Various Advanced CancerPhase 2CheckMate 908NCT03130959
A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies
A Phase 2 study testing Nivolumab and Ipilimumab in people with Various Advanced Cancer, run by Bristol-Myers Squibb at 54 sites in 15 countries.
Trial summary
The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Various Advanced Cancer
- What is being tested?
- Nivolumab and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 54 sitesin 15 countries
- Study dates
- 12 Jun 2017to 17 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Must have received standard of care therapy, and there must be no potentially-curative treatment available, in one of the following cohorts:
- A newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) that has been treated with radiation therapy (RT) but no chemotherapy
- A histologically confirmed recurrent or progressive non-brainstem High Grade Glioma (HGG) previously treated with surgical resection and RT
- A histologically confirmed medulloblastoma that has relapsed or is resistant to at least one line of prior therapy including surgery, RT, and chemotherapy
- A histologically confirmed ependymoma that has relapsed or is resistant to at least one line of prior therapy including surgical resection and RT
- A histologically-confirmed high grade CNS malignancy "other than above" which is recurrent or progressive after at least one line of prior therapy
- Lansky play score (LPS) for ≤ 16 years of age or Karnofsky performance scale (KPS) for > 16 years of age assessed within two weeks of enrollment must be >= 60
- A tumor sample must be available for submission to central laboratory (not required for DIPG)
Who cannot join
- An active, known, or suspected autoimmune disease
- A concurrent condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Other protocol defined inclusion/exclusion criteria apply
Trial locations and contacts
54 sites in 15 countries.
54 sites in 15 countries
United States14 sites
Local Institution - 0016
Aurora, Colorado, 80045
Local Institution - 0005
Baltimore, Maryland, 21287
Local Institution - 0043
Boston, Massachusetts, 02215
Local Institution
Charleston, South Carolina, 29425
Local Institution - 0011
Chicago, Illinois, 60611-2605
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, 45229
Local Institution - 0046
Gainesville, Florida, 32611
Local Institution - 0042
Houston, Texas, 77030
Local Institution - 0057
Los Angeles, California, 90027
Local Institution - 0012
Memphis, Tennessee, 38105
Local Institution - 0004
New York, New York, 10021
Local Institution - 0017
New York, New York, 10032
Local Institution - 0066
Philadelphia, Pennsylvania, 19104
Local Institution - 0044
St Louis, Missouri, 63110
France8 sites
Local Institution - 0028
Angers, 49100
Local Institution - 0029
Bordeaux, 33076
Local Institution - 0027
Lille, 59000
Local Institution - 0025
Lyon, 69008
Local Institution - 0024
Marseille, 13385 cedex 05
Local Institution - 0023
Paris, 75231 cedex 5
Local Institution - 0064
Vandœuvre-lès-Nancy, 54500
Local Institution - 0026
VIillejuif, 94805 CEDEX
Australia5 sites
Local Institution
Clayton, Victoria, 3168
Local Institution - 0033
Nedlands, Western Australia, 6009
Local Institution - 0034
Parkville, Victoria, 3052
Local Institution - 0022
Randwick, New South Wales, 2031
Local Institution - 0035
Sth Brisbane, Queensland, 4101
Brazil5 sites
Local Institution - 0051
Barretos, São Paulo, 14784-400
Local Institution - 0052
Porto Alegre, Rio Grande do Sul, 90035-074
Local Institution - 0053
Ribeirão Preto, São Paulo, 14048-900
Local Institution - 0049
São Paulo, 04023-062
Local Institution - 0050
São Paulo, 08270-070
Germany4 sites
Local Institution - 0060
Essen, 45147
Local Institution - 0061
Hamburg, 20246
Local Institution - 0063
Heidelberg, 69120
Local Institution - 0062
Würzburg, 97080
Canada3 sites
Local Institution - 0001
Montreal, Quebec, H4A 3J1
Local Institution - 0002
Québec, Quebec, G1V 4G2
Local Institution - 0021
Toronto, Ontario, M5G 1X8
Spain3 sites
Local Institution - 0037
Esplugues de Llobregat, 08950
Local Institution - 0038
Madrid, 28009
Local Institution - 0036
Valencia, 46026
United Kingdom3 sites
Local Institution - 0013
Liverpool, Merseyside, L12 2AP
Local Institution - 0010
London, Greater London, WC1N 3JH
Local Institution - 0015
Newcastle upon Tyne, Tyne and Wear, NEI 4LP
Israel2 sites
Local Institution - 0059
Haifa, 3109601
Local Institution - 0058
Ramat Gan, 5266202
Netherlands2 sites
Local Institution - 0007
Rotterdam, 3015 GJ
Local Institution - 0008
Utrecht, 3584 EA
About this study
Official title: Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Subjects With High Grade Primary CNS Malignancies
The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies.
- Conditions
- Various Advanced Cancer
- Being tested
- Nivolumab, Ipilimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called Opdivo, BMS-936558
Specified dose on specified days
IpilimumabBiological
Also called Yervoy, BMS-734016
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Module A | Experimental | Not described Receives: Biological: Nivolumab |
| Module B | Experimental | Not described Receives: Biological: Nivolumab; Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs)
A dose-limiting toxicity (DLT) is defined as a drug-related AE occurring in the first 6 weeks of study treatment. A participant was considered evaluable for a DLT if study treatment was delayed > 2 weeks or was discontinued due to a related Adverse Event (AE), or if planned study treatment (3 doses of nivolumab in Module A, 2 doses of nivolumab plus ipilimumab in Module B) was administered and safety evaluation after 6 weeks on study is available to the study steering committee (SSC).
Measured: up to 6 weeks post-dosing
Number of Safety Lead-In Participants With Serious Adverse Events (SAEs)
The number of Safety Lead-In Participants who experienced a Serious Adverse Event (SAE) during the course of the study.
Measured: up to 6 weeks post-dosing
Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation
The number of Safety Lead-In Participants who experienced an Adverse Event (AE) during the course of the study that lead to discontinuation of study therapy.
Measured: From first dose to 30 days post-last dose (up to approximately 6 weeks)
Overall Survival (OS), Cohort 1 Only
Overall survival (OS) is defined as the time between the date of diagnosis and the date of death in Cohort 1.
Measured: up to approximately 42 months
Progression-Free Survival (PFS), Cohorts 2-4
Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.
Measured: up to approximately 42 months
Progression-Free Survival (PFS), Cohort 5 Only
Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.
Measured: up to approximately 42 months
Secondary outcomes (11)
Progression-Free Survival (PFS), Cohort 1 Only
Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.
Progression is defined as:
- ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement
- Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids
- Any new lesion
- Clear clinical deterioration not attributable to other causes apart from the tumor
- Failure to return for evaluation as a result of death or deteriorating condition
- Clear progression of non-measurable disease
Measured: From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months)
Overall Survival at 12 Months (OS12), Cohorts 1-4
Overall survival at 12 months (OS12) is defined as the percentage of participants who are alive at 12 months, measured as the survival rate at 12 months from Kaplan-Meier product limit cumulative probability.
Measured: From first dose to up to 12 months after first dose
Progression-Free Survival at 6 Months (PFS6), Cohorts 2-5
Progression-free survival at 6 months (PFS6) is defined as the percentage of participants who are progression free and alive at 6 months following first dose date, measured as the survival rate at 6 months from Kaplan-Meier product limit cumulative probability of progression free.
Progression is defined as:
- ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement
- Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids
- Any new lesion
- Clear clinical deterioration not attributable to other causes apart from the tumor
- Failure to return for evaluation as a result of death or deteriorating condition
- Clear progression of non-measurable disease
Measured: From first dose to up to 6 months after first dose
Overall Survival (OS), Cohorts 2-5
Overall survival (OS) is defined as the time between date of first dose and the date of death for Cohorts 2-5.
