MelanomaPhase 1NCT05538130
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
A Phase 1 study testing PF-07799544 and PF-07799933 in people with Melanoma and Glioma, run by Pfizer at 66 sites in 7 countries.
Trial summary
The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Melanoma, Glioma, Thyroid Cancer
- What is being tested?
- PF-07799544 and PF-07799933
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 66 sitesin 7 countries
- Study dates
- 30 Nov 2022to 31 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Phase 1b Inclusion Criteria:
- Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer)
- Measurable disease by RECIST version 1.1
- Evidence of a BRAF V600 mutation
- Prior therapy per tumor cohort
- Adequate organ function per protocol
Phase 1b Exclusion Criteria:
- Other active malignancy within 3 years
- Presence of leptomeningeal disease
- History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease
- Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
- Active gastrointestinal disease as defined per protocol
- History of interstitial lung disease as defined per protocol
Trial locations and contacts
66 sites in 7 countries.
66 sites in 7 countries
United States44 sites
MSK Basking Ridge.
Basking Ridge, New Jersey, 07920
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35233
The University of Alabama at Birmingham
Birmingham, Alabama, 35249
University of Alabama at Birmingham - Phase I Clinical Trials Unit
Birmingham, Alabama, 35249
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland, Ohio, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
MSK Commack.
Commack, New York, 11725
Brigitte Harris Cancer Pavilion
Detroit, Michigan, 48202
Henry Ford Hospital
Detroit, Michigan, 48202
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72703
MSK Westchester.
Harrison, New York, 10604
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate
Los Angeles, California, 90025
Keck Hospital of USC
Los Angeles, California, 90033
Los Angeles General Medical Center
Los Angeles, California, 90033
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792
MSK Monmouth.
Middletown, New Jersey, 07748
MSK Bergen.
Montvale, New Jersey, 07645
SCRI Oncology Partners
Nashville, Tennessee, 37203
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Memorial Sloan Kettering Cancer Center 53rd street.
New York, New York, 10022
Columbia University Irving Medical Center
New York, New York, 10032
Columbia University Medical Center - Neurological Institute of New York
New York, New York, 10032
CUIMC Research Pharmacy
New York, New York, 10032
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
Keck Medical Center of USC Pasadena
Pasadena, California, 91105
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
Providence Portland Medical Center
Portland, Oregon, 97213
Highlands Oncology Group, PA
Rogers, Arkansas, 72758
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, 94143
UCSF Medical Center, Investigational Pharmacy
San Francisco, California, 94158
The Angeles Clinic and Research Institue, A Cedars-Sinai Affiliate (Emergency Back-up only)
Santa Monica, California, 90404
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
University of Washington Medical Center
Seattle, Washington, 98195
Highlands Oncology Group, PA
Springdale, Arkansas, 72762
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa, Florida, 33612
Moffitt Cancer Center
Tampa, Florida, 33612
Moffitt McKinley Hospital
Tampa, Florida, 33612
MSK Nassau.
Uniondale, New York, 11553
Canada8 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Alberta Health Services and The Governors of The University of Alberta
Edmonton, Alberta, T6G 2C8
Jewish General Hospital
Montreal, Quebec, H3T 1E2
McGill University Health Centre
Montreal, Quebec, H4A 3J1
The Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Israel4 sites
Soroka Medical Center
Beersheba, Southern District, 8410101
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001
Rabin Medical Center
Petah Tikva, Central District, 4941492
Sheba Medical Center
Ramat Gan, Central District, 5265601
Australia3 sites
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
The Alfred Hospital
Melbourne, Victoria, 3004
Royal Melbourne Hospital
Parkville, Victoria, 3050
Brazil3 sites
ANIMI - Unidade de Tratamento Oncologico
Lages, Santa Catarina, 88501001
Centro de Oncologia - CEON+ - Unidade São Caetano do Sul
São Caetano do Sul, 09541-270
IBCC - Núcleo de Pesquisa e Ensino
São Paulo, 04014-002
China2 sites
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Japan2 sites
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
About this study
Official title: A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS
The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).
Phase 1a is no longer open for enrollment. In Phase1b (noted as "this study"), we are seeking participants who have:
Read more
- a solid tumor which is metastatic or recurrent (excluding colorectal cancer)
- tumor with the mutation (abnormal gene) called "BRAF V600"
- received required prior treatment for cancer per cohort assigned.
All participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.
Participants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.
- Conditions
- Melanoma, Glioma, Thyroid Cancer, Non-Small Cell Lung Cancer, Malignant Neoplasms, Brain Neoplasms
- Being tested
- PF-07799544, PF-07799933
- Keywords
- solid tumors, BRAF, advanced solid tumors, B-Raf, MAPK, neoplasms, BRAF V600
- Medical subject headings
- Melanoma, Glioma, Thyroid Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07799544Drug
Also called ARRY-134
Tablet
PF-07799933Drug
Also called ARRY-440
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Monotherapy Dose Escalation | Experimental | Participants will receive PF-07799544 Receives: Drug: PF-07799544 |
| Phase 1b Combination Dose Escalation | Experimental | Participants will receive PF-07799544 and PF-07799933 Receives: Drug: PF-07799544; Drug: PF-07799933 |
| Phase 1b Combination Dose Expansion | Experimental | Participants will receive PF-07799544 and PF-07799933 Receives: Drug: PF-07799544; Drug: PF-07799933 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs)
DLTs will be evaluated during the first cycle (21 days) as a single agent (phase 1a monotherapy) or in combination with other agents (phase 1b dose escalation)
Measured: Cycle 1 (21 days)
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with treatment-emergent adverse events (AEs)
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Measured: Baseline to 28 days after last dose of study medication
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Measured: Baseline to 28 days after last dose of study treatment
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in vital sign abnormalities
Vital sign abnormalities as characterized by type, frequency, severity, and timing.
Measured: Baseline to 28 days after last dose of study treatment
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in physical exam abnormalities
Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Baseline to 28 days after last dose of study treatment
Phase 1b Dose Expansion: Overall response rate (ORR)
Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors
Measured: Baseline to 2 years
Secondary outcomes (13)
Phase 1a monotherapy and Phase 1b combination dose escalation: ORR
ORR as assessed using the RECIST version 1.1.
Measured: Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with treatment-emergent adverse events (AEs)
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Measured: Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with clinically significant change from baseline in vital sign abnormalities
Vital sign abnormalities as characterized by type, frequency, severity, and timing.
Measured: Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with clinically significant change from baseline in laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Measured: Baseline to 2 years
Phase 1b Dose Expansion: Duration of Response (Overall and in CNS)
Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors
Measured: Baseline to 2 years
Phase 1b Dose Expansion: Intracranial response
Intracranial response by RECIST version 1.1 (for brain metastases)
Measured: Baseline to 2 years
Phase 1b Dose Expansion: Progression Free Survival (PFS)
Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors
Measured: Baseline to 2 years
PK Parameters: Maximum Observed Concentration (Cmax)
Single dose and multiple dose PK will be calculated as data permits
Measured: Baseline to 2 years
PK Parameters: Maximum Plasma Concentration (Tmax)
Single dose and multiple dose PK will be calculated as data permits
Measured: Baseline to 2 years
PK Parameters: Area Under Curve (AUC)
Single dose and multiple dose PK will be calculated as data permits
Measured: Baseline to 2 years
PK Parameters: terminal elimination half-life (t½)
Singe dose and multiple dose PK will be calculated as data permits
Measured: Baseline to 2 years
PK Parameters: Apparent Oral Clearance (CL/F)
Singe dose and multiple dose PK will be calculated as data permits
Measured: Baseline to 2 years
PK Parameters: Apparent Volume of Distribution (Vz/F)
Singe dose and multiple dose PK will be calculated as data permits
Measured: Baseline to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start30 Nov 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538130
- Sponsor's protocol ID
- C4901001
- Other IDs
- NCT05538130
- Status last verified
- Aug 2026
- First submitted
- 9 Sep 2022
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS
- ClinicalTrials.gov ID
- NCT05538130
- Acronym / sponsor ID
- C4901001
- Conditions
- Melanoma, Glioma, Thyroid Cancer, Non-Small Cell Lung Cancer, Malignant Neoplasms, Brain Neoplasms
- Keywords
- solid tumors, BRAF, advanced solid tumors, B-Raf, MAPK, neoplasms, BRAF V600
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 148 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 13 Sep 2022 (actual)
- 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.
