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

AmMax Bio

Status and phase

Completed

Phase 2

Phase 1

Conditions

Non-Small Cell Lung Cancer

Colorectal Cancer

Pancreatic Cancer

Treatments

Biological: AMG820 and pembrolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02713529

20150195

MASTERKEY (Other Identifier)

2016-001080-36 (EudraCT Number)

KEYNOTE-347 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment

117 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 within 3 months prior to enrollment, when feasible.

Exclusion criteria

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.