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Metastatic Urothelial CancerPhase 2INDUCOMAINNCT03390595

Avelumab Plus Carboplatin-gemcitabine in Urothelial Carcinoma

A Phase 2 study testing avelumab 10mg/kg with carboplatin/gemcitabine and carboplatin/gemcitabine alone in people with Metastatic Urothelial Cancer, run by Associació per a la Recerca Oncologica, Spain at 15 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Phase II Multicentre, randomized, open-label study to evaluate the safety and efficacy of avelumab with gemcitabine/carboplatin versus gemcitabine/carboplatin alone in patients with unresectable or metastatic urothelial carcinoma (UC) who have not received prior systemic therapy and who are ineligible to receive… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Urothelial Cancer
What is being tested?
avelumab 10mg/kg with carboplatin/gemcitabine and carboplatin/gemcitabine alone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
15 sitesSpain
Study dates
17 May 2018to 31 Aug 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient has given written informed consent stating that he or she understands the purpose of the study and the procedures involved and agrees to participate in the study.
  • The patient has histologically confirmed unresectable UC (T4b, any N; or any T, N2-3) or metastatic (M1, Stage IV) UC of the urinary tract, including renal pelvis, ureters, urinary bladder, and urethra
  • No prior systemic therapy for inoperable locally advanced or metastatic UC. For patients who received prior adjuvant/neoadjuvant chemotherapy or chemo radiation for UC, a treatment-free interval >12 months between the last treatment administration and the date of recurrence is required in order to be considered treatment naive in the metastatic setting.
  • Ineligible ("unfit") for cisplatin-based chemotherapy as defined by any one of the following criteria:
  • Impaired renal function (GFR <60 mL/min)
  • ECOG performance status of 2
Show all 23Show fewer
  • Grade ≥2 hearing loss (measured by audiometry) or ≥25 dB at two contiguous frequencies
  • Grade ≥2 peripheral neuropathy * Criteria 4a and b are mutually exclusive: those patients with ECOG 2 won't be allowed to have an impaired renal function. For rest of the criteria, several of them may coexist.
  • The patient has at least one measurable tumour lesion (measurable disease, as defined by the RECIST criteria v1.1). If all sites of measurable disease have been irradiated, one site must have demonstrated growth after irradiation.
  • Age ≥18 years.
  • ECOG PS 0-2.
  • Life expectancy of at least 12 weeks.
  • Adequate hematologic, hepatic, and renal function, defined by:
  • Platelet count ≥100 x10^9/L.
  • Hemoglobin ≥ 9 g/dL (may have been transfused).
  • Absolute neutrophil count (ANC) ≥1.5x10^9/L.
  • Serum creatinine value not clinically significant; if creatinine >1.5 times the upper limit of normality (ULN), creatinine clearance will be calculated according to Chronic Kidney Disease Epidemiology group (CKD-EPI) formula or local formula and patients with creatinine clearance <30 mL/min shall be excluded.
  • NOTE: The CKD-EPI formula for creatinine clearance is as follows:
  • GFR = 141 x min(Scr/κ,1)^α x max(Scr/κ,1)^-1.209 x 0.993^Age x 1.018 [if female] x 1.159 [if black].
  • Where Scr is serum creatinine (mg/dL), κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1.
  • Alanine aminotransferase (ALT/SGPT), aspartate aminotransferase (AST/SGOT) and alkaline phosphatase (AP) ≤2.5 ×ULN (≤5 ×ULN in the presence of liver metastasis), unless this AP increase is explained due to the presence of bone metastases (with patient matching ALT, AST and bilirubin criteria), and serum total bilirubin ≤1.5 ×ULN.
  • Archival or newly-obtained representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks must be available.
  • Females of childbearing potential must have a negative serum pregnancy test within 7 days of study entry. Patients of childbearing potential who participate in this study must use effective contraceptive methods (e.g., abstinence, intrauterine device, oral or injectable contraceptives, a double barrier method or surgical sterility) to prevent pregnancy starting as soon as the informed consent form is signed and continuing for at least 13 weeks after the last dose of the study medication is administered.

