Glioblastoma MultiformePhase 3NCT02546102
Phase 3 Randomized, Double-blind, Controlled Study of ICT-107 in Glioblastoma
A Phase 3 study testing ICT-107 in people with Glioblastoma Multiforme, run by Precision Life Sciences Group at 65 sites in 3 countries.
Trial summary
ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA) present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107 in patients with newly diagnosed glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- ICT-107
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 65 sitesin 3 countries
- Study dates
- Dec 2024to Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must understand and sign the study specific informed consent
- Subjects must be in primary remission
- Subjects should have < 1 cm3 disease by MRI within the previous 4 weeks (by central read)
- Subjects must be HLA-A2 positive by central lab
- Subjects must have adequate renal, hepatic and bone marrow function based on screening laboratory assessments. Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:
- Hemoglobin (Hgb) > 8 g/dL
Show all 14Show fewer
- Absolute Neutrophil Count (ANC) > 1000/mm3
- Platelet count > 100,000/mm3
- Blood Urea Nitrogen (BUN) < 30 mg/dL
- Creatinine < 2 mg/dL
- Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 2 x upper limit of normal (ULN)
- Prothrombin Time (PT) and activated partial thromboplastin time (PTT) ≤ 1.6x unless therapeutically warranted
- Subjects must use effective contraceptive methods during the study and for three months following the last dose of study product, if of reproductive age and still retain fertility potential.
- Subjects must have at least one positive DTH skin response (more than 5 mm) to test item challenge prior to randomization.
Who cannot join
- Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia).
- Subjects with glioblastoma mutated IDH by Immunohistochemistry (IHC)
- Subjects with concurrent conditions that would jeopardize the safety of the subject or compliance with the protocol.
- Subjects with a history of chronic or acute hepatitis C or B infection.
- Subjects require or are likely to require more than a 2-week course of corticosteroids for intercurrent illness. Subjects must have completed the course of corticosteroids at the time of apheresis to meet eligibility.
- Subjects have any acute infection that requires specific therapy. Acute therapy must have been completed within seven days prior to study enrollment.
- Subjects with active other malignancy diagnosed in the past 3 years (excepting in situ tumors)
- Subjects known to be pregnant or nursing.
Trial locations and contacts
65 sites in 3 countries.
65 sites in 3 countries
United States58 sites
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87131
University of Michigan Health System
Ann Arbor, Michigan, 48109
Piedmont Hospital
Atlanta, Georgia, 30309
Georgia Regents University
Augusta, Georgia, 30912
University of Colorado Denver
Aurora, Colorado, 80045
Texas Oncology
Austin, Texas, 78705
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Delray Medical Center
Boca Raton, Florida, 33484
Boca Raton Regional Hospital Lynn Cancer Institute
Boca Raton, Florida, 33486
Dana Farber Cancer Institute
Boston, Massachusetts, 02114
Massachusetts General Hospital
Boston, Massachusetts, 02114
Harvard Medical School Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Virginia Health System
Charlottesville, Virginia, 22903
Northwestern University
Chicago, Illinois, 60611
The Ohio State University Medical Center
Columbus, Ohio, 43210
Baylor Health Charles Sammons Cancer Center
Dallas, Texas, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
City of Hope Cancer Center
Duarte, California, 91010
JFK New Jersey Neuroscience Institute
Edison, New Jersey, 08820
NorthShore University Health System
Evanston, Illinois, 60201
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, 06824
Penn State College of Medicine Hershey Medical Center
Hershey, Pennsylvania, 17033
Houston Methodist Hospital
Houston, Texas, 77030
University of Texas Health Science Center Memorial Hermann Hospital
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
University of Tennessee Medical Cancer Institute
Knoxville, Tennessee, 37920
UCSD Moores Cancer Center
La Jolla, California, 92093
North Shore University Hospital
Lake Success, New York, 11042
University of Kentucky
Lexington, Kentucky, 40536
Southern California Permanente Medical Group
Los Angeles, California, 90027
University of Southern California
Los Angeles, California, 90033
Cedars Sinai Medical Center
Los Angeles, California, 90048
Norton Cancer Institute
Louisville, Kentucky, 40202
John Nasseff Neuroscience Institute
Minneapolis, Minnesota, 55407
Smilow Cancer Hospital
New Haven, Connecticut, 06519
Perlmutter Cancer Center
New York, New York, 10016
Mount Sinai Medical Center
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032
Weil Cornell Medical Center
New York, New York, 10065
Christiana Care Health Services
Newark, Delaware, 19711
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of California Irvine Chao Family Cancer Center
Orange, California, 92868
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University of Pittsburgh Medical Center Cancer Pavilion
Pittsburgh, Pennsylvania, 15232
Kaiser Permanente
Redwood City, California, 94063
University of Rochester Medical Center
Rochester, New York, 14642
Kaiser Permanente
Sacramento, California, 95825
Metro-Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
CTRC at UTHSCSA
San Antonio, Texas, 78229
John Wayne Cancer Institute
Santa Monica, California, 90404
