MelanomaPhase 1NCT02575404
GR-MD-02 Plus Pembrolizumab in Melanoma, Non-small Cell Lung Cancer, and Squamous Cell Head and Neck Cancer Patients
A Phase 1 study testing GR-MD-02 and Pembrolizumab in people with Melanoma and Non-Small Cell Lung Cancer, run by Providence Health & Services at 1 site in United States.
Trial summary
This study is a dose escalation of GR-MD-02 with the standard therapeutic dose of pembrolizumab in patients with advanced melanoma, non-small cell lung cancer, and head and neck squamous cell cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- GR-MD-02 and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2016to 10 Oct 2022
- 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 pembrolizumab is indicated. Histological confirmation of melanoma will be required by previous biopsy or cytology.
- Patients with non-small cell lung cancer for whom treatment with pembrolizumab is indicated.
- Patients with squamous cell carcinoma of the head and neck for whom treatment with pembrolizumab is indicated
- Patients who have radiographic progression using Response Evaluation Criteria In Solid Tumors (RECIST) currently on pembrolizumab are also eligible.
- Patients must be ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
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- 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
- 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.
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- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
- Need for chronic steroids. Inhaled corticosteroids are acceptable.
- Laboratory values (to be performed within 28 days of enrollment) outside of protocol-specified ranges.
- 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.
- Unresolved immune-mediated pneumonitis, diarrhea, elevation of hepatocellular enzymes or other toxicities requiring greater than physiological replacement doses of steroids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IB Study of a Galectin Inhibitor (GR-MD-02) and Pembrolizumab in Patients With Metastatic Melanoma, Non-Small Cell Lung Cancer, and Head and Neck Squamous Cell Carcinoma.
This study is a dose escalation of GR-MD-02 with the standard therapeutic dose of pembrolizumab in patients with advanced melanoma, non-small cell lung cancer, and head and neck squamous cell cancer.
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 pembrolizumab in patients with advanced melanoma who have had progression after ipilimumab and/or BRAF targeted therapy when a BRAF mutation is present, non-small cell lung cancer patients with disease progression after targeted therapy, or head and neck squamous cell carcinoma patients with disease progression after at least one platinum-containing regimen.
In addition to monitoring for toxicity and clinical response, blood and tumor samples will be obtained to assess immunologic measures relevant to galectin biology and pembrolizumab T-cell checkpoint inhibition.
- Being tested
- GR-MD-02, Pembrolizumab
- Keywords
- Metastatic, Keytruda, pembrolizumab, GR-MD-02, Galactoarabino-rhamnogalacturonate, Immunotherapy
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GR-MD-02Drug
Also called Galactoarabino-rhamnogalactouronate
Patients will receive five doses of GR-MD-02 intravenously over 85 Days.
PembrolizumabDrug
Also called Keytruda
Patients will receive five 200mg doses of pembrolizumab intravenously over 85 days. After 85 days, patients may continue to receive pembrolizumab every 3 weeks if clinical benefit is noted.
| Study group | Role | What they receive |
|---|---|---|
| 2 mg/kg GR-MD-02 | Experimental | 2 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment. Receives: Drug: GR-MD-02; Drug: Pembrolizumab |
| 4 mg/kg GR-MD-02 | Experimental | 4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment. Receives: Drug: GR-MD-02; Drug: Pembrolizumab |
| 8 mg/kg GR-MD-02 | Experimental | 8 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment. Receives: Drug: GR-MD-02; Drug: Pembrolizumab |
| 4 mg/kg GR-MD-02 17 Cycles Maximum | Experimental | 4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment up to a maximum of 17 cycles. Receives: Drug: GR-MD-02; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Severity of Treatment-Related Adverse Events Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Patients are seen in clinic 7 times over 85 days. At each visit, a research nurse performs a toxicity check. Patients have 5 physical exams during the 85-day period.
Measured: 85 Days
Secondary outcomes (2)
Measure the response rate to combined therapy with GR-MD-02 and pembrolizumab in patients.
Patients will have PET and CT scans at baseline and after 85 days to assess response to treatment.
Measured: Baseline and at Day 85
Assess the biological activity of GR-MD-02 in combination with pembrolizumab.
