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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02527434 | Study of Tremelimumab in Patients With Advanced Solid Tumors | PHASE2 | COMPLETED | 64 | — | — | Nov 2, 2015 | Mar 28, 2023 | Nov 15, 2023 | 14 | United States, Belgium +3 |
Objective response rate (ORR) during the initial tremelimumab monotherapy phase was assessed by the site Investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) and was defined as the percentage of patients with a confirmed overall response of complete response (CR) or partial response (PR) and was based on all treated patients who had measurable disease at baseline (Day 1). 95% confidence intervals (CIs) were calculated using the Clopper Pearson method.
| Arm | Type | Description |
|---|---|---|
| treme mono to be sequenced to MEDI4736 mono or combination | EXPERIMENTAL | tremelimumab monotherapy, with the option for eligible patients to be sequenced to MEDI4736 monotherapy or MEDI4736 + tremelimumab combination therapy after progressive disease (PD) |
| Name | Type | Description |
|---|---|---|
| Tremelimumab monotherapy | BIOLOGICAL | IV infusion |
| MEDI4736 monotherapy | BIOLOGICAL | IV infusion |
| MEDI4736 + tremelimumab combination therapy | BIOLOGICAL | IV infusion |
Inclusion Criteria: 1\. histologically or cytologically documented solid tumor malignancies, including but not limited to 1 of the following: UBC, Metastatic PDAC, TNBC; Are intolerant, are ineligible for, or have refused treatment with standard first-line therapy; 2. At least 1 lesion, not previou...