PARP Inhibitor Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Not Candidate for Platinum RetreatmentPhase 2NCT05407584
Oregovomab and PLD in PARP Inhibitor Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment
A Phase 2 study testing Orevogomab+PLD and Orevogomab+Paclitaxel in people with PARP Inhibitor Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is phase II, open label, clinical trial to determine the efficacy of Oregovomab and non-platinum chemotherapy in PARP inhibitor resistant ovarian, fallopian tube, or primary peritoneal cancer patients who were not suitable for platinum retreatment. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- PARP Inhibitor Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment
- What is being tested?
- Orevogomab+PLD and Orevogomab+Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jul 2022to Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 20 years old or older.
- Subjects with histologically confirmed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin.
- Eligible histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, , and low-grade adenocarcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
- [only up to 5 patients with non-high grade serous carcinoma will be included]
- Prior PARP inhibitor exposure (progressed through a prior PARP inhibitor)
- CA-125 ≥ 50 U/ml
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- Prior platinum-based chemotherapy.
- Cohort 1 : 1-3 prior lines of therapies / Cohort 2 : Previous treatments of the 4th line or more.
- Not eligible for platinum re-treatment (prior allergic reaction or residual toxicity, patients who are not able to receive (in the physician's opinion) or willing to receive platinum treatment and platinum resistant patients)
- Received prior bevacizumab or not eligible for bevacizumab due to medical.
- Adequate bone marrow function:
- Absolute neutrophil count (ANC) ≥ 1,500/μL
- Platelets ≥ 100,000/μL
- Hemoglobin ≥ 8.0 g/dL (Note: Blood transfusion is permitted up to 48 hours before first dose of study treatment).
- Adequate liver function:
- Bilirubin < 1.5 times upper limit normal (ULN)
- Lactate Dehydrogenase (LDH), SGOT/AST and SGPT/ALT < 2.5 times ULN
- Adequate renal function:
- Creatinine ≤ 1.5 times ULN
- ECOG Performance Status of 0 or 1.
- For women of childbearing potential, must be willing to avoid pregnancy by using a highly effective method of contraception from the first dose of study treatment to 60 days after last dose of study treatment.
- Sign informed consent and authorization permitting release of personal health information.
Who cannot join
- Participant has mucinous, germ cell, or borderline tumor of the ovary.
- Female subjects who are lactating and breastfeeding, or have a positive serum pregnancy test within 7 days prior to the first dose of study treatment.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Active autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), or ankylosing spondylitis requiring active disease modifying treatment.
- Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab and PLD.
- Chronically treated with immunosuppressive drugs such as cyclosporine, adrenocorticotropic hormone (ACTH), etc.
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- Chronic therapeutic corticosteroid use, defined as > 5 days of prednisone or equivalent, with the exception of inhalers or those on a pre-planned steroid taper.
- Recognized acquired, hereditary, or congenital immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia.
- Clinically significant active infection(s) at the time of screening.
- Any of the following conditions (on-study testing is not required):
- Known HIV-infected subjects unless on effective anti-retroviral therapy with an undetectable viral load within 6 months, or
- Known or suspected hepatitis B if active infection (patients with chronic hepatitis B infection must have an undetectable HBV viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion), or
- Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load).
- Uncontrolled or life-threatening diseases compromising safety evaluation.
- Participant has a known additional malignancy that is progressing or has required active treatment within the past 2 years.
- Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ, endometrial carcinoma) that have undergone potentially curative therapy are not excluded.
- Note: Participants with synchronous primary endometrial cancer or a past history of primary endometrial cancer that met the following conditions are not excluded: Stage not greater than IA: no more than superficial myometrial invasion.
- Contraindications to the use of pressor agents
- History or evidence upon physical examination of CNS disease, seizures not controlled with standard medical therapy, or any brain metastases.
- Any of the following cardiovascular conditions:
- Acute myocardial infarction within 6 months before the first dose of study treatment.
- Current history of New York Heart Association (NYHA) Class III or IV heart failure (see Appendix H).
- Evidence of current uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiographic clinically significant findings.
- Unable to read or understand or unable to sign the necessary written consent before starting treatment.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Jung-Yun Lee, +82-2-2228-2237, jungyunlee@yuhs.ac
About this study
Official title: Oregovomab and Non-platinum Chemotherapy in PARP Inhibitor Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment: a Multicenter, Two-cohort, Single-arm Phase 2 Trial
This study is phase II, open label, clinical trial to determine the efficacy of Oregovomab and non-platinum chemotherapy in PARP inhibitor resistant ovarian, fallopian tube, or primary peritoneal cancer patients who were not suitable for platinum retreatment.
Patients who have received one to three prior lines of chemotherapy are to be assigned to Cohort 1 (oregovamab 2 mg [C1,2,3,5,7 for five doses] + pegylated liposomal doxorubicin [PLD] 40 mg/m2 q4w, n=28), while patients who have received more than three prior lines of chemotherapy are to be assigned to Cohort 2 (oregovamab 2 mg [C1,2,3,5,7 for five doses] + weekly paclitaxel 80 mg/m2 [D1,8,15 q4w], n=28). A total of 56 patients will be recruited and treated with oregovomab + PLD / weekly paclitaxel until disease progression, unacceptable toxicity, or withdrawal of patient consent. The primary endpoint is objective response rate by RECIST 1.1.
Read the detailed description
This study is a two-cohort, single arm phase II study in patients with PARP inhibitor-resistant ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of five administrations of Oregovomab 2mg IV in combination with non-platinum chemotherapy will be evaluated with recurrent ovarian cancer who have progressed with prior PARP inhibitor treatment.
Patients with disease under study will be screened for eligibility during the period 28 days immediately prior to starting study drug on Day 1. Laboratory and radiological assessments performed as part of standard of care before signing informed consent may be used if performed within the screening/baseline time window.
During this time, the inclusion and exclusion criteria will be assessed and all screening assessments, laboratory tests, and procedures will be performed.
Cohort 1(1-3 prior line of chemotherapy) PLD (40 mg / m2 IV over three hours in one day) to be repeated till progression or unacceptable toxicity every four weeks (28 days) Investigational agent (Oregovomab): 2 mg diluted in 50 mL saline for injection administered IV following PLD over approximately 20 (acceptable range 15-30) minutes for a total of 5 scheduled injections, one each at Cycle 1, Cycle 2, Cycle 3, Cycle 5, and Cycle 7
Cohort2 (>3prior line of chemotherapy) paclitaxel (80 mg / m2 IV over three hours in one day) to be repeated till progression or unacceptable toxicity every four weeks on day 1, 8, 15
Investigational agent (Oregovomab): 2 mg diluted in 50 mL saline for injection administered IV following paclitaxel over approximately 20 (acceptable range 15-30) minutes for a total of 5 scheduled injections, one each at Cycle 1, Cycle 2, Cycle 3, Cycle 5, and Cycle 7
- Being tested
- Orevogomab+PLD, Orevogomab+Paclitaxel
- Keywords
- PARP inhibitor Resistant, platinum resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orevogomab+PLDDrug
PLD (40 mg / m2 IV over three hours in one day) to be repeated till progression or unacceptable toxicity every four weeks (28 days)
Investigational agent (Oregovomab): 2 mg diluted in 50 mL saline for injection administered IV following PLD over approximately 20 (acceptable range 15-30) minutes for a total of 5 scheduled injections, one each at Cycle 1, Cycle 2, Cycle 3, Cycle 5, and Cycle 7
Orevogomab+PaclitaxelDrug
paclitaxel (80 mg / m2 IV over three hours in one day) to be repeated till progression or unacceptable toxicity every four weeks on day 1, 8, 15
Investigational agent (Oregovomab): 2 mg diluted in 50 mL saline for injection administered IV following paclitaxel over approximately 20 (acceptable range 15-30) minutes for a total of 5 scheduled injections, one each at Cycle 1, Cycle 2, Cycle 3, Cycle 5, and Cycle 7
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1(1-3 prior line of chemotherapy) | Experimental | Oregovomab and PLD is synergistic in PARPi-resistant recurrent ovarian cancer. Receives: Drug: Orevogomab+PLD |
| Cohort2 (>3prior line of chemotherapy) | Experimental | Oregovomab and Paclitaxel show synergistic in PARPi-resistant recurrent ovarian cancer. Receives: Drug: Orevogomab+Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed ORR
based on radiographically confirmed response according to CR+PR rate based on RECIST v1.1 as determined by the investigator
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes (6)
progression-free survival
PFS is calculated as the interval in months from the date of enrollment to the date of disease progression or the date of death, whichever comes first.
