Advanced Colorectal cancer (CRC), pancreatic cancer or non-small cell lung cancer (NSCLC), and other indications dependent on emerging data MedDRA version: 20.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Cla
Conditions
Interventions
Product Code: AMG-820
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Keytruda
Product Name: pembrolizumab
Pharm
Sponsors
Amgen Incorporated
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Pathologically documented, advanced colorectal, pancreatic or non-small cell lung cancer that is refractory to standard treatment, or the subjects have been intolerant to or refuse standard treatment. - Measurable disease per RECIST 1.1 guidelines. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 - Adequate hematologic, renal, and hepatic function determined by laboratory blood and urine tests. - Availability of recent tumor tissue with 3 months prior to enrollment, when feasible. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 47
Exclusion criteria
Exclusion criteria: - Has known active central nervous system metastases - History of other malignancy with the past 2 years with some exceptions - Subject has history of interstitial lung disease, (non-infectious) pneumonitis that required steroids, or current pneumonitis. - History or evidence of other active autoimmune diseases that has required prolonged systemic treatment in past 2 years (ie, with use of disease modifying agents such as corticosteroids or immunosuppressive drugs). - Prior chemotherapy, radiotherapy, biological cancer therapy or major surgery within 28 days prior to enrollment - Currently participating or has participated in a study (treatment period only) of an investigational agent or used an investigational device within 28 days of enrollment - Received live vaccine within 28 days prior to enrollment - Adverse event due to cancer therapy administered more than 28 days prior to enrollment that has not recovered to CTCAE grade 1 or better. - Positive for human immunodeficiency virus (HIV), Hepatitis B or C - Women planning to become pregnant or who are lactating/breastfeeding while on study through 4 months after receiving the last dose of study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the safety and tolerability of AMG 820 administered in combination with pembrolizumab in subjects with select advanced solid tumors Evaluate the objective response rate (ORR) of AMG 820 and pembrolizumab combination as per irRECIST in subjects with select advanced solid tumors ; Secondary Objective: Evaluate the anti-tumor activity of AMG 820 and pembrolizumab combination in select advanced solid tumors by assessing - ORR per RECIST1.1 - time to response (TTR), duration of response (DOR), and time to progression (TTP) - progression free survival (PFS) and overall survival (OS) at 6 and 12 months Characterize the pharmacokinetics (PK) of AMG 820 after intravenous (IV) infusion administration of AMG 820 in combination with pembrolizumab Evaluate the relationship between the immune infiltrate status in pre-study tumor biopsies vs. clinical response ; Primary end point(s): - Dose limiting toxicities (DLT), treatment-emergent adverse events, treatment-related adverse events and clinically significant changes in vital signs, physical examinations, and clinical laboratory tests - Objective response rate (ORR) per irRECIST in subjects treated at the recommended combination dose ; Timepoint(s) of evaluation of this end point: 1. At 6 months: once the target enrollment is complete and each subject has been treated for at least 6 months or responded or withdrawn from the study, the analysis of the primary endpoints will occur. 2. At 12 months: once the target enrollment is complete and each subject has been treated for at least 12 months or has been followed up for PFS and OS for 12 months or withdrawn from the study, the analysis of primary and secondary endpoints (safety endpoints, ORR, PFS and OS at 6 and 12 months) will occur | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - OR per RECIST 1.1; TTR, DOR and TTP; OS and PFS at 6 and 12 months - PK parameters for AMG 820 including, but not limited to, maximum observed concentration (Cmax) and minimum observed concentration (Cmin). In addition, area under the concentration-time curve (AUC) and, if feasible, half-life (t1/2) for AMG 820. - CD4, CD8 & CD68 cells number in fresh pre-treatment biopsies ; Timepoint(s) of evaluation of this end point: 1. At 6 months: once the target enrollment is complete and each subject has been treated for at least 6 months or responded or withdrawn from the study, the analysis of the primary endpoints will occur. 2. At 12 months: once the target enrollment is complete and each subject has been treated for at least 12 months or has been followed up for PFS and OS for 12 months or withdrawn from the study, the analysis of primary and secondary endpoints (safety endpoints, ORR, PFS and OS at 6 and 12 months) will occur Final Analysis - after all subjects have ended the study | — |
Countries
Australia, Belgium, Canada, Germany, Spain, United States
Contacts
Public ContactMedical Information
Amgen (EUROPE) GmbH
Outcome results
None listed