Patients will provide 5 blood samples over 85 days to measure the absolute number of CD4+T Cells, CD8+ T cells and melanoma-specific T cells
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 posted14 Oct 2015 (estimated)
- Study start16 May 2016
- Primary completion12 Jan 2021
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Galectin Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Brendan Curti, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575404
- Sponsor's protocol ID
- 15-166
- Status last verified
- May 2023
- First submitted
- 9 Oct 2015
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. 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 Pembrolizumab in Patients With Metastatic Melanoma, Non-Small Cell Lung Cancer, and Head and Neck Squamous Cell Carcinoma.
- ClinicalTrials.gov ID
- NCT02575404
- Acronym / sponsor ID
- 15-166
- Keywords
- Metastatic, Keytruda, pembrolizumab, GR-MD-02, Galactoarabino-rhamnogalacturonate, Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Galectin Therapeutics Inc.
- Study start
- 16 May 2016 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 14 Oct 2015 (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.
This study is a dose escalation of GR-MD-02 with the standard therapeutic dose of pembrolizumab in patients with advanced melanoma, non-small cell lung cancer, and head and neck squamous cell cancer.
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 pembrolizumab in patients with advanced melanoma who have had progression after ipilimumab and/or BRAF targeted therapy when a BRAF mutation is present, non-small cell lung cancer patients with disease progression after targeted therapy, or head and neck squamous cell carcinoma patients with disease progression after at least one platinum-containing regimen.
In addition to monitoring for toxicity and clinical response, blood and tumor samples will be obtained to assess immunologic measures relevant to galectin biology and pembrolizumab T-cell checkpoint inhibition.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 mg/kg GR-MD-02 | Experimental | Drug: GR-MD-02, Drug: Pembrolizumab2 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment. |
| 4 mg/kg GR-MD-02 | Experimental | Drug: GR-MD-02, Drug: Pembrolizumab4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment. |
| 8 mg/kg GR-MD-02 | Experimental | Drug: GR-MD-02, Drug: Pembrolizumab8 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment. |
| 4 mg/kg GR-MD-02 17 Cycles Maximum | Experimental | Drug: GR-MD-02, Drug: Pembrolizumab4 mg/kg GR-MD-02 in combination with standard pembrolizumab treatment up to a maximum of 17 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with metastatic or unresectable melanoma for whom treatment with pembrolizumab is indicated. Histological confirmation of melanoma will be required by previous biopsy or cytology.
- Patients with non-small cell lung cancer for whom treatment with pembrolizumab is indicated.
- Patients with squamous cell carcinoma of the head and neck for whom treatment with pembrolizumab is indicated
- Patients who have radiographic progression using Response Evaluation Criteria In Solid Tumors (RECIST) currently on pembrolizumab are also eligible.
- Patients must be ≥ 18 years of age.
Key exclusion criteria (12 listed)
- Patients who have previously received a galectin antagonist
- 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.
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 |
|---|---|---|
| GR-MD-02Also: Galactoarabino-rhamnogalactouronatePatients will receive five doses of GR-MD-02 intravenously over 85 Days. | Drug | 2 mg/kg GR-MD-02, 4 mg/kg GR-MD-02, 4 mg/kg GR-MD-02 17 Cycles Maximum, 8 mg/kg GR-MD-02 |
| PembrolizumabAlso: KeytrudaPatients will receive five 200mg doses of pembrolizumab intravenously over 85 days. After 85 days, patients may continue to receive pembrolizumab every 3 weeks if clinical benefit is noted. | Drug | 2 mg/kg GR-MD-02, 4 mg/kg GR-MD-02, 4 mg/kg GR-MD-02 17 Cycles Maximum, 8 mg/kg GR-MD-02 |
Primary outcome
Frequency and Severity of Treatment-Related Adverse Events Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Time frame: 85 Days
Patients are seen in clinic 7 times over 85 days. At each visit, a research nurse performs a toxicity check. Patients have 5 physical exams during the 85-day period.
2 secondary outcomes
Measure the response rate to combined therapy with GR-MD-02 and pembrolizumab in patients.
Time frame: Baseline and at Day 85
Assess the biological activity of GR-MD-02 in combination with pembrolizumab.
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 5 Jun 2023.
- 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 GR-MD-02 and Pembrolizumab in people with Melanoma and Non-Small Cell Lung Cancer, 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 10 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 5 Jun 2023. 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?
Frequency and Severity of Treatment-Related Adverse Events Measured by Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (time frame: 85 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 5 Jun 2023.