Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-08

Study Completion Date

2018-11-28

Brief Summary

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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.

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Detailed Description

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This study will employ a 3+3 phase I design with dose escalation of GR-MD-02 in conjunction with the standard therapeutic dose of ipilimumab in patients with advanced melanoma for whom ipilimumab would be considered standard of care. In addition to monitoring for toxicity and clinical response, blood samples will be obtained to assess immunologic measures relevant to galectin biology and ipilimumab T-cell check-point inhibition

Conditions

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Metastatic Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

1 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.

Group Type EXPERIMENTAL

1 mg/kg GR-MD-02

Intervention Type BIOLOGICAL

1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.

Ipilimumab

Intervention Type BIOLOGICAL

3 mg/kg ipilimumab on Days 1, 22, 43, and 65

Cohort 2

2 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.

Group Type EXPERIMENTAL

2 mg/kg GR-MD-02

Intervention Type BIOLOGICAL

2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.

Ipilimumab

Intervention Type BIOLOGICAL

3 mg/kg ipilimumab on Days 1, 22, 43, and 65

Cohort 3

4 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.

Group Type EXPERIMENTAL

4 mg/kg GR-MD-02

Intervention Type BIOLOGICAL

4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65

Ipilimumab

Intervention Type BIOLOGICAL

3 mg/kg ipilimumab on Days 1, 22, 43, and 65

Cohort 4

8 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.

Group Type EXPERIMENTAL

8 mg/kg GR-MD-02

Intervention Type BIOLOGICAL

8 mg/mg GR-MD-02

Ipilimumab

Intervention Type BIOLOGICAL

3 mg/kg ipilimumab on Days 1, 22, 43, and 65

Interventions

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1 mg/kg GR-MD-02

1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.

Intervention Type BIOLOGICAL

2 mg/kg GR-MD-02

2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.

Intervention Type BIOLOGICAL

4 mg/kg GR-MD-02

4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65

Intervention Type BIOLOGICAL

8 mg/kg GR-MD-02

8 mg/mg GR-MD-02

Intervention Type BIOLOGICAL

Ipilimumab

3 mg/kg ipilimumab on Days 1, 22, 43, and 65

Intervention Type BIOLOGICAL

Other Intervention Names

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galectin-3 inhibitor galactoarabino-rhamnogalacturonate galectin-3 inhibitor galactoarabino-rhamnogalacturonate galectin-3 inhibitor galactoarabino-rhamnogalacturonate galectin-3 inhibitor galactoarabino-rhamnogalacturonate Yervoy Anti-CTLA 4

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No