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A Phase 2 Clinical Trial of Combination Nivolumab, Ipilimumab, and Paclitaxel in Patients With Untreated Metastatic NSCLC: The OPTIMAL Trial.

Publication ,  Journal Article
Clarke, JM; Gu, L; Wang, XF; Stinchcombe, TE; Stevenson, MM; Ramalingam, S; Shariff, A; Garst, J; Nixon, AB; Antonia, SJ; Crawford, J; Ready, NE
Published in: JTO Clin Res Rep
June 2022

INTRODUCTION: Most patients with advanced NSCLC will experience disease progression and death within 2 years. Novel approaches are needed to improve outcomes. METHODS: We conducted an open-label, nonrandomized, phase 2 trial in patients with treatment-naive, advanced NSCLC to assess the safety and efficacy of nivolumab 360 mg every 3 weeks, ipilimumab 1 mg/kg every 6 weeks, and four to six cycles of paclitaxel 80 mg/m2 on days 1 and 8 of every 21-day treatment. The primary end point of the study was median progression-free survival (PFS), with secondary end points of safety, objective response rate, and median overall survival (OS). RESULTS: A total of 46 patients underwent consent and received treatment. The median age was 66 (range: 48-82) years, most had adenocarcinoma (63%), and 50% (23) had programmed death-ligand 1 greater than or equal to 1%. The median follow-up on the study as of October 2021 was 19 months. The primary end point of median PFS was 9.4 months (95% confidence interval [CI]: 5.9-16.6) in all patients regardless of programmed death-ligand 1 expression. The objective response rate for patients in the study was 47.8% (95% CI: 33.4-62.3). The 12-month OS rate was 69.5% (95% CI: 53%-81%), and median OS was not yet reached. Treatment-related grade greater than or equal to 3 adverse events was found in 54.3% of the patients. CONCLUSIONS: The toxicity observed was consistent with other reported chemo-immunotherapeutic combinations and was manageable. The primary end point of exceeding median PFS of 9 months was achieved with nivolumab, ipilimumab, and weekly paclitaxel and should be evaluated further in a randomized trial.

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Published In

JTO Clin Res Rep

DOI

EISSN

2666-3643

Publication Date

June 2022

Volume

3

Issue

6

Start / End Page

100337

Location

United States
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Clarke, J. M., Gu, L., Wang, X. F., Stinchcombe, T. E., Stevenson, M. M., Ramalingam, S., … Ready, N. E. (2022). A Phase 2 Clinical Trial of Combination Nivolumab, Ipilimumab, and Paclitaxel in Patients With Untreated Metastatic NSCLC: The OPTIMAL Trial. JTO Clin Res Rep, 3(6), 100337. https://doi.org/10.1016/j.jtocrr.2022.100337
Clarke, Jeffrey M., Lin Gu, Xiaofei F. Wang, Thomas E. Stinchcombe, Marvaretta M. Stevenson, Sundhar Ramalingam, Afreen Shariff, et al. “A Phase 2 Clinical Trial of Combination Nivolumab, Ipilimumab, and Paclitaxel in Patients With Untreated Metastatic NSCLC: The OPTIMAL Trial.JTO Clin Res Rep 3, no. 6 (June 2022): 100337. https://doi.org/10.1016/j.jtocrr.2022.100337.
Clarke JM, Gu L, Wang XF, Stinchcombe TE, Stevenson MM, Ramalingam S, et al. A Phase 2 Clinical Trial of Combination Nivolumab, Ipilimumab, and Paclitaxel in Patients With Untreated Metastatic NSCLC: The OPTIMAL Trial. JTO Clin Res Rep. 2022 Jun;3(6):100337.
Clarke, Jeffrey M., et al. “A Phase 2 Clinical Trial of Combination Nivolumab, Ipilimumab, and Paclitaxel in Patients With Untreated Metastatic NSCLC: The OPTIMAL Trial.JTO Clin Res Rep, vol. 3, no. 6, June 2022, p. 100337. Pubmed, doi:10.1016/j.jtocrr.2022.100337.
Clarke JM, Gu L, Wang XF, Stinchcombe TE, Stevenson MM, Ramalingam S, Shariff A, Garst J, Nixon AB, Antonia SJ, Crawford J, Ready NE. A Phase 2 Clinical Trial of Combination Nivolumab, Ipilimumab, and Paclitaxel in Patients With Untreated Metastatic NSCLC: The OPTIMAL Trial. JTO Clin Res Rep. 2022 Jun;3(6):100337.

Published In

JTO Clin Res Rep

DOI

EISSN

2666-3643

Publication Date

June 2022

Volume

3

Issue

6

Start / End Page

100337

Location

United States