The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).
Phase 1a is no longer open for enrollment. In Phase1b (noted as "this study"), we are seeking participants who have:
- a solid tumor which is metastatic or recurrent (excluding colorectal cancer)
- tumor with the mutation (abnormal gene) called "BRAF V600"
- received required prior treatment for cancer per cohort assigned.
All participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.
Participants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Monotherapy Dose Escalation | Experimental | Drug: PF-07799544Participants will receive PF-07799544 |
| Phase 1b Combination Dose Escalation | Experimental | Drug: PF-07799544, Drug: PF-07799933Participants will receive PF-07799544 and PF-07799933 |
| Phase 1b Combination Dose Expansion | Experimental | Drug: PF-07799544, Drug: PF-07799933Participants will receive PF-07799544 and PF-07799933 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| PF-07799544Also: ARRY-134Tablet | Drug | Phase 1a Monotherapy Dose Escalation, Phase 1b Combination Dose Escalation, Phase 1b Combination Dose Expansion |
| PF-07799933Also: ARRY-440Tablet | Drug | Phase 1b Combination Dose Escalation, Phase 1b Combination Dose Expansion |
Primary outcome
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs)
Time frame: Cycle 1 (21 days)
DLTs will be evaluated during the first cycle (21 days) as a single agent (phase 1a monotherapy) or in combination with other agents (phase 1b dose escalation)
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with treatment-emergent adverse events (AEs)
Time frame: Baseline to 28 days after last dose of study medication
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in laboratory abnormalities
Time frame: Baseline to 28 days after last dose of study treatment
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in vital sign abnormalities
Time frame: Baseline to 28 days after last dose of study treatment
Vital sign abnormalities as characterized by type, frequency, severity, and timing.
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in physical exam abnormalities
Time frame: Baseline to 28 days after last dose of study treatment
Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Phase 1b Dose Expansion: Overall response rate (ORR)
Time frame: Baseline to 2 years
Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors
13 secondary outcomes
Phase 1a monotherapy and Phase 1b combination dose escalation: ORR
Time frame: Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with treatment-emergent adverse events (AEs)
Time frame: Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with clinically significant change from baseline in vital sign abnormalities
Time frame: Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with clinically significant change from baseline in laboratory abnormalities
Time frame: Baseline to 2 years
Phase 1b Dose Expansion: Duration of Response (Overall and in CNS)
Time frame: Baseline to 2 years
Phase 1b Dose Expansion: Intracranial response
Time frame: Baseline to 2 years
Phase 1b Dose Expansion: Progression Free Survival (PFS)
Time frame: Baseline to 2 years
PK Parameters: Maximum Observed Concentration (Cmax)
Time frame: Baseline to 2 years
PK Parameters: Maximum Plasma Concentration (Tmax)
Time frame: Baseline to 2 years
PK Parameters: Area Under Curve (AUC)
Time frame: Baseline to 2 years
PK Parameters: terminal elimination half-life (t½)
Time frame: Baseline to 2 years
PK Parameters: Apparent Oral Clearance (CL/F)
Time frame: Baseline to 2 years
PK Parameters: Apparent Volume of Distribution (Vz/F)
Time frame: Baseline to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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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.
Pfizer CT.gov Call Center study director
Pfizer
66 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-07799544 and PF-07799933 in people with Melanoma and Glioma, run by Pfizer at 66 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Canada, Israel, Australia, Brazil and 2 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs) (time frame: Cycle 1 (21 days)). 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?
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 1 Sep 2026; AzTrials last refreshed its copy on 27 Oct 2026.