NCT03891238: ARIES

Avelumab as Single Agent in Metastatic or Locally Advanced Urothelial Cancer in Patients Unfit for Cisplatin. The ARIES Study

Completed Phase 2 Last updated 1 February 2024

What this trial tests

Phase 2 trial testing Avelumab in Metastatic or Locally Advanced PD-L1 Positive Urothelial Cancer in 67 participants. Completed in 15 September 2021.

Timeline

6 February 2019

Primary endpoint
15 September 2021

15 September 2021

Quick facts

Lead sponsor	Consorzio Oncotech
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	67
Start date	6 February 2019
Primary completion	15 September 2021
Estimated completion	15 September 2021
Sites	21 locations across Italy

Drugs / interventions tested

• Avelumab (avelumab) — full drug profile →

Conditions studied

• Metastatic or Locally Advanced PD-L1 Positive Urothelial Cancer — all drugs for Metastatic or Locally Advanced PD-L1 Positive Urothelial Cancer →

Sponsor

Consorzio Oncotech — full company profile →

Who can join

18 and older, any sex, with Metastatic or Locally Advanced PD-L1 Positive Urothelial Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single arm, open label, phase II study to evaluate the activity of avelumab (MSB0010718C) in patients with metastatic or locally advanced urothelial cancer considered unfit to cisplatin-based chemotherapy, to be conducted in conformance with Good Clinical Practices.

Cisplatin-unfit patients will be defined if at least one of these characteristics is present:

1. ECOG-Performance status = 2;
2. Creatinine Clearance \< 60 ml/min;
3. Grade 2 or worse peripheral neuropathy or hearing loss;
4. Previous treatment with cisplatin for adjuvant intent in six months before the progression of disease.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Research Status and Outlook of PD-1/PD-L1 Inhibitors for Cancer Therapy.
   Ai L, Chen J, Yan H, He Q, et al · · 2020 · cited 149× · PMID 32982171 · DOI 10.2147/dddt.s267433
2. Immunotherapy for advanced or metastatic urothelial carcinoma.
   Maisch P, Hwang EC, Kim K, Narayan VM, et al · · 2023 · cited 9× · PMID 37811690 · DOI 10.1002/14651858.cd013774.pub2
3. Immune Checkpoint Inhibitors in the Management of Urothelial Carcinoma.
   Patel A, Bisno DI, Patel HV, Ghodoussipour S, et al · · 2021 · cited 4× · PMID 34263255 · DOI 10.33696/cancerimmunol.3.047
4. Effectiveness and safety of PD-1/L1 inhibitors as first-line therapy for patients with advanced or metastatic urothelial carcinoma who are ineligible for platinum-based chemotherapy: a meta-analysis.
   Liang W, Wang Z, Huang Z, Huang Y, et al · · 2025 · cited 1× · PMID 40013152 · DOI 10.3389/fimmu.2025.1430673
5. Emerging molecular therapies in the treatment of bladder cancer.
   Bell SD, Quinn AE, Spitzer TD, Voss BB, et al · · 2024 · cited 1× · PMID 39351439 · DOI 10.37349/etat.2024.00267
6. Scientific advances in drug development and clinical trials for urothelial carcinoma: Highlights from the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium
   · 2025