Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-31 @ 11:45 PM
Study NCT ID:
NCT02331251
Status:
TERMINATED
Last Update Posted:
2018-07-02
First Post:
2015-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus)
Sponsor:
Western Regional Medical Center
Organization:
Study Overview
Official Title:
A Phase Ib/II Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus)
Status:
TERMINATED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI not longer at site.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: