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Clinical Trials/EUCTR2016-001080-36-ES
EUCTR2016-001080-36-ES
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 15, 2016
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ConditionsAdvanced 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]
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 15, 2016
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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
  • •\- Evidence of active non\-infectious pneumonitis/interstitial lung disease
  • •\- Evidence of other active autoimmune disease or significant immunosuppression that has required prolonged systemic treatment in past 2 years.
  • •\- 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

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