- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02117362
Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
March 19, 2019 updated by: Providence Health & Services
Phase IB Study of a Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
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.
Study Overview
Status
Completed
Conditions
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
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97213
- Providence Portland Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
Other Names:
3 mg/kg ipilimumab on Days 1, 22, 43, and 65
Other Names:
|
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.
|
3 mg/kg ipilimumab on Days 1, 22, 43, and 65
Other Names:
2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
Other Names:
|
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.
|
3 mg/kg ipilimumab on Days 1, 22, 43, and 65
Other Names:
4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65
Other Names:
|
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.
|
3 mg/kg ipilimumab on Days 1, 22, 43, and 65
Other Names:
8 mg/mg GR-MD-02
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
21 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
85 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 8, 2014
Primary Completion (ACTUAL)
November 28, 2018
Study Completion (ACTUAL)
November 28, 2018
Study Registration Dates
First Submitted
April 14, 2014
First Submitted That Met QC Criteria
April 15, 2014
First Posted (ESTIMATE)
April 17, 2014
Study Record Updates
Last Update Posted (ACTUAL)
March 21, 2019
Last Update Submitted That Met QC Criteria
March 19, 2019
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Ipilimumab
Other Study ID Numbers
- 14-004A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Melanoma
-
Mohammed M MilhemGenentech, Inc.TerminatedMelanoma | Metastatic Melanoma | BRAF-mutated Metastatic Melanoma | V600EBRAF-mutated Metastatic MelanomaUnited States
-
Delcath Systems Inc.Active, not recruitingMetastatic Uveal Melanoma | Metastatic Ocular MelanomaUnited States
-
National Cancer Institute (NCI)TerminatedMetastatic Uveal Melanoma | Metastatic Ocular MelanomaUnited States
-
MorphotekTerminatedMelanoma | Metastatic Melanoma | Advanced Melanoma | Malignant Metastatic MelanomaUnited States
-
GlaxoSmithKlineWithdrawnCancer | Metastatic Uveal Melanoma | GNA11 Mutation-positive Metastatic Melanoma | GNAQ Mutation-positive Metastatic Melanoma
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingMetastatic Melanoma | Metastatic Uveal Melanoma | Unresectable Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIB Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | Pathologic Stage IIID Cutaneous Melanoma AJCC v8 | Pathologic Stage III Cutaneous... and other conditionsUnited States
-
Elizabeth DavisBristol-Myers SquibbTerminatedMetastatic Melanoma | Advanced Melanoma | Metastatic Melanoma Stratified by MHC-II ExpressionUnited States
-
Fred Hutchinson Cancer CenterAmazon.com Services LLCRecruitingAnatomic Stage IV Breast Cancer AJCC v8 | Prognostic Stage IV Breast Cancer AJCC v8 | Metastatic Cutaneous Melanoma | Unresectable Cutaneous Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Pathologic Stage IIIC Cutaneous Melanoma AJCC v8 | Pathologic Stage IIID Cutaneous Melanoma AJCC... and other conditionsUnited States
-
Provectus Biopharmaceuticals, Inc.Active, not recruitingMetastatic Colorectal Cancer | Hepatocellular Carcinoma | Metastatic Lung Cancer | Metastatic Breast Cancer | Metastatic Melanoma | Metastatic Uveal Melanoma | Metastatic Pancreatic Cancer | Metastatic Colon Cancer | Metastatic Ocular Melanoma | Cancer Metastatic to the LiverUnited States
-
National Cancer Institute (NCI)Active, not recruitingMetastatic Cutaneous Melanoma | Clinical Stage III Cutaneous Melanoma AJCC v8 | Recurrent Cutaneous Melanoma | Clinical Stage IV Cutaneous Melanoma AJCC v8 | Recurrent Mucosal Melanoma | Metastatic Mucosal Melanoma | Non-Cutaneous Melanoma | Metastatic Non-Cutaneous Melanoma | Recurrent Non-Cutaneous...United States, Canada, Ireland
Clinical Trials on 1 mg/kg GR-MD-02
-
Galectin Therapeutics Inc.Completed
-
Galectin Therapeutics Inc.CompletedNon-Alcoholic Steatohepatitis (NASH)United States
-
Galectin Therapeutics Inc.Active, not recruitingCirrhosis | NASH - Nonalcoholic Steatohepatitis | Prevention of Esophageal VaricesUnited States, France, Spain, Australia, Canada, Israel, Puerto Rico, Belgium, Argentina, Chile, Germany, Korea, Republic of, Mexico, Poland, United Kingdom
-
Galectin Therapeutics Inc.CompletedNonalcoholic SteatohepatitisUnited States
-
Galectin Therapeutics Inc.Completed
-
Galectin Therapeutics Inc.Dr. Naga Chalasani, MD, Indiana University; Dr. Stephen A. Harrison, MD, Brooke...Completed
-
Providence Health & ServicesProvidence Cancer Center, Earle A. Chiles Research InstituteWithdrawnMetastatic Melanoma | Head and Neck Squamous Cell CarcinomaUnited States
-
Providence Health & ServicesGalectin Therapeutics Inc.CompletedMelanoma | Non-Small Cell Lung Cancer | Squamous Cell Carcinoma of the Head and NeckUnited States
-
MedImmune LLCCompletedHealthy SubjectsUnited States
-
Bio Sidus SACompleted