Melanoma MetastaticPhase 2NCT03514901
To Evaluate the Efficacy Beyond Progression of Vemurafenib+Cobimetinib Associated With Local Treatment Compared to Second-line Treatment in Patients With BRAFV600+ Metastatic Melanoma in Focal Progression With First-line+Vemurafenib+Cobimetinib.
A Phase 2 study testing Experimental combination beyond Focal Progression and Pembrolizumab or Nivolumab in people with Melanoma Metastatic and BRAF V600 Mutation, run by Intergruppo Melanoma Italiano at 14 sites in Italy.
Trial summary
The purpose of this study is to evaluate the efficacy beyond progression of vemurafenib combined with cobimetinib associated with local treatment compared to second-line treatment in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Metastatic, BRAF V600 Mutation
- What is being tested?
- Experimental combination beyond Focal Progression and Pembrolizumab or Nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 14 sitesItaly
- Study dates
- 18 Jun 2018to 29 Apr 2023
- Phase
- Phase 2
- 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
- Patients with histologically confirmed melanoma, either unresectable Stage IIIc or Stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th edition
- Patients previously untreated for metastatic melanoma
- Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) by a validated mutational test
- Adequate performance status to receive vemurafenib and cobimetinib therapy as determined by treating physician
- Male or female patient aged ≥18 years
- Able to participate and willing to give written informed consent prior to any treatment-related procedures and to comply with treatment guidance
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- Adequate end-organ function, defined by the following laboratory results obtained within 14 days prior to the first dose of program drug treatment:
- Bilirubin ≤ 1.5 x the upper limit of normal (ULN).
- AST, ALT, and alkaline phosphatase ≤ 3 x ULN, with the following exceptions:
- Patients with documented liver metastases: AST and/or ALT ≤ 5 x ULN.
- Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 x ULN.
- Serum creatinine ≤1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min based on measured CrCl from a 24-hour urine collection or Cockroft-Gault glomerular filtration rate estimation.
- Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use two effective forms of contraception during program therapy and for at least 6 months after completion of program therapy
- Negative serum pregnancy test prior to commencement of dosing in women of childbearing potential
- Patient should be able to swallow tablets
- Absence of any psychological, familial, sociological, or geographical condition that potentially hampers compliance with the treatment regimen
- Patient does not currently participate in other clinical trials
Who cannot join
- Palliative radiotherapy within 7 days prior to the first dose of program treatment
- Patients with active malignancy (other than BRAF-mutated melanoma) or a previous malignancy within the past 3 years except for patients with resected melanoma, resected BCC, resected cutaneous SCC, resected melanoma in situ, resected carcinoma in situ of the cervix, and resected carcinoma in situ of the breast
- 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
- Systemic risk factor for RVO including uncontrolled glaucoma, uncontrolled hypercholesterolemia, hypertriglyceridemia or hyperglycemia
- History of clinically significant cardiac dysfunction, including the following:
- Current unstable angina.
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- Symptomatic congestive heart failure of New York Heart Association class 2 or higher.
- History of congenital long QT syndrome or mean (average of triplicate measurements) QTcF ≥ 450 msec at baseline; presence of clinically significant ventricular or atrial dysrhythmias ≥ Grade 2.
- Uncontrolled hypertension ≥ Grade 2 (patients with a history hypertension controlled with anti-hypertensives to ≤ Grade 1 are eligible).
- Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower
- Current severe, uncontrolled systemic disease
- Major surgery or traumatic injury within 14 days prior to first dose of program treatment
- History of malabsorption or other condition that would interfere with absorption of program drugs
- Hypersensitivity to the active substance or to any of the excipients
- Pregnant or breastfeeding women
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
Istituto dei Tumori "Giovanni Paolo II"
Bari, BA, 70124
ASST Papa Giovanni XXIII
Bergamo, BG, 24127
Policlinico Sant'Orsola Malpighi
Bologna, BO, 40138
Ospedale Policlinico San Martino
Genova, GE, 16132
IRCCS IRST Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, FC, 47014
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, 20133
Istituto Europeo di Oncologia - Divisione Melanoma, Sarcoma e Tumori Rari
Milan, 20141
Istituto Oncologico Veneto - IRCCS
Padova, PD, 35128
Ospedale S. Chiara - A.O.U. Pisana
Pisa, PI, 56125
Istituti Fisioterapici Ospitalieri - IFO - Istituto "Regina Elena"
Roma, 00144
IDI Istituto Dermopatico Immacolata
Roma, 00167
A.O.U.S. Policlinico "Le Scotte"
Siena, SI, 53100
P.O. di Taormina - Azienda Sanitaria Provinciale di Messina
Taormina, ME, 98039
P.O. San Lazzaro - A.O.U. Città della Salute e della Scienza di Torino - Molinette
Torino, TO, 10126
About this study
Official title: An Evaluation of the Efficacy Beyond Progression of Vemurafenib Combined With Cobimetinib Associated With Local Treatment Compared to Second-line Treatment in Patients With BRAFV600 Mutation-positive Metastatic Melanoma in Focal Progression With First-line Combined Vemurafenib and Cobimetinib.
The purpose of this study is to evaluate the efficacy beyond progression of vemurafenib combined with cobimetinib associated with local treatment compared to second-line treatment in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.
Read the detailed description
Melanoma is a heterogeneous skin tumor, characterized by mutations of different oncogenes. Almost half of patients with advanced melanoma have a gene mutation of BRAF serine-threonine kinase. Over the past 5 years, two BRAF inhibitors targeting these mutations, vemurafenib and dabrafenib, have shown high rates of rapid response in phase II and III studies. However, the duration of responses is limited in most patients due to the development of acquired resistance. Mechanisms of resistance to BRAF inhibitor therapy are diverse and include the reactivation of the mitogen-activated protein kinase (MAPK) pathway in over two-thirds of tumors, along with promotion of parallel signaling networks.
Recently, the combination of drugs was superior in terms of responses, Progression Free Survival (PFS) and Overall Survival (OS) compared to monotherapy.
The data from recent studies confirm the clinical benefit of the combination of Vemurafenib with cobimetinib and support the use of the combination as a standard first-line approach to improve survival in patients.
The aim of this randomized, open-label, phase II study is to evaluate the efficacy, in terms of overall survival, of vemurafenib combined with cobimetinib associated with local treatment compared with second-line therapy, in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.
- Conditions
- Melanoma Metastatic, BRAF V600 Mutation
- Being tested
- Experimental combination beyond Focal Progression, Pembrolizumab or Nivolumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental combination beyond Focal ProgressionOther
Vemurafenib is taken on a 28-day cycle. Each dose consists of four 240 mg (960 mg) tablets twice daily for 28 consecutive days. The first dose should be taken in the morning and the second dose in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Vemurafenib tablets should be swallowed whole with a glass of water and should not be chewed or crushed.
Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken orally, once daily for 21 consecutive days, followed by a 7-day break. Each subsequent treatment cycle should start after the 7-day treatment break has elapsed. The dose should be taken in the morning.
Local treatment (i.e. surgery, radiotherapy).
Pembrolizumab or NivolumabDrug
Also called Keytruda or Opdivo
Pembrolizumab 2 mg/kg is administered as an intravenous infusion over 30 minutes every 3 weeks OR Nivolumab 3 mg/kg is administered intravenously over 60 minutes every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental combination beyond Focal Progression | Experimental | Local treatment (i.e. surgery, radiotherapy) + Vemurafenib 240mg tablets (4 tabs/twice daily for 28 consecutive days) + Cobimetinib 20mg tablets (3 tabs/day for 21 consecutive days) beyond focal progression. Receives: Other: Experimental combination beyond Focal Progression |
| Pembrolizumab or Nivolumab | Active comparator | Pembrolizumab daily dose 2 mg/kg milligram(s)/kilogram or Nivolumab daily dose 3 mg/kg milligram(s)/kilogram. Receives: Drug: Pembrolizumab or Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) time for patients with focal progression
Overall survival of patients with focal progression is defined as the time, in months, from randomization to the date of death from any cause. If a patient is not known to have died, survival time will be censored at the date of last contact ("last known date alive"). Overall survival of patients with focal progression will be compared between treatment groups using a log-rank test procedure with a two-sided α =0.2 level. The OS function for each treatment group will be estimated using the Kaplan-Meier product-limit method. Median and corresponding two-sided 80% confidence intervals will be computed by treatment group. A Cox proportional hazard model for OS with treatment arm as single factor will be used to estimate the hazard ratio of vemurafenib and cobimetinib plus local treatment to Standard of Care (SOC) second-line treatment and its corresponding 80% confidence interval.
