Clinical trial · Interventional
Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
Phase IB Study of a Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
NCT02117362CI-TRIAL-00037737completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this study is to determine a safe dose of GR-MD-02 used in combination with the FDA-approved dose of ipilimumab (3 mg/kg) in patients who have advanced melanoma. GR-MD-02 is a galectin. Galectins are a family of proteins that have numerous functions in normal mammalian biology including the facilitation of cell-cell interactions, regulation of cell-death and regulation of immune system responses. The hypothesis is that a safe dose of GR-MD-02 when given with the FDA-approved dose of ipilimumab can be found.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1 mg/kg GR-MD-02 | Biological | — | UNRESOLVED |
| 2 mg/kg GR-MD-02 | Biological | — | UNRESOLVED |
| 4 mg/kg GR-MD-02 | Biological | — | UNRESOLVED |
| 8 mg/kg GR-MD-02 | Biological | — | UNRESOLVED |
| Ipilimumab | Biological | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- 1 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
- interventionNames
- Biological: 1 mg/kg GR-MD-02
- Biological: Ipilimumab
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- 2 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
- interventionNames
- Biological: 2 mg/kg GR-MD-02
- Biological: Ipilimumab
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) performance status of 0-1. * Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy. * No active bleeding. * Anticipated lifespan greater than 12 weeks. * Patients must sign a study-specific consent document. Exclusion Criteria: * Patients who have previously received a galectin antagonist * Prior ipilimumab to treat metastatic melanoma (prior ipilimumab in the adjuvant setting is permitted if the patient did not experience ≥ grade 3 toxicity related to immunotherapy. * Patients with active autoimmune disease except for autoimmune thyroiditis or vitiligo. * Patients with history of colitis * Patients with untreated brain metastases. Patients with treated brain metastases who demonstrate control of brain metastases with follow-up imaging 4 or more weeks after initial therapy are eligible. * Other active metastatic cancer requiring treatment. * Patients with active infection requiring antibiotics. * Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus. * Laboratory exclusions (to be performed within 28 days of enrollment): * Need for chronic steroids. Inhaled corticosteroids are acceptable. * Inability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy. * Any medical condition that in the opinion of the Principal Investigator would compromise the safety or conduct of the study procedures.
References
Publications (0)
Data not yet available
No reference posted for this study.