Who cannot join

  • Women who are currently pregnant or breast-feeding.
  • Persisting toxicity related to prior therapy (NCI CTCAE v. 4.03 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
  • Patients who had undergone major surgery, radiation therapy or treatment with chemotherapy or any investigational agent within 28 days prior to Study day 1.
  • Evidence of severe or uncontrolled systemic disease or any concurrent condition (including uncontrolled diabetes mellitus) which in the Investigator's opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol.
  • History of another neoplasm. However, patients with prior history of either non-metastatic non melanoma skin cancers; carcinoma in situ of the cervix; or cancer cured by surgery, small field radiation or chemotherapy ≥3 years prior to randomisation; or treated patients with early stage and low risk prostate cancer (≤pT2 N0 M0, Gleason ≤6 and Prostate-specific antigen [PSA] ≤0.5 ng/mL) at study entry will be eligible.
  • Prior allogeneic stem cell or solid organ transplantation, or active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. However, patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible
Show all 19Show fewer
  • Current use of immunosuppressive medication, EXCEPT for the following:
  • Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
  • Systemic corticosteroids at doses ≤10 mg/day of prednisone or equivalent;
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • History of pulmonary fibrosis.
  • Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
  • Known history of testing positive for HIV or known acquired immunodeficiency syndrome.
  • Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive).
  • Active tuberculosis.
  • Active infection requiring systemic therapy.
  • Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
  • Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3).
  • Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behaviour; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Spain15 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Clìnic de Barcelona

    Barcelona, 08036

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Instituto Catalán de Oncología (ICO L'Hospitalet) - H. Durán i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario 12 de Octubre

    Madrid, 28026

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

  • Fundación Althaia - Xarxa Assistencial Univ. de Manresa

    Manresa, Barcelona, 08243

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Fundación Instituto Valenciano de Oncología

    Valencia, 46009

Other trials in Spain

About this study

Official title: Phase II Multicentre, Randomized, Open-label Study to Evaluate the Safety and Efficacy of Avelumab With Gemcitabine/Carboplatin Versus Gemcitabine/Carboplatin Alone in Patients With Unresectable or Metastatic Urothelial Carcinoma (UC) Who Have Not Received Prior Systemic Therapy and Who Are Ineligible to Receive Cisplatin-based Therapy.

Phase II Multicentre, randomized, open-label study to evaluate the safety and efficacy of avelumab with gemcitabine/carboplatin versus gemcitabine/carboplatin alone in patients with unresectable or metastatic urothelial carcinoma (UC) who have not received prior systemic therapy and who are ineligible to receive cisplatin-based therapy.

Read the detailed description

The aim of this study is to evaluate if the response rates (complete response [CR] + partial response [PR]) are sufficiently high and the severe acute toxicity rates acceptably low. Patients must be cisplatin-ineligible as defined by consensus criteria (see Inclusion criteria). Patients who experience disease progression >12 months following completion of a platinum-based adjuvant or neoadjuvant regimen will also be eligible for enrolment into the study.

Once it is confirmed that the subjects fulfil the eligibility criteria and have signed the informed consent form, they will be randomized in a 1:1 ratio to receive avelumab in combination with gemcitabine/carboplatin or gemcitabine/carboplatin alone as follows:

  • Arm A: patients will receive 2 cycles of induction avelumab 10mg/kg every 2 weeks followed by 6 cycles of carboplatin/gemcitabine plus avelumab (carboplatin 5AUC day +1, gemcitabine 1000mg/m2 day +1 and +8 and avelumab 10mg/kg day +15) every 3 weeks followed by avelumab monotherapy 10mg/kg every 2 weeks until progressive disease or intolerance.
  • Arm B: patients will receive 6 cycles of carboplatin/gemcitabine (carboplatin 5AUC day +1, gemcitabine 1000mg/m2 day +1 and +8) every 3 weeks.

Random assignment of treatment will be stratified by the presence or absence of visceral metastasis and ECOG < 2 versus ECOG 2.

All the patients enrolled in avelumab arm will receive avelumab monotherapy maintenance until disease progression or intolerable/unacceptable toxicity. Patients in the carboplatin-gemcitabine arm, will receive up to six cycles of treatment. Tumour evaluations will be scheduled every 6 weeks (±2 weeks) during carboplatin-gemcitabine treatment (in case of cycle delay this tumour evaluations every 6 weeks should be maintained to avoid any bias in the assessment of date of progression with appropriate imaging studies for response evaluation) and every 9 weeks thereafter until progressive disease (during this period, patients at arm A will be receiving avelumab maintenance treatment).

Patients with disease progression during the treatment phase will be withdrawn from the study and will receive their treatment according to the investigator's judgment and monitored to evaluate OS.

If a patient withdraws consent and refuses to receive more treatment, the patient must be followed up for survival. If a patient withdraws consent and refuses to continue in the study, the follow-up evaluations must be discontinued.

If at the moment of end of study there would be any patient still on maintenance treatment with avelumab, Sponsor will have commitment to provide the study drug in case patient is having clinical benefit.

Being tested
avelumab 10mg/kg with carboplatin/gemcitabine, carboplatin/gemcitabine alone
Keywords
Urothelial carcinoma
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

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

  • avelumab 10mg/kg with carboplatin/gemcitabineCombination product

    Also called Bavencio

    Dosage and schedule:

    • Avelumab 10mg/kg will be administered over 60 minutes in the experimental arm as follows:
    • Intravenously every 2 weeks for two cycles.
    • During carboplatin-gemcitabine treatment, on day +15 (carboplatin will be administered on day 1; gemcitabine on days 1 and 8), for six cycles. Intravenously every 2 weeks until progressive disease o intolerance.
    • Intravenously every 2 weeks until progressive disease or intolerance.
    • Carboplatin-gemcitabine will be administered for six cycles, every three weeks, with the following posology, according to the SmPC
    • Carboplatin 5AUC day +1.
    • Gemcitabine 1000mg/m2 day +1 and +8.

  • carboplatin/gemcitabine aloneCombination product

    Also called Standard of care for UC treatment

    •Carboplatin-gemcitabine will be administered for six cycles, every three weeks, with the following posology, according to the SmPC

    • Carboplatin 5AUC day +1.
    • Gemcitabine 1000mg/m2 day +1 and +8.
Study groups in NCT03390595
Study groupRoleWhat they receive
Avelumab plus gemcitabine/carboplatinExperimental2 cycles of induction avelumab 10mg/kg every 2 weeks followed by 6 cycles of carboplatin/gemcitabine plus avelumab (carboplatin 5AUC day +1, gemcitabine 1000mg/m2 day +1 and +8 and avelumab 10mg/kg day +15) every 3 weeks followed by avelumab monotherapy 10mg/kg every 2 weeks until progressive disease or intolerance.
Receives: Combination Product: avelumab 10mg/kg with carboplatin/gemcitabine
Gemcitabine/carboplatin aloneActive comparatorpatients will receive 6 cycles of carboplatin/gemcitabine (carboplatin 5AUC day +1, gemcitabine 1000mg/m2 day +1 and +8) every 3 weeks.
Receives: Combination Product: carboplatin/gemcitabine alone

What is being measured

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

  1. Objective Response Rate (ORR)

    The ORR is defined as the sum of the complete and partial responses (CR+PR), (according to Response Evaluation Criteria in Solid Tumours [RECIST criteria v1.1] and iRECIST).

    Measured: 24 months

Secondary outcomes (4)

  1. Progression-Free Survival (PFS)

    Time from randomisation to either documented disease progression or death from any cause (whichever occurs earlier).

    Measured: 24 months

  2. Overall Survival (OS)

    Time from randomisation to death from any cause. Patients still alive at the time of OS analysis will be censored on their last date of contact. Patients who withdraw from the study without having completed the withdrawal consent will be followed up to determine their status whenever possible.

    For the purposes of this study, subjects should be evaluated every 6 weeks with the appropriate imaging technique according to each centre's routine practice, during the combined treatment, and every 9 weeks during the maintenance period. In case of cycle delay every 6 weeks should be maintained to avoid any bias in the assessment of the date of progression with the appropriate imaging studies for response evaluation. Response will be monitored as per the RECIST 1.1 criteria.

    Measured: 24 months

  3. Duration of Response (DoR)

    Time from the first confirmation of objective response according to RECIST 1.1 criteria until disease progression or death.

    Measured: 24 months

  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Incidence and severity of adverse events. AEs will be coded and evaluated using the National Cancer Institute, Common Toxicity criteria for Adverse Events (NCI-CTCAE) v4.03 toxicity criteria (if NCI-CTCAE are not applicable, the Medical Dictionary for Regulatory Activities [MedDRA] will be used).

    Measured: 24 months

Timeline

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

  1. First posted4 Jan 2018
  2. Study start17 May 2018
  3. Primary completion31 Aug 2022
  4. Study completion31 Aug 2022

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03390595
Sponsor's protocol ID
MS100070_0160
Other IDs
2017-004260-36, 2017
Acronym
INDUCOMAIN
Status last verified
Oct 2023
First submitted
21 Dec 2017
Last updated
18 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bajorin DF, Dodd PM, Mazumdar M, Fazzari M, McCaffrey JA, Scher HI, Herr H, Higgins G, Boyle MG. Long-term survival in metastatic transitional-cell carcinoma and prognostic factors predicting outcome of therapy. J Clin Oncol. 1999 Oct;17(10):3173-81. doi: 10.1200/JCO.1999.17.10.3173.

    PubMed 10506615

  • Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.

    PubMed 21351269

  • Ferlay J, Parkin DM, Steliarova-Foucher E. Estimates of cancer incidence and mortality in Europe in 2008. Eur J Cancer. 2010 Mar;46(4):765-81. doi: 10.1016/j.ejca.2009.12.014. Epub 2010 Jan 29.

    PubMed 20116997

  • Witjes JA, Comperat E, Cowan NC, De Santis M, Gakis G, Lebret T, Ribal MJ, Van der Heijden AG, Sherif A; European Association of Urology. EAU guidelines on muscle-invasive and metastatic bladder cancer: summary of the 2013 guidelines. Eur Urol. 2014 Apr;65(4):778-92. doi: 10.1016/j.eururo.2013.11.046. Epub 2013 Dec 12.

