Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer
Completed · Phase 1/Phase 2
Conditions studied: Pancreatic Cancer, Colorectal Cancer, Non-Small Cell Lung Cancer
In brief
A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in subjects with select advanced solid tumors.
Key facts
- Study ID
- NCT02713529
- Run by
- AmMax Bio, Inc.
- People needed
- 117
- Starts
- 2016-04-14
- Expected to finish
- 2019-05-17
- Last updated by the study team
- 2023-01-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 within 3 months prior to enrollment, when feasible.
You may not qualify if…
- Has known active central nervous system metastases and/or carcinomatous meningitis.
- History of other malignancy with the past 2 years with some exceptions
- Evidence of active non-infectious pneumonitis/interstitial lung disease
- Evidence of other active autoimmune disease that has required prolonged systemic treatment in past 2 years.
- Evidence of clinically significant immunosuppression such as organ or stem cell transplantation, any severe congenital or acquired cellular and/or humoral immune deficiency, concurrent opportunistic infection.
- Receiving systemic immunostimulatory agents within 6 weeks or 5 half-lives, whichever is shorter, prior to first dose of study treatment (except ant PD-1/PD-L1 treatment if recruited into Group 4a or 4b).
- Evidence of active infection within 2 weeks prior to first dose of study treatment.
- 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 Common Terminology Criteria for Adverse Events (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.
Where it is running
- Research Site — Atlanta, Georgia, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Boston, Massachusetts, United States
- Research Site — Grand Rapids, Michigan, United States
- Research Site — New York, New York, United States
- Research Site — Philadelphia, Pennsylvania, United States
- Research Site — Greenville, South Carolina, United States
- South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
- Research Site — Camperdown, New South Wales, Australia
- Research Site — Parkville, Victoria, Australia
- Research Site — Wilrijk, Belgium
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada
- Research Site — Heidelberg, Germany
- Research Site — Madrid, Spain
- Research Site — Madrid, Spain
Full record on ClinicalTrials.gov
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