CompletedPhase 2

Study of NIVOLUMAB/IPILIMUMAB Maintenance in Unresectable Locally Advanced or Metastatic Urothelial Cancer

Spain25 participantsStarted 2022-07-06

Plain-language summary

Immunotherapy has improved clinical outcomes in metastatic urothelial carcinoma (mUC). Second-line treatment after progression to platinum-containing chemotherapy with immune checkpoint inhibitors (ICIs) have antitumor activity in advanced / metastatic UC and provide favorable safety profiles when compared with chemotherapy The study aims to determine if Nivolumab plus Ipilimumab maintenance therapy is effective in delaying disease progression in patients with unresectable locally advanced or metastatic urothelial cancer that did not progress during or following completion of first-line chemotherapy. Vexillum plans to recruit patients that achieve clinical benefit from first-line chemotherapy and may be candidates for maintenance immunotherapy to consolidate this benefit.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Haemoglobin ≥ 9.0 g/dL.
✓. Absolute neutrophil count (ANC) \> 1500 per mm3.
✓. Platelet count ≥ 100,000 per mm3.
✓. Serum bilirubin ≤ 1.5 X institutional upper limit of normal (ULN) unless liver metastases are present, in which case it must be ≤ 2X ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of haemolysis or hepatic pathology); however, they will be allowed only in consultation with their physician.
✓. Serum transaminases (ALT, AST and GGT) ≤ 2.5X institutional upper limit of normal unless liver metastases are present, in which case it must be ≤ 3X ULN.
✓. Measured creatinine clearance (CL) \> 30 mL/min or Calculated creatinine CL \> 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for the determination of creatinine clearance.
✓. Amenorrheic for ≥1 year in the absence of chemotherapy and/or hormonal treatments
✓. Luteinizing hormone (LH) and/or follicle stimulating hormone and/or estradiol levels in the post-menopausal range

Exclusion criteria

What they're measuring

progression-free survival (PFS)

Timeframe: Throughout the study period, approximately 12 months per patient from first study dose.

progression-free survival (PFS) in PL-D1 positive patients

Timeframe: Throughout the study period, approximately 12 months per patient from first study dose.

Trial details

NCT IDNCT05219435

SponsorSpanish Oncology Genito-Urinary Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-10

View on ClinicalTrials.gov More Urothelial Cancer trials