Table 1.
Basic characteristics of the included studies
| Author, year | Clinical trial information | Study title | Phase | Participants (N) | Disease |
|---|---|---|---|---|---|
| Iguchi et al, 201525 | NCT01938612 | A Phase I, open-label, multicenter study to evaluate the safety, tolerability, and pharmacokinetics of MEDI4736 in patients with advanced solid tumors. | I | 22 | Advanced solid tumors |
| Ribas et al, 201524 | NCT02027961 | A Phase I open-label study on safety and tolerability of MEDI4736 in subjects with metastatic or unresectable melanoma in combination with dabrafenib and trametinib or with trametinib alone. | I | 50 | Advanced melanoma |
| Takahashi et al, 201519 | NCT02141347 | A Phase I open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of tremelimumab/tremelimumab with MEDI4736 in Japanese with advanced solid malignancies or tremelimumab in Japanese with malignant mesothelioma. | I | 8 | Advanced solid malignancies |
| Lee et al, 201723 | NCT02484404 | Phase I/II study of the antiprogrammed death ligand-1 antibody MEDI4736 in combination with olaparib and/or cediranib for advanced solid tumors and advanced or recurrent ovarian, triple-negative breast, lung, prostate, and colorectal cancers. | I | 26 | Recurrent women’s cancers |
| Garassino et al, 201716 | NCT02087423 | A Phase II, noncomparative, open-label, multicenter, international study of MEDI4736 in patients with locally advanced or metastatic non-small cell lung cancer (stage IIIB–IV) who have received at least two prior systemic treatment regimens, including one platinum-based chemotherapy regimen. | II | 333 | Advanced or metastatic stage IIIB–IV NSCLC |
| Ahn et al, 201720 | NCT02143466 | A multiarm, Phase Ib, open-label, multicenter study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of AZD9291 in combination with ascending doses of novel therapeutics in patients with EGFR-mutant advanced NSCLC who have progressed following therapy with an EGFR TKI (TATTON). | Ib | 34 | EGFR-mutant NSCLC |
| Gibbons et al, 201622 | NCT02088112 | A Phase I, open-label, multicenter study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of gefitinib in combination with MEDI4736 (anti-PD-L1) in subjects with NSCLC. | I | 20 | TKI-naive with EGFR mutant NSCLC |
| Powles et al, 201717 | NCT01693562 | A Phase I/II study to evaluate the safety, tolerability, and pharmacokinetics of MEDI4736 in subjects with advanced solid tumors. | I/II | 191 | Locally advanced or metastatic UCC |
| Santa-Maria et al, 201726 | NCT02536794 | A single-arm Phase II study evaluating the efficacy and safety of MEDI4736 in combination with tremelimumab in patients with metastatic Her2-negative breast cancer. | NM | 18 | Metastatic breast cancer |
| Kelley et al, 201710 | NCT02519348 | A study of safety, tolerability, and clinical activity of MEDI4736 and tremelimumab administered as monotherapy and in combination to subjects with unresectable hepatocellular carcinoma. | I/II | 40 | Unresectable HCC |
| Wainberg et al, 201711 | NCT01693562 | A Phase I/II study to evaluate the safety, tolerability, and pharmacokinetics of MEDI4736 in subjects with advanced solid tumors. | I/II | 40 | Advanced HCC |
| Callahan et al, 201718 | NCT01975831 | A Phase I study to evaluate the safety and tolerability of anti-PD-L1, MEDI4736, in combination with tremelimumab in subjects with advanced solid tumors. | I | 105 | Advanced solid tumors |
| Reardon et al, 201712 | NCT02336165 | Phase II study to evaluate the clinical efficacy and safety of MEDI4736 in patients with glioblastoma. | II | 154 | Glioblastoma |
| Lin et al, 201613 | NCT02572687 | An open-label, multicenter, Phase I study of ramucirumab plus MEDI4736 in patients with locally advanced and unresectable or metastatic gastrointestinal or thoracic malignancies. | Ia | 20 | Advanced gastrointestinal or thoracic malignancies |
| Antonia et al, 201614 | NCT01693562 | A Phase I/II study to evaluate the safety, tolerability, and pharmacokinetics of MEDI4736 in subjects with advanced solid tumors. | I/II | 304 | NSCLC |
| Antonia et al, 201621 | NCT02000947 | A Phase Ib open-label study to evaluate the safety and tolerability of MEDI4736 in combination with tremelimumab in subjects with advanced NSCLC. | Ib | 102 | Advanced NSCLC |
| Segal et al, 201615 | NCT01693562 | A Phase I/II study to evaluate the safety, tolerability, and pharmacokinetics of MEDI4736 in subjects with advanced solid tumors. | I/II | 62 | Recurrent and metastatic SCCHN |
Abbreviations: EGFR, epidermal growth factor receptor; HCC, hepatocellular carcinoma; Her2, human epidermal growth factor receptor 2; NM, not mentioned; NSCLC, non-small-cell lung cancer; PD-L1, programmed cell death ligand-1; SCCHN, squamous cell carcinoma of head and neck; TKI, tyrosine kinase inhibitor; UCC, urothelial carcinoma.