Solid CancerPhase 1/2NCT03721679

Poly-ICLC (Hiltonol) and Anti-PD1 or Anti-PD-L1

A Phase 1/2 study testing Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 months in people with Solid Cancer, run by Oncovir, Inc. at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is an open labeled, non-randomized adaptive pilot study. The study interventions involved in this study are: Poly-ICLC (Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose, also known as Hiltonol®) treatment in combination with anti-PD-1 (Nivolumab, Cemiplimab or Pembrolizumab)… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Cancer
What is being tested?: Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 months
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 3 sitesUnited States
Study dates: 25 Sep 2018to 26 Jan 2021
Phase: Phase 1/2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed diagnosis of Solid Cancer, independent of PD-L1 tumor status.
Patients must be 18 years of age or older.
Unresectable disease. Patients with resectable disease but who refuse surgery may be enrolled after a documented consultation with a surgeon.
Radiologically or visually measurable disease that is at least 10mm in longest dimension, AND/OR with elevated disease specific serum markers that can be followed for progression (eg CA-125, AFP, PSA, CA19-9 or CEA)
ECOG performance status of ≤ 2.
Acceptable hematologic, renal and liver function as follows:

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Absolute neutrophil count > 1000/mm3 B) Platelets > 50,000/mm3, C) Creatinine ≤ 2.5 mg/dl, D) Total bilirubin ≤ 1.5 mg/dl, unless due to tumor or Gilbert's syndrome E) Transaminases ≤ 2 times above the upper limits of the institutional normal. F) INR<2 if off of anticoagulation. Patients on anticoagulation therapy with an INR>2 may be enrolled at the discretion of the investigator if they have not had any episodes of severe hemorrhage.
Patients must be able to provide informed consent.
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Contraception must be continued for at least 2 months following the last dose of Poly-ICLC. Women of childbearing potential must have a negative pregnancy test. While animal reproductive studies have been negative, the simulated viral infection and anti-proliferative activity of this experimental drug may theoretically affect the developing fetus or nursing infant.
Cohort Specific Inclusion Criteria (see § 9.5 Evaluation of Best Overall Response (BOR)
Cohort A
Patients who have received at least 8 weeks of immunotherapy.
Patients have progressive disease based on RECIST 1.1 criteria
Cohort B)
Patients who have received at least 8 weeks of aPD1 or aPDL1 immunotherapy.
Patients have stable disease or a partial response based on RECIST 1.1 criteria.
Cohort C)
Patients who have not received an anti-PD-1 or anti-PD-L1 agent, but who carry a diagnosis for which one of these agents is the SOC.
Patients willing to delay receipt of first dose of anti-PD-1 or anti-PD-L1 until after the receipt of their first two doses of intramuscular Poly-ICLC

Who cannot join

Patients may not be receiving any other investigational agents.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.
Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.

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HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with <200 CD4+ T cells/microliter in the peripheral blood.
Has known active Hepatitis B (e.g., HBV detected by elevated PCR or active Hepatitis C (e.g., HCV RNA [qualitative] is detected).
History of allogeneic hematopoietic cell transplantation or solid organ transplantation.
Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps)
Principal investigator believes that for one or multiple reasons the patient will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the patient.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Chevy Chase RCCA
Chevy Chase, Maryland, 20815
Bay Hematology Oncology
Easton, Maryland, 21601
Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Official title: Poly-ICLC (Hiltonol®) Plus Anti-PD1 or Anti-PD-L1 in Unresectable Solid Cancers An Adaptive Phase I/II Clinical Pilot Study

This is an open labeled, non-randomized adaptive pilot study. The study interventions involved in this study are:

Poly-ICLC (Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose, also known as Hiltonol®) treatment in combination with anti-PD-1 (Nivolumab, Cemiplimab or Pembrolizumab) or anti-PD-L1 (Atezolizumab or Durvalumab)

Read the detailed description

This research study is a PhaseI/II clinical trial investing a combination of targeted therapies as possible treatment for advanced solid cancers

FDA has not yet approved Poly-ICLC as treatment for diseases in this study

Pembrolizumab, Nivolumab, Atezolizumab, Cemiplimab and Durvalumab are now FDA approved for certain patients with multiple cancer types.

The study is designed to evaluate the safety of intramuscular (IM) Polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (Poly-ICLC, Hiltonol®) in combination with Anti-PD-1 or Anti-PD-L1 for treatment of study subjects with advanced solid cancers.

Conditions: Solid Cancer
Being tested: Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 months
Keywords: Immunotherapy, Vaccine Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 monthsBiological
Also called Same as above
Same as above

Study groups in NCT03721679
Study group	Role	What they receive
Poly-ICLC treatment combination aPD-1or aPD-1L1	Experimental	Weeks 1 and 2: Poly-ICLC (Hiltonol®) 1 mg (0.5 ml) IM ONLY twice a week with a 48-72 hour interval between the two injections Weeks 3-25: 1. Poly-ICLC (Hiltonol®) 1 mg (0.5 ml) IM twice a week with a 48-72 hour interval between the two injections, AND 2. ONLY 1 of the following regimens will be administered, per manufacturer's dosing and clinical oncologist's discretion as follows: * Nivolumab (Opdivo), OR * Pembrolizumab (Keytruda), OR * Cemiplimab (Libtayo) OR * Atezolizumab (Tecentriq) OR * Durvalumab (Imfinzi) Follow up: After completion of treatment subjects may be contacted by telephone at least twice over 12 months, or longer with patient consent, in order to inquire on their health status (e.g., in remission, progressive disease, on new cancer treatment). Receives: Biological: Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 months

What is being measured

The primary outcome is the main question the study is designed to answer.

Tumor assessment
Response and progression will be evaluated in this study. Tumor Response will be assessed by the RECIST 1.1 Criteria. Response is defined as CR, PR or SD over a period of at least 4 weeks. Changes in the sum of the two largest perpendicular diameters (SPD) of the tumor lesions, or the shortest diameter in the case of malignant lymph nodes are used in the RECIST 1.1 criteria. Study subjects with progressive disease will be evaluated to determine whether the progression causes symptoms and/or functional decline and study subjects with non-clinically relevant progression of disease may remain on study at the investigator's discretion.
Measured: 6 month timepoint compared to baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 201826 Jan 2021

First posted26 Oct 2018
Study start25 Sep 2018
Primary completion26 Jan 2021
Study completion26 Jan 2021

Why it stopped: Recruiting target patients is intermittent making it impracticable to enroll the required study sample. The administrative responsibilities have been met with extraordinary challenges. Current funding does not match the incurring costs.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Solid CancerStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Sequential
Model description: The study is largely a signal-finding exercise to determine if there is an immune and/or clinical response to the addition of poly-ICLC to aPD-1 or aPDL-1 therapy, as predicted by preclinical models.
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03721679
Sponsor's protocol ID: ONC2018-001
Status last verified: Dec 2020
First submitted: 1 Oct 2018
Last updated: 1 Feb 2021
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Bosio CM, Aman MJ, Grogan C, Hogan R, Ruthel G, Negley D, Mohamadzadeh M, Bavari S, Schmaljohn A. Ebola and Marburg viruses replicate in monocyte-derived dendritic cells without inducing the production of cytokines and full maturation. J Infect Dis. 2003 Dec 1;188(11):1630-8. doi: 10.1086/379199. Epub 2003 Nov 14.
PubMed 14639532
Brody JD, Ai WZ, Czerwinski DK, Torchia JA, Levy M, Advani RH, Kim YH, Hoppe RT, Knox SJ, Shin LK, Wapnir I, Tibshirani RJ, Levy R. In situ vaccination with a TLR9 agonist induces systemic lymphoma regression: a phase I/II study. J Clin Oncol. 2010 Oct 1;28(28):4324-32. doi: 10.1200/JCO.2010.28.9793. Epub 2010 Aug 9.
PubMed 20697067
Caskey M, Lefebvre F, Filali-Mouhim A, Cameron MJ, Goulet JP, Haddad EK, Breton G, Trumpfheller C, Pollak S, Shimeliovich I, Duque-Alarcon A, Pan L, Nelkenbaum A, Salazar AM, Schlesinger SJ, Steinman RM, Sekaly RP. Synthetic double-stranded RNA induces innate immune responses similar to a live viral vaccine in humans. J Exp Med. 2011 Nov 21;208(12):2357-66. doi: 10.1084/jem.20111171. Epub 2011 Nov 7.
PubMed 22065672

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Poly-ICLC (Hiltonol®) Plus Anti-PD1 or Anti-PD-L1 in Unresectable Solid Cancers An Adaptive Phase I/II Clinical Pilot Study
ClinicalTrials.gov ID: NCT03721679
Acronym / sponsor ID: ONC2018-001
Conditions: Solid Cancer
Keywords: Immunotherapy, Vaccine Therapy
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Recruiting target patients is intermittent making it impracticable to enroll the required study sample. The administrative responsibilities have been met with extraordinary challenges. Current funding does not match the incurring costs.
Enrolment: 7 participants (actual)
Lead sponsor: Oncovir, Inc.Industry (pharma, biotech, devices)
Collaborators: Chevy Chase Healthcare, Chevy Chase MD, Mt. Sinai School of Medicine, New York, New York, Bay Hematology Oncology PA, Easton MD
Study start: 25 Sep 2018 (actual)
Primary completion: 26 Jan 2021 (actual)
Study completion: 26 Jan 2021 (actual)
First posted: 26 Oct 2018 (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 is an open labeled, non-randomized adaptive pilot study. The study interventions involved in this study are:

Detailed description

This research study is a PhaseI/II clinical trial investing a combination of targeted therapies as possible treatment for advanced solid cancers

FDA has not yet approved Poly-ICLC as treatment for diseases in this study

Pembrolizumab, Nivolumab, Atezolizumab, Cemiplimab and Durvalumab are now FDA approved for certain patients with multiple cancer types.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: The study is largely a signal-finding exercise to determine if there is an immune and/or clinical response to the addition of poly-ICLC to aPD-1 or aPDL-1 therapy, as predicted by preclinical models.

