Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer
This study is currently recruiting participants.
Verified June 2017 by Amgen
Sponsor:
Amgen
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
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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:
Genetics Home Reference related topics:
lung cancer
Drug Information available for:
Pembrolizumab
U.S. FDA Resources
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
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


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