Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03869190 | Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) | PHASE1 | COMPLETED | 272 | — | — | Jun 1, 2019 | Dec 22, 2025 | Jan 22, 2026 | 33 | United States, France +5 |
Objective response rate, defined as the proportion of participants with a CR or PR on two consecutive occasions \>=4 weeks apart during Stage 1, as determined by the investigator according to RECIST v1.1.
pCR, defined as the proportion of participants with an absence of residual invasive cancer of the complete resected specimen.
| Arm | Type | Description |
|---|---|---|
| Atezolizumab for mUC Cohort (Stage 1) | ACTIVE_COMPARATOR | Participants will receive atezolizumab until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 1) | EXPERIMENTAL | Participants will receive atezolizumab and Enfortumab Vedotin (EV) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Niraparib for mUC Cohort (Stage 1) | EXPERIMENTAL | Participants will receive atezolizumab and Niraparib (Nira) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Magrolimab for mUC Cohort (Stage 1) | EXPERIMENTAL | Participants will receive atezolizumab and magrolimab (Hu5F9-G4) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Tiragolumab for mUC Cohort (Stage 1) | EXPERIMENTAL | Participants will receive atezolizumab and Tiragolumab (Tira) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 1) | EXPERIMENTAL | Participants will receive atezolizumab and Sacituzumab Govitecan (SG) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Tocilizumab for mUC Cohort (Stage 1) | EXPERIMENTAL | Participants will receive atezolizumab and Tocilizumab (TCZ) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + RO7122290 for mUC Cohort (Stage 1) | EXPERIMENTAL | Participants will receive atezolizumab and RO7122290 until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Enfortumab Vedotin for mUC Cohort (Stage 2) | EXPERIMENTAL | Participants will receive atezolizumab and Enfortumab Vedotin (EV) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab + Sacituzumab Govitecan for mUC Cohort (Stage 2) | EXPERIMENTAL | Participants will receive atezolizumab and Sacituzumab Govitecan (SG) until unacceptable toxicity or loss of clinical benefit, as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. Enrollment is closed. |
| Atezolizumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 1 | ACTIVE_COMPARATOR | Participants will receive Atezolizumab for 3 cycles pre-surgery and 14 cycles post-surgery. |
| Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 1 PD-L1+ Arm 2 | EXPERIMENTAL | Participants will receive Atezolizumab and Tiragolumab (Tira) for 3 cycles pre-surgery and 14 cycles post-surgery. |
| Atezolizumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 1 | ACTIVE_COMPARATOR | Participants will receive Atezolizumab for 3 cycles pre-surgery and 14 cycles post-surgery. |
| Atezolizumab + Tiragolumab for Cisplatin-ineligible MIBC Cohort 2 PD-L1- Arm 2 | EXPERIMENTAL | Participants will receive Atezolizumab and Tiragolumab (Tira) for 3 cycles pre-surgery and 14 cycles post-surgery. |
| Cisplatin-eligible MIBC Cohort 3 Arm 1 | ACTIVE_COMPARATOR | Participants will receive 3 cycles of Atezolizumab, Cisplatin, and Gemcitabine pre-surgery and 14 cycles of Atezolizumab only post-surgery. |
| Cisplatin-eligible MIBC Cohort 3 Arm 2 | EXPERIMENTAL | Participants will receive Atezolizumab, Tiragolumab (Tira), Cisplatin and Gemcitabine for 3 cycles pre-surgery and 14 cycles of Atezolizumab and Tiragolumab (Tira) post-surgery. |
| Name | Type | Description |
|---|---|---|
| Atezolizumab | DRUG | For the control, + EV, + Nira, + Tira, and + SG arms, + RO7122290, Atezolizumab will be administered intravenously (IV) at a fixed dose of 1200 mg every 3 weeks (Q3W) on Day 1 of each 21-day cycle. For the Atezo + Hu5F9-G4 and + TCZ arms, Atezo will be administered IV at a fixed dose of 840 mg every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle. |
| Enfortumab Vedotin | DRUG | Enfortumab vedotin will be administered at a dose of 1.25 mg/kg IV on Days 1 and 8 of each 21-day cycle. |
| Niraparib | DRUG | Niraparib will be administered at a dose of 200 mg once daily (QD) by mouth. |
| Magrolimab (Hu5F9-G4) | DRUG | Participants will receive an 1-mg/kg priming dose IV on Day 1 followed by three weekly IV doses of 30 mg/kg on Days 8, 15, and 22. During Cycle 2, participants will receive weekly IV doses of 30 mg/kg on Days 1, 8, 15, and 22. For all subsequent cycles, participants will receive 30 mg/kg on Days 1 and 15. Cycle = 28 days. |
| Tiragolumab | DRUG | Tiragolumab will be administered at a dose of 600 mg IV on Day 1 of each 21-day cycle. |
| Sacituzumab Govitecan | DRUG | Sacituzumab Govitecan will be administered at a dose of 10 mg/kg by IV on Day 1 and 8 of each 21-day cycle. |
| Tocilizumab | DRUG | Tocilizumab will be administered by IV infusion at a dose of 8 mg/kg every 4 weeks (Q4W) on Day 1 of each 28-day cycle. |
| Cisplatin | DRUG | Cisplatin will be administered at a dose of 70mg/m\^2 by IV on Day 1 of each cycle for Cycles 1-3 pre-surgery. |
| Gemcitabine | DRUG | Gemcitabine will be administered at a dose of 1000mg/m\^2 by IV on Days 1 and 8 of each cycle for Cycles 1-3 pre-surgery. |
Inclusion Criteria for mUC Cohort: * Histologically documented, locally advanced or metastatic UC (also termed TCC or urothelial cell carcinoma of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra) * Availability of a representative tumor specimen that is suitable for...