Treatment Of Metastic Bladder cancer at the time Of biochemical reLApse following radical cystectomy

Phase 1

• Conditions: Biochemical relapse in patients who have undergone radical cystectomy because of muscle-invasive transitional cell carcinoma of the urinary bladder; MedDRA version: 21.1Level: PTClassification code 10066754Term: Bladder transitional cell carcinoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001679-36-DK
• Lead Sponsor: Aarhus University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• =18 years of age at the time of signing the Informed Consent Form
• For male study subjects: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
• Signed Informed Consent Form
• ECOG PS 0, 1 or 2
• Is, according to the Investigator’s judgement, able to comply with the trial protocol
• Ability to understand the Participant Information Sheet orally and in writing
• Preoperative PET/CT of thorax, abdomen, and pelvis with no suspicion of organ metastases or untreated lymph node metastasis*
• Study Subjects undergoing radical cystectomy due to histopathological or clinical documented muscle invasive urothelial carcinoma (including subtypes) stage cT2-4a in the urinary bladder following NAC** in cisplatin-fit Study Subjects.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 282

Exclusion Criteria

• Subjects undergoing non-radical cystectomy for palliative reasons
• Non-radical surgery estimated intraoperative
• Other histology of BC than urothelial carcinoma – mixed tumours with urothelial features are allowed
• Concomitant invasive cancer within 5 years other than non-melanoma skin cancer and prostate cancer without metastasis
• Known contraindication to immunotherapy
• A history of autoimmune disease. Study Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• Study Subjects who meet any of the following criteria will be excluded from study entry:
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
• HIV positive
• History of pneumonitis (History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Hepatitis B or hepatitis C infection
• Subjects who have received a live, attenuated vaccine within 28 days prior to enrolment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified