This phase II trial tests how well GT103 in combination with pembrolizumab works in treating patients with STK11 mutant non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). GT103 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. GT103 targets the tumor cell-protein complement factor H found on some cancer cells and may provide specific anti-tumor activity that may help block the formation of growths that may become cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving GT103 in combination with pembrolizumab may kill more cancer cells and improve outcomes in patients with advanced or metastatic STK11 mutant non-small cell lung cancer.
PRIMARY OBJECTIVE: I. To evaluate the 6-month (24 week) progression-free survival (PFS) rate of anti-CFH monoclonal antibody GT103 (GT103) in combination with pembrolizumab in patients with advanced/metastatic STK11 mutant non-small cell lung cancer (NSCLC). SECONDARY OBJECTIVES: I. To evaluate secondary efficacy endpoints (i.e., investigator-assessed objective response rate, 12-month survival rate, overall survival, duration of response, and disease control rate) of GT103 in combination with pembrolizumab in patients with advanced/metastatic STK11 mutant NSCLC. II. To evaluate the safety and tolerability of GT103 in combination with pembrolizumab in advanced/metastatic STK11 mutant NSCLC. EXPLORATORY OBJECTIVES: I. To evaluate the effects of GT103 in combination with pembrolizumab on the tumor microenvironment. II. To explore study tissue and blood-based biomarkers as potential predictors of treatment efficacy. OUTLINE: Patients receive GT103 intravenously (IV) over 60 minutes and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography (ECHO) at baseline, magnetic resonance imaging (MRI) at baseline and as clinically indicated, and computed tomography (CT) and blood sample collection throughout the study. Patients may also undergo biopsy throughout the study. After completion of study treatment, patients are followed up every 30 days for 120 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Given IV
Undergo tumor biopsy
Undergo blood sample collection
Undergo CT
Undergo ECHO
Undergo MRI
Given IV
Roswell Park Cancer Institute
Buffalo, New York, United States
RECRUITINGProgression-free survival
Will be summarized using standard Kaplan-Meier methods, where estimates will be obtained with 90% confidence intervals.
Time frame: Between study registration and documentation of disease progression or death, whichever is observed first, assessed up to 6 months (24 weeks)
Objective response rate
Will be defined by the Response Evaluation Criteria in Solid Tumors version 1.1. Will be estimated using 90% credible regions obtained by Jeffrey's prior method.
Time frame: Up to 4 years
Overall survival
Will be assessed using standard Kaplan-Meier methods, where estimates will be obtained with 90% confidence intervals.
Time frame: Between registration and death from any cause, assessed up to 4 years
Duration of response
Will be summarized using standard Kaplan-Meier methods, where estimates will be obtained with 90% confidence intervals.
Time frame: From the first documented objective response until the first documented disease progression or death due to any cause, assessed up to 4 years
Disease control rate
Will be defined as the proportion of patients with a best overall response of confirmed complete response, confirmed partial response, or stable disease ≥ 12 weeks. The best response status will be summarized using frequencies and relative frequencies.
Time frame: From the first dose of study drug until the first documentation of disease progression or death, assessed up to 4 years
Incidence of adverse events
Toxicities and adverse events will be assessed per Common Terminology Criteria for Adverse Events version 5.0. Will be summarized by attribution and grade using frequencies and relative frequencies.
Time frame: Up to 120 days after end of treatment
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