NCT03573947

Phase II Clinical Trial of NIVO-IPI-TAXANE in Untreated Metastatic NSCLC

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]

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Jeffrey Clarke · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	360 mg intravenously every 3 weeks
DRUG	Ipilimumab	1 mg/kg intravenously over 30 minutes
DRUG	Paclitaxel	80 mg/m2 on days 1 and 8 of every 21-day treatment cycle

Timeline

• Start date: 2018-10-02
• Primary completion: 2023-03-12
• Completion: 2023-06-15
• First posted: 2018-06-29
• Last updated: 2025-10-14
• Results posted: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study