References
- Bril, G., Dykstra, R., Pillers, C., and Robertson, T. (1984), “Algorithm AS 206: Isotonic Regression in Two Independent Variables,” Journal of the Royal Statistical Society, Series C, 33, 352–357. DOI: https://doi.org/10.2307/2347723.
- Conaway, M. R. (2017a), “A Design for Phase I Trials in Completely or Partially Ordered Groups,” Statistics in Medicine, 36, 2323–2332. DOI: https://doi.org/10.1002/sim.7295.
- Conaway, M. R. (2017b), “Isotonic Designs for Phase I Trials in Partially Ordered Groups,” Clinical Trials, 14, 491–498.
- Conaway, M. R., and Wages, N. A. (2017), “Designs for Phase I Trials in Ordered Groups,” Statistics in Medicine, 36, 254–265. DOI: https://doi.org/10.1002/sim.7133.
- Das, I., Mukhopadhyay, S., and Xu, H. (2013), “Individualized Dosing for Multiple Ordered Groups of Patients,” Journal of Statistical Theory and Practice, 7, 95–106. DOI: https://doi.org/10.1080/15598608.2013.756348.
- Dykstra, R. L., and Robertson, T. (1982), “An Algorithm for Isotonic Regression for Two or More Independent Variables,” Annals of Statistics, 10, 708–716. DOI: https://doi.org/10.1214/aos/1176345866.
- Guo, W., Wang, S. J., Yang, S., Lynn, H., and Ji, Y. (2017), “A Bayesian Interval Dose-Finding Design Addressing Ockham’s Razor: mTPI-2,” Contemporary Clinical Trials, 58, 23–33. DOI: https://doi.org/10.1016/j.cct.2017.04.006.
- Horton, B. J., Wages, N. A., and Conaway, M. R. (2019), “Shift Models for Dose-Finding in Partially Ordered Groups,” Clinical Trials, 16, 32–40. DOI: https://doi.org/10.1177/1740774518801599.
- Ivanova, A., and Wang, K. (2004), “A Non-Parametric Approach to the Design and Analysis of Two-Dimensional Dose-Finding Trials,” Statistics in Medicine, 23, 1861–1870. DOI: https://doi.org/10.1002/sim.1796.
- Ivanova, A., and Wang, K. (2006), “Bivariate Isotonic Design for Dose-Finding With Ordered Groups,” Statistics in Medicine, 25, 2018–2026.
- Ji, Y., Liu, P., Li, Y., and Nebiyou Bekele, B. (2010), “A Modified Toxicity Probability Interval Method for Dose-Finding Trials,” Clinical Trials, 7, 653–663. DOI: https://doi.org/10.1177/1740774510382799.
- Langer, C. J., Gadgeel, S. M., Borghaei, H., Papadimitrakopoulou, V. A., Patnaik, A., Powell, S. F., Gentzler, R. D., Martins, R. G., Stevenson, J. P., Jalal, S. I., and Panwalkar, A. (2016), “Carboplatin and Pemetrexed With or Without Pembrolizumab for Advanced, Non-Squamous Non-Small-Cell Lung Cancer: A Randomised, Phase 2 Cohort of the Open-Label KEYNOTE-021 Study,” Lancet Oncology, 17, 1497–1508. DOI: https://doi.org/10.1016/S1470-2045(16)30498-3.
- Larkin, J., Chiarion-Sileni, V., Gonzalez, R., Grob, J. J., Cowey, C. L., Lao, C. D., Schadendorf, D., Dummer, R., Smylie, M., Rutkowski, P., and Ferrucci, P. F. (2015), “Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma,” New England Journal of Medicine, 373, 23–34. DOI: https://doi.org/10.1056/NEJMoa1504030.
- Lin, R., and Yin, G. (2015), “Bayesian Optimal Interval Design for Dose Finding in Drug-Combination Trials,” Statistical Methods in Medical Research, 26, 2155–2167. DOI: https://doi.org/10.1177/0962280215594494.
- Liu, S., and Yuan, Y. (2015), “Bayesian Optimal Interval Designs for Phase I Clinical Trials,” Journal of the Royal Statistical Society, Series C, 64, 507–523. DOI: https://doi.org/10.1111/rssc.12089.
- Mander, A. P., and Sweeting, M. J. (2015), “A Product of Independent Beta Probabilities Dose Escalation Design for Dual-Agent Phase I Trials,” Statistics in Medicine, 34, 1261–1276. DOI: https://doi.org/10.1002/sim.6434.
- Morrissey, K. M., Yuraszeck, T. M., Li, C. C., Zhang, Y., and Kasichayanula, S. (2016), “Immunotherapy and Novel Combinations in Oncology: Current Landscape, Challenges, and Opportunities,” Clinical and Translational Science, 9, 89–104. DOI: https://doi.org/10.1111/cts.12391.
- Neuenschwander, B., Matano, A., Tang, Z., Roychoudhury, S., Wandel, S., and Bailey, S. A. (2015), “Bayesian Industry Approach to Phase I Combination Trials in Oncology,” in Statistical Methods in Drug Combination Studies, eds. W. Zhao and H. Yang, Boca Raton, FL: CRC Press, pp. 95–135.
- O’Quigley, J., and Paoletti, X. (2003), “Continual Reassessment Method for Ordered Groups,” Biometrics, 59, 430–440. DOI: https://doi.org/10.1111/1541-0420.00050.
- O’Quigley, J., Pepe, M., and Fisher, L. (1990), “Continual Reassessment Method: A Practical Design for Phase 1 Clinical Trials in Cancer,” Biometrics, 46, 33–48. DOI: https://doi.org/10.2307/2531628.
- O’Quigley, J., Shen, L. Z., and Gamst, A. (1999), “Two-Sample Continual Reassessment Method,” Journal of Biopharmaceutical Statistics, 9, 17–44. DOI: https://doi.org/10.1081/BIP-100100998.
- Shi, Y., and Yin, G. (2013), “Escalation With Overdose Control for Phase I Drug-Combination Trials,” Statistics in Medicine, 32, 4400–4412. DOI: https://doi.org/10.1002/sim.5832.
- Storer, B. E. (1989), “Design and Analysis of Phase I Clinical Trials,” Biometrics, 45, 925–937. DOI: https://doi.org/10.2307/2531693.
- Tang, J., Pearce, L., O’Donnell-Tormey, J., and Hubbard-Lucey, V. M. (2018), “Trends in the Global Immuno-Oncology Landscape,” Nature Reviews Drug Discovery, 17, 783–784. DOI: https://doi.org/10.1038/nrd.2018.167.
- Wages, N. A., Conaway, M. R., and O’Quigley, J. (2011), “Dose-Finding Design for Multi-Drug Combinations,” Clinical Trials, 8, 380–389. DOI: https://doi.org/10.1177/1740774511408748.
- Wolchok, J. D., Kluger, H., Callahan, M. K., Postow, M. A., Rizvi, N. A., Lesokhin, A. M., Segal, N. H., Ariyan, C. E., Gordon, R. A., Reed, K., and Burke, M. M. (2013), “Nivolumab Plus Ipilimumab in Advanced Melanoma,” New England Journal of Medicine, 369, 122–133. DOI: https://doi.org/10.1056/NEJMoa1302369.
- Yan, F., Mandrekar, S. J., and Yuan, Y. (2017), “Keyboard: A Novel Bayesian Toxicity Probability Interval Design for Phase I Clinical Trials,” Clinical Cancer Research, 23, 3994–4003. DOI: https://doi.org/10.1158/1078-0432.CCR-17-0220.
- Yin, G., and Yuan, Y. (2009), “Bayesian Dose Finding in Oncology for Drug Combinations by Copula Regression,” Journal of the Royal Statistical Society, Series C, 58, 211–224. DOI: https://doi.org/10.1111/j.1467-9876.2009.00649.x.
- Yuan, Z., and Chappell, R. (2004), “Isotonic Designs for Phase I Cancer Clinical Trials With Multiple Risk Groups,” Clinical Trials, 1, 499–508. DOI: https://doi.org/10.1191/1740774504cn058oa.
- Zhang, L., and Yuan, Y. (2016), “A Practical Bayesian Design to Identify the Maximum Tolerated Dose Contour for Drug Combination Trials,” Statistics in Medicine, 35, 4924–4936. DOI: https://doi.org/10.1002/sim.7095.
- Zou,W.,Wolchok,J.D.,andChen,L.(2016),“PD-L1(B7-H1)andPD-1PathwayBlockadeforCancer Therapy: Mechanisms, Response Biomarkers, and Combinations,” Science Translational Medicine, 8, 328rv4. DOI: https://doi.org/10.1126/scitranslmed.aad7118.