Malignant MelanomaPhase 2ImmunoCobiVemNCT02902029
Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
A Phase 2 study testing Vemurafenib, Cobimetinib and Atezolizumab in people with Malignant Melanoma, run by University Hospital, Essen at 27 sites in 4 countries.
Trial summary
Most patients with locally advanced or metastatic tumors succumb to their disease. Thus, there is a substantial need for novel therapeutic strategies to improve the outcome for patients with advanced or metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Vemurafenib, Cobimetinib and Atezolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 27 sitesin 4 countries
- Study dates
- Nov 2016to Mar 2024
- 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
- Be willing and able to provide written informed consent for the trial.
- Male or female patient being ≥18 years of age on day of signing informed consent.
- Histologically confirmed diagnosis of locally advanced, unresectable or metastatic melanoma AJCC (unresectable stage IIIB, IIIC, IVM1a, IVM1b, or IVM1c) without active or untreated brain metastases; all known CNS lesions must have been treated with stereotactic therapy or surgery at least 4 weeks prior to the first dose of trial treatment AND the patient must be without evidence of clinical or radiographic disease progression in the CNS for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms must have returned to baseline, the patient must have no evidence of new or enlarging brain metastases, and the patient must not have used steroids for at least 3 weeks prior to trial treatment.
- No previous therapy for the advanced or metastatic stage. Prior adjuvant therapy is permitted (e.g. Interferon, Interleukin-2-therapy, chemo- or radiotherapy). Prior adjuvant therapy has to be terminated (last dose) at least 28 days before enrolment. Patients who are in follow-up period of a clinical trial in adjuvant setting and progressing may be enrolled / randomized.
- Measurable disease, i.e., present with at least one measurable lesion per RECIST, version 1.1, for the definition of a measureable lesion.
- Presence of BRAF mutation (V600) in tumor tissue.
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- Performance status of 0 or 1 on the ECOG Performance Scale.
- Adequate organ function.
- Adequate cardiac function.
- Able to take oral medications.
- Female subject of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication.
- Female patients of childbearing potential and male patients with partners of childbearing potential must agree to always use a highly effective form of contraception according to CTFG during the course of this study and for at least 6 months after completion of study therapy.
Who cannot join
- Use of any investigational or non-registered product within the 30 days before registration.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study Day 1.
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Prior therapy with a BRAF inhibitor (including but not limited to vemurafenib, dabrafenib, encorafenib and / or MEK inhibitor
- Prior major surgery.
- Known additional malignancy that is progressing or requires active treatment within 5 years prior to the study.
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- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- History of leptomeningeal metastases.
- History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO) or predisposing factors to RVO or CSR.
- History of retinal degenerative disease.
- History of allogenic bone marrow transplantation or organ transplantation.
- History of Gilbert's syndrome.
- Impaired cardiovascular function or clinically significant cardiovascular diseases.
- Uncontrolled arterial hypertension despite medical treatment.
- Impairment of gastrointestinal function or gastrointestinal disease.
- Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Active infection requiring systemic therapy.
- Positive test for Human Immunodeficiency Virus (HIV).
- Positive test for Hepatitis B or Hepatitis C.
- Known hypersensitivity reaction to any of the components of study treatment.
- Medical, psychiatric, cognitive or other conditions, including known alcohol or drug abuse.
- Patients having received a live, attenuated vaccine within 4 weeks prior to the first dose of trial treatment.
- Legal incapacity or limited legal capacity.
Trial locations and contacts
27 sites in 4 countries.
27 sites in 4 countries
Germany20 sites
Charité-Universitätsmedizin Berlin
Berlin, 10117
Elbe Kliniken Stade - Buxtehude
Buxtehude, 21614
Universitätsklinikum Köln
Cologne, 50937
Universitätsklinik Dresden
Dresden, 01307
HELIOS Klinikum Erfurt
Erfurt, Thuringia, 99089
University Hospital Essen, Department of Dermatology, Skin Cancer Center
Essen, North Rhine-Westphalia, 45122
Medizinische Hochschule Hannover
Hanover, 30625
National Centre for Tumour Diseases (NCT)
Heidelberg, Baden-Wurttemberg, 69120
SLK-Kliniken Heilbronn GmbH
Heilbronn, Baden-Wurttemberg, 74078
Universitätsklinikum des Saarlandes
Homburg/Saar, 66421
Universitäts-Hautklinik Kiel
Kiel, 24105
Universitätsklinikum Leipzig
Leipzig, 04103
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538
Gesellschaft für Klinische Forschung Ludwigshafen mbH
Ludwigshafen, 67063
Universitätsklinikum Mainz
Mainz, 55131
University Hospital Mannheim, Clinic for Dermatology
Mannheim, Baden-Wurttemberg, 68167
Johannes Wesling Klinikum Minden
Minden, 32429
Klinikum der Universität München
München, 80337
Universitätsklinikum Tübingen
Tübingen, 72076
Uniklinikum Würzburg
Würzburg, 97080
France5 sites
Hôpital Ambroise-Paré
Boulogne-Billancourt, 92104
Hospital Claude Huriez
Lille, 59000
Hôpital de la Timone
Marseille, 13885
CHU de Nantes
Nantes, 44093
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
About this study
Official title: A Phase II, Open-label, Randomized-controlled Trial Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody Atezolizumab for the Treatment in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
Most patients with locally advanced or metastatic tumors succumb to their disease. Thus, there is a substantial need for novel therapeutic strategies to improve the outcome for patients with advanced or metastatic melanoma. Targeting the the Ras/Raf signalling pathway by BRAF and MEK inhibition as well as targeting immunologic checkpoint control with an antiPD-L1 antibody have emerged as treatment option.
