SOGUG-AVELUMAB_RWD

NCT05700344 | Completed

• 1 other identifier: SOGUG-2021-IEC(VEJ)-5
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 22

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

Conditions

Metastatic Urothelial Carcinoma

Outcome Measures

Primary Outcomes (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.

  Throughout the study period. Approximately 8 months

Secondary Outcomes (4)

• Median overall survival (mOS)

  Throughout the study period. Approximately 8 months

• Progression free survival rate at 12 months (PFS12)

  Throughout the study period. Approximately 8 months

• Collection of any adverse reaction (AR) or serious adverse reaction (SAR)

  Throughout the study period. Approximately 8 months

• Collection of any adverse event (AE) or serious adverse event (SAE)

  Throughout the study period. Approximately 8 months

Interventions

Avelumab DRUG

Single Group Assignment

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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).

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead
• Adknoma Health Research: collaborator

Study Sites (22)

Complexo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Location

Complexo Hospitalario Universitario A Coruña

A Coruña, Spain

Location

Complejo Hospitalario Universitario Albacete

Albacete, Spain

Location

Complejo Hospitalario Torrecárdenas

Almería, Spain

Location

Hospital Universitario Basurto

Bilbao, Spain

Location

Hospital Universitario de Burgos

Burgos, Spain

Location

Hospital Provincial de Castellón

Castellon, Spain

Location

Hospital Universitario Vinalopó

Elche, Spain

Location

Hospital General Universitario de Elda

Elda, Spain

Location

Hospital Universitario de Guadalajara

Guadalajara, Spain

Location

Hospital Clínico Universitario San Carlos

Madrid, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario Virgen de la Arrixaca

Murcia, Spain

Location

Complexo Hospitalario Universitario Ourense

Ourense, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Hospital Río Carrión

Palencia, Spain

Location

Hospital Sagunto

Sagunto, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Complexo Hospitalario Universitario Santiago

Santiago de Compostela, Spain

Location

Fundación Instituto Valenciano de Oncología

Valencia, Spain

Location

Hospital Universitario Politècnic La Fe

Valencia, Spain

Location

Hospital Marina Baixa Villajosyosa

Villajoyosa, Spain

Location

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• 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.

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• 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.

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• 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.

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• Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, Kalofonos H, Radulovic S, Demey W, Ullen A, Loriot Y, Sridhar SS, Tsuchiya N, Kopyltsov E, Sternberg CN, Bellmunt J, Aragon-Ching JB, Petrylak DP, Laliberte R, Wang J, Huang B, Davis C, Fowst C, Costa N, Blake-Haskins JA, di Pietro A, Grivas P. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020 Sep 24;383(13):1218-1230. doi: 10.1056/NEJMoa2002788. Epub 2020 Sep 18.

  PMID: 32945632 RESULT

Related Links

• ASC. American Cancer Society. Bladder cancer

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

avelumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Áurea Molina

  Complejo Hospitalario Universitario A Coruña (CHUAC)

  PRINCIPAL INVESTIGATOR

• Ovidio Fernández

  Complejo Hospitalario Universitario Ourense (CHOU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 26, 2023
• Study Start: September 5, 2022
• Primary Completion: July 31, 2023
• Study Completion: November 2, 2023
• Last Updated: February 29, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (22)