MelanomaPhase 2NEO-TIMNCT04722575
Combination or Sequence of Vemurafenib, Cobimetinib, and Atezolizumab in High-risk, Resectable Melanoma
A Phase 2 study testing Cobimetinib 20 MG Oral Tablet, Vemurafenib 240 Mg Oral Capsule and Atezolizumab 1200 MG in 20 ML Injection in people with Melanoma, run by Fondazione Melanoma Onlus at 6 sites in Italy.
Trial summary
Neoadjuvant plus adjuvant treatment with target therapy and immunotherapy given in combination or sequence may have an anti-tumour activity and may reduce the risk of relapse in patients with high-risk resectable melanoma (stage III B / C / D and oligometastatic stage IV). 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 20 MG Oral Tablet, Vemurafenib 240 Mg Oral Capsule and Atezolizumab 1200 MG in 20 ML Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 6 sitesItaly
- Study dates
- 3 Dec 2020to Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex aged ≥18 years;
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form;
- Patients must have histologically or cytologically confirmed Stage IIIB/C/D or oligometastatic stage IV1 resectable melanoma. The definition of resectability can be determined by the patient's surgical oncologist and verified via discussion at Multidisciplinary Tumour Conference attended by melanoma medical and surgical oncology staff. Resectable tumours are defined as having no significant vascular, neural or bony involvement. Only cases where a complete surgical resection with tumour-free margins can safely be achieved are defined as resectable;
- All patients must have a BRAF V600E/K mutation status known;
- Patients must be medically fit enough to undergo surgery as determined by the surgical oncology team;
- Patients must have measurable disease, defined by RECIST 1.1;
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- ECOG performance status 0-1; *
- Patients must have organ and marrow function
- Absence of any psychological, familiar or social condition that may affect compliance with study protocol and schedule follow-up;
- Female subjects of childbearing potential must have a negative pregnancy test result at baseline and must practice a reliable method of contraception for the total study duration plus 23 weeks (i.e. 30 days plus the time required for experimental drugs to undergo five half-lives) after the last dose of experimental drugs; *
- Men who are sexually active with women of childbearing potential must practice a reliable method of contraception for the total study duration plus 31 weeks (i.e. 80 days plus the time required for experimental drugs to undergo five half-lives) after the last dose of experimental drugs.
Who cannot join
- Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug; *
- Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 years;
- Any major surgery within the last 3 weeks;
- Pregnancy and/or breast feeding or of childbearing potential and not practicing a reliable method of birth control;*
- Unwillingness or inability to follow the procedures required in the protocol; *
- Uncontrolled diabetes, hypertension or other medical conditions that may interfere with assessment of toxicity;*
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- Current use of anticoagulants (warfarin, heparin, direct thrombin inhibitors) at therapeutic levels*
- Patients with a history of uncontrolled cardiovascular or interstitial lung disease and evidence or risk of retinal vein occlusion or central serous retinopathy;
- Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment; *
- Prior BRAF or MEK directed therapy; patients who have received prior interferon are eligible;
- History of retinopathy or any finding at ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/central serous chorioretinopathy, retinal vein occlusion (RVO), or neovascular macular de generation;
- Presence of any of the following risk factors for RVO: a) Uncontrolled glaucoma with intraocular pressures ≥ 21mmHg; b) Serum cholesterol ≥Grade 2; c) Hypertriglyceridemia ≥ Grade 2; d) Hyperglycaemia (fasting) ≥Grade 2;
- Correct QT interval > 450msec to baseline, history of congenital long QT syndrome;
- Uncontrolled medical condition among which endocrine disorders (such as hypothyroidism, hyperthyroidism and diabetes mellitus);
- Other severe medical or psychiatric conditions (like depression) or abnormalities of laboratory tests that may increase the risk associated with study participation or the assumption of Vemurafenib, Atezolizumab and Cobimetinib or that may interfere with the interpretation of study results, which in the judgment of the Investigator can make the patient not eligible for the study;
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, cerebrovascular accident or transient ischemic attack, pulmonary embolism, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent;
- History of active primary immunodeficiency;
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IMP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IMP and up to 30 days after the last dose of IMP; *
- Prior treatment with an anti- PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody;
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients;
- Positive test for HBV sAg or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection;
- Known history of testing positive for HIV or known AIDS;
- Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Ospedale S.M. Annunziata - Azienda USL Toscana Centro
Bagno a Ripoli, Firenze, 50012
IRCCS San Martino - IST
Genova, 16132
IRCCS - Istituto Scientifico Romagnolo per la Cura e lo Studio dei Tumori (I.R.S.T) S.r.l.
Meldola, Forlì-Cesena, 47014
Fondazione I.R.C.C.S. Istituto Nazionale dei Tumori
Milan, Milano, 20133
Istituto Nazionale per lo Studio e la Cura dei Tumori "Fondazione Giovanni Pascale"
Naples, Naples, 80131
Istituto Oncologico Veneto
Padova, Padova, 35128
About this study
Official title: "NEOadjuvant Plus Adjuvant Therapy With Combination or Sequence of Vemurafenib, cobImetinib, and atezolizuMab in Patients With High-risk, Surgically Resectable BRAF Mutated and Wild-type Melanoma"
Neoadjuvant plus adjuvant treatment with target therapy and immunotherapy given in combination or sequence may have an anti-tumour activity and may reduce the risk of relapse in patients with high-risk resectable melanoma (stage III B / C / D and oligometastatic stage IV).
Read the detailed description
Melanoma represents a considerable health burden and an ongoing area of unmet need in oncology. Despite melanoma accounts for only 1% of diagnosed skin cancers, it is the cause of most skin cancer-related deaths. Until recently, limited effective treatment options were available to patients with advanced melanoma. Historically, response rates to conventional chemotherapy and immunomodulation therapy (interleukin-2 or interferon-γ) have been reported at approximately 5-19%.
Adjuvant immune checkpoint blockade (ICB) and target therapy improve outcomes of patients with high-risk resectable melanoma. It has recently been demonstrated that treatment with neoadjuvant and adjuvant targeted therapy (dabrafenib and trametinib) is associated with a high pathologic complete response (pCR) rate and improved outcomes over surgery alone. However, treatment with ICB has not been well studied in the neoadjuvant setting, despite preclinical studies suggesting that neoadjuvant administration of ICB is associated with improved survival and enhanced anti-tumour immune responses compared to the same therapy administered in the adjuvant setting.
The advantage of neoadjuvant trials is the availability of blood and tumour tissue samples before and after systemic therapy for the conduct of novel mechanistic and biomarker studies in the circulation and the tumour microenvironment.
Prospective neoadjuvant clinical trials with targeted (dabrafenib/trametinib combo) or immunotherapeutic agents (nivolumab alone or nivolumab/ipilimumab combo) and combinations are now running in a subgroup of highrisk melanoma patients with pooled overall promising preliminary results of high rates of pathologic complete responses (pCRs, 30-50%) and early data of positive correlation between pCR and relapse-free survival. Based on the available results to date, we aim to conduct a randomized, noncomparative phase II trial to define the role of neoadjuvant plus adjuvant target and immunotherapy, given in combination or sequence, in patients with high risk surgically resectable melanoma.This approach has the potential to define whether neoadjuvant treatment has antitumour activity and whether it reduces the risk of relapse after surgery.
- Conditions
- Melanoma
- Being tested
- Cobimetinib 20 MG Oral Tablet, Vemurafenib 240 Mg Oral Capsule, Atezolizumab 1200 MG in 20 ML Injection
- Keywords
- resectable melanoma, BRAF mutated, high risk melanoma, wild type
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cobimetinib 20 MG Oral TabletDrug
Also called Cotellic
Cobimetinib 60 mg qd p.o. from week 1 to week 3 and week 5 to week 6. Week 4 off.
Vemurafenib 240 Mg Oral CapsuleDrug
Also called Zelboraf
960 (arm A) /720 (arm B) mg bid p.o. from week 1 to week 6.
