Back to resultsAn Expanded Access Program for AM0010 (Pegilodecakin)
Primary Purpose
Melanoma, Prostate Cancer, Ovarian Cancer
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
AM0010
Sponsored by
About this trial
This is an expanded access trial for Melanoma
Eligibility Criteria
- Patient is NOT eligible for other AM0010 clinical trials currently open in the region
- Patient is in urgent need of therapy who fail to meet eligibility criteria for other clinical trials related to AM0010 (PEG-IL-10) can be considered for enrollment into this Expanded Access Program.
- Patient has advanced cancer in indications where preliminary anti-tumor efficacy of AM0010 has been demonstrated or where AM0010 mediated immune activation is likely to benefit the patient.
- Patient has failed or progressed on standard of care (SOC) systemic therapy
- Patient is refusing SOC therapy
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03554434
First Posted
May 31, 2018
Last Updated
February 27, 2020
Sponsor
Eli Lilly and Company
Collaborators
ARMO BioSciences
1. Study Identification
Unique Protocol Identification Number
NCT03554434
Brief Title
An Expanded Access Program for AM0010 (Pegilodecakin)
Official Title
An Expanded Access Program for AM0010 (Pegilodecakin) Subcutaneous Injection
Study Type
Expanded Access
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
ARMO BioSciences
4. Oversight
5. Study Description
Brief Summary
This is an Expanded Access Program (EAP) available to patients who have advanced cancers, who have failed or progressed on standard of care systemic therapy and do not qualify for ongoing clinical trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma, Colorectal Carcinoma, Pancreatic Carcinoma, Non-small Cell Lung Carcinoma, Solid Tumors, Breast Cancer
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
AM0010
Other Intervention Name(s)
LY3500518, Pegilodecakin
Intervention Description
AM0010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Patient is NOT eligible for other AM0010 clinical trials currently open in the region
Patient is in urgent need of therapy who fail to meet eligibility criteria for other clinical trials related to AM0010 (PEG-IL-10) can be considered for enrollment into this Expanded Access Program.
Patient has advanced cancer in indications where preliminary anti-tumor efficacy of AM0010 has been demonstrated or where AM0010 mediated immune activation is likely to benefit the patient.
Patient has failed or progressed on standard of care (SOC) systemic therapy
Patient is refusing SOC therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Contact Lilly at 1-800-LillyRx (1-800-545-5979)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
An Expanded Access Program for AM0010 (Pegilodecakin)
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