Measured: Up to 1 years
Overall survival (OS)
Overall survival (OS) will be calculated using the date of death OS is calculated as the interval in months from the date of enrollment to the date of death.
Measured: Up to 1 years
Time to first Subsequent Therapy
TFST, defined as time from the date of enrollment into the study to second anti-cancer therapy start date following study treatment completion, treatment exit [EOT] or death, will be determined.
Measured: The date of first documented first subsequent treatment or date of death, assessed up to 72 months
Time to Second Subsequent Therapy
TSST, defined as time from the date of enrollment into the study to third anti-cancer therapy start date following study treatment completion, treatment exit [EOT] or death, will be determined.
Measured: The date of first documented second subsequent treatment assessed up to 72 months
Duration of response
DOR, defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Measured: Up to 1 years
second objective disease progression
PFS2, defined as the time from enrollment into the study to the earlier date of progression on next-line therapy or death from any cause, will be determined.
Measured: Up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start5 Jul 2022
- Primary completionMay 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PARP Inhibitor Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Not Candidate for Platinum RetreatmentStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- CanariaBio Inc.
- Responsible party
- Sponsor
- Investigators
- Jung-Yun Lee, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407584
- Sponsor's protocol ID
- 4-2022-0430
- Status last verified
- May 2023
- First submitted
- 1 Jun 2022
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park J, Cho HW, Lim MC, Choi CH, Lee JY. OPERA: a phase II trial of oregovomab plus non-platinum chemotherapy in PARP inhibitor/platinum-resistant ovarian cancer. Future Oncol. 2024;20(26):1893-1899. doi: 10.1080/14796694.2024.2357533. Epub 2024 Jun 28.
PubMed 38940373
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oregovomab and Non-platinum Chemotherapy in PARP Inhibitor Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment: a Multicenter, Two-cohort, Single-arm Phase 2 Trial
- ClinicalTrials.gov ID
- NCT05407584
- Acronym / sponsor ID
- 4-2022-0430
- Keywords
- PARP inhibitor Resistant, platinum resistant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- CanariaBio Inc.
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 7 Jun 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.
This study is phase II, open label, clinical trial to determine the efficacy of Oregovomab and non-platinum chemotherapy in PARP inhibitor resistant ovarian, fallopian tube, or primary peritoneal cancer patients who were not suitable for platinum retreatment.
Patients who have received one to three prior lines of chemotherapy are to be assigned to Cohort 1 (oregovamab 2 mg [C1,2,3,5,7 for five doses] + pegylated liposomal doxorubicin [PLD] 40 mg/m2 q4w, n=28), while patients who have received more than three prior lines of chemotherapy are to be assigned to Cohort 2 (oregovamab 2 mg [C1,2,3,5,7 for five doses] + weekly paclitaxel 80 mg/m2 [D1,8,15 q4w], n=28). A total of 56 patients will be recruited and treated with oregovomab + PLD / weekly paclitaxel until disease progression, unacceptable toxicity, or withdrawal of patient consent. The primary endpoint is objective response rate by RECIST 1.1.
Detailed description
This study is a two-cohort, single arm phase II study in patients with PARP inhibitor-resistant ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of five administrations of Oregovomab 2mg IV in combination with non-platinum chemotherapy will be evaluated with recurrent ovarian cancer who have progressed with prior PARP inhibitor treatment.
Patients with disease under study will be screened for eligibility during the period 28 days immediately prior to starting study drug on Day 1. Laboratory and radiological assessments performed as part of standard of care before signing informed consent may be used if performed within the screening/baseline time window.
During this time, the inclusion and exclusion criteria will be assessed and all screening assessments, laboratory tests, and procedures will be performed.
Cohort 1(1-3 prior line of chemotherapy) PLD (40 mg / m2 IV over three hours in one day) to be repeated till progression or unacceptable toxicity every four weeks (28 days) Investigational agent (Oregovomab): 2 mg diluted in 50 mL saline for injection administered IV following PLD over approximately 20 (acceptable range 15-30) minutes for a total of 5 scheduled injections, one each at Cycle 1, Cycle 2, Cycle 3, Cycle 5, and Cycle 7
Cohort2 (>3prior line of chemotherapy) paclitaxel (80 mg / m2 IV over three hours in one day) to be repeated till progression or unacceptable toxicity every four weeks on day 1, 8, 15
Investigational agent (Oregovomab): 2 mg diluted in 50 mL saline for injection administered IV following paclitaxel over approximately 20 (acceptable range 15-30) minutes for a total of 5 scheduled injections, one each at Cycle 1, Cycle 2, Cycle 3, Cycle 5, and Cycle 7
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1(1-3 prior line of chemotherapy) | Experimental | Drug: Orevogomab+PLDOregovomab and PLD is synergistic in PARPi-resistant recurrent ovarian cancer. |
| Cohort2 (>3prior line of chemotherapy) | Experimental | Drug: Orevogomab+PaclitaxelOregovomab and Paclitaxel show synergistic in PARPi-resistant recurrent ovarian cancer. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Adults 20 years old or older.
- Subjects with histologically confirmed epithelial adenocarcinoma of ovarian, fallopian tube or peritoneal origin.
- Eligible histologic epithelial cell types: high grade serous adenocarcinoma, high grade endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, , and low-grade adenocarcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
- [only up to 5 patients with non-high grade serous carcinoma will be included]
- Prior PARP inhibitor exposure (progressed through a prior PARP inhibitor)
Key exclusion criteria (24 listed)
- Participant has mucinous, germ cell, or borderline tumor of the ovary.
- Female subjects who are lactating and breastfeeding, or have a positive serum pregnancy test within 7 days prior to the first dose of study treatment.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Active autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), or ankylosing spondylitis requiring active disease modifying treatment.
- Known allergy to murine proteins or hypersensitivity to any of the excipients of the oregovomab and PLD.
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 |
|---|---|---|
| Orevogomab+PLDPLD (40 mg / m2 IV over three hours in one day) to be repeated till progression or unacceptable toxicity every four weeks (28 days) Investigational agent (Oregovomab): 2 mg diluted in 50 mL saline for injection administered IV following PLD over approximately 20 (acceptable range 15-30) minutes for a total of 5 scheduled injections, one each at Cycle 1, Cycle 2, Cycle 3, Cycle 5, and Cycle 7 | Drug | Cohort 1(1-3 prior line of chemotherapy) |
| Orevogomab+Paclitaxelpaclitaxel (80 mg / m2 IV over three hours in one day) to be repeated till progression or unacceptable toxicity every four weeks on day 1, 8, 15 Investigational agent (Oregovomab): 2 mg diluted in 50 mL saline for injection administered IV following paclitaxel over approximately 20 (acceptable range 15-30) minutes for a total of 5 scheduled injections, one each at Cycle 1, Cycle 2, Cycle 3, Cycle 5, and Cycle 7 | Drug | Cohort2 (>3prior line of chemotherapy) |
Primary outcome
Confirmed ORR
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
based on radiographically confirmed response according to CR+PR rate based on RECIST v1.1 as determined by the investigator
6 secondary outcomes
progression-free survival
Time frame: Up to 1 years
Overall survival (OS)
Time frame: Up to 1 years
Time to first Subsequent Therapy
Time frame: The date of first documented first subsequent treatment or date of death, assessed up to 72 months
Time to Second Subsequent Therapy
Time frame: The date of first documented second subsequent treatment assessed up to 72 months
Duration of response
Time frame: Up to 1 years
second objective disease progression
Time frame: Up to 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Derived from this study: PubMed 38940373Park J, Cho HW, Lim MC, Choi CH, Lee JY. OPERA: a phase II trial of oregovomab plus non-platinum chemotherapy in PARP inhibitor/platinum-resistant ovarian cancer. Future Oncol. 2024;20(26):1893-1899. doi: 10.1080/14796694.2024.2357533. Epub 2024 Jun 28.
- Individual participant dataSharing planned: No
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.
Jung-Yun Lee principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orevogomab+PLD and Orevogomab+Paclitaxel in people with PARP Inhibitor Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment, run by Yonsei University at 1 site in South Korea.
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 22 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Yun Lee (82-2-2228-2237, jungyunlee@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed ORR (time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05407584, 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 24 May 2023.