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. 2020 Feb 18;12(4):3993–4009. doi: 10.18632/aging.102787

Table 1. Summary of ongoing clinical studies of metformin and immune checkpoint inhibitors combination therapy in nondiabetic patients with cancer.

No. NCT Number Title Study design Enrollment Status Diseases Interventions Sponsor Start date
1 NCT03994744 Assessing Safety and Efficacy of Sintilimab and Metformin Combination Therapy in SCLC Phase 2 Open Label 68 Recruiting ED-stage SCLC patients resistant to or relapsed after standard chemotherapy PD-1 inhibitor Sintilimab plus Metformin Hunan Cancer Hospital, China 20-Aug-2019
2 NCT03800602 Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer Phase 2 Open Label 28 Recruiting MSS stage IV colorectal cancer Nivolumab plus Metformin Emory University Hospital, Emory Saint Joseph's Hospital, United States 15-Jan-2019
3 NCT03618654 Durvalumab With or Without Metformin in Treating Participants With Head and Neck Squamous Cell Carcinoma Phase 1 Randomized Open Label 38 Recruiting Head and neck squamous cell carcinoma Durvalumab vs Durvalumab plus Metformin Sidney Kimmel Cancer Center at Thomas Jefferson University, United States 1-Nov-2018
4 NCT03311308 A Trial of Pembrolizumab and Metformin Versus Pembrolizumab Alone in Advanced Melanoma Phase 1 Non-Randomized Open Label 30 Recruiting Advanced Melanoma Pembrolizumab vs Pembrolizumab plus Metformin University of Pittsburgh Medical Center Hillman Cancer Center, United States 6-Dec-2017
5 NCT03048500 Nivolumab and Metformin Hydrochloride in Treating Patients With Stage III-IV Non-small Cell Lung Cancer That Cannot Be Removed by Surgery Phase 2 Open Label 51 Recruiting Recurrent or Stage III-IV NSCLC Nivolumab plus Metformin Northwestern University, United States 6-Jun-2017
6 NCT04114136 Anti-PD-1 mAb Plus Metabolic Modulator in Solid Tumor Malignancies Phase 2 Open Label 108 Not yet recruiting Solid Tumor Malignancies Anti-PD-1 mAb (nivolumab or pembrolizumab) plus Metformin vs Anti-PD-1 mAb (nivolumab or pembrolizumab) plus Rosiglitazone UPMC Hillman Cancer Center, United States 15-Oct-2019

Abbreviation: SCLC: small cell lung cancer, ED-stage: extensive stage disease, PD-1: programmed cell death protein 1, MSS: microsatellite stable, NSCLC: non-small-cell lung cancer.