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Metastatic Urothelial CarcinomaSOGUGNCT05700344

SOGUG-AVELUMAB_RWD

An observational study of Metastatic Urothelial Carcinoma, run by Spanish Oncology Genito-Urinary Group at 22 sites in Spain.

Completed

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

Official record
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Trial summary

The study goal is to evaluate the effectiveness in clinical practice of Avelumab as first line maintenance therapy in patients with locally advanced or metastatic Urothelial Carcinoma, who have not progressed after first line platinum-based treatment. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Metastatic Urothelial Carcinoma
What is being tested?
Avelumab
How many people
125 participants
Where
22 sitesSpain
Study dates
5 Sep 2022to 2 Nov 2023
Phase
Observational
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with locally advanced or metastatic Urothelial Carcinoma who have not progressed after first line platinum-based treatment and who received or are receiving Avelumab as the first-line maintenance therapy in routine clinical practice.

Who may be able to join

  • Patients understanding the nature of the study by providing their informed consent prior to participation.
  • Patients of both sexes diagnosed with locally advanced or metastatic Urothelial Carcinoma, stage IV disease (AJCC ed. 8th, 2017) before first line with carboplatin/cisplatin-based chemotherapy (ChT). No disease progression after four-six cycles of ChT according to the Response Evaluation Criteria in Solid Tumor (RECIST 1.1) with a treatment free interval of 4-10 weeks before Avelumab initiation date.
  • Patients who started Avelumab as maintenance therapy in first line after 21/Jan./2021 and before 27/Apr./2022 (both dates included).

Who cannot join

None listed.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Spain22 sites

  • Complexo Hospitalario Universitario A Coruña

    A Coruña

  • Complejo Hospitalario Universitario Albacete

    Albacete

  • Complejo Hospitalario Torrecárdenas

    Almería

  • Hospital Universitario Basurto

    Bilbao

  • Hospital Universitario de Burgos

    Burgos

  • Hospital Provincial de Castellón

    Castellon

  • Hospital Universitario Vinalopó

    Elche

  • Hospital General Universitario de Elda

    Elda

  • Hospital Universitario de Guadalajara

    Guadalajara

  • Hospital Clínico Universitario San Carlos

    Madrid

  • Hospital Universitario Ramón y Cajal

    Madrid

  • Hospital Universitario Virgen de la Arrixaca

    Murcia

  • Complexo Hospitalario Universitario Ourense

    Ourense

  • Hospital Universitario Central de Asturias

    Oviedo

  • Hospital Río Carrión

    Palencia

  • Hospital Sagunto

    Sagunto

  • Hospital Universitario de Salamanca

    Salamanca

  • Complexo Hospitalario Universitario Santiago

    Santiago de Compostela

  • Fundación Instituto Valenciano de Oncología

    Valencia

  • Hospital Universitario Politècnic La Fe

    Valencia

  • Complexo Hospitalario Universitario de Vigo

    Vigo, Pontevedra

  • Hospital Marina Baixa Villajosyosa

    Villajoyosa

Other trials in Spain

About this study

Official title: Multicentric, Observational Study to Evaluate Real World Data of Avelumab in First Line Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma, a SOGUG Study

The study goal is to evaluate the effectiveness in clinical practice of Avelumab as first line maintenance therapy in patients with locally advanced or metastatic Urothelial Carcinoma, who have not progressed after first line platinum-based treatment.

Study is performed at national hospitals from approximately 22 different sites and expecting to recruit 120 patients.

Read more

Patients understanding the nature of the study by providing their informed consent prior to participation.

  • Patients of both sexes diagnosed with locally advanced or metastatic Urothelial Carcinoma, stage IV disease before first line with carboplatin/cisplatin-based chemotherapy. No disease progression after four-six cycles of ChT according to the Response Evaluation Criteria in Solid Tumor with a treatment free interval of 4-10 weeks before Avelumab initiation date.
  • Patients who started Avelumab as maintenance therapy in first line after 21/Jan./2021 and before 27/Apr./2022 (both dates included).
Read the detailed description

Multicentre, observational, ambispective (retrospective and prospective) study to evaluate the real-world evidence of Avelumab as maintenance therapy in patients diagnosed with Urothelial Carcinoma (WHO classification) and previously treated with platinum-based treatment in first line. Study is performed at national hospitals from approximately 22 different sites and expecting to recruit 120 patients. Patients are selected based on the existing medical record of have been treated with Avelumab as maintenance therapy in first line before initiating the study (retrospective data); patients who continues receiving Avelumab after inclusion will also contribute to data collection until the end of treatment or end of study (prospective data).

According to mUC incidence and the selective inclusion criteria from this study of having initiated Avelumab as maintenance therapy in 1L between EMA approval date (Jan. 2021) and date of national reimbursement prize (Apr.2022), which is a narrow period of time to recruit the necessary number of candidates, therefore, prospective data from each participant patient will be a key to ensure the assessment of the study objective eventually.

Investigators will review the medical history of patients treated or under treatment of Avelumab and select chronologically those who matches the inclusion criteria. Patients will be informed during a regular follow up visit about the nature of the study and requested to sign the patient consent form once the decision of participating is made. At this point, the retrospective data from patients is collected (such as demographics, toxicity, anthropometrics, vital signs, comorbidities, hemogram, dosage modification etc.) previous adverse reactions (ARs) and serious adverse reaction (SARs) related to Avelumab. Included patients, that continues under Avelumab treatment will be monitored by investigators and prospective data from them will be collected during follow up visits and/or from electronic medical records (eMR).

Deceased patient who fulfils the inclusion criteria can be also included, being able to access to its clinical data at the beginning of the study according to Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) and the Spanish Organic Law 3/2018 of 5th December, on the protection of personal data and digital rights. Additionally, the investigator team will consult in the eMR of deceased patients to ensure that they did not express in life opposition to the use of their data for investigational purposes.

Being tested
Avelumab
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.

What is being measured

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

  1. Median progression free survival (mPFS)

    median time for patients from treatment initiation with Bavencio® to the date of real world progression event or death due to any cause. Patients without a real-world progression event or date of death will be censored at the most recent visit with the treating oncologist or end of follow up.

    Measured: Throughout the study period. Approximately 8 months

Secondary outcomes (4)

  1. Median overall survival (mOS)

    median length of the time from the date patient initiates treatment with Bavencio® to the date of death. Patients not dead will be censored at the most recent visit with the treating oncologist or end of follow up.

    Measured: Throughout the study period. Approximately 8 months

  2. Progression free survival rate at 12 months (PFS12)

    percentage of alive patients and progression free 12 month after treatment initiation with Bavencio®. Patients without a real-world progression event or date of death will be censored at month 12th.

    Measured: Throughout the study period. Approximately 8 months

  3. Collection of any adverse reaction (AR) or serious adverse reaction (SAR)

    Collection of any adverse reaction (AR) or serious adverse reaction (SAR) occurring during treatment period (retrospective and prospective).

    Measured: Throughout the study period. Approximately 8 months

  4. Collection of any adverse event (AE) or serious adverse event (SAE)

    Collection of any adverse event (AE) or serious adverse event (SAE) during prospective data collection. Immune check points inhibitors have unique side effects known as immune-related adverse event (irAE) that along with the treatment related AE (TRAE) are of interest to the study (3, 4).

    Measured: Throughout the study period. Approximately 8 months

Timeline

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

  1. First posted26 Jan 2023
  2. Study start5 Sep 2022
  3. Primary completion31 Jul 2023
  4. Study completion2 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05700344
Sponsor's protocol ID
SOGUG-2021-IEC(VEJ)-5
Acronym
SOGUG
Status last verified
Nov 2023
First submitted
17 Jan 2023
Last updated
29 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kumar V, Chaudhary N, Garg M, Floudas CS, Soni P, Chandra AB. Current Diagnosis and Management of Immune Related Adverse Events (irAEs) Induced by Immune Checkpoint Inhibitor Therapy. Front Pharmacol. 2017 Feb 8;8:49. doi: 10.3389/fphar.2017.00049. eCollection 2017.

    PubMed 28228726

  • Galsky MD, Balar AV, Black PC, Campbell MT, Dykstra GS, Grivas P, Gupta S, Hoimes CJ, Lopez LP, Meeks JJ, Plimack ER, Rosenberg JE, Shore N, Steinberg GD, Kamat AM. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of urothelial cancer. J Immunother Cancer. 2021 Jul;9(7):e002552. doi: 10.1136/jitc-2021-002552.

    PubMed 34266883

  • Kim JW, Tomita Y, Trepel J, Apolo AB. Emerging immunotherapies for bladder cancer. Curr Opin Oncol. 2015 May;27(3):191-200. doi: 10.1097/CCO.0000000000000177.

    PubMed 25811346

  • Morales-Barrera R, Suarez C, Gonzalez M, Valverde C, Serra E, Mateo J, Raventos C, Maldonado X, Morote J, Carles J. The future of bladder cancer therapy: Optimizing the inhibition of the fibroblast growth factor receptor. Cancer Treat Rev. 2020 Jun;86:102000. doi: 10.1016/j.ctrv.2020.102000. Epub 2020 Mar 13.

    PubMed 32203842

  • Wolacewicz M, Hrynkiewicz R, Grywalska E, Suchojad T, Leksowski T, Rolinski J, Niedzwiedzka-Rystwej P. Immunotherapy in Bladder Cancer: Current Methods and Future Perspectives. Cancers (Basel). 2020 May 7;12(5):1181. doi: 10.3390/cancers12051181.

    PubMed 32392774

  • Powles T, Rosenberg JE, Sonpavde GP, Loriot Y, Duran I, Lee JL, Matsubara N, Vulsteke C, Castellano D, Wu C, Campbell M, Matsangou M, Petrylak DP. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021 Mar 25;384(12):1125-1135. doi: 10.1056/NEJMoa2035807. Epub 2021 Feb 12.

