RELEVENT
Efficacy and safety of ramucirumab plus carboplatin and paclitaxel in untreated metastatic thymic carcinoma: RELEVENT phase II trial (NCT03921671)
Phase 2N = 35NCT03921671
- Population
- Treatment-naive advanced thymic carcinoma; median age 60.8 years, 71.4% male, 85.7% Masaoka-Koga stage IVB, ECOG performance status 0 in 68.5% and 1 in 31.4%.
- Design
- Single-arm phase II trial within the Italian TYME network (the design paper describes it as multicentre, open-label and single-arm), November 2018 to June 2023: 52 patients screened, 35 enrolled. Ramucirumab, carboplatin and paclitaxel for six cycles, then ramucirumab maintenance until progression or intolerable toxicity. Primary endpoint: objective response rate by RECIST v1.1 as assessed by the investigator. Secondary endpoints: progression-free survival, overall survival and safety. Centralised radiological review was also carried out.
- Primary endpoint
- ORR
- Arms
- Ramucirumab with carboplatin and paclitaxel (experimental, n = 35): Ramucirumab, carboplatin and paclitaxel for six cycles, then ramucirumab maintenance until progression or intolerable toxicity
- People
- Proto C, Italian TYME network
Show the numbers
| Endpoint | Analysis | Ramucirumab with carboplatin and paclitaxel | Control | Effect |
|---|---|---|---|---|
| ORR35 enrolled patients (investigator assessment) | primarymedian follow-up 31.6 monthsProto 2024 | 80% (63.1–91.6%) | — | The analysis was carried out some months after an interim analysis that was earlier than expected. Treatment-related adverse events occurred in 32 of 35 patients (91.4%), grade 3 or worse in 48.6%. |
| ORR33 of 35 patients assessable at centralised radiological review | primaryProto 2024 | 57.6% (39.2–74.5%) | — | The central review covered 33 of the 35 patients. |
| PFS35 enrolled patients | primarymedian follow-up 31.6 monthsProto 2024 | median 18.1 months (10.8–52.3) | — | — |
| OS35 enrolled patients | primarymedian follow-up 31.6 monthsProto 2024 | median 43.8 months | — | The printed 95% confidence interval is 31.9 months to not reached, so no interval is entered. |
| Endpoint | Analysis | Ramucirumab with carboplatin and paclitaxel | Control | Effect |
|---|---|---|---|---|
| ORR35 enrolled patients (investigator assessment) | primarymedian follow-up 31.6 monthsProto 2024 | 80% (63.1–91.6%) | — | The analysis was carried out some months after an interim analysis that was earlier than expected. Treatment-related adverse events occurred in 32 of 35 patients (91.4%), grade 3 or worse in 48.6%. |
| ORR33 of 35 patients assessable at centralised radiological review | primaryProto 2024 | 57.6% (39.2–74.5%) | — | The central review covered 33 of the 35 patients. |
| PFS35 enrolled patients | primarymedian follow-up 31.6 monthsProto 2024 | median 18.1 months (10.8–52.3) | — | — |
| OS35 enrolled patients | primarymedian follow-up 31.6 monthsProto 2024 | median 43.8 months | — | The printed 95% confidence interval is 31.9 months to not reached, so no interval is entered. |
- Ramucirumab with carboplatin and paclitaxel (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Ramucirumab with carboplatin and paclitaxel |
|---|---|
| 0 | 100.0% |
| 11 | 65.6% |
| 23 | 41.4% |
| 34 | 27.2% |
| 45 | 17.8% |
- Ramucirumab with carboplatin and paclitaxel (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Ramucirumab with carboplatin and paclitaxel |
|---|---|
| 0 | 100.0% |
| 27 | 65.2% |
| 55 | 41.9% |
| 82 | 27.3% |
| 110 | 17.5% |