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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02713529
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Amgen

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Actual Study Start Date : April 14, 2016
Actual Primary Completion Date : January 2, 2019
Actual Study Completion Date : May 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AMG820 and pembrolizumab
Treatment with AMG820 and pembrolizumab
Biological: AMG820 and pembrolizumab
Treatment with AMG820 and pembrolizumab




Primary Outcome Measures :
  1. Number of participants with treatment related adverse events as assessed by CTCAE version 4.0 [ Time Frame: 12 months ]
  2. 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).

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

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. CD4, CD8, and CD68 cell numbers in pre-treatment tumor biopsy tissue [ Time Frame: 12 months ]
  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713529


Locations
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United States, Georgia
Research Site
Atlanta, Georgia, United States, 30332
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02114
Research Site
Boston, Massachusetts, United States, 02215
United States, Michigan
Research Site
Grand Rapids, Michigan, United States, 49546
United States, New York
Research Site
New York, New York, United States, 10021
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
Research Site
Greenville, South Carolina, United States, 29605
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Australia, New South Wales
Research Site
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Research Site
Parkville, Victoria, Australia, 3050
Belgium
Research Site
Wilrijk, Belgium, 2610
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Germany
Research Site
Heidelberg, Germany, 69120
Spain
Research Site
Madrid, Spain, 28040
Research Site
Madrid, Spain, 28050
Sponsors and Collaborators
Amgen
Merck Sharp & Dohme Corp.
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02713529     History of Changes
Other Study ID Numbers: 20150195
MASTERKEY ( Other Identifier: Amgen )
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

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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:
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Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Pancreatic Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
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, Immunological
Antineoplastic Agents