EpendymomaPhase 1/2PIVOT IO 020NCT04730349
A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer
A Phase 1/2 study testing Nivolumab and NKTR-214 in people with Ependymoma and Ewing Sarcoma, run by Bristol-Myers Squibb at 18 sites in 6 countries.
Trial summary
The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer. Read more about this study
- Who is it for?
- Ages Up to 30 years
- Conditions the study is for
- Ependymoma, Ewing Sarcoma, High-grade Glioma
- What is being tested?
- Nivolumab and NKTR-214
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 3 Jun 2021to 22 Jun 2022
- Phase
- Phase 1/2
- 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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age < 18 years for Part A and Part B
- Age up to 30 years for Part B Cohorts B2, B3 and B4
- Must have received standard of care therapy and there must be no potentially curative treatment available
- Histologically confirmed with malignant neoplasms that are refractory, relapsed, or curative treatments are lacking
- Must have measurable or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for solid tumors, Response Assessment in Neuro-Oncology (RANO) or Response Assessment in Pediatric Neuro-Oncology (RAPNO) for central nervous system tumors, International Pediatric Non-Hodgkin Lymphoma Response Criteria for non-Hodgkin lymphoma (NHL), revised International Neuroblastoma Response Criteria (INRC) for neuroblastoma, modified National Comprehensive Cancer Network (NCCN) Criteria for acute lymphoblastic leukemia, and modified Cheson et al International Working Group criteria for acute myeloid leukemia
- Lansky play score for age ≤ 16 years or Karnofsky performance score for age > 16 years assessed within 2 weeks of enrollment must be ≥ 60
Who cannot join
- Osteosarcoma, T-cell/Natural Killer (NK) cell leukemia/lymphoma, and Hodgkin's lymphoma
- Need for > 2 antihypertensive medications for management of hypertension (including diuretics)
- Known cardiovascular history, including unstable or deteriorating cardiac disease, within the previous 12 months prior to screening
- Inadequately treated adrenal insufficiency
- Active, known, or suspected autoimmune disease
- Active infection requiring systemic therapy within 14 days prior to first dose
Show all 10Show fewer
- Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
- Prior allogeneic stem cell transplant
- Previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection either suspected or confirmed within 4 weeks prior to screening
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Australia4 sites
Local Institution - 0002
Parkville, Victoria, 3052
Local Institution - 0003
Perth, Western Australia, 6009
Local Institution - 0001
Randwick, New South Wales, 2031
Local Institution
South Brisbane, Queensland, 4101
France4 sites
Local Institution - 0014
Lyon, 69373 cedex 03
Local Institution - 0016
Marseille, 13385
Local Institution - 0015
Paris, 75005
Local Institution - 0013
Villejuif, Val-de-Marne, 94805
Spain4 sites
Local Institution - 0008
Barcelona, 08035
Local Institution - 0009
Madrid, Madrid, Comunidad de, 28009
Local Institution - 0059
Seville, 41013
Local Institution - 0028
Valencia, 46026
Germany3 sites
Local Institution - 0038
Hamburg, 20246
Local Institution - 0039
Tübingen, 72076
Local Institution - 0037
Würzburg, 97080
United States2 sites
Local Institution - 0029
Little Rock, Arkansas, 72202
Local Institution - 0011
St Louis, Missouri, 63110
About this study
Official title: Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)
The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.
- Conditions
- Ependymoma, Ewing Sarcoma, High-grade Glioma, Leukemia and Lymphoma, Medulloblastoma, Miscellaneous Brain Tumors
- Being tested
- Nivolumab, NKTR-214
- Keywords
- B-cell leukemia/lymphoma/non-Hodgkin lymphoma (NHL), BEMPEG, Bempegaldesleukin, CD122-Biased Agonist, CD122-Biased Cytokine, Check point inhibitor, Ependymoma, Ewing sarcoma, High-grade glioma (HGG)/diffuse intrinsic pontine glioma (DIPG), Immunotherapy, IL-2, IL-2 Receptor Agonist, Leukemia and lymphoma, Medulloblastoma, Melanoma, Miscellaneous brain tumors, Miscellaneous solid tumors, Neuroblastoma, Nivolumab, NKTR-214
- Medical subject headings
- Ependymoma, Sarcoma, Ewing, Glioma, Leukemia, Lymphoma, Medulloblastoma, Neuroblastoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called BMS-936558-01
Specified dose on specified days
NKTR-214Biological
Also called Bempegaldesleukin (BEMPEG)
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| A1W Dosing schema | Experimental | Not described Receives: Biological: Nivolumab; Biological: NKTR-214 |
| A1F Dosing schema | Experimental | Not described Receives: Biological: Nivolumab; Biological: NKTR-214 |
| A2W Dosing schema | Experimental | Not described Receives: Biological: Nivolumab; Biological: NKTR-214 |
| A2F Dosing schema | Experimental | Not described Receives: Biological: Nivolumab; Biological: NKTR-214 |
| Part B: Cohort B1 Neuroblastoma | Experimental | Not described Receives: Biological: Nivolumab; Biological: NKTR-214 |
| Part B: Cohort B2 Ewing sarcoma | Experimental | Not described Receives: Biological: Nivolumab; Biological: NKTR-214 |
| Part B: Cohort B3 Rhabdomyosarcoma | Experimental | Not described Receives: Biological: Nivolumab; Biological: NKTR-214 |
| Part B: Cohort B4 Miscellaneous solid tumors | Experimental | Not described Receives: Biological: Nivolumab; Biological: NKTR-214 |
| Part B: Cohort B5 NHL/leukemia | Experimental | Not described Receives: Biological: Nivolumab; Biological: NKTR-214 |
| Part B: Cohort B6 High-grade glioma | Experimental | Not described Receives: Biological: Nivolumab; Biological: NKTR-214 |
| Part B: Cohort B7 Medulloblastoma and Embryonal Tumors | Experimental | Not described Receives: Biological: Nivolumab; Biological: NKTR-214 |
| Part B: Cohort B8 Ependymoma | Experimental | Not described Receives: Biological: Nivolumab; Biological: NKTR-214 |
| Part B: Cohort B9 Miscellaneous brain tumors | Experimental | Not described Receives: Biological: Nivolumab; Biological: NKTR-214 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A
Number of participants with dose-limiting toxicities (DLTs). DLTs were collected and evaluated for Part A within the DLT evaluation period, which started on Cycle 1 Day 1 (first dose) and ended at Day 42 (42 days after first dose of the study therapy).
Measured: From first dose to 42 days after first dose
Number of Participants With Adverse Events (AEs) - Part A
Number of participants with adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: From first dose to 30 days after last dose (up to approximately 6 months)
Number of Participants With Serious Adverse Events (SAEs) - Part A
Number of participants with serious adverse events (SAEs). 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, or is an important medical event.
Measured: From first dose to 30 days after last dose (up to approximately 6 months)
Number of Participants With Drug-Related Adverse Events - Part A
Number of participants with drug-related adverse events. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: From first dose to 30 days after last dose (up to approximately 6 months)
Number of Participants With Adverse Events Leading to Discontinuation - Part A
Number of participants with adverse events leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: From first dose to 30 days after last dose (up to approximately 6 months)
Number of Participants Who Died - Part A
Number of participants who died.
Measured: From first dose to 30 days after last dose (up to approximately 6 months)
Maximum Observed Plasma Concentration (Cmax) - Part A
Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
Measured: From first dose to 30 days after last dose (up to approximately 6 months)
Trough Observed Concentration (Ctrough) - Part A
Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
Measured: From first dose to 30 days after last dose (up to approximately 6 months)
Area Under the Plasma Concentration (AUC) - Part A
Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
Measured: From first dose to 30 days after last dose (up to approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start3 Jun 2021
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
Why it stopped: Business objectives have changed
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.
- Other trials for EpendymomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nektar Therapeutics
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730349
- Sponsor's protocol ID
- CA045-020
- Other IDs
- 2020-000854-85
- Acronym
- PIVOT IO 020
- Status last verified
- Mar 2023
- First submitted
- 26 Jan 2021
- Last updated
- 24 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)
- ClinicalTrials.gov ID
- NCT04730349
- Acronym / sponsor ID
- PIVOT IO 020 / CA045-020
- Conditions
- Ependymoma, Ewing Sarcoma, High-grade Glioma, Leukemia and Lymphoma, Medulloblastoma, Miscellaneous Brain Tumors
- Keywords
- B-cell leukemia/lymphoma/non-Hodgkin lymphoma (NHL), BEMPEG, Bempegaldesleukin, CD122-Biased Agonist, CD122-Biased Cytokine, Check point inhibitor, Ependymoma, Ewing sarcoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Nektar Therapeutics
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Posted 24 Mar 2023
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 first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| A1W Dosing schema | Experimental | Biological: Nivolumab, Biological: NKTR-214 |
| A1F Dosing schema | Experimental | Biological: Nivolumab, Biological: NKTR-214 |
| A2W Dosing schema | Experimental | Biological: Nivolumab, Biological: NKTR-214 |
| A2F Dosing schema | Experimental | Biological: Nivolumab, Biological: NKTR-214 |
| Part B: Cohort B1 Neuroblastoma | Experimental | Biological: Nivolumab, Biological: NKTR-214 |
| Part B: Cohort B2 Ewing sarcoma | Experimental | Biological: Nivolumab, Biological: NKTR-214 |
| Part B: Cohort B3 Rhabdomyosarcoma | Experimental | Biological: Nivolumab, Biological: NKTR-214 |
| Part B: Cohort B4 Miscellaneous solid tumors | Experimental | Biological: Nivolumab, Biological: NKTR-214 |
| Part B: Cohort B5 NHL/leukemia | Experimental | Biological: Nivolumab, Biological: NKTR-214 |
| Part B: Cohort B6 High-grade glioma | Experimental | Biological: Nivolumab, Biological: NKTR-214 |
| Part B: Cohort B7 Medulloblastoma and Embryonal Tumors | Experimental | Biological: Nivolumab, Biological: NKTR-214 |
| Part B: Cohort B8 Ependymoma | Experimental | Biological: Nivolumab, Biological: NKTR-214 |
| Part B: Cohort B9 Miscellaneous brain tumors | Experimental | Biological: Nivolumab, Biological: NKTR-214 |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age < 18 years for Part A and Part B
- Age up to 30 years for Part B Cohorts B2, B3 and B4
- Must have received standard of care therapy and there must be no potentially curative treatment available
- Histologically confirmed with malignant neoplasms that are refractory, relapsed, or curative treatments are lacking
- Must have measurable or evaluable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for solid tumors, Response Assessment in Neuro-Oncology (RANO) or Response Assessment in Pediatric Neuro-Oncology (RAPNO) for central nervous system tumors, International Pediatric Non-Hodgkin Lymphoma Response Criteria for non-Hodgkin lymphoma (NHL), revised International Neuroblastoma Response Criteria (INRC) for neuroblastoma, modified National Comprehensive Cancer Network (NCCN) Criteria for acute lymphoblastic leukemia, and modified Cheson et al International Working Group criteria for acute myeloid leukemia
Key exclusion criteria (10 listed)
- Osteosarcoma, T-cell/Natural Killer (NK) cell leukemia/lymphoma, and Hodgkin's lymphoma
- Need for > 2 antihypertensive medications for management of hypertension (including diuretics)
- Known cardiovascular history, including unstable or deteriorating cardiac disease, within the previous 12 months prior to screening
- Inadequately treated adrenal insufficiency
- Active, known, or suspected autoimmune disease
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: BMS-936558-01Specified dose on specified days | Biological | A1F Dosing schema, A1W Dosing schema, A2F Dosing schema, A2W Dosing schema, Part B: Cohort B1 Neuroblastoma, Part B: Cohort B2 Ewing sarcoma, Part B: Cohort B3 Rhabdomyosarcoma, Part B: Cohort B4 Miscellaneous solid tumors, Part B: Cohort B5 NHL/leukemia, Part B: Cohort B6 High-grade glioma, Part B: Cohort B7 Medulloblastoma and Embryonal Tumors, Part B: Cohort B8 Ependymoma, Part B: Cohort B9 Miscellaneous brain tumors |
| NKTR-214Also: Bempegaldesleukin (BEMPEG)Specified dose on specified days | Biological | A1F Dosing schema, A1W Dosing schema, A2F Dosing schema, A2W Dosing schema, Part B: Cohort B1 Neuroblastoma, Part B: Cohort B2 Ewing sarcoma, Part B: Cohort B3 Rhabdomyosarcoma, Part B: Cohort B4 Miscellaneous solid tumors, Part B: Cohort B5 NHL/leukemia, Part B: Cohort B6 High-grade glioma, Part B: Cohort B7 Medulloblastoma and Embryonal Tumors, Part B: Cohort B8 Ependymoma, Part B: Cohort B9 Miscellaneous brain tumors |
Primary outcome
Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A
Time frame: From first dose to 42 days after first dose
Number of participants with dose-limiting toxicities (DLTs). DLTs were collected and evaluated for Part A within the DLT evaluation period, which started on Cycle 1 Day 1 (first dose) and ended at Day 42 (42 days after first dose of the study therapy).
Number of Participants With Adverse Events (AEs) - Part A
Time frame: From first dose to 30 days after last dose (up to approximately 6 months)
Number of participants with adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Number of Participants With Serious Adverse Events (SAEs) - Part A
Time frame: From first dose to 30 days after last dose (up to approximately 6 months)
Number of participants with serious adverse events (SAEs). 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, or is an important medical event.
Number of Participants With Drug-Related Adverse Events - Part A
Time frame: From first dose to 30 days after last dose (up to approximately 6 months)
Number of participants with drug-related adverse events. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Number of Participants With Adverse Events Leading to Discontinuation - Part A
Time frame: From first dose to 30 days after last dose (up to approximately 6 months)
Number of participants with adverse events leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Number of Participants Who Died - Part A
Time frame: From first dose to 30 days after last dose (up to approximately 6 months)
Number of participants who died.
Maximum Observed Plasma Concentration (Cmax) - Part A
Time frame: From first dose to 30 days after last dose (up to approximately 6 months)
Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
Trough Observed Concentration (Ctrough) - Part A
Time frame: From first dose to 30 days after last dose (up to approximately 6 months)
Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
Area Under the Plasma Concentration (AUC) - Part A
Time frame: From first dose to 30 days after last dose (up to approximately 6 months)
Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nivolumab and NKTR-214 in people with Ependymoma and Ewing Sarcoma, run by Bristol-Myers Squibb at 18 sites in 6 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Australia, France, Spain, Germany, United States and 1 more country. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 24 Mar 2023). 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 Participants With Dose-Limiting Toxicities (DLTs) - Part A (time frame: From first dose to 42 days after first dose). The study lists 9 primary outcomes in all. 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 24 Mar 2023.