Atezolizumab 1200 MG in 20 ML InjectionDrug
Also called Tecentriq
840 mg IV for 2 cycles for Arm B and C. After surgery in all arms 1200 mg IV for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Experimental | Arm A BRAF mutated patients. Over a period of 6 weeks (1) + (2):
1. Vemurafenib 960 mg bid p.o. from week 1 to week 6.
2. Cobimetinib 60 mg qd p.o. from week 1 to week 3 and week 5 to week 6. Week 4 off.
After surgery and a second screening period (up to six weeks): Atezolizumab 1200 mg IV for 52 weeks Receives: Drug: Cobimetinib 20 MG Oral Tablet; Drug: Vemurafenib 240 Mg Oral Capsule; Drug: Atezolizumab 1200 MG in 20 ML Injection |
| ARM B | Experimental | Arm B BRAF mutated patients. Over a period of 6 weeks (1) + (2) + (3):
1. Vemurafenib 720 mg bid p.o. from week 1 to week 6.
2. Cobimetinib 60 mg qd p.o. from week 1 to week 3 and from week 5 to week 6. Week 4 off.
3. Atezolizumab 840 mg IV for 2 cycles (day 1 of week 4 and day 1 of week 7).
After surgery and a second screening period (up to six weeks): Atezolizumab 1200 mg IV for 52 weeks Receives: Drug: Cobimetinib 20 MG Oral Tablet; Drug: Vemurafenib 240 Mg Oral Capsule; Drug: Atezolizumab 1200 MG in 20 ML Injection |
| ARM C | Experimental | Arm C BRAF WT patients. Over a period of six weeks (1) + (2):
1. Cobimetinib 60 mg qd p.o. from week 1 to week 3 and from week 5 to week 6,
2. Atezolizumab 840 mg IV for 2 cycles (day 1 of week 1 and day 1 of week 4).
After surgery and a second screening period (up to six weeks): Atezolizumab 1200 mg IV for 52 weeks Receives: Drug: Cobimetinib 20 MG Oral Tablet; Drug: Atezolizumab 1200 MG in 20 ML Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR) rate (Centrally/Independently determined)
Defined as the lack of all signs of cancer in tissue samples removed during surgery
Measured: At surgery (from week 8 to week 9)
Secondary outcomes (5)
Recurrence-free survival (RFS)
Defined as the time from randomisation to recurrence event or last follow-up
Measured: At 2-years, 3-years and at the end of the study
Overall survival (OS)
Defined as the time from the date of randomisation to the date of death due to any cause
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
pORR
Defined as the sum of pathologic complete responses (pCRs), near pathologic complete responses near pCRs) and pathologic partial responses (pPRs).
Measured: At surgery (from week 8 to week 9) after neoadjuvant treatment and at disease relapse up to 5 years
Safety - adverse events
All AEs, Grade 3 to 4 AEs, serious adverse events (SAEs), deaths, AEs of special interest (AESIs), and AEs leading to treatment discontinuation or withdrawal from the study
Measured: Continuosly during the trial while on treatment or within 30 days after the last study treatment
Molecular and immunophenotypic changes
Immunoscore, Circulating cytokines and chemokines profiling, Metabolomic profiling,Tumour mutational burden, Myeloid-derived suppressors cells, immune cell subtypes expression and lymphocyte activation, Additional analysis of protein levels (i.e. CCR5), DNA mutations, and/or mRNA analysis
Measured: At baseline, prior to surgery, every 12 weeks during adjuvant treatment and at the disease relapse up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start3 Dec 2020
- Primary completion15 Dec 2023
- Study completionJun 2027 (estimated)
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.
- 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
- The study will be conducted according to an open-label, randomized, not comparative phase II design. Three arms for a total of 88 patients will be considered. BRAF mutated patients will be randomized in two arms: Arm A and Arm B (27 patients per arm). BRAF WT patients will be included in Arm C (34 patients).
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Melanoma Onlus
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research Technology S.r.l.
