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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02713529
Ethics application status
Date submitted
3/03/2016
Date registered
18/03/2016
Date last updated
20/01/2023

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
Treatment: Other - AMG820 and pembrolizumab

Experimental: AMG820 and pembrolizumab - Treatment with AMG820 and pembrolizumab


Treatment: Other: AMG820 and pembrolizumab
Treatment with AMG820 and pembrolizumab
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants With Dose Limiting Toxicities (DLT)
Timepoint [1] 0 0
The DLT evaluation period was Day 1 to Day 21
Primary outcome [2] 0 0
Participants With Treatment -Emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2
Primary outcome [3] 0 0
Participants With Treatment -Emergent Adverse Events (TEAEs) Related to AMG 820 Treatment
Timepoint [3] 0 0
Day 1 up to 207 days for Part 1; Day 1 up to 572 days for Part 2
Primary outcome [4] 0 0
Participants With Treatment -Emergent Adverse Events (TEAEs) Related to Pembrolizumab Treatment
Timepoint [4] 0 0
Day 1 up to 207 days for Part 1 and Day 1 up to 572 days for Part 2
Primary outcome [5] 0 0
Objective Response Rate (ORR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST)
Timepoint [5] 0 0
Baseline: Day -28; Treatment: up to Month 13.7
Secondary outcome [1] 0 0
Time to Response (TTR) Per Immune-Related Response Evaluation Criteria in Solid Tumors (irRECIST) For Participants Who Responded
Timepoint [1] 0 0
Day 1 up to Month 16 (max time to censoring)
Secondary outcome [2] 0 0
Time to Progression (TTP) for Participants Who Had Progressive Disease
Timepoint [2] 0 0
Day 1 up to 14.4 months (max time to censoring)
Secondary outcome [3] 0 0
Kaplan-Meier Estimates for Overall Survival (OS) at Month 6 and Month 12
Timepoint [3] 0 0
Day 1 up to Month 6 or Month 12
Secondary outcome [4] 0 0
Kaplan-Meier Estimates for Progression-Free Survival (PFS) as Per irRECIST at Month 6 and Month 12
Timepoint [4] 0 0
Day 1 up to Month 6 or Month 12
Secondary outcome [5] 0 0
AMG 820 Pharmacokinetic Parameter by Dose Group: Time of Maximum Observed Concentration (Tmax) During Treatment Cycles 1 + 2
Timepoint [5] 0 0
Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36
Secondary outcome [6] 0 0
AMG 820 Pharmacokinetic Parameter by Dose Group: Maximum Observed Drug Concentration (Cmax) During Treatment Cycles 1 + 2
Timepoint [6] 0 0
Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36
Secondary outcome [7] 0 0
AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Last (AUClast) During Treatment Cycles 1 + 2
Timepoint [7] 0 0
Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36
Secondary outcome [8] 0 0
AMG 820 Pharmacokinetic Parameter by Dose Group: Area Under the Curve Over the Dose Interval (AUCtau) During Treatment Cycles 1 + 2
Timepoint [8] 0 0
Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36
Secondary outcome [9] 0 0
AMG 820 Pharmacokinetic Parameter by Dose Group: Minimum Observed Drug Concentration (Cmin) During Treatment Cycles 1 + 2
Timepoint [9] 0 0
Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36
Secondary outcome [10] 0 0
AMG 820 Pharmacokinetic Parameter by Dose Group: Terminal Elimination Half-life (t1/2z) During Treatment Cycles 1 + 2
Timepoint [10] 0 0
Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36
Secondary outcome [11] 0 0
AMG 820 Pharmacokinetic Parameter by Dose Group: Volume of Distribution (Vz) During Treatment Cycles 1 + 2
Timepoint [11] 0 0
Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36
Secondary outcome [12] 0 0
AMG 820 Pharmacokinetic Parameter by Dose Group: Drug Clearance (CL) During Treatment Cycles 1 + 2
Timepoint [12] 0 0
Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36
Secondary outcome [13] 0 0
AMG 820 Pharmacokinetic Parameter by Dose Group: Accumulation Ratio (AR)
Timepoint [13] 0 0
Cycle 1, Study Day 1: pre-infusion, at end of infusion, hours 1, 6 and 24 post infusion, Days 5, 8 and 15. Cycle 2, Study Day 22: pre-infusion, at end of infusion, hours 1, 6, 24 post infusion, Days 26, 29 and 36

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 within 3 months prior to enrollment, when feasible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/05/2019
Sample size
Target
Accrual to date
Final
117
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
AmMax Bio, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02713529