Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02117362 | Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma | PHASE1 | COMPLETED | 8 | — | — | May 8, 2014 | Nov 28, 2018 | Mar 21, 2019 | 1 | United States |
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...