Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
M7824 · 1 trial · 3 indications
Confirmed objective response was defined as the percentage of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC.
| Arm | Type | Description |
|---|---|---|
| M7824 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| M7824 | DRUG | Participants received an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal. |
Inclusion Criteria * Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC. * Availability of tumor (primary or metastatic) archival material or fresh biopsies is mandatory * Participants with BTC must have failed or be intolerant to 1L systemic platinum...
M7824 is an investigational small molecule being studied for the treatment of biliary tract cancer, including cholangiocarcinoma and gallbladder cancer. It is being evaluated as a monotherapy in patients with locally advanced or metastatic disease who have received prior second-line therapy.
M7824 is being developed by Merck KGaA, a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with biliary tract cancer.
M7824 is in Phase 2 clinical development. A Phase 2 trial of M7824 as a monotherapy in second-line biliary tract cancer has been completed, with 159 patients enrolled.
M7824 has been studied in a completed Phase 2 clinical trial with the identifier NCT03833661. The trial evaluated M7824 monotherapy in patients with locally advanced or metastatic second-line biliary tract cancer, including cholangiocarcinoma and gallbladder cancer.
M7824 is an investigational drug and has not been approved by the FDA. It is still in clinical development, with a completed Phase 2 trial in biliary tract cancer.
M7824 is a small molecule designed to target pathways involved in cancer. However, its specific molecular target has not been disclosed in the available clinical trial information.