Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2016-001080-36-BE
EUCTR2016-001080-36-BE
Active, not recruiting
Phase 1

A Phase 1b/2 Study Assessing Safety and Anti-tumor Activity of AMG 820 in Combination With Pembrolizumab in Select Advanced Solid Tumors

Amgen Incorporated0 sites197 target enrollmentNovember 4, 2016
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsAdvanced Colorectal cancer (CRC), pancreatic cancer or non-small cell lung cancer (NSCLC), and other indications dependent on emerging dataMedDRA version: 20.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10049280 Term: Solid tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10033604Therapeutic area: Diseases [C] - Cancer [C04]
DrugsKeytruda

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Advanced Colorectal cancer (CRC), pancreatic cancer or non-small cell lung cancer (NSCLC), and other indications dependent on emerging data
Sponsor
Amgen Incorporated
Enrollment
197
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 4, 2016
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Amgen Incorporated

Eligibility 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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 150
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •\- Has known active central nervous system metastases
  • •\- History of other malignancy with the past 2 years with some exceptions
  • •\- Subject has history of interstitial lung disease, (non\-infectious) pneumonitis that required steroids, or current pneumonitis.
  • •\- History or evidence of other active autoimmune diseases that has required prolonged systemic treatment in past 2 years (ie, with use of disease modifying agents such as corticosteroids or immunosuppressive drugs).
  • •\- 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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
Safety Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor CancerAdvanced Colorectal cancer (CRC), pancreatic cancer or non-small cell lung cancer (NSCLC), and other indications dependent on emerging dataMedDRA version: 20.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10049280 Term: Solid tumour System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10033605 Term: Pancreatic cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: LLT Classification code 10033604Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2016-001080-36-DEAmgen Incorporated197
Active, not recruiting
Phase 1
Safety Study of AMG 820 and Pembrolizumab Combination in Select Advanced Solid Tumor CancerAdvanced Colorectal cancer (CRC), pancreatic cancer or non-small cell lung cancer (NSCLC), and other indications dependent on emerging dataMedDRA version: 19.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2016-001080-36-ESAmgen Incorporated197
Active, not recruiting
Phase 1
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumorslocally advanced (primary or recurrent) or metastatic solid tumors with a pathogenic or likely pathogenic germline or loss-of-function somatic BRCA1, or BRCA2, or ATM gene defectMedDRA version: 20.0 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2018-000345-39-NLPfizer Inc., 235 East 42nd Street, New York, NY 10017541
Completed
Phase 2
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumors
NL-OMON48840Pfizer22
Active, not recruiting
Phase 1
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumorslocally advanced (primary or recurrent) or metastatic solid tumors with a pathogenic or likely pathogenic germline or loss-of-function somatic BRCA1, or BRCA2, or ATM gene defectMedDRA version: 20.0Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2018-000345-39-FRPfizer Inc., 235 East 42nd Street, New York, NY 10017541