Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
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ClinicalTrials.gov Identifier: NCT02117362 |
Recruitment Status :
Completed
First Posted : April 17, 2014
Last Update Posted : March 21, 2019
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Melanoma | Biological: 1 mg/kg GR-MD-02 Biological: 2 mg/kg GR-MD-02 Biological: 4 mg/kg GR-MD-02 Biological: 8 mg/kg GR-MD-02 Biological: Ipilimumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase IB Study of a Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma |
Actual Study Start Date : | May 8, 2014 |
Actual Primary Completion Date : | November 28, 2018 |
Actual Study Completion Date : | November 28, 2018 |

Arm | Intervention/treatment |
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Experimental: Cohort 1
1 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
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Biological: 1 mg/kg GR-MD-02
1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
Other Names:
Biological: Ipilimumab 3 mg/kg ipilimumab on Days 1, 22, 43, and 65
Other Names:
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Experimental: Cohort 2
2 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
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Biological: 2 mg/kg GR-MD-02
2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
Other Names:
Biological: Ipilimumab 3 mg/kg ipilimumab on Days 1, 22, 43, and 65
Other Names:
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Experimental: Cohort 3
4 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
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Biological: 4 mg/kg GR-MD-02
4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65
Other Names:
Biological: Ipilimumab 3 mg/kg ipilimumab on Days 1, 22, 43, and 65
Other Names:
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Experimental: Cohort 4
8 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
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Biological: 8 mg/kg GR-MD-02
8 mg/mg GR-MD-02
Other Names:
Biological: Ipilimumab 3 mg/kg ipilimumab on Days 1, 22, 43, and 65
Other Names:
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- Determine a safe dose of GR-MD-02 used in combination with the approved dose of ipilimumab (3 mg/kg) [ Time Frame: 21 Days ]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.
- Response rate to combined therapy [ Time Frame: 85 Days ]Tumor burden assessments will occur at screening, Day 85, and every 12 weeks thereafter to determine the response rate.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117362
United States, Oregon | |
Providence Portland Medical Center | |
Portland, Oregon, United States, 97213 |
Principal Investigator: | Brendan Curti, MD | Providence Health & Services |
Responsible Party: | Providence Health & Services |
ClinicalTrials.gov Identifier: | NCT02117362 |
Other Study ID Numbers: |
14-004A |
First Posted: | April 17, 2014 Key Record Dates |
Last Update Posted: | March 21, 2019 |
Last Verified: | April 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
GR-MD-02 Melanoma Ipilimumab Yervoy Galectin galactoarabino-rhamnogalacturonate |
galectin-3 inhibitor Providence Health & Services Earle A. Chiles Research Institute Robert W. Franz Cancer Center Immunotherapy |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue |
Nevi and Melanomas Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |