Table 4.
Ongoing (until January 2020) clinical trials ipilimumab plus nivolumab in SCLC.
| Estimated time | Enrollment | Trial Phase | Primary Endpoints | Treatment Arms | Clinical Trial Identifier |
|---|---|---|---|---|---|
| 2017–2022 | 21 participants | Phase 1/2 | PFS (Time Frame: 6 months) | Thoracic Radiation Therapy (3Gy × 10 fractions) for 10 days Ipilimumab 3 mg/kg (90 min IV infusion) every 3 weeks plus Nivolumab 1 mg/kg (30 min IV infusion) will be administered every 3 weeks |
NCT03043599 |
| 2018–2021 | 41 participants | Phase 2 | Disease Control Rate (DCR) (TimeFrame: up to 3 years) | Combination immunotherapy with Ipilimumab and Nivolumab plus a Dendritic Cell-based p53 Vaccine (Ad.p53-DC) | NCT03406715 |
| 2014–2022 | 264 participants | Phase 2 | The OS and PFS rates (at a maximum of 6,5 years) | Induction: Nivolumab at a dose of 1 mg/kg i.v. followed (on the same day) by Ipilimumab at a dose of 3 mg/kg i.v. once every 3 weeks, 4 cycles Maintenance: Nivolumab 240 mg i.v. once every 2 weeks, for a maximum of 12 months from the start of maintenance |
NCT02046733 |
| 2018–2022 | 55 participants | Phase 1/2 | Phase I: Maximum tolerated dose (MTD) (Time Frame: 9 Months) Phase II: PFS (Time Frame: 36 Months) |
Phase I: nivolumab, ipilimumab, and plinabulin Phase II Arm A: nivolumab and ipilimumab Phase II Arm B: nivolumab, ipilimumab, and plinabulin |
NCT03575793 |