JAVELIN Ovarian 100
Chemotherapy with or without avelumab followed by avelumab maintenance versus chemotherapy alone in patients with previously untreated epithelial ovarian cancer (JAVELIN Ovarian 100): an open-label, randomised, phase 3 trial
Phase 3N = 998NCT02718417
- Population
- Women with previously untreated stage III-IV epithelial ovarian, fallopian tube or peritoneal cancer
- Design
- Global, open-label, three-arm randomised phase 3 trial at 159 hospitals and cancer treatment centres in 25 countries. Women aged 18 or older with stage III-IV epithelial ovarian, fallopian tube or peritoneal cancer (after debulking surgery, or candidates for neoadjuvant chemotherapy), ECOG performance status 0 or 1, were randomly assigned 1:1:1 to chemotherapy (six cycles of carboplatin AUC 5 or 6 every 3 weeks plus paclitaxel 175 mg/m2 every 3 weeks or 80 mg/m2 weekly) followed by avelumab maintenance 10 mg/kg every 2 weeks; chemotherapy plus avelumab 10 mg/kg every 3 weeks followed by avelumab maintenance; or chemotherapy followed by observation. Primary endpoint PFS assessed by blinded independent central review in all randomly assigned patients. 998 patients were randomised; at the planned interim analysis (data cutoff 7 September 2018) prespecified futility boundaries for PFS were crossed and the trial was stopped.
- Primary endpoint
- PFS
- Arms
- Chemotherapy followed by observation (control, n = 335): Six cycles of carboplatin AUC 5 or 6 plus paclitaxel 175 mg/m2 every 3 weeks or 80 mg/m2 weekly, then observation
- Chemotherapy followed by avelumab maintenance (experimental, n = 332): The same chemotherapy followed by avelumab 10 mg/kg every 2 weeks as maintenance
- Chemotherapy plus avelumab followed by avelumab maintenance (experimental, n = 331): The same chemotherapy plus avelumab 10 mg/kg every 3 weeks, followed by avelumab maintenance
- People
- Monk BJ
PFSHR 1.43 (95% CI 1.05–1.95)PFSHR 1.14 (95% CI 0.83–1.56)
Show the numbers
| Endpoint | Analysis | Chemotherapy followed by avelumab maintenance / Chemotherapy plus avelumab followed by avelumab maintenance | Chemotherapy followed by observation | Effect |
|---|---|---|---|---|
| PFS | interimmedian follow-up 10.8 monthsMonk 2021 | median 16.8 months | — | HR 1.43 (95% CI 1.05–1.95)P=0.99 (one-sided)Planned interim analysis at which the futility boundary was crossed. The control median was 'not estimable' (95% CI 18.2 to not estimable) and cannot be entered as a number; the avelumab maintenance 95% CI upper bound is also not estimable. Blinded independent central review. |
| PFS | interimmedian follow-up 10.8 monthsMonk 2021 | median 18.1 months | — | HR 1.14 (95% CI 0.83–1.56)P=0.79 (one-sided)Planned interim analysis at which the futility boundary was crossed. The control median was 'not estimable' and cannot be entered as a number; the avelumab combination 95% CI upper bound is also not estimable. Blinded independent central review. |
| Endpoint | Analysis | Chemotherapy followed by avelumab maintenance / Chemotherapy plus avelumab followed by avelumab maintenance | Chemotherapy followed by observation | Effect |
|---|---|---|---|---|
| PFS | interimmedian follow-up 10.8 monthsMonk 2021 | median 16.8 months | — | HR 1.43 (95% CI 1.05–1.95)P=0.99 (one-sided)Planned interim analysis at which the futility boundary was crossed. The control median was 'not estimable' (95% CI 18.2 to not estimable) and cannot be entered as a number; the avelumab maintenance 95% CI upper bound is also not estimable. Blinded independent central review. |
| PFS | interimmedian follow-up 10.8 monthsMonk 2021 | median 18.1 months | — | HR 1.14 (95% CI 0.83–1.56)P=0.79 (one-sided)Planned interim analysis at which the futility boundary was crossed. The control median was 'not estimable' and cannot be entered as a number; the avelumab combination 95% CI upper bound is also not estimable. Blinded independent central review. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| PFS | 1.43 | 1.05–1.95 |
| PFS | 1.14 | 0.83–1.56 |
- Chemotherapy followed by avelumab maintenance (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Chemotherapy followed by avelumab maintenance |
|---|---|
| 0 | 100.0% |
| 11 | 63.5% |
| 21 | 42.0% |
| 32 | 26.7% |
| 42 | 17.7% |
- Chemotherapy plus avelumab followed by avelumab maintenance (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Chemotherapy plus avelumab followed by avelumab maintenance |
|---|---|
| 0 | 100.0% |
| 11 | 65.6% |
| 23 | 41.4% |
| 34 | 27.2% |
| 45 | 17.8% |
Appears in
Sources
Monk BJ, Colombo N, Oza AM, Fujiwara K, Birrer MJ, Randall L, et al. Chemotherapy with or without avelumab followed by avelumab maintenance versus chemotherapy alone in patients with previously untreated epithelial ovarian cancer (JAVELIN Ovarian 100): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021;22(9):1275-1289.