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

Primary Purpose

Metastatic Melanoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
1 mg/kg GR-MD-02
2 mg/kg GR-MD-02
4 mg/kg GR-MD-02
8 mg/kg GR-MD-02
Ipilimumab
Sponsored by
Providence Health & Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring Melanoma, Ipilimumab, Yervoy, Galectin, GR-MD-02, galactoarabino-rhamnogalacturonate, galectin-3 inhibitor, Providence Health & Services, Earle A. Chiles Research Institute, Robert W. Franz Cancer Center, Immunotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Providence Portland Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Determine a safe dose of GR-MD-02 used in combination with the approved dose of ipilimumab (3 mg/kg)
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.

Secondary Outcome Measures

Response rate to combined therapy
Tumor burden assessments will occur at screening, Day 85, and every 12 weeks thereafter to determine the response rate.

Full Information

First Posted
April 14, 2014
Last Updated
March 19, 2019
Sponsor
Providence Health & Services
Collaborators
Providence Cancer Center, Earle A. Chiles Research Institute, Galectin Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02117362
Brief Title
Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
Official Title
Phase IB Study of a Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 8, 2014 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Providence Health & Services
Collaborators
Providence Cancer Center, Earle A. Chiles Research Institute, Galectin Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
Melanoma, Ipilimumab, Yervoy, Galectin, GR-MD-02, galactoarabino-rhamnogalacturonate, galectin-3 inhibitor, Providence Health & Services, Earle A. Chiles Research Institute, Robert W. Franz Cancer Center, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
1 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
2 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
4 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
8 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
Intervention Type
Biological
Intervention Name(s)
1 mg/kg GR-MD-02
Other Intervention Name(s)
galectin-3 inhibitor, galactoarabino-rhamnogalacturonate
Intervention Description
1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
Intervention Type
Biological
Intervention Name(s)
2 mg/kg GR-MD-02
Other Intervention Name(s)
galectin-3 inhibitor, galactoarabino-rhamnogalacturonate
Intervention Description
2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
Intervention Type
Biological
Intervention Name(s)
4 mg/kg GR-MD-02
Other Intervention Name(s)
galectin-3 inhibitor, galactoarabino-rhamnogalacturonate
Intervention Description
4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65
Intervention Type
Biological
Intervention Name(s)
8 mg/kg GR-MD-02
Other Intervention Name(s)
galectin-3 inhibitor, galactoarabino-rhamnogalacturonate
Intervention Description
8 mg/mg GR-MD-02
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy, Anti-CTLA 4
Intervention Description
3 mg/kg ipilimumab on Days 1, 22, 43, and 65
Primary Outcome Measure Information:
Title
Determine a safe dose of GR-MD-02 used in combination with the approved dose of ipilimumab (3 mg/kg)
Description
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.
Time Frame
21 Days
Secondary Outcome Measure Information:
Title
Response rate to combined therapy
Description
Tumor burden assessments will occur at screening, Day 85, and every 12 weeks thereafter to determine the response rate.
Time Frame
85 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brendan Curti, MD
Organizational Affiliation
Providence Health & Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://oregon.providence.org/our-services/p/providence-cancer-center/
Description
Providence Cancer Center

Learn more about this trial

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

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