Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus)
Summary
The Phase Ib and II cohorts will enroll patients with metistatic solid tumors. Phase II only will enroll the following patients: Patients with metastatic sarcoma to be enrolled in the following 4 arms: pembro plus gemcitabine, pembro plus gemcitabine and docetaxel, pembro plus gemcitabine and vinorelbine, and pembro plus liposomal doxorubicin. Patients with metastatic pancreatic adenocarcinoma to be enrolled in the pembro plus gemcitabine and nab-paclitaxel arm. Patients with extensive-stage small cell lung cancer to be enrolled in the pembro plus irinotecan arm. Patients with ER+ breast cancer to be enrolled in the pembro and vinorelbine arm. Patients with ovarian cancer to be enrolled in the pembroplus liposomal doxorubicin arm. Patients with metastatic TNBC (ER/PR/HER2 negative) to be enrolled in the pembro plus gemcitabine arm.
Timeline
- Start
- 2014-12
- Primary completion
- 2018-01
- Completion
- 2018-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 30 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 900 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Irinotecan | Small molecule | 300 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 125 mg/m2 | — |
| Subject | Pembrolizumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Vinorelbine | Small molecule | 25 mg/m2 | — |