    PubMed 24373477

  • AJCC cancer staging manual. 7th ed. New York: Springer, pp. 497-502.

  • National Comprehensive Cancer Network (2011) NCCN clinical practice guidelines for bladder cancer. www nccn org.

  • Bellmunt J, Albiol S. New chemotherapy combinations for advanced bladder cancer. Curr Opin Urol. 2001 Sep;11(5):517-22. doi: 10.1097/00042307-200109000-00011.

    PubMed 11493774

  • Loehrer PJ Sr, Einhorn LH, Elson PJ, Crawford ED, Kuebler P, Tannock I, Raghavan D, Stuart-Harris R, Sarosdy MF, Lowe BA, et al. A randomized comparison of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: a cooperative group study. J Clin Oncol. 1992 Jul;10(7):1066-73. doi: 10.1200/JCO.1992.10.7.1066.

    PubMed 1607913

  • Galsky MD, Hahn NM, Rosenberg J, Sonpavde G, Hutson T, Oh WK, Dreicer R, Vogelzang N, Sternberg CN, Bajorin DF, Bellmunt J. Treatment of patients with metastatic urothelial cancer "unfit" for Cisplatin-based chemotherapy. J Clin Oncol. 2011 Jun 10;29(17):2432-8. doi: 10.1200/JCO.2011.34.8433. Epub 2011 May 9.

    PubMed 21555688

  • De Santis M, Bellmunt J, Mead G, Kerst JM, Leahy M, Maroto P, Gil T, Marreaud S, Daugaard G, Skoneczna I, Collette S, Lorent J, de Wit R, Sylvester R. Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: EORTC study 30986. J Clin Oncol. 2012 Jan 10;30(2):191-9. doi: 10.1200/JCO.2011.37.3571. Epub 2011 Dec 12.

    PubMed 22162575

  • Dogliotti L, Carteni G, Siena S, Bertetto O, Martoni A, Bono A, Amadori D, Onat H, Marini L. Gemcitabine plus cisplatin versus gemcitabine plus carboplatin as first-line chemotherapy in advanced transitional cell carcinoma of the urothelium: results of a randomized phase 2 trial. Eur Urol. 2007 Jul;52(1):134-41. doi: 10.1016/j.eururo.2006.12.029. Epub 2006 Dec 26.

    PubMed 17207911

  • Rosenberg JE, Hoffman-Censits J, Powles T, van der Heijden MS, Balar AV, Necchi A, Dawson N, O'Donnell PH, Balmanoukian A, Loriot Y, Srinivas S, Retz MM, Grivas P, Joseph RW, Galsky MD, Fleming MT, Petrylak DP, Perez-Gracia JL, Burris HA, Castellano D, Canil C, Bellmunt J, Bajorin D, Nickles D, Bourgon R, Frampton GM, Cui N, Mariathasan S, Abidoye O, Fine GD, Dreicer R. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016 May 7;387(10031):1909-20. doi: 10.1016/S0140-6736(16)00561-4. Epub 2016 Mar 4.

    PubMed 26952546

  • Plimack ER, et al. Pembrolizumab (MK-3475) for advanced urothelial cancer: Updated results and biomarker analysis from KEYNOTE-012. J Clin Oncol 33, 2015 (suppl;abstr 4502).

  • Massard C, Gordon MS, Sharma S, Rafii S, Wainberg ZA, Luke J, Curiel TJ, Colon-Otero G, Hamid O, Sanborn RE, O'Donnell PH, Drakaki A, Tan W, Kurland JF, Rebelatto MC, Jin X, Blake-Haskins JA, Gupta A, Segal NH. Safety and Efficacy of Durvalumab (MEDI4736), an Anti-Programmed Cell Death Ligand-1 Immune Checkpoint Inhibitor, in Patients With Advanced Urothelial Bladder Cancer. J Clin Oncol. 2016 Sep 10;34(26):3119-25. doi: 10.1200/JCO.2016.67.9761. Epub 2016 Jun 6.

    PubMed 27269937

  • Galsky M, et al. Efficacy and safety of nivolumab monotherapy in patients with metastatic urothelial cancer (mUC) who have received prior treatment: Results from the phase II CheckMate 275 study. Presented at ESMO 2016 (abstract LBA31_PR).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing avelumab 10mg/kg with carboplatin/gemcitabine and carboplatin/gemcitabine alone in people with Metastatic Urothelial Cancer, run by Associació per a la Recerca Oncologica, Spain at 15 sites in Spain.

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 23 inclusion and 19 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: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Objective Response Rate (ORR) (time frame: 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 NCT03390595, which also lists 29 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 18 Oct 2023.

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