Measured: From first dose to the date of death (up to approximately 55 months)
Number of Treated Participants With Adverse Events (AEs)
The number of treated participants who experienced an Adverse Event (AE) during the course of the study.
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
Measured: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Number of Treated Participants With Serious Adverse Events (SAEs)
The number of treated participants who experienced a Serious Adverse Event (SAE) during the course of the study.
SAE is defined as any untoward medical occurrence that, at any dose:
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or causes prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- Is a congenital anomaly/birth defect
- Is an important medical event
Note: The reporting timeframe of the SAEs for this Outcome Measure (first dose to 30 days post last dose) differs than that of the reporting timeframe of the SAEs reported under the AE section of the results form (first dose to 100 days post last dose) and thus, the data in each table of SAEs reflects the specific timeframe applied.
Measured: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Number of Treated Participants With Drug-Related Adverse Events
The number of treated participants who experienced a Drug-Related Adverse Event during the course of the study.
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
Measured: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Number of Treated Participants With Adverse Events Leading to Discontinuation
The number of treated participants who experienced an Adverse Event leading to discontinuation during the course of the study.
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
Measured: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Number of Treated Participant Deaths
The number of treated participants who died during the course of the study.
Measured: From first dose to the date of death (up to approximately 55 months)
Number of Treated Participant With Laboratory Abnormalities - Liver
The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study.
Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Units per Liter (U/L) Results reported in International System of Units (SI)
Measured: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Number of Treated Participant With Laboratory Abnormalities - Thyroid
The number of treated participants who experienced a laboratory abnormality of the thyroid during the course of the study.
Free T3 (FT3) Free T4 (FT4) Thyroid stimulating hormone (TSH) Lower Limit of Normal (LLN) Upper limit of normal (ULN) Milliunits per Liter (mlU/L) Results reported in International System of Units (SI)
Measured: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start12 Jun 2017
- Primary completion10 Mar 2020
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Various Advanced CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130959
- Sponsor's protocol ID
- CA209-908
- Other IDs
- 2016-004441-82, 2016
- Acronym
- CheckMate 908
- Status last verified
- Jul 2022
- First submitted
- 5 Apr 2017
- Last updated
- 9 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Publications
Dunkel IJ, Doz F, Foreman NK, Hargrave D, Lassaletta A, Andre N, Hansford JR, Hassall T, Eyrich M, Gururangan S, Bartels U, Gajjar A, Howell L, Warad D, Pacius M, Tam R, Wang Y, Zhu L, Cohen K. Nivolumab with or without ipilimumab in pediatric patients with high-grade CNS malignancies: Safety, efficacy, biomarker, and pharmacokinetics-CheckMate 908. Neuro Oncol. 2023 Aug 3;25(8):1530-1545. doi: 10.1093/neuonc/noad031.
PubMed 36808285
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Subjects With High Grade Primary CNS Malignancies
- ClinicalTrials.gov ID
- NCT03130959
- Acronym / sponsor ID
- CheckMate 908 / CA209-908
- Conditions
- Various Advanced Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Posted 1 Apr 2021
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 determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Module A | Experimental | Biological: Nivolumab |
| Module B | Experimental | Biological: Nivolumab, Biological: Ipilimumab |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Must have received standard of care therapy, and there must be no potentially-curative treatment available, in one of the following cohorts:
- A newly diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) that has been treated with radiation therapy (RT) but no chemotherapy
- A histologically confirmed recurrent or progressive non-brainstem High Grade Glioma (HGG) previously treated with surgical resection and RT
- A histologically confirmed medulloblastoma that has relapsed or is resistant to at least one line of prior therapy including surgery, RT, and chemotherapy
- A histologically confirmed ependymoma that has relapsed or is resistant to at least one line of prior therapy including surgical resection and RT
Key exclusion criteria (4 listed)
- An active, known, or suspected autoimmune disease
- A concurrent condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Other protocol defined inclusion/exclusion criteria apply
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 |
|---|---|---|
| NivolumabAlso: Opdivo, BMS-936558Specified dose on specified days | Biological | Module A, Module B |
| IpilimumabAlso: Yervoy, BMS-734016Specified dose on specified days | Biological | Module B |
Primary outcome
Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs)
Time frame: up to 6 weeks post-dosing
A dose-limiting toxicity (DLT) is defined as a drug-related AE occurring in the first 6 weeks of study treatment. A participant was considered evaluable for a DLT if study treatment was delayed > 2 weeks or was discontinued due to a related Adverse Event (AE), or if planned study treatment (3 doses of nivolumab in Module A, 2 doses of nivolumab plus ipilimumab in Module B) was administered and safety evaluation after 6 weeks on study is available to the study steering committee (SSC).