    PubMed 33577729

  • Balar AV, Galsky MD, Rosenberg JE, Powles T, Petrylak DP, Bellmunt J, Loriot Y, Necchi A, Hoffman-Censits J, Perez-Gracia JL, Dawson NA, van der Heijden MS, Dreicer R, Srinivas S, Retz MM, Joseph RW, Drakaki A, Vaishampayan UN, Sridhar SS, Quinn DI, Duran I, Shaffer DR, Eigl BJ, Grivas PD, Yu EY, Li S, Kadel EE 3rd, Boyd Z, Bourgon R, Hegde PS, Mariathasan S, Thastrom A, Abidoye OO, Fine GD, Bajorin DF; IMvigor210 Study Group. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. Lancet. 2017 Jan 7;389(10064):67-76. doi: 10.1016/S0140-6736(16)32455-2. Epub 2016 Dec 8.

    PubMed 27939400

  • Balar AV, Castellano D, O'Donnell PH, Grivas P, Vuky J, Powles T, Plimack ER, Hahn NM, de Wit R, Pang L, Savage MJ, Perini RF, Keefe SM, Bajorin D, Bellmunt J. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017 Nov;18(11):1483-1492. doi: 10.1016/S1470-2045(17)30616-2. Epub 2017 Sep 26.

    PubMed 28967485

  • Sharma P, Retz M, Siefker-Radtke A, Baron A, Necchi A, Bedke J, Plimack ER, Vaena D, Grimm MO, Bracarda S, Arranz JA, Pal S, Ohyama C, Saci A, Qu X, Lambert A, Krishnan S, Azrilevich A, Galsky MD. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2017 Mar;18(3):312-322. doi: 10.1016/S1470-2045(17)30065-7. Epub 2017 Jan 26.

    PubMed 28131785

  • Bukhari N, Al-Shamsi HO, Azam F. Update on the Treatment of Metastatic Urothelial Carcinoma. ScientificWorldJournal. 2018 Jun 6;2018:5682078. doi: 10.1155/2018/5682078. eCollection 2018.

    PubMed 29977169

  • von der Maase H, Sengelov L, Roberts JT, Ricci S, Dogliotti L, Oliver T, Moore MJ, Zimmermann A, Arning M. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005 Jul 20;23(21):4602-8. doi: 10.1200/JCO.2005.07.757.

    PubMed 16034041

  • von der Maase H, Hansen SW, Roberts JT, Dogliotti L, Oliver T, Moore MJ, Bodrogi I, Albers P, Knuth A, Lippert CM, Kerbrat P, Sanchez Rovira P, Wersall P, Cleall SP, Roychowdhury DF, Tomlin I, Visseren-Grul CM, Conte PF. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: results of a large, randomized, multinational, multicenter, phase III study. J Clin Oncol. 2000 Sep;18(17):3068-77. doi: 10.1200/JCO.2000.18.17.3068.

    PubMed 11001674

  • Grivas P, Agarwal N, Pal S, Kalebasty AR, Sridhar SS, Smith J, Devgan G, Sternberg CN, Bellmunt J. Avelumab first-line maintenance in locally advanced or metastatic urothelial carcinoma: Applying clinical trial findings to clinical practice. Cancer Treat Rev. 2021 Jun;97:102187. doi: 10.1016/j.ctrv.2021.102187. Epub 2021 Mar 22.

    PubMed 33839438

  • Apolo AB, Infante JR, Balmanoukian A, Patel MR, Wang D, Kelly K, Mega AE, Britten CD, Ravaud A, Mita AC, Safran H, Stinchcombe TE, Srdanov M, Gelb AB, Schlichting M, Chin K, Gulley JL. Avelumab, an Anti-Programmed Death-Ligand 1 Antibody, In Patients With Refractory Metastatic Urothelial Carcinoma: Results From a Multicenter, Phase Ib Study. J Clin Oncol. 2017 Jul 1;35(19):2117-2124. doi: 10.1200/JCO.2016.71.6795. Epub 2017 Apr 4.

    PubMed 28375787

  • O'Donnell JC, Le TK, Dobrin R, Higashi M, Pereira A, Wagner S, Yang A, Hukkelhoven M. Evolving use of real-world evidence in the regulatory process: a focus on immuno-oncology treatment and outcomes. Future Oncol. 2021 Jan;17(3):333-347. doi: 10.2217/fon-2020-0591. Epub 2020 Oct 19.

    PubMed 33074018

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Urothelial Carcinoma, run by Spanish Oncology Genito-Urinary Group at 22 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 3 inclusion and 0 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 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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.

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?

Median progression free survival (mPFS) (time frame: Throughout the study period. Approximately 8 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 NCT05700344, which also lists 20 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 29 Feb 2024.

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