Clinical trial NCT02117362: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
Collaborators: name: Providence Cancer Center, Earle A. Chiles Research Institute
name: Galectin Therapeutics Inc.
First posted: 2014-04-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Determine a safe dose of GR-MD-02 used in combination with the approved dose of ipilimumab (3 mg/kg)
timeFrame: 21 Days
Secondary outcomes:
measure: Response rate to combined therapy
timeFrame: 85 Days
Other outcomes:
Locations:
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
Study officials:
affiliation: Providence Health & Services
name: Brendan Curti, MD
role: PRINCIPAL_INVESTIGATOR
References: