- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05913388
GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma
April 5, 2024 updated by: Providence Health & Services
Randomized Double-Blind Placebo Controlled Phase II Study of a Galectin-3 Inhibitor (GB1211) and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma
The purpose of this study is to determine the objective response of GB1211 and pembrolizumab versus pembrolizumab and placebo in patients with advance metastatic melanoma or head and neck squamous cell carcinoma.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Eligible patients will be registered, stratified by diagnosis (melanoma versus oral, head and neck (OHN) cancer), and the number of prior systemic therapies, and randomized to receive either GB1211 + pembrolizumab or pembrolizumab + placebo.
Study Type
Interventional
Enrollment (Estimated)
92
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chris Fountain, RN, ONC
- Phone Number: 503-215-2691
- Email: Christopher.Fountain@providence.org
Study Locations
-
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Oregon
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Portland, Oregon, United States, 97213
- Recruiting
- Providence Portland Medical Center
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Sub-Investigator:
- Matthew Taylor, MD
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Contact:
- Chris Fountain, RN
- Phone Number: 503-215-2691
- Email: Christopher.Fountain@providence.org
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Principal Investigator:
- Brendan D. Curti, MD
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Sub-Investigator:
- Rom S. Leidner, MD
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Sub-Investigator:
- William L. Redmond, PhD
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with unresectable or metastatic melanoma including unknown primary or mucosal melanomas. Histological confirmation of melanoma will be required by previous biopsy or cytology. Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression during or after platinum-containing chemotherapy are eligible. PD-L1 testing is not needed for OHN cancers.
- Patients who have received anti-PD1 or anti-PD-L1 in the past are eligible if it has been at least 6 months since the last anti-PD-1 or PD-L1 dose, they meet all other eligibility criteria and progression of malignancy has been documented on imaging. Progression for this patient subset is defined as the appearance of one or more new metastatic sites, or a 5% or greater increase in the sum of diameter of target lesions or an unequivocal increase in non-target site. Treatment naïve melanoma patients are eligible.
- Patients must be ≥ 18 years of age.
- ECOG performance status of 0-2.
- 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.
- Patients with active autoimmune disease except for autoimmune thyroiditis or vitiligo.
- Patients with history of autoimmune 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.
- Patients requiring other systemic oncologic therapy, including experimental therapies.
- Patients who have received anti-cancer treatment within 3 weeks or 5 half-lives before first study drug dose.
- Patients with Child-Pugh C hepatic impairment.
- Patients with active infection requiring antibiotics.
- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
- Need for steroids at greater than physiologic replacement doses. Inhaled corticosteroids are acceptable.
Laboratory exclusions (to be performed within 28 days of enrollment):
- WBC < 3.0 x 109/L
- Hgb < 9.0 g/dL
- AST or ALT > 1.5 times ULN
- Total bilirubin > 1.9 g/dL, unless due to Gilbert's Syndrome. If Gilbert's Syndrome is present by clinical history, then direct bilirubin must by < 3.0 g/dl.
- Active or known history of HIV
- Active or known history of Hepatitis B
- Active or known history of Hepatitis C
- Platelet counts < 100 x 10E9 / L (100,000/ μL) without transfusion
- INR > 1.5x ULN
- Inability to give informed consent and comply with the protocol. Patients 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.
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GB1211 + Pembrolizumab
GB1211 will be administered orally twice a day at 400mg in combination with standard pembrolizumab treatment.
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Administered orally twice daily at 400mg.
Administered at a fixed dose of 200 mg every 3 weeks intravenously.
Other Names:
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Placebo Comparator: Pembrolizumab Monotherapy
Placebo will have the same appearance as GB1211 and administered orally twice a day in combination with standard pembrolizumab treatment.
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Administered at a fixed dose of 200 mg every 3 weeks intravenously.
Other Names:
Administered orally twice daily at 400mg.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate based on disease imaging
Time Frame: From the date of randomization until the date of first documented progression, assessed up to 63 weeks.
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Determine the response of Gal-3 inhibitor and pembrolizumab versus pembrolizumab monotherapy (plus placebo) in patients with metastatic melanoma or head and neck squamous cell carcinoma (HNSCC).
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From the date of randomization until the date of first documented progression, assessed up to 63 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of GAL-3 Expression
Time Frame: Screening and Day 68
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Compare Gal-3 expression in paired biopsies after GB1211 + pembrolizumab or pembrolizumab monotherapy
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Screening and Day 68
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Frequency of Immune-mediated Adverse Events
Time Frame: From the time of informed consent to week 63
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Compare the frequency of immune-mediated adverse events after GB1211 + pembrolizumab versus pembrolizumab + placebo
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From the time of informed consent to week 63
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Evaluation of Antiviral Immunity
Time Frame: Day 85
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Assess the biological activity of GB1211 + pembrolizumab and in comparison to pembrolizumab monotherapy by measuring CD4+T cells with a memory phenotype (CD3+CD4+Ki67+CD25+FoxP3-CCR7-CD45RA-CD27+CD28+/-).
|
Day 85
|
Evaluation of Antiviral Immunity
Time Frame: Day 85
|
Assess the biological activity of GB1211 + pembrolizumab and in comparison to pembrolizumab monotherapy by measuring CD8+ T cells with effector phenotype (CD3+CD8+CD28-CD95+).
|
Day 85
|
Evaluation of Antiviral Immunity
Time Frame: Day 85
|
Assess the biological activity of GB1211 + pembrolizumab and in comparison to pembrolizumab monotherapy by measuring tumor-specific T cells using autologous and/or HLA-matched tumor when available.
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Day 85
|
Evaluation of Predictive Biomarker
Time Frame: Day 85
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Characterize myeloid-derived suppressor cells (MDSC) expression over time as a predictive biomarker of response after GB1211 + pembrolizumab or pembrolizumab monotherapy
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Day 85
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Brendan D. Curti, MD, Providence Health & Services
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)
February 29, 2024
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2030
Study Registration Dates
First Submitted
June 6, 2023
First Submitted That Met QC Criteria
June 19, 2023
First Posted (Actual)
June 22, 2023
Study Record Updates
Last Update Posted (Actual)
April 9, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Neoplasms, Squamous Cell
- Skin Neoplasms
- Carcinoma
- Melanoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Pembrolizumab
Other Study ID Numbers
- 2023000353
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.
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