Arm	Type	Receives
Poly-ICLC treatment combination aPD-1or aPD-1L1	Experimental	Biological: Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 monthsWeeks 1 and 2: Poly-ICLC (Hiltonol®) 1 mg (0.5 ml) IM ONLY twice a week with a 48-72 hour interval between the two injections Weeks 3-25: 1. Poly-ICLC (Hiltonol®) 1 mg (0.5 ml) IM twice a week with a 48-72 hour interval between the two injections, AND 2. ONLY 1 of the following regimens will be administered, per manufacturer's dosing and clinical oncologist's discretion as follows: * Nivolumab (Opdivo), OR * Pembrolizumab (Keytruda), OR * Cemiplimab (Libtayo) OR * Atezolizumab (Tecentriq) OR * Durvalumab (Imfinzi) Follow up: After completion of treatment subjects may be contacted by telephone at least twice over 12 months, or longer with patient consent, in order to inquire on their health status (e.g., in remission, progressive disease, on new cancer treatment).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Histologically confirmed diagnosis of Solid Cancer, independent of PD-L1 tumor status.
Patients must be 18 years of age or older.
Unresectable disease. Patients with resectable disease but who refuse surgery may be enrolled after a documented consultation with a surgeon.
Radiologically or visually measurable disease that is at least 10mm in longest dimension, AND/OR with elevated disease specific serum markers that can be followed for progression (eg CA-125, AFP, PSA, CA19-9 or CEA)
ECOG performance status of ≤ 2.

Key exclusion criteria (11 listed)

Patients may not be receiving any other investigational agents.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.
Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.

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
Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 monthsAlso: Same as aboveSame as above	Biological	Poly-ICLC treatment combination aPD-1or aPD-1L1

Primary outcome

Tumor assessment
Time frame: 6 month timepoint compared to baseline
Response and progression will be evaluated in this study. Tumor Response will be assessed by the RECIST 1.1 Criteria. Response is defined as CR, PR or SD over a period of at least 4 weeks. Changes in the sum of the two largest perpendicular diameters (SPD) of the tumor lesions, or the shortest diameter in the case of malignant lymph nodes are used in the RECIST 1.1 criteria. Study subjects with progressive disease will be evaluated to determine whether the progression causes symptoms and/or functional decline and study subjects with non-clinically relevant progression of disease may remain on study at the investigator's discretion.

Results and safety

The study was stopped early (reason given: Recruiting target patients is intermittent making it impracticable to enroll the required study sample. The administrative responsibilities have been met with extraordinary challenges. Current funding does not match the incurring costs.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
Results publication: PubMed 14639532Bosio CM, Aman MJ, Grogan C, Hogan R, Ruthel G, Negley D, Mohamadzadeh M, Bavari S, Schmaljohn A. Ebola and Marburg viruses replicate in monocyte-derived dendritic cells without inducing the production of cytokines and full maturation. J Infect Dis. 2003 Dec 1;188(11):1630-8. doi: 10.1086/379199. Epub 2003 Nov 14.
Results publication: PubMed 20697067Brody JD, Ai WZ, Czerwinski DK, Torchia JA, Levy M, Advani RH, Kim YH, Hoppe RT, Knox SJ, Shin LK, Wapnir I, Tibshirani RJ, Levy R. In situ vaccination with a TLR9 agonist induces systemic lymphoma regression: a phase I/II study. J Clin Oncol. 2010 Oct 1;28(28):4324-32. doi: 10.1200/JCO.2010.28.9793. Epub 2010 Aug 9.
Results publication: PubMed 22065672Caskey M, Lefebvre F, Filali-Mouhim A, Cameron MJ, Goulet JP, Haddad EK, Breton G, Trumpfheller C, Pollak S, Shimeliovich I, Duque-Alarcon A, Pan L, Nelkenbaum A, Salazar AM, Schlesinger SJ, Steinman RM, Sekaly RP. Synthetic double-stranded RNA induces innate immune responses similar to a live viral vaccine in humans. J Exp Med. 2011 Nov 21;208(12):2357-66. doi: 10.1084/jem.20111171. Epub 2011 Nov 7.
Individual participant dataSharing planned: No

Related trials for Solid Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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.

Frederick P Smith, MD principal investigator

Chevy Chase Healthcare

David H Smith, MD principal investigator

Bay Hematology Oncology PA

Nina Bhardwaj, MD, PhD principal investigator

Icahn School of Medicine at Mount Sinai

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 19 inclusion and 11 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 1 Feb 2021. 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 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?

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?

Tumor assessment (time frame: 6 month timepoint compared to baseline). 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 NCT03721679, which also lists 3 linked publications.

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 Feb 2021.