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.