Clinical Trials Directory

Trials / Terminated

TerminatedNCT02318901

Pembrolizumab and Monoclonal Antibody Therapy in Advanced Cancer

A Phase Ib/II Study of Pembrolizumab and Monoclonal Antibody Therapy in Patients With Advanced Cancer (PembroMab

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

Summary

There will be two phase II cohorts for pembro plus trastuzumab: one cohort will be for patients with unresectable HER2 overexpressing gastric or GEJ cancers, the other cohort will be for patients with HER2 overexpressing metastatic breast cancer (MBC). The pembro plus ado-trastuzumab emtansine phase II arm will be for patients with HER2 overexpressing MBC. There will be two phase II cohorts for pembro plus cetuximab: one cohort will be for patients with HNSCC, the other cohort will be for patients with K-ras, B-raf, N-ras wildtype metastatic CRC.

Detailed description

Pembrolizumab 2mg/kg administered intravenously over 30 minutes every 3 weeks. Pembrolizumab will be infused prior to the start of the assigned monoclonal antibody (Mab) arm. . Dosing for the Mab arms will begin as follows: Arm 1: Cycle length is 21 days. Intravenous (i.v.) trastuzumab 6 mg/kg on day 1 every 21 days. Arm 2: Cycle length is 21 days. i.v. ado-trastuzumab emtansine 3.6 mg/kg on day 1 every 21 days. Arm 3: Cycle length is 21 days. i.v. cetuximab 400 mg/m2 on cycle 1 day 1, then i.v. cetuximab 250 mg/m2 on day 8. Each subsequent cycle will be i.v. cetuximab 250 mg/m2 on days 1 and 8 every 21 days.

Conditions

Interventions

TypeNameDescription
DRUGPembrolizumab
DRUGTrastuzumab
DRUGado-trastuzumab emtansine
DRUGCetuximab

Timeline

Start date
2014-10-01
Primary completion
2018-08-01
Completion
2018-08-01
First posted
2014-12-17
Last updated
2019-10-21
Results posted
2018-11-02

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02318901. Inclusion in this directory is not an endorsement.