Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Livmoniplimab · 5 trials · 5 indications
OS is defined as the time measured from randomization until death from any cause.
BOR of CR/PR is defined as achieving CR or PR according to response evaluation criteria in solid tumors (RECIST) v1.1 as determined by investigators at any time prior to subsequent anticancer therapy. Objective response rate (ORR), defined as the percentage of participants with a BOR of CR/PR, will be summarized.
OS is defined as the time measured from randomization until death from any cause.
BOR is defined as a participant achieving confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by investigators at any time prior to subsequent anticancer therapy.
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Maximum Plasma Concentration (Cmax) of livmoniplimab and Budigalimab
AUC of livmoniplimab and Budigalimab
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation portion of the study.
The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamic (PD) data collected during the dose escalation portion of the study.
ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Livmoniplimab (Dose A) + Budigalimab | EXPERIMENTAL | Participants will receive livmoniplimab (dose A) in combination with budigalimab, as part of the approximately 3.5 years study duration. |
| Arm 2: Livmoniplimab (Dose B) + Budigalimab | EXPERIMENTAL | Participants will receive livmoniplimab (dose B) in combination with budigalimab, as part of the approximately 3.5 years study duration. |
| Arm 3: Docetaxel, Paclitaxel, or Gemcitabine | EXPERIMENTAL | Participants will receive docetaxel, paclitaxel, or gemcitabine, investigator's choice, as part of the approximately 3.5 years study duration. |
| Stage 1 (Cohort 1): Livmoniplimab Dose A | EXPERIMENTAL | Participants will receive livmoniplimab (dose A)+ budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. |
| Stage 1 (Cohort 2): Livmoniplimab Dose B | EXPERIMENTAL | Participants will receive livmoniplimab (dose B) + budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. |
| Stage 1 (Cohort 3): Budigalimab | EXPERIMENTAL | Participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed. |
| Stage 1 (Cohort 4): Pembrolizumab | EXPERIMENTAL | Participants will receive pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. |
| Stage 2 (Arm 1): Livmoniplimab (Dose Optimized) | EXPERIMENTAL | Participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. |
| Stage 2 (Arm 2): Placebo | EXPERIMENTAL | Participants will receive placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. |
| Stage 1: Cohort 1 | EXPERIMENTAL | Participants will receive livmoniplimab Dose 1 in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met. |
| Stage 1: Cohort 2 | EXPERIMENTAL | Participants will receive livmoniplimab Dose 2 in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met. |
| Stage 1: Cohort 3 - Group 1 (Control) | ACTIVE_COMPARATOR | Participants will receive atezolizumab in combination with bevacizumab every 3 weeks until disease progression or until discontinuation criteria are met. |
| Stage 1: Cohort 3 - Group 2 (Control) | ACTIVE_COMPARATOR | Participants will receive a single dose of tremelimumab in combination with durvalumab every four weeks until disease progression or until discontinuation criteria are met. |
| Stage 2: Arm 1 | EXPERIMENTAL | Participants will receive livmoniplimab (optimized dose) in combination with budigalimab every 3 weeks until disease progression or until discontinuation criteria are met. |
| Stage 2: Arm 2 (Control) | ACTIVE_COMPARATOR | Participants will receive a single dose of tremelimumab in combination with durvalumab every 4 weeks until disease progression or until discontinuation criteria are met. |
| Stage 1: Cohort 1 Livmoniplimab + Budigalimab Dose A | EXPERIMENTAL | Participants will receive livmoniplimab Dose A in combination with budigalimab every 3 weeks for approximately 2 years. |
