Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABBV-151
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...
Livmoniplimab is an investigational monoclonal antibody developed by AbbVie Inc. (ticker ABBV) for oncology. It is being studied in advanced solid tumors, including hepatocellular carcinoma, non-small cell lung cancer, and urothelial carcinoma. It is administered intravenously and is evaluated in clinical trials both as a combination agent and alongside chemotherapy.
Livmoniplimab is being studied in hepatocellular carcinoma as an intravenous combination treatment with budigalimab. Trials in this indication include a Phase 2 study in adults with HCC and a Phase 1 study in Chinese participants with locally advanced or metastatic HCC. It remains investigational and is not established as a marketed therapy.
Livmoniplimab is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie sponsors the clinical program, including the Phase 2 urothelial carcinoma study, the Phase 2 non-small cell lung cancer study, and the hepatocellular carcinoma trials conducted across sites in the United States, Europe, Asia, and other regions.
Livmoniplimab is in clinical development, with its trials registered as Phase 1 and Phase 2 studies. It is investigational and has not been approved by the FDA. The program includes a Phase 2 urothelial carcinoma trial, a Phase 2 non-small cell lung cancer trial, and hepatocellular carcinoma studies.
Livmoniplimab is studied in registered trials including NCT06632951 in urothelial carcinoma, NCT06236438 in untreated metastatic non-squamous non-small cell lung cancer comparing the livmoniplimab and budigalimab combination plus chemotherapy against pembrolizumab plus chemotherapy, NCT06109272 in hepatocellular carcinoma, and NCT06487559 in Chinese participants with hepatocellular carcinoma.
Livmoniplimab is administered as an intravenous infusion in its clinical trials. It is studied in combination with intravenously infused budigalimab, and in the non-small cell lung cancer trial the combination is given with chemotherapy. Trials enroll adults aged 18 years and older and do not include healthy volunteers.