Measured: From date of randomization until the date of death from any cause, assessed up to 24 months
Secondary outcomes (12)
Progression Free Survival (PFS) time for patients with focal progression
PFS of patients with focal progression is defined as the time, in months, from randomization to the date of the first documented tumor progression or death due to any cause, whichever comes first. Clinical deterioration will not be considered progression. For subjects who neither progress nor die, time will be censored at the date of their last tumor assessment. For subjects who start a new anti-tumor treatment, time will be censored at the start of the new treatment. For a randomized subject who does not have any post-randomization tumor assessments and who has not died, time will be censored at the randomization date. PFS will be compared between treatment groups using a log-rank test procedure with a two-sided α =0.2 level. The PFS function for each treatment group will be estimated using the Kaplan-Meier product-limit method. Median and two-sided 80% confidence intervals (CI) for median PFS will be computed by treatment group. A Cox proportional hazard model for PFS with treatment
Measured: From date of randomization until the date of death from any cause, assessed up to 24 months
Overall Survival (OS) time for patients with non-focal progression
Overall survival of patients with non-focal progression is defined as the time, in months, from date of non-focal progression to first-line to the date of death from any cause. If a patient is not known to have died, survival time will be censored at the date of last contact ("last known date alive"). The OS function will be estimated using the Kaplan-Meier product-limit method. Median and corresponding two-sided 80% confidence intervals will be computed. Overall survival results of patients with non-focal progression will be descriptively compared with OS results of patients with focal progression (i.e. primary efficacy endpoint).
Measured: From date of the last dose of vemurafenib and cobimetinib until the date of death from any cause, assessed up to 24 months
Comparison between Overall Survival (OS) time for patients with non-focal progression and Overall Survival (OS) results of patients with focal progression
Overall survival results of patients with non-focal progression will be descriptively compared with OS results of patients with focal progression (i.e. primary efficacy endpoint). No statistical test will be foreseen for this comparison. The overall survival results are defined as the time, in months, from the date of progression to the date of death.
Measured: From date of randomization or date of the last dose of vemurafenib and cobimetinib until the date of death from any cause, assessed up to 24 months
Nature of adverse events (AE) and serious adverse events (SAE) reported throughout the study
Nature of adverse events (AE) and serious adverse events (SAE) verified during the study. Safety analyses will be reported by actual treatment group and on the Non-focal Progression Set. AE and SAE will be assessed according to the Common Terminology Criteria for AEs (CTCAE version 4).
Measured: From baseline up to 24 months after the last treatment
Frequency of adverse events (AE) and serious adverse events (SAE) reported throughout the study
Frequency of adverse events (AE) and serious adverse events (SAE) verified during the study. Safety analyses will be reported by actual treatment group and on the Non-focal Progression Set. AE and SAE will be assessed according to the Common Terminology Criteria for AEs (CTCAE version 4).
Measured: From baseline up to 24 months after the last treatment
Severity of adverse events (AE) and serious adverse events (SAE) reported throughout the study
Severity of adverse events (AE) and serious adverse events (SAE) verified during the study. Safety analyses will be reported by actual treatment group and on the Non-focal Progression Set. AE and SAE will be assessed according to the Common Terminology Criteria for AEs (CTCAE version 4).
Measured: From baseline up to 24 months after the last treatment
Timing of adverse events (AE) and serious adverse events (SAE) reported throughout the study
Timing of adverse events (AE) and serious adverse events (SAE) verified during the study. Safety analyses will be reported by actual treatment group and on the Non-focal Progression Set. AE and SAE will be assessed according to the Common Terminology Criteria for AEs (CTCAE version 4).
Measured: From baseline up to 24 months after the last treatment
Changes in blood pressure
Changes in blood pressure during and following vemurafenib + cobimetinib administration. Blood pressure will be measured in mmHg (millimetres of mercury).
Measured: From baseline up to 24 months
Changes in heart rate
Changes in heart rate during and following vemurafenib + cobimetinib administration. Heart rate will be measured in bpm (beats per minute).