Ivy Center for Advanced Brain Tumor Treatment Swedish Medical Center
Seattle, Washington, 98122
University of Washington Medical Center
Seattle, Washington, 98195
Stanford Cancer Institute
Stanford, California, 95124
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Canada4 sites
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Montreal Neurological Institute & Hospital
Montreal, Quebec, H3A2B4
CHUS Service de Neurochirurgie
Sherbrooke, Quebec, J1K2R1
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Austria3 sites
Medical University Innsbruck, Dept. of Neurology
Innsbruck, 6020
Kepler Universitätsklinikum, Neuromed Campus
Linz, 4020
University Clinic for Neurology
Salzburg, 5020
About this study
Official title: A Phase 3 Randomized Double-blind, Controlled Study of ICT-107 With Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma Following Resection and Concomitant TMZ Chemoradiotherapy
ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA) present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107 in patients with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target glioblastoma tumour cells.
Read the detailed description
This is a double blind Phase III study where eligible subjects are randomized into two treatment arms following the SOC primary treatment with chemoradiation: Arm 1 will receive ICT-107 in combination with the standard of care, temozolomide (TMZ), Arm 2 will receive TMZ with a blinded control. A 1:1 randomization will be employed, where ARM 1 will receive ICT-107 and Arm 2 will receive placebo control. All subjects must be HLA-A2+. All subjects must have glioblastoma tissue that has tumor assessment for MGMT methylation status prior to randomization (for stratification). Subjects will have had tumor resection and magnetic resonance imaging (MRI) prior to enrollment into the study. After signing of written informed consent and any required privacy compliance forms and screening, enrolled subjects will undergo large volume apheresis at the study site for collection of PBMCs. Apheresis product will be sent to the manufacturing site where both active therapy (ICT-107) and control will be prepared for each subject prior to randomization The study period consists of 4 time periods; a 6-week Post-Surgery Standard of Care Treatment Phase where subjects receive radiotherapy and TMZ; TMZ and radiation to be initiated no more than 8 weeks after surgical resection of glioblastoma; a Rest Period of no more than 14 days where subjects are reassessed for eligibility, and then randomized; a 4 week Induction Phase where study therapy (ICT-107 or Control) is given weekly; followed by a Maintenance Phase where study therapy is given monthly for 11 months, and then every 6 months until either progression, withdrawal from the study, death, or the supply of autologous study therapy is exhausted. Randomized subjects will receive 4 weekly administrations of subject-specific study therapy (ICT-107 or Control) during the Induction Phase. No TMZ will be given during the 4 week Induction Phase. Each study therapy injection will be delivered intradermally (axilla).
The Maintenance Phase will consist of administration of subject-specific study therapy monthly for 11 months after the Induction Phase (for a total of 15 injections over 12 months during the Induction and Maintenance Phases), and then every 6 mos. thereafter until depletion or confirmation of progressive disease (PD). During the Maintenance Phase (where ICT-107 or control are given monthly), the administration of TMZ and subject specific study therapy or control will be separated in time by approximately 2 weeks (see Section 9.1.4). Pre-treatment, treatment and assessment schedules will be the same for all subjects.
- Conditions
- Glioblastoma Multiforme
- Being tested
- ICT-107, Placebo
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICT-107Biological
Autologous dendritic cells pulsed with peptides associated with tumor antigens
PlaceboBiological
Control, autologous monocytes-enriched PBMC.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Arm 1 will receive ICT-107 in combination with the standard of care, temozolomide (TMZ). ICT-107 will be given once a week for 4 weeks in the induction phase. During the maintenance phase, ICT-107 will be given monthly for the 11 months after induction and once every 6 months thereafter until depletion of supply or confirmation of progressive disease (PD). Administration is intradermal in axilla. Receives: Biological: ICT-107 |
| 2 | Placebo comparator | Arm 2 will receive TMZ with a blinded control. Control will be given once a week for 4 weeks in the induction phase. During the maintenance phase, Control will be given monthly for the 11 months after induction and once every 6 months thereafter until depletion of supply or confirmation of progressive disease (PD). Administration is intradermal in axilla. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival (OS) of subjects treated with ICT-107 and standard of care (radiation (RT) and TMZ) vs. placebo control and standard of care (RT and TMZ)
Measured: 46 months
Secondary outcomes (4)
Overall survival in patients with unmethylated MGMT tumors
OS of subjects with unmethylated MGMT (O6-methylguanine-DNA methyltransferase) tumors treated with ICT-107 and standard of care vs. control and standard of care
Measured: 46 months
Overall survival in patients with methylated MGMT (O6-methylguanine-DNA methyltransferase) tumors
OS of subjects with methylated MGMT tumors treated with ICT-107 and standard of care vs. control and standard of care.
