer responds to vemurafenib and cobimetinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase I: Dose Level 1: LY3022855 (50mg) + Vemurafenib + Cobimetinib | Experimental | Drug: LY3022855, Drug: Vemurafenib, Drug: Cobimetinib* Starting dose level of LY3022855 50mg IV administered intravenously every week * Vemurafenib 960 mg BID administered by mouth twice daily * Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle |
| Phase I: Dose Level 2: LY3022855 (75mg) + Vemurafenib + Cobimetinib | Experimental | Drug: LY3022855, Drug: Vemurafenib, Drug: Cobimetinib* LY3022855 50mg IV administered intravenously every week * Vemurafenib 960 mg BID administered by mouth twice daily * Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle |
| Phase I: Dose Level 3: LY3022855 (100mg) + Vemurafenib + Cobimetinib | Experimental | Drug: LY3022855, Drug: Vemurafenib, Drug: Cobimetinib* LY3022855 100mg IV administered intravenously every week * Vemurafenib 960 mg BID administered by mouth twice daily * Cobimetinib 60 mg administered by mouth once daily on days 1-21of each cycle |
| Phase II: LY3022855 (MTD) + Vemurafenib + Cobimetinib | Experimental | Drug: LY3022855, Drug: Vemurafenib, Drug: Cobimetinib* MTD of LY3022855 was not established * Vemurafenib planned 960 mg BID administered by mouth twice daily * Cobimetinib planned 60 mg administered by mouth once daily on days 1-21of each cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- For enrollment to the phase I portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective.
- For enrollment to the phase II portion: participants must have a histologically confirmed melanoma with a BRAF V600E or BRAF V600K mutation (identified via NextGen sequencing using the DFCI/BWH OncoPanel or any CLIA-certified method) and cannot have received prior BRAF or MEK inhibitor therapy.
- Participants enrolling to the phase I portion of the trial must have evaluable or measurable disease (see Section 11 for definitions).
- Participants enrolling to the phase II portion of the trial must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
- Age ≥ 18 years. As no dosing or adverse event data are currently available in participants < 18 years of age, children are excluded from this study but will be eligible for future pediatric trials.
Key exclusion criteria (15 listed)
- Participants who have had chemotherapy, radiotherapy, biologic therapy, major surgery, or another investigational agent within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
- Participants who have not recovered to ≤ CTCAE grade 1 or baseline from toxicity as a result of previous cancer treatment prior to entering the study (with the exception of alopecia and peripheral neuropathy which can be ≤ grade 2).
- For enrollment to the phase II portion: participants who have received prior BRAF or MEK inhibitor therapy.
- Participants with known untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Participants with a history of brain metastases that have been treated, are no longer taking corticosteroids, and have been stable on imaging for ≥ 4 weeks following the last date of treatment are permitted.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to LY3022855, vemurafenib, or cobimetinib.
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 |
|---|---|---|
| LY3022855LY3022855 is a colony-stimulating factor-1 receptor (CSF-1R) inhibitor | Drug | Phase I: Dose Level 1: LY3022855 (50mg) + Vemurafenib + Cobimetinib, Phase I: Dose Level 2: LY3022855 (75mg) + Vemurafenib + Cobimetinib, Phase I: Dose Level 3: LY3022855 (100mg) + Vemurafenib + Cobimetinib, Phase II: LY3022855 (MTD) + Vemurafenib + Cobimetinib |
| VemurafenibAlso: ZelborafVemurafenib is a BRAF inhibitor that works by blocking altered BRAF proteins from stimulating the growth of melanoma cancer cells | Drug | Phase I: Dose Level 1: LY3022855 (50mg) + Vemurafenib + Cobimetinib, Phase I: Dose Level 2: LY3022855 (75mg) + Vemurafenib + Cobimetinib, Phase I: Dose Level 3: LY3022855 (100mg) + Vemurafenib + Cobimetinib, Phase II: LY3022855 (MTD) + Vemurafenib + Cobimetinib |
| CobimetinibAlso: CotellicCobimetinib works by blocking a protein called MEK that has been known to promote melanoma growth | Drug | Phase I: Dose Level 1: LY3022855 (50mg) + Vemurafenib + Cobimetinib, Phase I: Dose Level 2: LY3022855 (75mg) + Vemurafenib + Cobimetinib, Phase I: Dose Level 3: LY3022855 (100mg) + Vemurafenib + Cobimetinib, Phase II: LY3022855 (MTD) + Vemurafenib + Cobimetinib |
Primary outcome
Dose Limiting Toxicity (DLT) [Phase I]
Time frame: Participants were assessed cycle 1 on day 1, 8, 15 and 22. The observation period for DLT evaluation was the first cycle (28 days).
DLT is based on CTCAE v4.03. DLT refers to toxicities experienced during the first cycle of treatment that are possibly, probably, or definitely related to the study medication regimen, and grade or category outlined in protocol section 5.4.
LY3022855 Maximum Tolerated Dose (MTD) With Vemurafenib and Cobimetinib Combination [Phase I]
Time frame: Participants were assessed cycle 1 on day 1, 8, 15 and 22. The observation period is the first cycle (28 days).
See previous primary outcome measure for the DLT defination. A conventional algorithm (3+3 design) will be used to identify the MTD, escalating on 0/3 or 1/6 DLTs, and de-escalating if two DLTs are encountered. The MTD will be the highest dose level at which ≤ 1/6 subjects experience a DLT. If dose level 1 is discovered to be intolerable (with 2/3 or ≥ 2/6 subjects experiencing a DLT), the trial will be discontinued.
3 secondary outcomes
Median Progression-Free Survival (PFS) [Phase I]
Time frame: Disease was assessed radiologically at baseline and after treatment every 3-4 months. Median follow-up for survival was 202 days with maximum of 480 days.
Overall Response Rate (ORR) [Phase I]
Time frame: Radiologic measurements is performed at Cycle 2 Day 28 and at the day 28 of every 2 cycles of treatment thereafter. Median treatment duration is 112 days (range 56 - 1008 days ).
Grade 3-5 Treatment-related Toxicity Rate [Phase II]
Time frame: AE evaluated on treatment on each cycle at day 1, 8, 15 and 22. Median treatment duration for this study cohort was 112 days (range 56 - 1008 days).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Elizabeth Buchbinder, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LY3022855, Vemurafenib and Cobimetinib in people with Melanoma, run by Dana-Farber Cancer Institute 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 20 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: finished, as of the sponsor's last update on 17 Jul 2024. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 17 Jul 2024). 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?
Dose Limiting Toxicity (DLT) [Phase I] (time frame: Participants were assessed cycle 1 on day 1, 8, 15 and 22. The observation period for DLT evaluation was the first cycle (28 days).). The study lists 2 primary outcomes in all. 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 17 Jul 2024.