Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer



Status:Active, not recruiting
Conditions:Lung Cancer, Colorectal Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/18/2018
Start Date:April 14, 2016
End Date:May 19, 2020

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A Phase1b/2 Study Assessing Safety and Anti-tumor Activity of AMG 820 in Combination With Pembrolizumab in Select Advanced Solid Tumors

A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in
subjects with select advanced solid tumors.

Phase 1b is AMG 820 dose determining and aimed at assessing the safety and tolerability of
the selected starting dose of AMG 820 in combination with pembrolizumab. Phase 2 of the study
will further evaluate safety and tolerability and additionally test whether AMG 820 can
enhance the anti-tumor activity observed historically with pembrolizumab alone and/or
overcome lack of response to pembrolizumab monotherapy in subjects with select solid tumors.

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.

Exclusion Criteria:

- Has known active central nervous system metastases

- 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 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.
We found this trial at
8
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Atlanta, GA
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Boston, MA
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Camperdown,
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Grand Rapids, MI
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Greenville, South Carolina 29605
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Greenville, SC
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Philadelphia, PA
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San Antonio, TX
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