- Responsible party
- Sponsor
- Investigators
- Paolo Ascierto, Study chair, Fondazione Melanoma Onlus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722575
- Sponsor's protocol ID
- NEO-TIM
- Acronym
- NEO-TIM
- Status last verified
- Jun 2026
- First submitted
- 18 Jan 2021
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "NEOadjuvant Plus Adjuvant Therapy With Combination or Sequence of Vemurafenib, cobImetinib, and atezolizuMab in Patients With High-risk, Surgically Resectable BRAF Mutated and Wild-type Melanoma"
- ClinicalTrials.gov ID
- NCT04722575
- Acronym / sponsor ID
- NEO-TIM / NEO-TIM
- Conditions
- Melanoma
- Keywords
- resectable melanoma, BRAF mutated, high risk melanoma, wild type
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Fondazione Melanoma OnlusUniversity, hospital or other
- Collaborators
- Clinical Research Technology S.r.l.
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 25 Jan 2021 (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.
Neoadjuvant plus adjuvant treatment with target therapy and immunotherapy given in combination or sequence may have an anti-tumour activity and may reduce the risk of relapse in patients with high-risk resectable melanoma (stage III B / C / D and oligometastatic stage IV).
Detailed description
Melanoma represents a considerable health burden and an ongoing area of unmet need in oncology. Despite melanoma accounts for only 1% of diagnosed skin cancers, it is the cause of most skin cancer-related deaths. Until recently, limited effective treatment options were available to patients with advanced melanoma. Historically, response rates to conventional chemotherapy and immunomodulation therapy (interleukin-2 or interferon-γ) have been reported at approximately 5-19%.
Adjuvant immune checkpoint blockade (ICB) and target therapy improve outcomes of patients with high-risk resectable melanoma. It has recently been demonstrated that treatment with neoadjuvant and adjuvant targeted therapy (dabrafenib and trametinib) is associated with a high pathologic complete response (pCR) rate and improved outcomes over surgery alone. However, treatment with ICB has not been well studied in the neoadjuvant setting, despite preclinical studies suggesting that neoadjuvant administration of ICB is associated with improved survival and enhanced anti-tumour immune responses compared to the same therapy administered in the adjuvant setting.
The advantage of neoadjuvant trials is the availability of blood and tumour tissue samples before and after systemic therapy for the conduct of novel mechanistic and biomarker studies in the circulation and the tumour microenvironment.
Prospective neoadjuvant clinical trials with targeted (dabrafenib/trametinib combo) or immunotherapeutic agents (nivolumab alone or nivolumab/ipilimumab combo) and combinations are now running in a subgroup of highrisk melanoma patients with pooled overall promising preliminary results of high rates of pathologic complete responses (pCRs, 30-50%) and early data of positive correlation between pCR and relapse-free survival. Based on the available results to date, we aim to conduct a randomized, noncomparative phase II trial to define the role of neoadjuvant plus adjuvant target and immunotherapy, given in combination or sequence, in patients with high risk surgically resectable melanoma.This approach has the potential to define whether neoadjuvant treatment has antitumour activity and whether it reduces the risk of relapse after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study will be conducted according to an open-label, randomized, not comparative phase II design. Three arms for a total of 88 patients will be considered. BRAF mutated patients will be randomized in two arms: Arm A and Arm B (27 patients per arm). BRAF WT patients will be included in Arm C (34 patients).