In this study the best timing for sequential use of both treatment options (BRAF/MEK inhibition and antiPD-L1 antibody) in patients with unresectable or metastatic BRAFV600 mutant melanoma will be assessed.
Read the detailed description
At this time there is no experience concerning the sequencing strategy when using the two effective therapeutical approaches as targeting the Ras/Raf signalling pathway by BRAF and MEK inhibition or targeting immunologic checkpoint control with an antiPD-L1 antibody.
This is a prospective, open, multicenter, randomized phase II study in patients with unresectable or metastatic BRAFV600 mutant melanoma. In this study the scheduling of the treatment with a combined BRAF/MEK inhibition and the treatment with an anti-PD-L1 antibody will be assessed.
After a 3 months run-in period with vemurafenib and cobimetinib, all patients who did not show disease progression or treatment interruption for more than 28 days during run-in phase will be randomized in a 1:1 ratio:
- either to proceed vemurafenib and cobimetinib until disease progression and subsequently cross-over to atezolizumab treatment until disease progression (Arm A).
- or to receive the anti-PD-L1 antibody atezolizumab until disease progression and subsequently cross-back to vemurafenib and cobimetinib until disease progression (Arm B). In a translational research program tumor tissue, blood plasma and peripheral blood mononuclear cell will be analyzed to evaluate the biologic effects of treatment sequence on the molecular profile and biomarker expression in tissue and plasma.
- Conditions
- Malignant Melanoma
- Being tested
- Vemurafenib, Cobimetinib, Atezolizumab
- Keywords
- unresectable stage IIIB, IIIC, IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VemurafenibDrug
960 mg vemurafenib BID until progression or unacceptable toxicity develops
CobimetinibDrug
60 mg cobimetinib QD, 21/7 until progression or unacceptable toxicity develops
AtezolizumabDrug
1200 mg atezolizumab administered intravenously on day 1 of each 21 day-cycle. Will be given until progression or unacceptable toxicity develops
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | After a 3 months run-in period with vemurafenib and cobimetinib [960 mg vemurafenib twice daily (BID), 28/0; 60 mg cobimetinib daily (QD), 21/7], all patients who do not show disease progression or definite treatment interruption (e.g. due to unacceptable toxicity) for more than 28 days will be randomized.
Further treatment with vemurafenib and cobimetinib (960 mg vemurafenib BID, 28/0; 60 mg cobimetinib QD, 21/7).
After progression of disease patients in Arm A will subsequently receive atezolizumab treatment (1200 mg/ q3w). Receives: Drug: Vemurafenib; Drug: Cobimetinib; Drug: Atezolizumab |
| Arm B | Experimental | After a 3 months run-in period with vemurafenib and cobimetinib (960 mg vemurafenib BID, 28/0; 60 mg cobimetinib QD, 21/7), all patients who do not show disease progression or definite treatment interruption (e.g. due to unacceptable toxicity) for more than 28 days will be randomized.
Further treatment with atezolizumab. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on day 1 of each 21 day-cycle.
After progression of disease patients in Arm B will cross back to vemurafenib and cobimetinib treatment (960 mg vemurafenib BID, 28/0; 60 mg cobimetinib QD, 21/7). Receives: Drug: Vemurafenib; Drug: Cobimetinib; Drug: Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Documented Disease Progression
Time to first documented disease progression (PFS1) defined as time from start of run-in phase (date of first intake of study drug) to first documented disease progression date according to RECIST v. 1.1. (PD1) or death by any cause, whichever occurs first.
Measured: 4 years
Secondary outcomes (11)
Time to Second Objective Disease Progression (PFS2)
Time to second objective disease progression (PFS2) defined as time from start of run-in phase (date of first intake of study drug) to second documented disease progression according to RECIST v. 1.1. (PD2) following randomization or death by any cause.
Measured: 4 years
Adverse events according to CTCAE Version 4.03 criteria (Safety / Toxicity)
All adverse events according to CTCAE Version 4.03 criteria, and all serious adverse events regardless of causal relationship to the administration of the investigational agents will be assessed
Measured: Until 90 days of discontinuation of dosing of the investigational product
Overall survival
Overall Survival (OS) of a patient defined as the time from start of run-in phase (date of first intake of study drug) until documented date of death
Measured: 4 years
Overall survival 12 months
Overall survival rate at 12 months defined as the rate of patients alive 12 months after start of run-in phase (date of first intake of study drug)
Measured: 1 year
Overall survival 24 months
Overall survival rate at 24 months defined as the rate of patients alive 24 months after start of run-in phase (date of first intake of study drug)
Measured: 2 years
Overall survival 36 months
Overall survival rate at 36 months defined as the rate of patients alive 36 months after start of run-in phase (date of first intake of study drug)
Measured: 3 years
Overall survival 48 months
Overall survival rate at 48 months defined as the rate of patients alive 48 months after start of run-in phase (date of first intake of study drug)
Measured: 4 years
12-months disease control rate (DCR)
DCR is defined as the rate of patients showing complete response (CR) or partial response (PR) or stable disease (SD) at 12 months after start of run-in phase (date of first intake of study drug).
Measured: 1 year
24-months disease control rate (DCR).
DCR is defined as the rate of patients showing complete response (CR) or partial response (PR) or stable disease (SD) at 24 months after start of run-in phase (date of first intake of study drug).
Measured: 2 years
Rate of patients with progressive disease who could not cross-over to subsequent line of therapy due to deterioration of ECOG status or multiple and/or symptomatic brain metastases and/or leptomengial disease
- From vemurafenib + cobimetinib to atezolizumab (Arm A)
- From atezolizumab to vemurafenib + cobimetinib (Arm B)
Measured: 4 years
Time from first documented tumor progression until second documented tumor progression
PFS3 definded as time from first documented tumor progression (PD1) until second documented tumor progression (PD2) after randomization or death by any cause, whichever occurs first.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2024
- Study completionMar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant 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
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Dirk Schadendorf, University Hospital, Essen
- Investigators
- Dirk Schadendorf, Prof. Dr., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902029
- Sponsor's protocol ID
- ImmunoCobiVem_2015
- Acronym
- ImmunoCobiVem
- Status last verified
- Apr 2025
- First submitted
- 12 Sep 2016
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label, Randomized-controlled Trial Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody Atezolizumab for the Treatment in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
- ClinicalTrials.gov ID
- NCT02902029
- Acronym / sponsor ID
- ImmunoCobiVem / ImmunoCobiVem_2015
- Conditions
- Malignant Melanoma
- Keywords
- unresectable stage IIIB, IIIC, IV melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Mar 2024 (actual)
- Study completion
- Mar 2024 (actual)
- First posted
- 15 Sep 2016 (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.
Most patients with locally advanced or metastatic tumors succumb to their disease. Thus, there is a substantial need for novel therapeutic strategies to improve the outcome for patients with advanced or metastatic melanoma. Targeting the the Ras/Raf signalling pathway by BRAF and MEK inhibition as well as targeting immunologic checkpoint control with an antiPD-L1 antibody have emerged as treatment option.
In this study the best timing for sequential use of both treatment options (BRAF/MEK inhibition and antiPD-L1 antibody) in patients with unresectable or metastatic BRAFV600 mutant melanoma will be assessed.
Detailed description
At this time there is no experience concerning the sequencing strategy when using the two effective therapeutical approaches as targeting the Ras/Raf signalling pathway by BRAF and MEK inhibition or targeting immunologic checkpoint control with an antiPD-L1 antibody.
This is a prospective, open, multicenter, randomized phase II study in patients with unresectable or metastatic BRAFV600 mutant melanoma. In this study the scheduling of the treatment with a combined BRAF/MEK inhibition and the treatment with an anti-PD-L1 antibody will be assessed.
After a 3 months run-in period with vemurafenib and cobimetinib, all patients who did not show disease progression or treatment interruption for more than 28 days during run-in phase will be randomized in a 1:1 ratio:
- either to proceed vemurafenib and cobimetinib until disease progression and subsequently cross-over to atezolizumab treatment until disease progression (Arm A).
