Study Stopped
The CYPRESS-2 trial was closed early after the planned final analysis because the risk benefit ratio is unfavorable.
Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
Cypress 2
A Randomized Phase 2 Trial of AM0010 in Combination With Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1
3 other identifiers
interventional
52
1 country
35
Brief Summary
To compare the efficacy of pegilodecakin in combination with nivolumab versus nivolumab alone in participants with metastatic non-small cell lung cancer as measured by objective response rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2018
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2017
CompletedFirst Posted
Study publicly available on registry
December 26, 2017
CompletedStudy Start
First participant enrolled
March 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2020
CompletedResults Posted
Study results publicly available
September 11, 2020
CompletedSeptember 11, 2020
June 1, 2020
1.4 years
December 18, 2017
August 22, 2020
August 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
Objective response rate is the best overall tumor response of complete response (CR) or partial response (PR) as classified by the independent central review according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
From Date of Randomization to Progressive Disease, Death from Any cause (Up to 6 months after the last participant randomized)
Secondary Outcomes (4)
Overall Survival (OS)
From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)
Progression Free Survival (PFS)
From Date of Randomization to Progressive Disease or Death Due to Any Cause (Up to 6 months after the last participant randomized)
Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
From Date of Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months after the last participant randomization)
Duration of Response
From Date of Randomization to Death Due to Any Cause (Up to 6 months after the last participant randomized)
Study Arms (2)
Pegilodecakin+Nivolumab
EXPERIMENTALParticipants received Pegilodecakin subcutaneously at 0.8 milligrams (mg) (≤80 kilograms (kg) body weight) or 1.6 mg (\>80 kg body weight) once daily (QD) in the abdomen, thigh or back of upper arm. Nivolumab administered on day 1 of each 14 or 28 day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every 2 weeks (Q2W), or 480 mg every 4 weeks (Q4W).
Nivolumab
ACTIVE COMPARATORParticipants received Nivolumab on day 1 of each 14- or 28- day cycle over approximately 30 minutes intravenous (IV) infusion at 240 mg every two weeks (Q2W), or 480 mg every 4 weeks (Q4W).
Interventions
Pegilodecakin plus Nivolumab
Eligibility Criteria
You may qualify if:
- Participants must have histologically or cytologically confirmed Wild Type NSCLC that is stage IV / metastatic or recurrent
- Participants must have received at least one prior systemic therapy that was not an anti-PD-1, anti-PD-L1 and/or anti-CTLA-4 treatment for the advanced stage of the disease
- Participants with tumor tissue low expression of PD-L1 as defined by Tumor Proportion Score (TPS) 0% - 49%
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Participants with measurable disease by spiral computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumor (RECIST) v.1.1 criteria
- Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks prior to randomization
You may not qualify if:
- Participants with active central nervous system (CNS) metastases or carcinomatous meningitis
- Participants with any serious or uncontrolled medical disorder or active infection with the hepatitis virus or the human immunodeficiency virus (HIV)
- Participants with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior anti-cancer therapy (other than alopecia and fatigue) prior to randomization
- Participants that have received nivolumab
- Participants that have received therapy with anti-tumor vaccines or other immuno-stimulatory antitumor agents
- Participants with a history of severe hypersensitivity reactions to monoclonal antibodies
- Participants that have received therapy with anti-PD-1, anti-PD-L1, anti-PD-L-2, anti-CD-137, and/or anti CTLA-4 antibodies
- Participants receiving any investigational agent within 28 days of first administration of trial treatment
- Pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eli Lilly and Companylead
- ARMO BioSciencescollaborator
Study Sites (35)
Arizona Oncology Associates, P.C.
Tempe, Arizona, 85284, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
Glendale Adventist Medical Center
Los Angeles, California, 90017, United States
Redwood Regional Oncology Center
Santa Rosa, California, 95403, United States
The Oncology Institute of Hope and Innovation
Whittier, California, 90602, United States
Rocky Mountain Cancer Center
Lone Tree, Colorado, 80124, United States
John B. Amos Cancer Center
Columbus, Georgia, 31904, United States
Covenant Clinic
Waterloo, Iowa, 50702, United States
Baptist Health Medical Group
Lexington, Kentucky, 40503, United States
MedStar Health Research Institute
Baltimore, Maryland, 21237, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044, United States
Frederick Memorial Hospital
Frederick, Maryland, 21701, United States
Sparrow Health System
Lansing, Michigan, 48912, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
The Valley Hospital - Luckow Pavilion
Westwood, New Jersey, 07675, United States
Broome Oncology LLC
Johnson City, New York, 13790, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Clinical Research Alliance, Inc.
New Hyde Park, New York, 11042, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Christ Hospital
Cincinnati, Ohio, 45219, United States
University of Toledo Medical Center
Toledo, Ohio, 43614-2598, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, 29414, United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, 77702, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, 75231, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology-Memorial City
Houston, Texas, 77024, United States
Millennium Oncology
Houston, Texas, 77090, United States
Joe Arrington Cancer Center
Lubbock, Texas, 79410, United States
Texas Oncology - Midland Allison Cancer Center
Midland, Texas, 79701, United States
US Oncology
The Woodlands, Texas, 77380, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Fairfax Northern Virginia Hematology Oncology, PC
Fairfax, Virginia, 22031, United States
Oncology and Hematology Associates of Southwest Virginia Inc
Roanoke, Virginia, 24014, United States
MultiCare Regional Cancer Center - Auburn
Tacoma, Washington, 98002, United States
Related Publications (2)
Spigel D, Jotte R, Nemunaitis J, Shum M, Schneider J, Goldschmidt J, Eisenstein J, Berz D, Seneviratne L, Socoteanu M, Bhanderi V, Konduri K, Xia M, Wang H, Hozak RR, Gueorguieva I, Ferry D, Gandhi L, Chao BH, Rybkin I. Randomized Phase 2 Studies of Checkpoint Inhibitors Alone or in Combination With Pegilodecakin in Patients With Metastatic NSCLC (CYPRESS 1 and CYPRESS 2). J Thorac Oncol. 2021 Feb;16(2):327-333. doi: 10.1016/j.jtho.2020.10.001. Epub 2020 Nov 6.
PMID: 33166722DERIVEDAlbrethsen M, Creeden J, Morand S, DeBiase J, Berry B, Stanbery L, Edelman G, Nemunaitis J. Relationship of hypothyroidism and immune response to pegylated IL-10/nivolumab. Immunotherapy. 2020 Oct;12(14):1041-1046. doi: 10.2217/imt-2020-0016. Epub 2020 Aug 18.
PMID: 32808556DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2017
First Posted
December 26, 2017
Study Start
March 22, 2018
Primary Completion
August 28, 2019
Study Completion
March 3, 2020
Last Updated
September 11, 2020
Results First Posted
September 11, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Yes Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.