RECRUITING

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

Conditions

Metastatic Melanoma Head and Neck Squamous Cell Carcinoma pembrolizumab galecto GB1211

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-29

Study Completion:2030-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05913388

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Chris Fountain, RN, ONC

CONTACT

503-215-2691

Christopher.Fountain@providence.org

Principal Investigator

Brendan D. Curti, MD

PRINCIPAL_INVESTIGATOR

Providence Health & Services

Study Locations (Sites)

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Collaborators and Investigators

Sponsor: Providence Health & Services

Brendan D. Curti, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2024-02-29

Study Completion Date2030-02

Study Record Updates

Study Start Date2024-02-29

Study Completion Date2030-02

Terms related to this study

Keywords Provided by Researchers

metastatic melanoma
head and neck squamous cell carcinoma
pembrolizumab
galecto
GB1211

Additional Relevant MeSH Terms

Metastatic Melanoma
Head and Neck Squamous Cell Carcinoma