- or to receive the anti-PD-L1 antibody atezolizumab until disease progression and subsequently cross-back to vemurafenib and cobimetinib until disease progression (Arm B). In a translational research program tumor tissue, blood plasma and peripheral blood mononuclear cell will be analyzed to evaluate the biologic effects of treatment sequence on the molecular profile and biomarker expression in tissue and plasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Vemurafenib, Drug: Cobimetinib, Drug: AtezolizumabAfter a 3 months run-in period with vemurafenib and cobimetinib [960 mg vemurafenib twice daily (BID), 28/0; 60 mg cobimetinib daily (QD), 21/7], all patients who do not show disease progression or definite treatment interruption (e.g. due to unacceptable toxicity) for more than 28 days will be randomized. Further treatment with vemurafenib and cobimetinib (960 mg vemurafenib BID, 28/0; 60 mg cobimetinib QD, 21/7). After progression of disease patients in Arm A will subsequently receive atezolizumab treatment (1200 mg/ q3w). |
| Arm B | Experimental | Drug: Vemurafenib, Drug: Cobimetinib, Drug: AtezolizumabAfter a 3 months run-in period with vemurafenib and cobimetinib (960 mg vemurafenib BID, 28/0; 60 mg cobimetinib QD, 21/7), all patients who do not show disease progression or definite treatment interruption (e.g. due to unacceptable toxicity) for more than 28 days will be randomized. Further treatment with atezolizumab. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on day 1 of each 21 day-cycle. After progression of disease patients in Arm B will cross back to vemurafenib and cobimetinib treatment (960 mg vemurafenib BID, 28/0; 60 mg cobimetinib QD, 21/7). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Be willing and able to provide written informed consent for the trial.
- Male or female patient being ≥18 years of age on day of signing informed consent.
- Histologically confirmed diagnosis of locally advanced, unresectable or metastatic melanoma AJCC (unresectable stage IIIB, IIIC, IVM1a, IVM1b, or IVM1c) without active or untreated brain metastases; all known CNS lesions must have been treated with stereotactic therapy or surgery at least 4 weeks prior to the first dose of trial treatment AND the patient must be without evidence of clinical or radiographic disease progression in the CNS for at least 4 weeks prior to the first dose of trial treatment and any neurologic symptoms must have returned to baseline, the patient must have no evidence of new or enlarging brain metastases, and the patient must not have used steroids for at least 3 weeks prior to trial treatment.
- No previous therapy for the advanced or metastatic stage. Prior adjuvant therapy is permitted (e.g. Interferon, Interleukin-2-therapy, chemo- or radiotherapy). Prior adjuvant therapy has to be terminated (last dose) at least 28 days before enrolment. Patients who are in follow-up period of a clinical trial in adjuvant setting and progressing may be enrolled / randomized.
- Measurable disease, i.e., present with at least one measurable lesion per RECIST, version 1.1, for the definition of a measureable lesion.
Key exclusion criteria (23 listed)
- Use of any investigational or non-registered product within the 30 days before registration.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to study Day 1.
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- Prior therapy with a BRAF inhibitor (including but not limited to vemurafenib, dabrafenib, encorafenib and / or MEK inhibitor
- Prior major surgery.
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 |
|---|---|---|
| Vemurafenib960 mg vemurafenib BID until progression or unacceptable toxicity develops | Drug | Arm A, Arm B |
| Cobimetinib60 mg cobimetinib QD, 21/7 until progression or unacceptable toxicity develops | Drug | Arm A, Arm B |
| Atezolizumab1200 mg atezolizumab administered intravenously on day 1 of each 21 day-cycle. Will be given until progression or unacceptable toxicity develops | Drug | Arm A, Arm B |
Primary outcome
Time to First Documented Disease Progression
Time frame: 4 years
Time to first documented disease progression (PFS1) defined as time from start of run-in phase (date of first intake of study drug) to first documented disease progression date according to RECIST v. 1.1. (PD1) or death by any cause, whichever occurs first.
11 secondary outcomes
Time to Second Objective Disease Progression (PFS2)
Time frame: 4 years
Adverse events according to CTCAE Version 4.03 criteria (Safety / Toxicity)
Time frame: Until 90 days of discontinuation of dosing of the investigational product
Overall survival
Time frame: 4 years
Overall survival 12 months
Time frame: 1 year
Overall survival 24 months
Time frame: 2 years
Overall survival 36 months
Time frame: 3 years
Overall survival 48 months
Time frame: 4 years
12-months disease control rate (DCR)
Time frame: 1 year
24-months disease control rate (DCR).
Time frame: 2 years
Rate of patients with progressive disease who could not cross-over to subsequent line of therapy due to deterioration of ECOG status or multiple and/or symptomatic brain metastases and/or leptomengial disease
Time frame: 4 years
Time from first documented tumor progression until second documented tumor progression
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- 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.
Dirk Schadendorf, Prof. Dr. principal investigator
University Hospital, Essen
27 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vemurafenib, Cobimetinib and Atezolizumab in people with Malignant Melanoma, run by University Hospital, Essen at 27 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 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: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Germany, France, Greece, Serbia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to First Documented Disease Progression (time frame: 4 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 9 Apr 2025.