| Stage 2: Cohort 2 Livmoniplimab + Budigalimab Dose B | EXPERIMENTAL | Participants will receive livmoniplimab Dose B in combination with budigalimab every 3 weeks for approximately 2 years. |
| Dose Escalation: Cohort 1 Livmoniplimab | EXPERIMENTAL | Various doses of Livmoniplimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D). |
| Dose Escalation: Cohort 2 Livmoniplimab + Budigalimab | EXPERIMENTAL | Various doses of Livmoniplimab + Budigalimab administered during dose escalation to determine the Recommended Phase 2 Dose (RP2D). |
| Dose Expansion: Cohort 3 Livmoniplimab + Budigalimab | EXPERIMENTAL | Participants with programmed cell death protein 1 (PD-1)-naïve pancreatic adenocarcinoma will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W. |
| Dose Expansion: Cohort 4 Livmoniplimab + Budigalimab | EXPERIMENTAL | Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W. |
| Dose Expansion: Cohort 5 Livmoniplimab + Budigalimab | EXPERIMENTAL | Participants with PD-1-naïve hepatocellular carcinoma (HCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W. |
| Dose Expansion: Cohort 6 Livmoniplimab + Budigalimab | EXPERIMENTAL | Participants with PD-1-ref head and neck squamous cell carcinoma (HNSCC) will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W. |
| Dose Expansion: Cohort 7 Livmoniplimab + Budigalimab | EXPERIMENTAL | Participants with PD-1-naïve microsatellite stable colorectal cancer (MSS-CRC) \[unselected\] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W. |
| Dose Expansion: Cohort 8 Livmoniplimab + Budigalimab | EXPERIMENTAL | Participants with non-small cell lung cancer (NSCLC) \[programmed death ligand 1 (PDL1) relapsed/refractory (R/R)\] will receive livmoniplimab at the RP2D Q2W plus budigalimab Dose A administered Q4W. |
| Dose Expansion: Cohort 10A Livmoniplimab + Budigalimab | EXPERIMENTAL | Participants with microsatellite stable colorectal cancer (MSS-CRC) \[consensus molecular subtype 4 (CMS4) enriched\] will receive livmoniplimab at the dose B Q3W plus budigalimab Dose B administered Q3W. |
| Dose Expansion: Cohort 10B Livmoniplimab + Budigalimab | EXPERIMENTAL | Participants with MSS-CRC (CMS4 enriched) will receive livmoniplimab at the dose C Q3W plus budigalimab Dose B administered Q3W. |
| Dose Expansion: Cohort 11A Livmoniplimab + Budigalimab | EXPERIMENTAL | Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the Dose B Q3W plus budigalimab Dose B administered Q3W. |
| Dose Expansion: Cohort 11B Livmoniplimab + Budigalimab | EXPERIMENTAL | Participants with PD-1-ref urothelial cancer will receive livmoniplimab at the Dose C Q3W plus budigalimab Dose B administered Q3W. |
| Dose Expansion: Cohort 11C Budigalimab | EXPERIMENTAL | Participants with PD-1-ref urothelial cancer will receive budigalimab Dose B administered Q3W. |
| Dose Expansion: Cohort 12A Livmoniplimab + Budigalimab | EXPERIMENTAL | Participants with PD-1-naïve ovarian granulosa (OG) cell tumors will receive livmoniplimab at the Dose B Q3W plus budigalimab Dose B administered Q3W. |
| Dose Expansion: Cohort 12B Livmoniplimab + Budigalimab | EXPERIMENTAL | Participants with PD-1-naïve ovarian granulosa (OG) cell tumors will receive livmoniplimab at the Dose C Q3W plus budigalimab Dose B administered Q3W. |
| Name | Type | Description |
|---|---|---|
| Livmoniplimab | DRUG | Intravenous (IV) Infusion |
| Budigalimab | DRUG | IV Infusion |
| Docetaxel | DRUG | IV Infusion |
| Paclitaxel | DRUG | IV Injection |
| Gemcitabine | DRUG | IV Infusion |
| Pembrolizumab | DRUG | IV Infusion |
| Pemetrexed | DRUG | IV Infusion |
| Cisplatin | DRUG | IV Infusion |
| Carboplatin | DRUG | IV Injection |
| Durvalumab | DRUG | Intravenous (IV) Solution |
| Atezolizumab | DRUG | Intravenous (IV) Solution |
| Bevacizumab | DRUG | Intravenous (IV) Solution |
| Tremelimumab | DRUG | Intravenous (IV) Solution |
Inclusion Criteria: * Participant has histologically or cytologically confirmed urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Mixed histologic types are allowed if urothelial (transitional cell) is the predominant histology. * Participant has radiologically d...