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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02713529




Registration number
NCT02713529
Ethics application status
Date submitted
3/03/2016
Date registered
18/03/2016
Date last updated
16/10/2018

Titles & IDs
Public title
Safety and Efficacy Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor Cancer
Scientific title
A Phase1b/2 Study Assessing Safety and Anti-tumor Activity of AMG 820 in Combination With Pembrolizumab in Select Advanced Solid Tumors
Secondary ID [1] 0 0
MASTERKEY
Secondary ID [2] 0 0
20150195
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Colorectal Cancer 0 0
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - AMG820 and pembrolizumab

Experimental: AMG820 and pembrolizumab - Treatment with AMG820 and pembrolizumab


Other interventions: AMG820 and pembrolizumab
Treatment with AMG820 and pembrolizumab

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment related adverse events as assessed by CTCAE version 4.0
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Objective response rate of tumors using irRECIST criteria for total measureable tumor burden - 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).
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Number of participants with treatment emergent adverse events as assessed by CTCAE version 4.0
Timepoint [3] 0 0
12 months
Secondary outcome [1] 0 0
Objective response rate of tumors using RECIST 1.1 criteria for total measurable tumor burden - Analyze CT/MRI scans using defined criteria for bidimensional measurements of index lesions.
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Maximum observed concentration [Cmax] of AMG820 - Analyze serum concentration of AMG 820 after intravenous infusion administration of AMG 820 in combination with pembrolizumab.
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
CD4, CD8, and CD68 cell numbers in pre-treatment tumor biopsy tissue
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Minimum observed concentration [Cmin] of AMG 820 - Analyze serum concentration of AMG 820 after intravenous infusion administration of AMG 820 in combination with pembrolizumab.
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Area Under the Curve [AUC] of AMG820 - Analyze serum concentration of AMG 820 after intravenous infusion administration of AMG 820 in combination with pembrolizumab.
Timepoint [5] 0 0
12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
South Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Belgium
State/province [8] 0 0
Wilrijk
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Germany
State/province [10] 0 0
Heidelberg
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A multi-center Phase 1b/2 study testing the combination of AMG 820 and pembrolizumab in
subjects with select advanced solid tumors.
Trial website
https://clinicaltrials.gov/show/NCT02713529
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications