Metastatic MelanomaPhase 1NCT02117362
Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
A Phase 1 study testing 1 mg/kg GR-MD-02, 2 mg/kg GR-MD-02 and 4 mg/kg GR-MD-02 in people with Metastatic Melanoma, run by Providence Health & Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- 1 mg/kg GR-MD-02, 2 mg/kg GR-MD-02 and 4 mg/kg GR-MD-02
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2014to 28 Nov 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Portland Medical Center
Portland, Oregon, 97213
About this study
Official title: 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.
Read the 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
- Conditions
- Metastatic Melanoma
- Being tested
- 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
- 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
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 mg/kg GR-MD-02Biological
Also called galectin-3 inhibitor, galactoarabino-rhamnogalacturonate
1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
2 mg/kg GR-MD-02Biological
Also called galectin-3 inhibitor, galactoarabino-rhamnogalacturonate
2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
4 mg/kg GR-MD-02Biological
Also called galectin-3 inhibitor, galactoarabino-rhamnogalacturonate
4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65
8 mg/kg GR-MD-02Biological
Also called galectin-3 inhibitor, galactoarabino-rhamnogalacturonate
8 mg/mg GR-MD-02
IpilimumabBiological
Also called Yervoy, Anti-CTLA 4
3 mg/kg ipilimumab on Days 1, 22, 43, and 65
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 1 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65. Receives: Biological: 1 mg/kg GR-MD-02; Biological: Ipilimumab |
| Cohort 2 | Experimental | 2 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65. Receives: Biological: 2 mg/kg GR-MD-02; Biological: Ipilimumab |
| Cohort 3 | Experimental | 4 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65. Receives: Biological: 4 mg/kg GR-MD-02; Biological: Ipilimumab |
| Cohort 4 | Experimental | 8 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65. Receives: Biological: 8 mg/kg GR-MD-02; Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 Days
Secondary outcomes (1)
Response rate to combined therapy
Tumor burden assessments will occur at screening, Day 85, and every 12 weeks thereafter to determine the response rate.
Measured: 85 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study start8 May 2014
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Cancer Center, Earle A. Chiles Research Institute, Galectin Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Brendan Curti, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117362
- Sponsor's protocol ID
- 14-004A
- Status last verified
- Apr 2018
- First submitted
- 14 Apr 2014
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IB Study of a Galectin Inhibitor (GR-MD-02) and Ipilimumab in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT02117362
- Acronym / sponsor ID
- 14-004A
- Conditions
- Metastatic Melanoma
- Keywords
- Melanoma, Ipilimumab, Yervoy, Galectin, GR-MD-02, galactoarabino-rhamnogalacturonate, galectin-3 inhibitor, Providence Health & Services
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Providence Cancer Center, Earle A. Chiles Research Institute, Galectin Therapeutics Inc.
- Study start
- 8 May 2014 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 17 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: 1 mg/kg GR-MD-02, Biological: Ipilimumab1 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65. |
| Cohort 2 | Experimental | Biological: 2 mg/kg GR-MD-02, Biological: Ipilimumab2 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65. |
| Cohort 3 | Experimental | Biological: 4 mg/kg GR-MD-02, Biological: Ipilimumab4 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65. |
| Cohort 4 | Experimental | Biological: 8 mg/kg GR-MD-02, Biological: Ipilimumab8 mg/kg GR-MD-02 administered 1 hour before 3 mg/kg of ipilimumab on Days 1, 22, 43, and 65. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 mg/kg GR-MD-02Also: galectin-3 inhibitor, galactoarabino-rhamnogalacturonate1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65. | Biological | Cohort 1 |
| 2 mg/kg GR-MD-02Also: galectin-3 inhibitor, galactoarabino-rhamnogalacturonate2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65. | Biological | Cohort 2 |
| 4 mg/kg GR-MD-02Also: galectin-3 inhibitor, galactoarabino-rhamnogalacturonate4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65 | Biological | Cohort 3 |
| 8 mg/kg GR-MD-02Also: galectin-3 inhibitor, galactoarabino-rhamnogalacturonate8 mg/mg GR-MD-02 | Biological | Cohort 4 |
| IpilimumabAlso: Yervoy, Anti-CTLA 43 mg/kg ipilimumab on Days 1, 22, 43, and 65 | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
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.
1 secondary outcome
Response rate to combined therapy
Time frame: 85 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Providence Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brendan Curti, MD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1 mg/kg GR-MD-02, 2 mg/kg GR-MD-02 and 4 mg/kg GR-MD-02 in people with Metastatic Melanoma, run by Providence Health & Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine a safe dose of GR-MD-02 used in combination with the approved dose of ipilimumab (3 mg/kg) (time frame: 21 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.