CancerPhase 1/2NCT03363776
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers
A Phase 1/2 study testing BMS-986277 and Nivolumab in people with Cancer, run by Bristol-Myers Squibb at 3 sites in 2 countries.
Trial summary
The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- BMS-986277 and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 6 Dec 2017to 22 Nov 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological confirmation of metastatic and/or unresectable metastatic colorectal, prostate, pancreatic, breast, ovarian, or urothelial carcinoma with measureable disease for solid tumors per RECIST v1.1 and for prostate carcinoma per PCWG3
- Presence of at least 2 lesions: at least one with measurable disease as defined by RECIST v1.1 for solid tumors and by PCWG3 for prostate carcinoma for response assessment; at least 1 lesion must be accessible for biopsy in addition to the target lesion
- Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting, if such a therapy exists, and have been considered for all other potentially efficacious therapies prior to enrollment
- ECOG performance status less than or equal to 2
Who cannot join
- Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease
- Participants with carcinomatous meningitis
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study treatment
- Participants with active, known, or suspected autoimmune disease
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Local Institution
Ottawa, Ontario, K1H 8L6
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5
About this study
Official title: Phase 1/2a First in Human Study of BMS-986277 Administered Alone and in Combination With Nivolumab in Advanced Epithelial Tumors
The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986277Biological
Specified dose on specified days
NivolumabBiological
Also called Opdivo, BMS-963558
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Experimental | BMS-986277 administered alone Receives: Biological: BMS-986277 |
| Combination Dose Escalation Therapy | Experimental | BMS-986277 administered in combination with Nivolumab Receives: Biological: BMS-986277; Biological: Nivolumab |
| Combination Expansion Therapy | Experimental | BMS-986277 monotherapy with option for subsequent Nivolumab therapy Receives: Biological: BMS-986277; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Adverse Event (AE)
Number of participants who experienced an AE during the course of the study.
Measured: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of Participants With a Serious Adverse Event (SAE)
Number of participants who experienced a SAE during the course of the study.
Measured: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of Participants With an Adverse Event (AE) Meeting Protocol-defined Dose Limiting Toxicity (DLT) Criteria
Number of participants who experienced an AE meeting protocol-defined DLT criteria during the course of the study.
Measured: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of Participants With an Adverse Event (AE) Leading to Discontinuation
Number of participants who experienced an AE leading to discontinuation during the course of the study.
Measured: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of Participants With an Adverse Event (AE) Leading to Death
Number of participants who experienced an AE leading to death during the course of the study.
Measured: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of Participants With a Clinical Laboratory Test Abnormality
Number of participants who experienced a clinical laboratory test abnormality during the course of the study.
Measured: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of Participants With a Vital Sign Abnormality or Other Safety Biomarkers
Number of participants who experienced a vital sign abnormality or other safety biomarkers during the course of the study.
Measured: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Secondary outcomes (22)
Objective Response Rate (ORR)
ORR is defined as the proportion of all treated participants whose BOR is either CR or PR. BOR was determined by investigators for the reported data.
Estimate of ORR and corresponding 2-sided exact 95% CI using the Clopper-Pearson method
Measured: at Weeks 8, 16 and 24
Disease Control Rate (DCR)
DCR includes complete response (CR), partial response (PR), and stable disease (SD).
Estimate of DCR and corresponding 2-sided exact 95% CI using the Clopper-Pearson method
Measured: at Weeks 8, 16 and 24
Median Duration of Response (mDOR)
DOR for a participant with a BOR of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1/PCWG3 or death, whichever occurs first.
Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation)
Measured: at Weeks 8, 16 and 24
Median Progression-Free Survival (mPFS)
PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first.
Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) for the median and Greenwood formula for the rate.
Measured: at Weeks 8, 16 and 24, to progression
Progression-Free Survival Rate (PFSR)
PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first.
Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) for the median and Greenwood formula for the rate.
Measured: at Weeks 8, 16 and 24
Cmax
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
Cmax is defined as the maximum observed blood concentration.
Measured: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Tmax
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
Tmax is defined as the time of maximum observed blood concentration.
Measured: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
AUC(0-T)
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
AUC(0-T) is the area under the blood concentration-time curve from time zero to time of last quantifiable concentration.
Measured: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
AUC(INF)
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
AUC(INF) is the area under the blood concentration-time curve from time zero extrapolated to infinite time.
Measured: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
T-HALF
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
T-HALF is defined as the apparent terminal half-life.
Measured: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
CLT
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
CLT is defined as the total body clearance.
Measured: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Vss
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
Vss is defined as the volume of distribution at steady-state.
Measured: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Vz
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
Vz is defined as the volume of distribution of the elimination phase.
Measured: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
AUC(0-48)
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
AUC(0-T) is the area under the blood concentration-time curve from time zero to 48 hours postdose
Measured: Cycle 1 (from time zero to 48 hours postdose)
AUC(0-8)
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
AUC(0-T) is the area under the blood concentration-time curve from time zero to 8 hours postdose
Measured: Cycle 1 (from time zero to 8 hours postdose)
C48
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
C48 is defined as the blood concentration at 48 hours postdose.
Measured: Cycle 1 at 48 hours postdose
Css-avg
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
Css-avg is defined as the average blood concentration over a dosing interval at steady state (AUC[0-48]/48).
Measured: Cycle 1 (from time zero to 48 hours postdose)
AI_AUC
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
AUC accumulation index; ratio of AUC(0-48) on Cycle 1 Day 19 to AUC(0-48) on Cycle 1 Day 15 for monotherapy.