Measured: 46 months
Progression-free survival
Progression-free survival (PFS) of subjects treated with ICT-107 and standard of care vs. control and standard of care
Measured: 46 months
Type and frequency of treatment emergent adverse events
Compare the type and frequency of treatment emergent adverse events of ICT-107 vs. control treatment groups
Measured: 46 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Company is discussing with FDA to reinitiate the trial now.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma MultiformeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precision Life Sciences Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medelis Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546102
- Sponsor's protocol ID
- ICT-107-301
- Status last verified
- Apr 2024
- First submitted
- 7 Sep 2015
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Phuphanich S, Wheeler CJ, Rudnick JD, Mazer M, Wang H, Nuno MA, Richardson JE, Fan X, Ji J, Chu RM, Bender JG, Hawkins ES, Patil CG, Black KL, Yu JS. Phase I trial of a multi-epitope-pulsed dendritic cell vaccine for patients with newly diagnosed glioblastoma. Cancer Immunol Immunother. 2013 Jan;62(1):125-35. doi: 10.1007/s00262-012-1319-0. Epub 2012 Jul 31.
PubMed 22847020
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Double-blind, Controlled Study of ICT-107 With Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma Following Resection and Concomitant TMZ Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT02546102
- Acronym / sponsor ID
- ICT-107-301
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Company is discussing with FDA to reinitiate the trial now.
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Precision Life Sciences GroupIndustry (pharma, biotech, devices)
- Collaborators
- Medelis Inc.
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ICT-107 consists of dendritic cells, prepared from autologous mononuclear cells that are pulsed with six synthetic peptides that were derived from tumor associated antigens (TAA) present on glioblastoma tumor cells. This is a Phase 3 study to evaluate ICT-107 in patients with newly diagnosed glioblastoma. Subjects will be randomized to receive standard of care chemoradiation (temozolomide (TMZ) with either ICT-107 or a blinded control. Reinfusion with the pulsed dendritic cells should stimulate cytotoxic T cells to specifically target glioblastoma tumour cells.
Detailed description
This is a double blind Phase III study where eligible subjects are randomized into two treatment arms following the SOC primary treatment with chemoradiation: Arm 1 will receive ICT-107 in combination with the standard of care, temozolomide (TMZ), Arm 2 will receive TMZ with a blinded control. A 1:1 randomization will be employed, where ARM 1 will receive ICT-107 and Arm 2 will receive placebo control. All subjects must be HLA-A2+. All subjects must have glioblastoma tissue that has tumor assessment for MGMT methylation status prior to randomization (for stratification). Subjects will have had tumor resection and magnetic resonance imaging (MRI) prior to enrollment into the study. After signing of written informed consent and any required privacy compliance forms and screening, enrolled subjects will undergo large volume apheresis at the study site for collection of PBMCs. Apheresis product will be sent to the manufacturing site where both active therapy (ICT-107) and control will be prepared for each subject prior to randomization The study period consists of 4 time periods; a 6-week Post-Surgery Standard of Care Treatment Phase where subjects receive radiotherapy and TMZ; TMZ and radiation to be initiated no more than 8 weeks after surgical resection of glioblastoma; a Rest Period of no more than 14 days where subjects are reassessed for eligibility, and then randomized; a 4 week Induction Phase where study therapy (ICT-107 or Control) is given weekly; followed by a Maintenance Phase where study therapy is given monthly for 11 months, and then every 6 months until either progression, withdrawal from the study, death, or the supply of autologous study therapy is exhausted. Randomized subjects will receive 4 weekly administrations of subject-specific study therapy (ICT-107 or Control) during the Induction Phase. No TMZ will be given during the 4 week Induction Phase. Each study therapy injection will be delivered intradermally (axilla).