Number of Safety Lead-In Participants With Serious Adverse Events (SAEs)
Time frame: up to 6 weeks post-dosing
The number of Safety Lead-In Participants who experienced a Serious Adverse Event (SAE) during the course of the study.
Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation
Time frame: From first dose to 30 days post-last dose (up to approximately 6 weeks)
The number of Safety Lead-In Participants who experienced an Adverse Event (AE) during the course of the study that lead to discontinuation of study therapy.
Overall Survival (OS), Cohort 1 Only
Time frame: up to approximately 42 months
Overall survival (OS) is defined as the time between the date of diagnosis and the date of death in Cohort 1.
Progression-Free Survival (PFS), Cohorts 2-4
Time frame: up to approximately 42 months
Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.
Progression-Free Survival (PFS), Cohort 5 Only
Time frame: up to approximately 42 months
Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause.
11 secondary outcomes
Progression-Free Survival (PFS), Cohort 1 Only
Time frame: From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months)
Overall Survival at 12 Months (OS12), Cohorts 1-4
Time frame: From first dose to up to 12 months after first dose
Progression-Free Survival at 6 Months (PFS6), Cohorts 2-5
Time frame: From first dose to up to 6 months after first dose
Overall Survival (OS), Cohorts 2-5
Time frame: From first dose to the date of death (up to approximately 55 months)
Number of Treated Participants With Adverse Events (AEs)
Time frame: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Number of Treated Participants With Serious Adverse Events (SAEs)
Time frame: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Number of Treated Participants With Drug-Related Adverse Events
Time frame: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Number of Treated Participants With Adverse Events Leading to Discontinuation
Time frame: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Number of Treated Participant Deaths
Time frame: From first dose to the date of death (up to approximately 55 months)
Number of Treated Participant With Laboratory Abnormalities - Liver
Time frame: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Number of Treated Participant With Laboratory Abnormalities - Thyroid
Time frame: From first dose to 30 days post-last dose (up to approximately an average of 3 months and a maximum of 51 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36808285Dunkel IJ, Doz F, Foreman NK, Hargrave D, Lassaletta A, Andre N, Hansford JR, Hassall T, Eyrich M, Gururangan S, Bartels U, Gajjar A, Howell L, Warad D, Pacius M, Tam R, Wang Y, Zhu L, Cohen K. Nivolumab with or without ipilimumab in pediatric patients with high-grade CNS malignancies: Safety, efficacy, biomarker, and pharmacokinetics-CheckMate 908. Neuro Oncol. 2023 Aug 3;25(8):1530-1545. doi: 10.1093/neuonc/noad031.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
54 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Ipilimumab in people with Various Advanced Cancer, run by Bristol-Myers Squibb at 54 sites in 15 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 8 inclusion and 4 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 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, France, Australia, Brazil, Germany and 10 more countries. 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?
Yes. Results are posted in the registry (first posted 1 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs) (time frame: up to 6 weeks post-dosing). The study lists 6 primary outcomes in all. 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 NCT03130959, 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 9 Aug 2022.