Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INCMGA00012 · 1 trial · 1 indication
Per modified response assessment in neuro-oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=50% decrease in the sum of the products of the perpendicular diameters of target lesions; Overall Response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | Subjects in this arm (N=16) receive a single priming dose of both INCMGA00012 (500mg) and INCAGN01876 (300mg) prior to stereotactic radiosurgery (SRS), then undergo SRS (8 Gy x 3 fractions). Following SRS, INCMGA00012 (500mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) are resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. |
| Cohort B sub-arm #1 | EXPERIMENTAL | Subjects in this arm (N=8) receive neoadjuvant immunotherapy INCMGA00012 (500mg) + INCAGN01876 (300mg) + SRS. Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (500 mg IV every 4 weeks) and INCAGN01876 (300mg IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. |
| Cohort B sub-arm #2 | EXPERIMENTAL | Subjects in this arm (N=8) receive neoadjuvant immunotherapy INCMGA00012 + INCAGN01876 (without SRS). Subjects then undergo surgery. Postoperatively, the immunotherapy combination of INCMGA00012 (IV every 4 weeks) and INCAGN01876 (IV every 2 weeks) is resumed and continued until disease progression, unacceptable toxicity, or for 2 years, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| INCMGA00012 | DRUG | 500mg IV neoadjuvant treatment; 500 mg adjuvant treatment |
| INCAGN01876 | DRUG | 300mg IV neoadjuvant treatment; 300 mg adjuvant treatment |
| SRS | DRUG | administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy). |
| Brain surgery | PROCEDURE | maximal safe surgical resection of the tumor. |
Inclusion Criteria: 1. Prior histopathologically proven diagnosis of World Health Organization (WHO) grade IV glioblastoma, OR histopathologically proven diagnosis of gliosarcoma, OR molecular diagnosis of glioblastoma per c-IMPACT-NOW criteria ("diffuse astrocytic glioma, IDH-wildtype, with molecu...
INCMGA00012 is an investigational small molecule being studied for the treatment of glioblastoma. It is currently in Phase 2 clinical development for this indication. The drug is being evaluated in patients with recurrent glioblastoma as part of a combination therapy approach.
INCMGA00012 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with glioblastoma.
INCMGA00012 is currently in Phase 2 clinical development. It is being studied in an active clinical trial for recurrent glioblastoma, though the trial is no longer recruiting participants. The drug remains investigational and has not been approved by regulatory authorities.
INCMGA00012 is being evaluated in a Phase 2 clinical trial with the identifier NCT04225039. This trial, titled 'Anti-GITR/Anti-PD1/Stereotactic Radiosurgery, in Recurrent Glioblastoma,' is active but not recruiting. The study is enrolling 39 participants in the United States and is open to adults aged 18 years and older.
INCMGA00012 is being studied in combination with other therapies for glioblastoma. The clinical trial evaluates the drug alongside anti-GITR and anti-PD1 agents, as well as stereotactic radiosurgery. The specific molecular target of INCMGA00012 is not disclosed in the available information.