The Maintenance Phase will consist of administration of subject-specific study therapy monthly for 11 months after the Induction Phase (for a total of 15 injections over 12 months during the Induction and Maintenance Phases), and then every 6 mos. thereafter until depletion or confirmation of progressive disease (PD). During the Maintenance Phase (where ICT-107 or control are given monthly), the administration of TMZ and subject specific study therapy or control will be separated in time by approximately 2 weeks (see Section 9.1.4). Pre-treatment, treatment and assessment schedules will be the same for all subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: ICT-107Arm 1 will receive ICT-107 in combination with the standard of care, temozolomide (TMZ). ICT-107 will be given once a week for 4 weeks in the induction phase. During the maintenance phase, ICT-107 will be given monthly for the 11 months after induction and once every 6 months thereafter until depletion of supply or confirmation of progressive disease (PD). Administration is intradermal in axilla. |
| 2 | Placebo comparator | Biological: PlaceboArm 2 will receive TMZ with a blinded control. Control will be given once a week for 4 weeks in the induction phase. During the maintenance phase, Control will be given monthly for the 11 months after induction and once every 6 months thereafter until depletion of supply or confirmation of progressive disease (PD). Administration is intradermal in axilla. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must understand and sign the study specific informed consent
- Subjects must be in primary remission
- Subjects should have < 1 cm3 disease by MRI within the previous 4 weeks (by central read)
- Subjects must be HLA-A2 positive by central lab
- Subjects must have adequate renal, hepatic and bone marrow function based on screening laboratory assessments. Baseline hematologic studies and chemistry and coagulation profiles must meet the following criteria:
Key exclusion criteria (8 listed)
- Subjects receiving investigational study drug for any indication or immunological-based treatment for any reason (Filgrastim may be used for prevention of severe neutropenia).
- Subjects with glioblastoma mutated IDH by Immunohistochemistry (IHC)
- Subjects with concurrent conditions that would jeopardize the safety of the subject or compliance with the protocol.
- Subjects with a history of chronic or acute hepatitis C or B infection.
- Subjects require or are likely to require more than a 2-week course of corticosteroids for intercurrent illness. Subjects must have completed the course of corticosteroids at the time of apheresis to meet eligibility.
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 |
|---|---|---|
| ICT-107Autologous dendritic cells pulsed with peptides associated with tumor antigens | Biological | 1 |
| PlaceboControl, autologous monocytes-enriched PBMC. | Biological | 2 |
Primary outcome
Overall survival
Time frame: 46 months
Overall survival (OS) of subjects treated with ICT-107 and standard of care (radiation (RT) and TMZ) vs. placebo control and standard of care (RT and TMZ)
4 secondary outcomes
Overall survival in patients with unmethylated MGMT tumors
Time frame: 46 months
Overall survival in patients with methylated MGMT (O6-methylguanine-DNA methyltransferase) tumors
Time frame: 46 months
Progression-free survival
Time frame: 46 months
Type and frequency of treatment emergent adverse events
Time frame: 46 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Results publication: PubMed 22847020Phuphanich S, Wheeler CJ, Rudnick JD, Mazer M, Wang H, Nuno MA, Richardson JE, Fan X, Ji J, Chu RM, Bender JG, Hawkins ES, Patil CG, Black KL, Yu JS. Phase I trial of a multi-epitope-pulsed dendritic cell vaccine for patients with newly diagnosed glioblastoma. Cancer Immunol Immunother. 2013 Jan;62(1):125-35. doi: 10.1007/s00262-012-1319-0. Epub 2012 Jul 31.
Related trials for Glioblastoma Multiforme
RecruitingPhase 2/3
A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma
Glioblastoma
Not yet recruitingPhase 1
Novel endOvascular Therapy With beVAcizumab and Cannabinoids for Glioblastoma
GBM
Not yet recruiting
Safety and Efficacy of Autologous Natural Killer Cell Therapy (CHANK-101) in Patients With Recurrent Glioblastoma
Recurrent Glioblastoma
Not yet recruitingPhase 1/2
DLL3 CAR-T Therapy Targeting Brain Tumors
Glioblastoma of Cerebellum
Active, not recruitingPhase 2
Pediatric Trial of Indoximod With Chemotherapy and Radiation for Relapsed Brain Tumors or Newly Diagnosed DIPG
Glioblastoma, Medulloblastoma
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.
The record lists no contact. Use the official record to reach the sponsor.
65 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ICT-107 in people with Glioblastoma Multiforme, run by Precision Life Sciences Group at 65 sites in 3 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 14 inclusion and 8 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: paused, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Canada, Austria. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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 (time frame: 46 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02546102, which also lists 1 linked publication.
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 3 Apr 2024.