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
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2014
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2014
CompletedFirst Posted
Study publicly available on registry
April 17, 2014
CompletedStudy Start
First participant enrolled
May 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2018
CompletedMarch 21, 2019
April 1, 2018
4.6 years
April 14, 2014
March 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
21 Days
Secondary Outcomes (1)
Response rate to combined therapy
85 Days
Study Arms (4)
Cohort 1
EXPERIMENTAL1 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
Cohort 2
EXPERIMENTAL2 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
Cohort 3
EXPERIMENTAL4 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
Cohort 4
EXPERIMENTAL8 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65.
Interventions
1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65
8 mg/mg GR-MD-02
3 mg/kg ipilimumab on Days 1, 22, 43, and 65
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brendan Curti, MD
Providence Health & Services
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2014
First Posted
April 17, 2014
Study Start
May 8, 2014
Primary Completion
November 28, 2018
Study Completion
November 28, 2018
Last Updated
March 21, 2019
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share