KEYNOTE-087
A Phase II Clinical Trial of MK-3475 (Pembrolizumab) in Subjects With Relapsed or Refractory (R/R) Classical Hodgkin Lymphoma (cHL)
Phase 2N = 210NCT02453594
- Population
- Relapsed or refractory classic Hodgkin lymphoma; 210 patients enrolled and treated.
- Design
- Single-arm phase 2 study of pembrolizumab 200 mg once every 3 weeks in three cohorts: progression after autologous stem cell transplantation and subsequent brentuximab vedotin (cohort 1, n=69); salvage chemotherapy and brentuximab vedotin and ineligible for transplantation because of chemoresistant disease (cohort 2, n=81); transplantation without brentuximab vedotin after transplant (cohort 3, n=60). Response assessed every 12 weeks. Primary endpoints: ORR by central review and safety.
- Primary endpoint
- ORR
- Arms
- Pembrolizumab (experimental, n = 210): Pembrolizumab 200 mg once every 3 weeks
- People
- Chen R
Show the numbers
| Endpoint | Analysis | Pembrolizumab | Control | Effect |
|---|---|---|---|---|
| ORRAll enrolled and treated patients (210) | primaryChen 2017 | 69% (62.3–75.2%) | — | Per central review. ORR by cohort: 73.9% (cohort 1), 64.2% (cohort 2) and 70.0% (cohort 3). |
| CR rateAll enrolled and treated patients (210) | primaryChen 2017 | 22.4% (16.9–28.6%) | — | Per central review. |
| Endpoint | Analysis | Pembrolizumab | Control | Effect |
|---|---|---|---|---|
| ORRAll enrolled and treated patients (210) | primaryChen 2017 | 69% (62.3–75.2%) | — | Per central review. ORR by cohort: 73.9% (cohort 1), 64.2% (cohort 2) and 70.0% (cohort 3). |
| CR rateAll enrolled and treated patients (210) | primaryChen 2017 | 22.4% (16.9–28.6%) | — | Per central review. |