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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Amgen
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02713529
First received: March 3, 2016
Last updated: June 19, 2017
Last verified: June 2017
  Purpose
A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in subjects with select advanced solid tumors.

Condition Intervention Phase
Pancreatic Cancer Colorectal Cancer Non-Small Cell Lung Cancer Biological: AMG820 and pembrolizumab Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase1b/2 Study Assessing Safety and Anti-tumor Activity of AMG 820 in Combination With Pembrolizumab in Select Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Number of participants with treatment related adverse events as assessed by CTCAE version 4.0 [ Time Frame: 12 months ]
  • Objective response rate of tumors using irRECIST criteria for total measureable tumor burden [ Time Frame: 12 months ]
    Analyze CT/MRI scans using a modified criteria (irRECIST) adapting the immune-related response criteria to conventional RECIST 1.1 (irRECIST accounts for index and measureable lesions in total tumor burden).

  • Number of participants with treatment emergent adverse events as assessed by CTCAE version 4.0 [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Objective response rate of tumors using RECIST 1.1 criteria for total measurable tumor burden [ Time Frame: 12 months ]
    Analyze CT/MRI scans using defined criteria for bidimensional measurements of index lesions.

  • Maximum observed concentration [Cmax] of AMG820 [ Time Frame: 12 months ]
    Analyze serum concentration of AMG 820 after intravenous infusion administration of AMG 820 in combination with pembrolizumab.

  • CD4, CD8, and CD68 cell numbers in pre-treatment tumor biopsy tissue [ Time Frame: 12 months ]
  • Minimum observed concentration [Cmin] of AMG 820 [ Time Frame: 12 months ]
    Analyze serum concentration of AMG 820 after intravenous infusion administration of AMG 820 in combination with pembrolizumab.

  • Area Under the Curve [AUC] of AMG820 [ Time Frame: 12 months ]
    Analyze serum concentration of AMG 820 after intravenous infusion administration of AMG 820 in combination with pembrolizumab.


Estimated Enrollment: 197
Actual Study Start Date: April 14, 2016
Estimated Study Completion Date: April 19, 2019
Estimated Primary Completion Date: March 18, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG820 and pembrolizumab
Treatment with AMG820 and pembrolizumab
Biological: AMG820 and pembrolizumab
Treatment with AMG820 and pembrolizumab

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02713529

Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States, 30332
United States, Michigan
Research Site Recruiting
Grand Rapids, Michigan, United States, 49503
United States, New York
Research Site Recruiting
New York, New York, United States, 10021
United States, Pennsylvania
Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Research Site Recruiting
Greenville, South Carolina, United States, 29605
United States, Texas
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Australia, New South Wales
Research Site Recruiting
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Research Site Recruiting
Parkville, Victoria, Australia, 3050
Belgium
Research Site Recruiting
Wilrijk, Belgium, 2610
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Spain
Research Site Recruiting
Madrid, Spain, 28040
Research Site Recruiting
Madrid, Spain, 28050
Sponsors and Collaborators
Amgen
Merck Sharp & Dohme Corp.
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02713529     History of Changes
Other Study ID Numbers: 20150195
MASTERKEY ( Other Identifier: Amgen )
Study First Received: March 3, 2016
Last Updated: June 19, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:
Solid Tumor
Pancreatic Cancer
Colorectal Cancer
Non-Small Cell Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Pancreatic Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Pembrolizumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 17, 2017