The purpose of this study is to assess the antitumor activity of avelumab in combination with tuvusertib in terms of objective response in participants with advanced urothelial carcinoma. Study details include: Condition/Disease: Participants with urothelial carcinoma (locally advanced and unresectable, or metastatic) that has progressed on prior anti-PD-(L)1 therapy Treatment Duration: Participants will be treated until progressive disease, death, or discontinuation due to e.g. withdrawal of consent or lost to follow-up Visit Frequency: While receiving study intervention, participants will visit the site twice per every 21-day study intervention period. 1 week after end of study intervention, participants will visit the site for an End of Study Intervention Visit, followed by 2 Safety Follow-Up visits at 1 and 3 months after last dose, and thereafter have remote Long-Term Follow-up every 3 months. Study Duration: The overall study is planned to close after the last participant has been followed up for at least 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Participants will be administered Avelumab intravenously (IV).
Participants will be administered Tuvusertib orally.
Confirmed Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 as Assessed by Investigator in Participants with Selected Tumor Chromatin Modifier Mutations
Time frame: Up to 18 months
Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator
Time frame: Up to 18 months
Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator
Time frame: Up to 18 months
Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator
Time frame: Up to 18 months
Overall Survival (OS)
Time frame: From the date of randomization until death, assessed up to 1.5 years
Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs and Related TEAEs
Time frame: Up to 18 months
Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator in Subpopulations as Defined by Selected Tumor Biomarkers
Time frame: Up to 18 months
Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator in Subpopulations as Defined by Selected Tumor Biomarkers
Time frame: Up to 18 months
Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator in Subpopulations as Defined by Selected Tumor Biomarkers
Time frame: Up to 18 months
Overall Survival (OS) in Subpopulations as Defined by Selected Tumor Biomarkers
Time frame: From the date of randomization until death, assessed up to 1.5 years
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