GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma

NCT ID: NCT05913388

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2030-02-28

Brief Summary

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.

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.

Conditions

Metastatic Melanoma; Head and Neck Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GB1211 + Pembrolizumab

GB1211 will be administered orally twice a day at 400mg in combination with standard pembrolizumab treatment.

Group Type: EXPERIMENTAL

GB1211

Intervention Type: DRUG

Administered orally twice daily at 100mg.

Pembrolizumab

Intervention Type: DRUG

Administered at a fixed dose of 200 mg every 3 weeks intravenously.

Pembrolizumab Monotherapy

Placebo will have the same appearance as GB1211 and administered orally twice a day in combination with standard pembrolizumab treatment.

Group Type: PLACEBO_COMPARATOR

Pembrolizumab

Intervention Type: DRUG

Administered at a fixed dose of 200 mg every 3 weeks intravenously.

Placebo

Intervention Type: DRUG

Administered orally twice daily at 100mg.

Interventions

GB1211

Administered orally twice daily at 100mg.

Intervention Type: DRUG

Pembrolizumab

Administered at a fixed dose of 200 mg every 3 weeks intravenously.

Intervention Type: DRUG

Placebo

Administered orally twice daily at 100mg.

Intervention Type: DRUG

Other Intervention Names

Keytruda

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Providence Cancer Center

UNKNOWN

Sponsor Role: collaborator

Providence Cancer Center, Earle A. Chiles Research Institute

OTHER

Sponsor Role: collaborator

Galecto Biotech AB

INDUSTRY

Sponsor Role: collaborator

Providence Health & Services

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brendan D. Curti, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Health & Services

Locations

Providence Portland Medical Center

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chris Fountain, RN, ONC

Role: CONTACT

Christopher.Fountain@providence.org

503-215-2691

Facility Contacts

Chris Fountain, RN

Role: primary

Christopher.Fountain@providence.org

503-215-2691

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

2023000353

Identifier Type: -

Identifier Source: org_study_id