NCT02331251

Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus)

A Phase Ib/II Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Western Regional Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks.

Conditions

• Advanced Cancer
• Breast Cancer
• Sarcoma
• Pancreatic Cancer
• Small Cell Lung Cancer
• Ovarian

Interventions

Type	Name	Description
DRUG	Pembrolizumab
DRUG	Gemcitabine
DRUG	Docetaxel
DRUG	Nab-paclitaxel
DRUG	Vinorelbine
DRUG	Irinotecan
DRUG	Liposomal Doxorubicin

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2015-01-06
• Last updated: 2018-07-02

Locations

2 sites across 1 country: United States