| Arm | Type | Receives |
|---|---|---|
| ARM A | Experimental | Drug: Cobimetinib 20 MG Oral Tablet, Drug: Vemurafenib 240 Mg Oral Capsule, Drug: Atezolizumab 1200 MG in 20 ML InjectionArm A BRAF mutated patients. Over a period of 6 weeks (1) + (2): 1. Vemurafenib 960 mg bid p.o. from week 1 to week 6. 2. Cobimetinib 60 mg qd p.o. from week 1 to week 3 and week 5 to week 6. Week 4 off. After surgery and a second screening period (up to six weeks): Atezolizumab 1200 mg IV for 52 weeks |
| ARM B | Experimental | Drug: Cobimetinib 20 MG Oral Tablet, Drug: Vemurafenib 240 Mg Oral Capsule, Drug: Atezolizumab 1200 MG in 20 ML InjectionArm B BRAF mutated patients. Over a period of 6 weeks (1) + (2) + (3): 1. Vemurafenib 720 mg bid p.o. from week 1 to week 6. 2. Cobimetinib 60 mg qd p.o. from week 1 to week 3 and from week 5 to week 6. Week 4 off. 3. Atezolizumab 840 mg IV for 2 cycles (day 1 of week 4 and day 1 of week 7). After surgery and a second screening period (up to six weeks): Atezolizumab 1200 mg IV for 52 weeks |
| ARM C | Experimental | Drug: Cobimetinib 20 MG Oral Tablet, Drug: Atezolizumab 1200 MG in 20 ML InjectionArm C BRAF WT patients. Over a period of six weeks (1) + (2): 1. Cobimetinib 60 mg qd p.o. from week 1 to week 3 and from week 5 to week 6, 2. Atezolizumab 840 mg IV for 2 cycles (day 1 of week 1 and day 1 of week 4). After surgery and a second screening period (up to six weeks): Atezolizumab 1200 mg IV for 52 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients of either sex aged ≥18 years;
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form;
- Patients must have histologically or cytologically confirmed Stage IIIB/C/D or oligometastatic stage IV1 resectable melanoma. The definition of resectability can be determined by the patient's surgical oncologist and verified via discussion at Multidisciplinary Tumour Conference attended by melanoma medical and surgical oncology staff. Resectable tumours are defined as having no significant vascular, neural or bony involvement. Only cases where a complete surgical resection with tumour-free margins can safely be achieved are defined as resectable;
- All patients must have a BRAF V600E/K mutation status known;
- Patients must be medically fit enough to undergo surgery as determined by the surgical oncology team;
Key exclusion criteria (23 listed)
- Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug; *
- Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 years;
- Any major surgery within the last 3 weeks;
- Pregnancy and/or breast feeding or of childbearing potential and not practicing a reliable method of birth control;*
- Unwillingness or inability to follow the procedures required in the protocol; *
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 |
|---|---|---|
| Cobimetinib 20 MG Oral TabletAlso: CotellicCobimetinib 60 mg qd p.o. from week 1 to week 3 and week 5 to week 6. Week 4 off. | Drug | ARM A, ARM B, ARM C |
| Vemurafenib 240 Mg Oral CapsuleAlso: Zelboraf960 (arm A) /720 (arm B) mg bid p.o. from week 1 to week 6. | Drug | ARM A, ARM B |
| Atezolizumab 1200 MG in 20 ML InjectionAlso: Tecentriq840 mg IV for 2 cycles for Arm B and C. After surgery in all arms 1200 mg IV for 52 weeks | Drug | ARM A, ARM B, ARM C |
Primary outcome
Pathologic Complete Response (pCR) rate (Centrally/Independently determined)
Time frame: At surgery (from week 8 to week 9)
Defined as the lack of all signs of cancer in tissue samples removed during surgery
5 secondary outcomes
Recurrence-free survival (RFS)
Time frame: At 2-years, 3-years and at the end of the study
Overall survival (OS)
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
pORR
Time frame: At surgery (from week 8 to week 9) after neoadjuvant treatment and at disease relapse up to 5 years
Safety - adverse events
Time frame: Continuosly during the trial while on treatment or within 30 days after the last study treatment
Molecular and immunophenotypic changes
Time frame: At baseline, prior to surgery, every 12 weeks during adjuvant treatment and at the disease relapse up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- 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.
Paolo Ascierto study chair
Fondazione Melanoma Onlus
6 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 Cobimetinib 20 MG Oral Tablet, Vemurafenib 240 Mg Oral Capsule and Atezolizumab 1200 MG in 20 ML Injection in people with Melanoma, run by Fondazione Melanoma Onlus at 6 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 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) rate (Centrally/Independently determined) (time frame: At surgery (from week 8 to week 9)). 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 18 Jun 2026.