Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ipilimumab · 1 trial · 1 indication
Patients return to clinic 9 times in 85 days, receiving treatment on Days 1, 22, 43, and 65. Patients will have physical exams, blood tests, and toxicity evaluations by a research nurse during this time to identify any protocol-defined dose limiting toxicity.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 1 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65. |
| Cohort 2 | EXPERIMENTAL | 2 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65. |
| Cohort 3 | EXPERIMENTAL | 4 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65. |
| Cohort 4 | EXPERIMENTAL | 8 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65. |
| Name | Type | Description |
|---|---|---|
| 1 mg/kg GR-MD-02 | BIOLOGICAL | 1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65. |
| 2 mg/kg GR-MD-02 | BIOLOGICAL | 2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65. |
| 4 mg/kg GR-MD-02 | BIOLOGICAL | 4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65 |
| 8 mg/kg GR-MD-02 | BIOLOGICAL | 8 mg/mg GR-MD-02 |
| Ipilimumab | BIOLOGICAL | 3 mg/kg ipilimumab on Days 1, 22, 43, and 65 |
Inclusion Criteria: * Patients with metastatic or unresectable melanoma for whom treatment with ipilimumab is indicated. Histological confirmation of melanoma will be required by previous biopsy or cytology. * Patients must be ≥ 18 years of age. * Eastern Collaborative Oncology Group (ECOG) perform...
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Ipilimumab is a monoclonal antibody being studied for use in metastatic melanoma. It is currently in Phase 1 clinical development as an investigational therapy. In a completed Phase 1 trial, it was evaluated in combination with another agent in patients with metastatic melanoma.
Ipilimumab is a monoclonal antibody. Its specific molecular target is not disclosed in the available information. The drug is being investigated for its potential role in treating metastatic melanoma, but the precise mechanism of action has not been detailed.
Ipilimumab is being developed by Galectin Therapeutics Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GALT. The company is conducting clinical research on this monoclonal antibody for the treatment of metastatic melanoma.
Ipilimumab is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, involving a small number of patients with metastatic melanoma.
Ipilimumab has been studied in one completed Phase 1 clinical trial, identified as NCT02117362. This trial, titled "Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma," enrolled 8 participants in the United States. The study was controlled but not randomized or double-blinded.
No, Ipilimumab is not the same as GR-MD-02. In the clinical trial NCT02117362, Ipilimumab was studied in combination with GR-MD-02, which is a galectin inhibitor. Ipilimumab is a monoclonal antibody, while GR-MD-02 is a separate investigational agent.