Table 2.
Clinical trials on programmed cell death 1
| Target molecule | Drug name | Study phase | Study design | Status | Condition | Intervention | Cohort | Estimated enrollment | Dose | End point | Study Arm | Adverse event | Response | Survival | Ref. |
| PD-1 | Nivolumab (BMS-936558/MDX-1106/ONO-4538) | 1|2 | Randomized | Recruiting | PC | Neoadjuvant | Resectable | 50 | 3 mg/kg | Safety | Cy/GVAX ( Arm A) | NA | NA | NA | NCT02451982 |
| Adjuvant | Efficacy (IRAEs, OS, DFS) | Cy/GVAX, Nivolumab (Arm B) | |||||||||||||
| Median-[IL17A] in Vaccine-induced Lymphoid Aggregates | |||||||||||||||
| 1|2 | Non-randomized | Recruiting | PC, NSCLC, RCC, CrC, EC, UC | Palliative | Metastatic | 49 | NA | Safety | Nivolumab, Temsirolimus (Arm A) | NA | NA | NA | NCT02423954 | ||
| Efficacy | Nivolumab, Irinotecan (Arm B) | ||||||||||||||
| RD | Nivolumab, Irinotecan, capecitabine (Arm C) | ||||||||||||||
| 1 | Non-randomized | Recruiting | PC, NSCLC, CrC, MM, HNSCC, GBM | Palliative | Locally advanced | 270 | 3 mg/kg | Safety (AE) | Phase 1a: | NA | NA | NA | NCT02526017 | ||
| Efficacy (OS; mOS, oyOS, DOR, PFS, ORR; CR, PR) | FPA008 (Arm A) | ||||||||||||||
| Tolerability | FPA008, Nivolumab (Arm B) | ||||||||||||||
| RD | Phase 1b: | ||||||||||||||
| PK | MTD/RD FPA008, Nivolumab | ||||||||||||||
| Immunogenicity | |||||||||||||||
| PDA biomarkers | |||||||||||||||
| 1 | Non-randomized | Recruiting | PC, OC, BC, CrC, RCC, MM, PrC, NSCLC | Palliative | Locally advanced | 300 | 3 mg/kg | Safety | DE AM0010 (Arm A) | NA | NA | NA | NCT02009449 | ||
| Metastatic | Tolerability | DE AM0010, Paclitaxel/Docetaxel, Carboplatin/Cisplatin (Arm B) | |||||||||||||
| PK | DE AM0010, FOLFOX, (Arm C) | ||||||||||||||
| DE AM0010, gemcitabine/nab-paclitaxel (Arm D) | |||||||||||||||
| DE AM0010, Capecitabine (Arm E) | |||||||||||||||
| DE AM0010, Paclitaxel (Arm F) | |||||||||||||||
| DE AM0010, Pazopanib (Arm G) | |||||||||||||||
| DE AM0010, Pembrolizumab (Arm H) | |||||||||||||||
| DE AM0010, Nivolumab (Arm I) | |||||||||||||||
| DE AM0010, Gemcitabine/carboplatin (Arm J) | |||||||||||||||
| Pembrolizumab (MK-3475/SCH 900475) | 2 | NA | Not recruiting | PC | Palliative | Locally advanced | 54 | 200 mg | Safety (IRAEs) | Cy/GVAX, Pembrolizumab, SBRT | NA | NA | NA | NCT02648282 | |
| Efficacy (DMFS, OS, LPFS) | |||||||||||||||
| 2 | Randomized | Active | PC | Palliative | Locally advanced | 76 | NA | Safety (TEAE) | ACP-196 (Arm A) | NA | NA | NA | NCT02362048 | ||
| Not recruiting | Metastatic | Efficacy | ACP-196, Pembrolizumab (Arm B) | ||||||||||||
| 1|2 | Randomized | Recruiting | PC | Neoadjuvant | Resectable | 56 | 200 mg | Safety (DLT) | Pembrolizumab, Capecitabine, Radiotherapy | NA | NA | NA | NCT02305186 | ||
| Borderline resectable | Efficacy (DFS, OS, RR) | ||||||||||||||
| [TILs] | |||||||||||||||
| 1|2 | Non-randomized | Recruiting | PC, SCLC, OC, BC, Sarcoma | Palliative | Metastatic | 90 | 2 mg/kg | Safety (AE) | Pembrolizumab, Gemcitabine (Arm A) | NA | NA | NA | NCT02331251 | ||
| Efficacy (ORR, OS, PFS) | Pembrolizumab, Gemcitabine, Docetaxel (Arm B) | ||||||||||||||
| RD | Pembrolizumab, Gemcitabine, Nab-paclitaxel (Arm C) | ||||||||||||||
| Pembrolizumab, Gemcitabine, Vinorelbine (Arm D) | |||||||||||||||
| Pembrolizumab, Irinotecan (Arm E) | |||||||||||||||
| Pembrolizumab, Liposomal, Doxorubicin (Arm F) | |||||||||||||||
| 1 | Non-randomized | Recruiting | PC | Palliative | Locally advanced | 50 | 200 mg | Safety | Pembrolizumab, Defactinib, Gemcitabine | NA | NA | NA | NCT02546531 | ||
| Metastatic | Efficacy | ||||||||||||||
| 1 | NA | Active | PC, RC, NSCLC, BlC, ASN, RCC, CC, HCC, BC, MM, HNSCC, Sarcoma | Palliative | Metastatic | 12 | NA | Safety | Pembrolizumab, p53MVA | NA | NA | NA | NCT02432963 | ||
| Not recruiting | Efficacy (Clinical Response) | ||||||||||||||
| Tolerability | |||||||||||||||
| 2 | Non-randomized | Suspended | PC, ChC, GeC, CrC, HCC | Palliative | Metastatic | 290 | 2 mg/kg | Safety | Pebrolizumab, Young TIL, Aldesleukin, Cyclophosphamide, Fludarabine | NA | NA | NA | NCT01174121 | ||
| Efficacy | |||||||||||||||
| 1 | NA | Recruiting | PC | Palliative | Locally advanced | 9 | 2 mg/kg | Safety (DLT) | Pembrolizumab, Reolysin, Gemcitabine/Irinotecan/Leucovorin with 5-FU | NA | NA | NA | NCT02620423 | ||
| Metastatic | Efficacy (ORR, PFS, OS) | ||||||||||||||
| 1|2 | NA | Recruiting | PC, ChC, GeC, CrC | Palliative | Locally advanced | 128 | DE | Safety | Pembrolizumab, mFOLFOX6, Celecoxib | NA | NA | NA | NCT02268825 | ||
| Metastatic | Efficacy (RR, PFS, OS) | ||||||||||||||
| 1 | Non-randomized | Recruiting | PC, OC, BC, CrC, RCC, MM, PrC, NSCLC | Palliative | Locally advanced | 300 | 3 mg/kg | Safety | DE AM0010 (Arm A) | NA | NA | NA | NCT02009449 | ||
| Metastatic | Tolerability | DE AM0010, Paclitaxel/Docetaxel, Carboplatin/Cisplatin (Arm B) | |||||||||||||
| PK | DE AM0010, FOLFOX, (Arm C) | ||||||||||||||
| DE AM0010, gemcitabine/nab-paclitaxel (Arm D) | |||||||||||||||
| DE AM0010, Capecitabine (Arm E) | |||||||||||||||
| DE AM0010, Paclitaxel (Arm F) | |||||||||||||||
| DE AM0010, Pazopanib (Arm G) | |||||||||||||||
| DE AM0010, Pembrolizumab (Arm H) | |||||||||||||||
| DE AM0010, Nivolumab (Arm I) | |||||||||||||||
| DE AM0010, Gemcitabine/carboplatin (Arm J) | |||||||||||||||
| Pidilizumab (CT-011) | 2 | NA | Suspended | PC | Adjuvant | Resectable | 29 | 3 mg/kg | Safety | Pidilizumab, Gemcitabine | NA | NA | NA | NCT01313416 | |
| Efficacy (Median DFS) | |||||||||||||||
| 1 | Non-randomized | Withdrawn | PC, OC, BC, CC, Sarcoma | Palliative | NA | 0 | DE | Safety | Pidilizumab, p53 Vaccine | NA | NA | NA | NCT01386502 | ||
| Efficacy |
AE: Adverse event; NA: Not available.