Measured: From baseline up to 24 months
Changes in temperature
Changes in temperature during and following vemurafenib + cobimetinib administration. Temperature will be measured in °C (degrees centigrade).
Measured: From baseline up to 24 months
Changes in respiratory rate
Changes in respiratory rate during and following vemurafenib + cobimetinib administration. Respiratory rate will be measured in breaths per minute.
Measured: From baseline up to 24 months
Changes in clinical laboratory results
Changes in clinical laboratory results during and following vemurafenib + cobimetinib administration. Laboratory results will be assessed according to the Common Terminology Criteria for AEs (CTCAE version 4).
Measured: From baseline up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start18 Jun 2018
- Primary completion29 Apr 2023 (estimated)
- Study completion29 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma MetastaticStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, open-label study
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergruppo Melanoma Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paola Queirolo, Dr., Principal investigator, Ospedale Policlinico San Martino di Genova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514901
- Sponsor's protocol ID
- BeyPro2
- Status last verified
- Dec 2021
- First submitted
- 28 Mar 2018
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Efficacy Beyond Progression of Vemurafenib Combined With Cobimetinib Associated With Local Treatment Compared to Second-line Treatment in Patients With BRAFV600 Mutation-positive Metastatic Melanoma in Focal Progression With First-line Combined Vemurafenib and Cobimetinib.
- ClinicalTrials.gov ID
- NCT03514901
- Acronym / sponsor ID
- BeyPro2
- Conditions
- Melanoma Metastatic, BRAF V600 Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Intergruppo Melanoma ItalianoUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 29 Apr 2023 (estimated)
- Study completion
- 29 Apr 2023 (estimated)
- First posted
- 3 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy beyond progression of vemurafenib combined with cobimetinib associated with local treatment compared to second-line treatment in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.
Detailed description
Melanoma is a heterogeneous skin tumor, characterized by mutations of different oncogenes. Almost half of patients with advanced melanoma have a gene mutation of BRAF serine-threonine kinase. Over the past 5 years, two BRAF inhibitors targeting these mutations, vemurafenib and dabrafenib, have shown high rates of rapid response in phase II and III studies. However, the duration of responses is limited in most patients due to the development of acquired resistance. Mechanisms of resistance to BRAF inhibitor therapy are diverse and include the reactivation of the mitogen-activated protein kinase (MAPK) pathway in over two-thirds of tumors, along with promotion of parallel signaling networks.
Recently, the combination of drugs was superior in terms of responses, Progression Free Survival (PFS) and Overall Survival (OS) compared to monotherapy.
The data from recent studies confirm the clinical benefit of the combination of Vemurafenib with cobimetinib and support the use of the combination as a standard first-line approach to improve survival in patients.
The aim of this randomized, open-label, phase II study is to evaluate the efficacy, in terms of overall survival, of vemurafenib combined with cobimetinib associated with local treatment compared with second-line therapy, in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, open-label study
| Arm | Type | Receives |
|---|---|---|
| Experimental combination beyond Focal Progression | Experimental | Other: Experimental combination beyond Focal ProgressionLocal treatment (i.e. surgery, radiotherapy) + Vemurafenib 240mg tablets (4 tabs/twice daily for 28 consecutive days) + Cobimetinib 20mg tablets (3 tabs/day for 21 consecutive days) beyond focal progression. |
| Pembrolizumab or Nivolumab | Active comparator | Drug: Pembrolizumab or NivolumabPembrolizumab daily dose 2 mg/kg milligram(s)/kilogram or Nivolumab daily dose 3 mg/kg milligram(s)/kilogram. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients with histologically confirmed melanoma, either unresectable Stage IIIc or Stage IV metastatic melanoma, as defined by the American Joint Committee on Cancer 7th edition
- Patients previously untreated for metastatic melanoma
- Documentation of BRAFV600 mutation-positive status in melanoma tumor tissue (archival or newly obtained tumor samples) by a validated mutational test
- Adequate performance status to receive vemurafenib and cobimetinib therapy as determined by treating physician
- Male or female patient aged ≥18 years
Key exclusion criteria (15 listed)
- Palliative radiotherapy within 7 days prior to the first dose of program treatment
- Patients with active malignancy (other than BRAF-mutated melanoma) or a previous malignancy within the past 3 years except for patients with resected melanoma, resected BCC, resected cutaneous SCC, resected melanoma in situ, resected carcinoma in situ of the cervix, and resected carcinoma in situ of the breast
- 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
- Systemic risk factor for RVO including uncontrolled glaucoma, uncontrolled hypercholesterolemia, hypertriglyceridemia or hyperglycemia
- History of clinically significant cardiac dysfunction, including the following:
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 |
|---|---|---|
| Experimental combination beyond Focal ProgressionVemurafenib is taken on a 28-day cycle. Each dose consists of four 240 mg (960 mg) tablets twice daily for 28 consecutive days. The first dose should be taken in the morning and the second dose in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Vemurafenib tablets should be swallowed whole with a glass of water and should not be chewed or crushed. Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken orally, once daily for 21 consecutive days, followed by a 7-day break. Each subsequent treatment cycle should start after the 7-day treatment break has elapsed. The dose should be taken in the morning. Local treatment (i.e. surgery, radiotherapy). | Other | Experimental combination beyond Focal Progression |
| Pembrolizumab or NivolumabAlso: Keytruda or OpdivoPembrolizumab 2 mg/kg is administered as an intravenous infusion over 30 minutes every 3 weeks OR Nivolumab 3 mg/kg is administered intravenously over 60 minutes every 2 weeks. | Drug | Pembrolizumab or Nivolumab |
Primary outcome
Overall Survival (OS) time for patients with focal progression
Time frame: From date of randomization until the date of death from any cause, assessed up to 24 months
Overall survival of patients with focal progression is defined as the time, in months, from randomization to the date of death from any cause. If a patient is not known to have died, survival time will be censored at the date of last contact ("last known date alive"). Overall survival of patients with focal progression will be compared between treatment groups using a log-rank test procedure with a two-sided α =0.2 level. The OS function for each treatment group will be estimated using the Kaplan-Meier product-limit method. Median and corresponding two-sided 80% confidence intervals will be computed by treatment group. A Cox proportional hazard model for OS with treatment arm as single factor will be used to estimate the hazard ratio of vemurafenib and cobimetinib plus local treatment to Standard of Care (SOC) second-line treatment and its corresponding 80% confidence interval.
12 secondary outcomes
Progression Free Survival (PFS) time for patients with focal progression
Time frame: From date of randomization until the date of death from any cause, assessed up to 24 months
Overall Survival (OS) time for patients with non-focal progression
Time frame: From date of the last dose of vemurafenib and cobimetinib until the date of death from any cause, assessed up to 24 months
Comparison between Overall Survival (OS) time for patients with non-focal progression and Overall Survival (OS) results of patients with focal progression
Time frame: From date of randomization or date of the last dose of vemurafenib and cobimetinib until the date of death from any cause, assessed up to 24 months
Nature of adverse events (AE) and serious adverse events (SAE) reported throughout the study
Time frame: From baseline up to 24 months after the last treatment
Frequency of adverse events (AE) and serious adverse events (SAE) reported throughout the study
Time frame: From baseline up to 24 months after the last treatment
Severity of adverse events (AE) and serious adverse events (SAE) reported throughout the study
Time frame: From baseline up to 24 months after the last treatment
Timing of adverse events (AE) and serious adverse events (SAE) reported throughout the study
Time frame: From baseline up to 24 months after the last treatment
Changes in blood pressure
Time frame: From baseline up to 24 months
Changes in heart rate
Time frame: From baseline up to 24 months
Changes in temperature
Time frame: From baseline up to 24 months
Changes in respiratory rate
Time frame: From baseline up to 24 months
Changes in clinical laboratory results
Time frame: From baseline up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
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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.
Paola Queirolo, Dr. principal investigator
Ospedale Policlinico San Martino di Genova
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Experimental combination beyond Focal Progression and Pembrolizumab or Nivolumab in people with Melanoma Metastatic and BRAF V600 Mutation, run by Intergruppo Melanoma Italiano at 14 sites in Italy.
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 17 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: status not confirmed, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. 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?
Results are not available in the source record.
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?
Overall Survival (OS) time for patients with focal progression (time frame: From date of randomization until the date of death from any cause, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.