Phase II Clinical Trial of NIVO-IPI-TAXANE in Untreated Metastatic NSCLC (TOP1705)
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|ClinicalTrials.gov Identifier: NCT03573947|
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : December 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Nivolumab Drug: Ipilimumab Drug: Paclitaxel||Phase 2|
This is an open-label, non-randomized, phase II clinical research study designed to assess the safety and efficacy of nivolumab and ipilimumab in combination with paclitaxel in patients with treatment naïve NSCLC.
Patients with histologically confirmed stage IV or recurrent non curable NSCLC of squamous or non-squamous histology, with no prior systemic anticancer chemotherapy or immunotherapy given as primary treatment for advanced or metastatic disease may be eligible to participate in this study.
Patients enrolled into the study will be given the study drugs, nivolumab (360 mg) (Day 1) every 3 weeks, ipilimumab 1 mg/kg (Day 1) every 6 weeks, and paclitaxel 80mg/m2 on days 1 and 8 of each 21- day study treatment cycle. Paclitaxel will be stopped after a total of 4-6 cycles of treatment. Blood samples and possibly a small piece of tissue may be removed the patient's lung to see what type of lung cancer cells that she or he may have. Patients will also have other tests, exams, and procedures for study purposes and their standard of care. Subject participation in the study will last for up to approximately 48 months after the start of the study drug or until their condition worsens or they experience intolerable adverse events as deemed by the study doctor.
There are possible patient risk to this study that include but are not limited to diarrhea, itching, rash and a feeling of weakness.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Trial of Combination Nivolumab (Opdivo), Ipilimumab (Yervoy), and Paclitaxel in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (NSCLC) (The OPTIMAL Trial) [TOP 1705]|
|Actual Study Start Date :||October 2, 2018|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2023|
|Experimental: nivolumab, ipilimumab and paclitaxel||
360 mg intravenously every 3 weeks
Other Name: Opdivo
1 mg/kg intravenously over 30 minutes
Other Name: Yervoy
80 mg/m2 on days 1 and 8 of every 21-day treatment cycle
Other Name: Taxol
- Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria In Solid Tumors RECIST 1.1 (brand name) or death, whichever occurs first [ Time Frame: Up to 5 years ]PFS will be defined as the time from first dosing date to the date of the first documented tumor progression or death, whichever occurs first
- Description of the safety and adverse events of the combination nivolumab, ipilimumab, and paclitaxel in untreated, metastatic NSCLC. [ Time Frame: Up to 4 years ]The study will assess the number and percentage of participants who experience high grade (Grade 3-4 and Grade 5) treatment-related select and immune-mediated adverse events that include: pneumonitis, interstitial nephritis, diarrhea/colitis, hepatitis, rash, endocrinopathies, and hypersensitivity/infusion reaction events.
- Estimate the overall response rate with the study combination. [ Time Frame: Up to 5 years ]Objective Response Rate (ORR) defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573947
|Contact: Ellen Parker||919-681-3510||Ellen.firstname.lastname@example.org|
|Contact: Jeffrey Clarke, MDemail@example.com|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Ellen Parker 919-681-3510 Ellen.s.Parker@duke.edu|
|Contact: Debra Shoemaker 919-681-4768 Debra.firstname.lastname@example.org|
|Principal Investigator: Jeffrey Clarke, MD|