A multi-center Phase 2 study of neoadjuvant immunotherapy in combination with the anti-GDF-15 antibody visugromab (CTL-002) for the treatment of muscle invasive bladder cancer

Muscle invasive bladder cancer set to undergo radical cystectomy who cannot receive or refuse to receive cisplatin-based chemotherapy

Pathological complete response (pCR) rate of visugromab (CTL-002) in combination with an anti-PD-1 checkpoint inhibitor or an anti-PD-1 checkpoint inhibitor alone, as determined by local pathologist review, Radiological response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 of visugromab (CTL-002) in combination with an anti-PD-1 checkpoint inhibitor or an anti-PD-1 checkpoint inhibitor alone, as assessed by the Investigator

Evaluation of the number of participants with adverse events (AEs) including serious adverse events (SAEs), (related or unrelated to IMPs), abnormal clinical laboratory data, and physical findings of visugromab (CTL-002) in combination with an anti-PD-1 checkpoint inhibitor or an anti-PD-1 checkpoint inhibitor alone, Evaluation of number of participants with treatment-related delay of surgery, Evaluation of PK parameters of visugromab (CTL-002; e.g., maximum concentration [Cmax], area under the curve [AUC], and half-life [t1/2]), Evaluation of GDF-15 baseline serum levels and their correlation with pharmacodynamics and clinical activity, Evaluation of visugromab-induced anti-drug antibodies (ADA) development., Pathological complete response (pCR) rate of visugromab (CTL-002) in combination with an anti-PD-1 checkpoint inhibitor or an anti-PD-1 checkpoint inhibitor alone, as determined by central independent pathologist review, Radiological response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 of visugromab (CTL-002) in combination with an anti-PD-1 checkpoint inhibitor or an anti-PD-1 checkpoint inhibitor alone, as assessed by central independent review, Major pathological response (MPR) rate defined as residual ypT0/1/a/isN0M0 (including pathological complete responses) of visugromab (CTL-002) in combination with an anti-PD-1 checkpoint inhibitor or an anti-PD-1 checkpoint inhibitor alone, as determined by local pathologist review or central independent pathologist review, Evaluation of event-free survival (EFS), time to relapse (TTR), and overall survival (OS), Positron emission tomography (PET)-computed tomography (CT) and/or multiparametric (mp) magnetic resonance imaging (MRI) assessed response of visugromab (CTL-002) in combination with an anti-PD-1 checkpoint inhibitor or an anti-PD-1 checkpoint inhibitor alone, if available

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