Active — Not RecruitingPhase 2

Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy

Denmark154 participantsStarted 2020-03-24

Plain-language summary

Immunotherapy (checkpoint inhibitors) is approved as first and second line treatment to patients with metastatic bladder cancer. However, response rates are low and no biomarkers have yet shown strong predictive value for patient selection. Moreover, the term 'metastatic' is based on metastases visible on conventional CT scans and, thus, require a certain size of tumour load. Clinical trials are currently being conducted that investigate the use of adjuvant immunotherapy for this group of patients (treatment to all), which will result in massive over-treatment and huge costs to the healthcare system. This project has the primary objective to identify new indications for initiating immunotherapy in patients with metastatic bladder cancer. Sensitive molecular techniques for detection of tumor DNA in the blood will be used to identify patients with early signs of metastatic disease. In addition, comprehensive biomarker analysis will be performed to identify predictors of treatment response.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 lymph node metastasis\* above the aortic bifuraction * Study Subjects undergoing radical cystectomy due to histologically documented muscle invasive urothelial carcinoma (including subtypes) stage cT2-4a in the urinary bladder following NAC\*\* in cisplatin-fit Study Subjects. * Study Subjects who have undergone down-staging chemotherapy because of lymph node metastasis with no organ metastases can be included if complete response regarding lymph nodes are identified on preoperative imaging. * NAC includes Study Subjects who have stopped after one course of chemotherapy because of side effects or local non-metastatic progression 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 th…

What they're measuring

Complete response (CR) after treatment with investigational agent initiated by ctDNA positive status after radical cystectomy (with or without concomitant visible metastases on CT).

Timeframe: Time from treatment initiation with investigational agent until 12 months after initiation

Trial details

NCT IDNCT04138628

SponsorJørgen Bjerggaard Jensen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-01