Biomarkers of Response to Ipilimumab and Nivolumab in First-line NSCLC
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ClinicalTrials.gov Identifier: NCT03425331 |
Recruitment Status :
Suspended
(Slow accrual, competing studies, and lack of efficacy)
First Posted : February 7, 2018
Last Update Posted : April 25, 2023
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Tracking Information | |||||
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First Submitted Date ICMJE | February 1, 2018 | ||||
First Posted Date ICMJE | February 7, 2018 | ||||
Last Update Posted Date | April 25, 2023 | ||||
Actual Study Start Date ICMJE | February 28, 2018 | ||||
Actual Primary Completion Date | May 18, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Best overall objective response rate [ Time Frame: 2 years ] RECIST1.1 measurements of CT scans will be measured during treatment to determine the objective response rate for patients being treated with nivolumab and ipilimumab.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Biomarkers of Response to Ipilimumab and Nivolumab in First-line NSCLC | ||||
Official Title ICMJE | Biomarkers of Response to Ipilimumab and Nivolumab as First-line Therapy for Metastatic Non-small Cell Lung Cancer (NSCLC): an Open-label, Single Arm Phase 2 Study | ||||
Brief Summary | This research study is studying two immunotherapy drugs as a possible treatment for advanced non-small cell lung cancer (NSCLC). The drugs involved in this study are:
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Detailed Description | This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied. The FDA (the U.S. Food and Drug Administration) has not approved ipilimumab for this specific disease but it has been approved for other uses, including for patients with advanced melanoma. The FDA (the U.S. Food and Drug Administration) has approved nivolumab as a treatment option for this disease. However, nivolumab it is not approved in combination with ipilimumab to treat NSCLC. Nivolumab and ipilimumab are both types of immunotherapy. Immunotherapy works by stimulating the body's own immune system to attack cancer cells. The combination of ipilimumab with nivolumab may or may not increase anti-cancer activity by further boosting the immune system. In this research study, the investigators are investigating if the combination of ipilimumab and nivolumab is effective in treating advanced NSCLC. The investigators are also investigating whether there are certain DNA or protein markers in the blood or tumor tissue that may indicate whether the combination will work in future patients. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-small Cell Lung Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Nivolumab+Ipilimumab
Nivolumab will be administered once every 2 weeks intravenously Ipilimumab will be administered once every 6 weeks intravenously
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Suspended | ||||
Actual Enrollment ICMJE |
5 | ||||
Original Estimated Enrollment ICMJE |
80 | ||||
Estimated Study Completion Date ICMJE | August 28, 2025 | ||||
Actual Primary Completion Date | May 18, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03425331 | ||||
Other Study ID Numbers ICMJE | 17-566 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Mark Awad, MD, Dana-Farber Cancer Institute | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Bristol-Myers Squibb | ||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||
Verification Date | April 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |