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NCT Number: NCT07207928

Evaluation of Clinical Outcomes, Tolerability, and Costs of Avelumab Maintenance and Pembrolizumab Second-Line Therapy in Advanced Urothelial Cancer.

The goal of this observational study is to evaluate the clinical outcomes, side effects, and costs of Avelumab maintenance therapy in first-line and Pembrolizumab in second-line for platinum-fit patients with advanced urothelial cancer who have not shown disease progression after 4-6 cycles of platinum-based first-line chemotherapy.

Researchers will compare the effects of Avelumab (used as maintenance in first-line) and Pembrolizumab (used in second-line) to see if there are differences in clinical outcomes, toxicity profiles, and costs.

Participants will:

Receive Avelumab as maintenance therapy in the first-line or Pembrolizumab in the second-line as per standard clinical practice.

Be monitored for clinical outcomes, side effects, and costs over a period of up to 12 months prospectively and 10 years retrospectively.

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Key information

Conditions

Urothelial Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, 37134, Italy

About this study

Retrospective-prospective study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age
  • ECOG PS 0-2
  • Diagnosis of pathologically confirmed stage IV urothelial cancer, regardless of PD-L1 status
  • Patients treated with platinum-based chemotherapy (Cisplatin or Carboplatin) in the first-line setting who have not shown disease progression after 4-6 cycles of chemotherapy
  • Patients receiving Avelumab as maintenance therapy in the first-line setting or Pembrolizumab in the second-line setting
  • Availability of hospital and/or outpatient medical records for clinical data collection
  • Ability to understand and willingness to provide informed consent, or deceased patients at the time of enrollment, in compliance with Article 110 of the Privacy Code and the safeguards established by the Data Protection Authority in Provision No. 298 of May 9, 2024.

Exclusion criteria

  • History of another malignancy or concurrent malignancy (except for cured non-melanoma skin cancer, low-risk prostate cancer, T1/T2 glottic cancer, stage 0 or I breast cancer, non-invasive bladder cancer, or in situ cervical cancer).

Treatment and study plan

Primary outcomes

  1. Progression-free survival

    Time frame: 1 year

    Radiologic Progression-Free Survival (PFS) Evaluation in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy. These patients are treated with Avelumab in first-line maintenance therapy, or Pembrolizumab in second-line therapy. Radiologic progression is defined as the time from the start of first-line platinum-based chemotherapy to the date of radiologic progression (according to RECIST v1.1) after initiation of Avelumab maintenance therapy in the first-line or Pembrolizumab in the second-line, or death from any cause.

  2. Overall Survival

    Time frame: 1 year

    Overall Survival (OS) Evaluation in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy. These patients are treated with Avelumab in first-line maintenance therapy, or Pembrolizumab in second-line therapy.

Secondary outcomes

  1. Duration of Subsequent Oncologic Treatments

    Time frame: 1 year

    Duration of Subsequent Oncologic Treatments in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy treated with Avelumab in first-line maintenance therapy compared to patients treated with Pembrolizumab in second-line therapy.

  2. Adverse Events

    Time frame: 1 year

    Adverse Events of Any Grade Related to Treatment according to CTCAE 5.0, in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy treated with Avelumab in first-line maintenance therapy, compared to patients treated with Pembrolizumab in second-line therapy. Adverse events will be evaluated based on their severity and relationship to the treatment received.

  3. Serious Adverse Events

    Time frame: 1 year

    Adverse Events of Grade 3 or Higher Related to Treatment according to CTCAE 5.0, in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy. These patients are treated with Avelumab in first-line maintenance therapy, compared to patients treated with Pembrolizumab in second-line therapy. Adverse events of grade 3 or higher will be monitored and assessed for their relationship to the treatment received.

  4. Overall Cost of Oncologic Therapy

    Time frame: 1 year

    Overall Cost of Oncologic Therapy in patients with advanced platinum-fit urothelial carcinoma who have no disease progression after 4-6 cycles of first-line platinum-based chemotherapy treated with Avelumab in first-line maintenance therapy, compared to patients treated with Pembrolizumab in second-line therapy. The cost will be evaluated for each treatment approach and compared between the two groups.

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Collaborators

  • Casa di Cura Dott. Pederzoli
  • Ospedale Mater Salutis-Legnago(Verona), Italy

Registry information

Official study title

Evaluation of Clinical Outcomes, Tolerability, and Costs of Avelumab as First-Line Maintenance Therapy and Pembrolizumab as Second-Line Therapy in Patients With Advanced Urothelial Cancer Without Disease Progression After First-Line Platinum-Based Chemotherapy: A Multicenter Retro-Prospective Observational Study in Real-World Clinical Practice

Acronym: AvePem

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 6, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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