Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 10:47 PM
Study NCT ID:
NCT05022394
Status:
WITHDRAWN
Last Update Posted:
2022-05-27
First Post:
2020-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sapanisertib and Nivolumab for the Treatment of Stage I-IV Non-small Cell Lung Cancer in Patients Who Have Progressed on Prior PD-1/PD-L1 Inhibitor Therapy, I-OVERCOME Study
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase I/II Study to OVERCOME Resistance to PD-1/PD-L1 Inhibitor Immunotherapy in Advanced Non-Small Cell Lung Cancer - I-OVERCOME Trial
Status:
WITHDRAWN
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants Enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I/II trial studies the side effects of sapanisertib and nivolumab and to see how well they work in treating patients with stage I-IV non-small cell lung cancer whose disease got worse on previous PD-1/PD-L1 inhibitor therapy. Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sapanisertib and nivolumab may help to control the disease.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate the toxicity of the combination of sapanisertib and nivolumab in patients with advanced non-small cell lung cancer (NSCLC) who have had disease progression on prior PD-1/PD-L1 inhibitor therapy.
II. To confirm recommended phase 2 dose (RP2D) of the combination of sapanisertib and nivolumab in patients with advanced NSCLC who have had disease progression on prior PD-1/PD-L1 inhibitor therapy.
III. To estimate the objective response rate of the combination of sapanisertib and nivolumab in patients with advanced NSCLC who have had disease progression on prior PD-1/PD-L1 inhibitor therapy.
SECONDARY OBJECTIVES:
I. To determine progression free survival (PFS) of the combination of sapanisertib and nivolumab in patients with advanced NSCLC who have had disease progression on prior PD-1/PD-L1 inhibitor therapy.
II. To determine overall survival (OS) of the combination of sapanisertib and nivolumab in patients with advanced NSCLC who have had disease progression on prior PD-1/PD-L1 inhibitor therapy.
III. To estimate the disease control rate of the combination of sapanisertib and nivolumab in patients with advanced NSCLC who have had disease progression on prior PD-1/PD-L1 inhibitor therapy.
IV. To determine if there are drug-drug interaction (DDI) for the combination of sapanisertib and nivolumab.
EXPLORATORY OBJECTIVES:
I. To compare gene and protein expression in pre-treatment and on-treatment tumor samples.
II. To compare gene and protein expression in tumor samples of responders and nonresponders.
III. To compare immune cell infiltration and immune markers in pre-treatment and on-treatment tumor samples.
IV. To compare immune cell infiltration and immune markers in tumor samples of responders and non-responders.
V. To correlate clinical outcomes with tumor mutational burden and cancer gene mutations detected by molecular profiling.
VI. To compare gene expression at the single-cell level in pre-treatment and on-treatment tumor samples.
VII. To compare gene expression at the single-cell level in tumor samples of responders and non-responders.
VIII. To compare cell-free deoxyribonucleic acid (DNA) levels in pre-treatment, on-treatment, and at progression tumor samples.
OUTLINE:
Patients receive sapanisertib orally (PO) once daily (QD) on days 1, 8, 15, and 22 and nivolumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
I. To evaluate the toxicity of the combination of sapanisertib and nivolumab in patients with advanced non-small cell lung cancer (NSCLC) who have had disease progression on prior PD-1/PD-L1 inhibitor therapy.
II. To confirm recommended phase 2 dose (RP2D) of the combination of sapanisertib and nivolumab in patients with advanced NSCLC who have had disease progression on prior PD-1/PD-L1 inhibitor therapy.
III. To estimate the objective response rate of the combination of sapanisertib and nivolumab in patients with advanced NSCLC who have had disease progression on prior PD-1/PD-L1 inhibitor therapy.
SECONDARY OBJECTIVES:
I. To determine progression free survival (PFS) of the combination of sapanisertib and nivolumab in patients with advanced NSCLC who have had disease progression on prior PD-1/PD-L1 inhibitor therapy.
II. To determine overall survival (OS) of the combination of sapanisertib and nivolumab in patients with advanced NSCLC who have had disease progression on prior PD-1/PD-L1 inhibitor therapy.
III. To estimate the disease control rate of the combination of sapanisertib and nivolumab in patients with advanced NSCLC who have had disease progression on prior PD-1/PD-L1 inhibitor therapy.
IV. To determine if there are drug-drug interaction (DDI) for the combination of sapanisertib and nivolumab.
EXPLORATORY OBJECTIVES:
I. To compare gene and protein expression in pre-treatment and on-treatment tumor samples.
II. To compare gene and protein expression in tumor samples of responders and nonresponders.
III. To compare immune cell infiltration and immune markers in pre-treatment and on-treatment tumor samples.
IV. To compare immune cell infiltration and immune markers in tumor samples of responders and non-responders.
V. To correlate clinical outcomes with tumor mutational burden and cancer gene mutations detected by molecular profiling.
VI. To compare gene expression at the single-cell level in pre-treatment and on-treatment tumor samples.
VII. To compare gene expression at the single-cell level in tumor samples of responders and non-responders.
VIII. To compare cell-free deoxyribonucleic acid (DNA) levels in pre-treatment, on-treatment, and at progression tumor samples.
OUTLINE:
Patients receive sapanisertib orally (PO) once daily (QD) on days 1, 8, 15, and 22 and nivolumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: