Table 1.
Selected Clinical Trials investigating Immunotherapy in MPM.
| Name | Trial ID | IO Agent | Phase | No. pts | Treatment Arms | Result/ Status |
Endpoint |
|---|---|---|---|---|---|---|---|
| Relapsed/Recurrent MPM | |||||||
| MESOT-TREM-2008 [18] | NCT01649024. | Tremelimumab | II | 25 | Tremelimumab (15 mg/kg every 90 days) |
Negative | ORR |
| MESOT-TREM-2008 [19] | NCT01655888. | Tremelimumab | II | 29 | Tremelimumab (10 mg/kg every 4 weeks) |
Negative | ORR |
| DETERMINE [20] | NCT01843374. | Tremelimumab | IIB | 571 | Temelimumab (10 mg/kg) vs. placebo | Negative | OS |
| KEYNOTE-028 [21] | NCT02054806 | Pembrolizumab | I | 25 | Pembrolizumab (10 mg/kg q14) |
/ | ORR |
| KEYNOTE-158 [22] |
NCT02628067 | Pembrolizumab | II | 118 | Pembrolizumab 200 mg q21 up to 35 cycles | Negative | ORR |
| PROMISE-Meso [23] | NCT02991482 | Pembrolizumab | III | 114 | Pembrolizumab vs. CHT | Negative | PFS |
| JAVELIN Solid Tumor [24] | NCT01772004 | Avelumab | IB | 53 | Avelumab (10 mg/kg q14) | Negative | ORR |
| NivoMes [25] | NCT02497508 | Nivolumab | II | 38 | Nivolumab (3 mg/kg q14) | Positive | DCR |
| MERIT [26] | JapicCTI163247 | Nivolumab | II | 34 | Nivolumab (3 mg/kg q14) | Positive | ORR |
| CONFIRM [27] | NCT03048474 | Nivolumab | III | 332 | Nivolumab (240 mg q14) | Positive | PFS/OS |
| NCT03075527 [28] | NCT03075527 | Tremelimumab + Durvalumab | II | 19 | Trem + Durv (4 Cycles) − Durv |
Negative | ORR |
| NIBIT-Meso-1 [29] | NCT02588131 | Tremelimumab + Durvalumab | II | 40 | Trem + Durv (4 Cycles) − Durv |
Positive | ORR |
| MAPS2/IFCT1501 [30] | NCT02716272 | Ipilimumab + Nivolumab | II | 125 | Nivolumab +/− Ipilimumab | Positive | 12W DCR |
| INITIATE [31] | NCT03048474 | Ipilimumab + Nivolumab | II | 35 | Nivolumab + Ipilimumab | Positive | 12W DCR |
| Upfront treatment | |||||||
| Checkmate 743 [32] | NCT02899299 | Ipilimumab + Nivolumab |
III | 92 | CDDP + PEM vs. IPI + NIVO | Positive | OS |
| IND-227 | NCT02784171 | Pembrolizumab | II-III | 520 | CDDP + PEM +/− PEMBRO | Active, not recruiting | PFS/OS |
| PrE505 [33] | NCT02899195 | Durvalumab | II | 55 | CDDP + PEM + DURVA | Positive | OS |
| DREAM [34] | ACTRN 12616001170415 |
Durvalumab | II | 54 | CDDP + PEM + DURVA | Positive | PFS |
| DREAM3R | NCT04334759 | Durvalumab | III | 480 | CDDP + PEM +/− DURVA | Recruiting | OS |
| ETOP BEAT-meso trial | NCT03762018 | Atezolizumab | III | 320 | CBDCA + PEM + BEVA +/− ATEZO |
Recruiting | PFS, OS |
List of abbreviations: Trem = Tremelimumab; Durva: Durvalumab; IPI = ipilimumab; NIVO = Nivoliumab; PEMBRO = pembrolizumab; CDDP = cisplatino; PEM = pemetrexed; ATEZO = atezolizumab; ORR = objective response rate; DCR = disease control rate; 12W DCR = disease control rate at 12 weeks; PFS = progression-free survival; OS = overall survival.