Measured: Cycle 1 (Day 19, Day 15)
AI_Cmax
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
Cmax accumulation index; ratio of Cmax on Cycle 1 Day 19 to Cmax on Cycle 1 Day 15 for monotherapy.
Measured: Cycle 1 (Day 19, Day 15)
T-HALFeff
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
T-HALFeff is defined as effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (exposure measure includes AUC, Cmax)
Measured: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Ctrough
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data.
Ctrough is defined as the trough observed blood concentration.
Measured: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Number of Participants With a Positive Antibody-Drug-Antibody (ADA) Response
Baseline ADA-positive participant is defined as a participant who has an ADA-detected sample at baseline.
ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment.
Frequency distribution of baseline ADA-positive participants and ADA-positive participants after initiation of the treatment
Measured: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start6 Dec 2017
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT03363776
- Sponsor's protocol ID
- CA034-001
- Other IDs
- 2017-002199-24, 2017
- Status last verified
- Nov 2020
- First submitted
- 1 Dec 2017
- Last updated
- 19 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2a First in Human Study of BMS-986277 Administered Alone and in Combination With Nivolumab in Advanced Epithelial Tumors
- ClinicalTrials.gov ID
- NCT03363776
- Acronym / sponsor ID
- CA034-001
- Conditions
- Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 6 Dec 2017 (actual)
- Results
- Posted 19 Dec 2020
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 investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | Experimental | Biological: BMS-986277BMS-986277 administered alone |
| Combination Dose Escalation Therapy | Experimental | Biological: BMS-986277, Biological: NivolumabBMS-986277 administered in combination with Nivolumab |
| Combination Expansion Therapy | Experimental | Biological: BMS-986277, Biological: NivolumabBMS-986277 monotherapy with option for subsequent Nivolumab therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histological or cytological confirmation of metastatic and/or unresectable metastatic colorectal, prostate, pancreatic, breast, ovarian, or urothelial carcinoma with measureable disease for solid tumors per RECIST v1.1 and for prostate carcinoma per PCWG3
- Presence of at least 2 lesions: at least one with measurable disease as defined by RECIST v1.1 for solid tumors and by PCWG3 for prostate carcinoma for response assessment; at least 1 lesion must be accessible for biopsy in addition to the target lesion
- Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting, if such a therapy exists, and have been considered for all other potentially efficacious therapies prior to enrollment
- ECOG performance status less than or equal to 2
Key exclusion criteria (5 listed)
- Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease
- Participants with carcinomatous meningitis
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study treatment
- Participants with active, known, or suspected autoimmune disease
- Other protocol defined inclusion/exclusion criteria could 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 |
|---|---|---|
| BMS-986277Specified dose on specified days | Biological | Combination Dose Escalation Therapy, Combination Expansion Therapy, Monotherapy |
| NivolumabAlso: Opdivo, BMS-963558Specified dose on specified days | Biological | Combination Dose Escalation Therapy, Combination Expansion Therapy |
Primary outcome
Number of Participants With an Adverse Event (AE)
Time frame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of participants who experienced an AE during the course of the study.
Number of Participants With a Serious Adverse Event (SAE)
Time frame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of participants who experienced a SAE during the course of the study.
Number of Participants With an Adverse Event (AE) Meeting Protocol-defined Dose Limiting Toxicity (DLT) Criteria
Time frame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of participants who experienced an AE meeting protocol-defined DLT criteria during the course of the study.
Number of Participants With an Adverse Event (AE) Leading to Discontinuation
Time frame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of participants who experienced an AE leading to discontinuation during the course of the study.
Number of Participants With an Adverse Event (AE) Leading to Death
Time frame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of participants who experienced an AE leading to death during the course of the study.
Number of Participants With a Clinical Laboratory Test Abnormality
Time frame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of participants who experienced a clinical laboratory test abnormality during the course of the study.
Number of Participants With a Vital Sign Abnormality or Other Safety Biomarkers
Time frame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Number of participants who experienced a vital sign abnormality or other safety biomarkers during the course of the study.
22 secondary outcomes
Objective Response Rate (ORR)
Time frame: at Weeks 8, 16 and 24
Disease Control Rate (DCR)
Time frame: at Weeks 8, 16 and 24
Median Duration of Response (mDOR)
Time frame: at Weeks 8, 16 and 24
Median Progression-Free Survival (mPFS)
Time frame: at Weeks 8, 16 and 24, to progression
Progression-Free Survival Rate (PFSR)
Time frame: at Weeks 8, 16 and 24
Cmax
Time frame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Tmax
Time frame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
AUC(0-T)
Time frame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
AUC(INF)
Time frame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
T-HALF
Time frame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
CLT
Time frame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Vss
Time frame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Vz
Time frame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
AUC(0-48)
Time frame: Cycle 1 (from time zero to 48 hours postdose)
AUC(0-8)
Time frame: Cycle 1 (from time zero to 8 hours postdose)
C48
Time frame: Cycle 1 at 48 hours postdose
Css-avg
Time frame: Cycle 1 (from time zero to 48 hours postdose)
AI_AUC
Time frame: Cycle 1 (Day 19, Day 15)
AI_Cmax
Time frame: Cycle 1 (Day 19, Day 15)
T-HALFeff
Time frame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Ctrough
Time frame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Number of Participants With a Positive Antibody-Drug-Antibody (ADA) Response
Time frame: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- 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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-986277 and Nivolumab in people with Cancer, run by Bristol-Myers Squibb at 3 sites in 2 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 4 inclusion and 5 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, United States. 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 19 Dec 2020). 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 an Adverse Event (AE) (time frame: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)). The study lists 7 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 19 Dec 2020.