Non-Small Cell Lung Cancer Clinical Trial
— CheckMate370Official title:
A Master Protocol of Phase 1/2 Studies of Nivolumab in Advanced NSCLC Using Nivolumab as Maintenance After Induction Chemotherapy or as First-line Treatment Alone or in Combination With Standard of Care Therapies (CheckMate 370: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 370)
Verified date | April 2021 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.
Status | Completed |
Enrollment | 341 |
Est. completion date | April 15, 2020 |
Est. primary completion date | April 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histologically confirmed locally advanced or stage IV NSCLC - Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2 - Tumor tissue sections must be available for biomarker evaluation Exclusion Criteria: - Untreated or active/progressing Central Nervous system (CNS) metastases - Active, known or suspected autoimmune disease - Known history of testing positive for HIV or AIDS - Active or chronic infection of hepatitis B virus or hepatitis C |
Country | Name | City | State |
---|---|---|---|
United States | Texas Oncology-Abilene | Abilene | Texas |
United States | New York Oncology Hematology, Pc | Albany | New York |
United States | Christus St. Francis Cabrini Cancer Center | Alexandria | Louisiana |
United States | Lehigh Valley Hospital | Allentown | Pennsylvania |
United States | Texas Oncology - Amarillo | Amarillo | Texas |
United States | Community Clinical Research Center | Anderson | Indiana |
United States | Anne Arundel Medical Center | Annapolis | Maryland |
United States | Texas Oncology-Arlington North | Arlington | Texas |
United States | University Cancer Blood Ctr | Athens | Georgia |
United States | Texas Oncology-Central Austin Cancer Center | Austin | Texas |
United States | Comprehensive Blood And Cancer Center | Bakersfield | California |
United States | Sinai Hospital Of Baltimore | Baltimore | Maryland |
United States | University Of Maryland | Baltimore | Maryland |
United States | Texas Oncology-Beaumont | Beaumont | Texas |
United States | Texas Oncology | Bedford | Texas |
United States | Center For Cancer And Blood Disorders | Bethesda | Maryland |
United States | St. Luke's University Hospital Bethlehem | Bethlehem | Pennsylvania |
United States | Saint Vincent Frontier Cancer Center | Billings | Montana |
United States | Alabama Oncology | Birmingham | Alabama |
United States | Cancer Care Center | Bismarck | North Dakota |
United States | Oncology & Hematology Associates Of Southwest Virginia, Inc. | Blacksburg | Virginia |
United States | St. Louis Cancer Care, Llp | Bridgeton | Missouri |
United States | Charleston Hematology Oncology Associates, Pa | Charleston | South Carolina |
United States | Chattanooga Oncology Hematology Associates | Chattanooga | Tennessee |
United States | Oncology Hematology Care, Inc. | Cincinnati | Ohio |
United States | Louis Stokes Cleveland VA Medical Center | Cleveland | Ohio |
United States | MetroHealth Medical Center | Cleveland | Ohio |
United States | Maryland Oncology Hematology, P.A. | Columbia | Maryland |
United States | Mid Ohio Oncology Hematology | Columbus | Ohio |
United States | Texas Oncology | Dallas | Texas |
United States | Texas Oncology | Dallas | Texas |
United States | Texas Oncology, P.A. | Dallas | Texas |
United States | Texas Oncology/Methodist Charlton Cancer Ctr | Dallas | Texas |
United States | Texas Oncology | Denton | Texas |
United States | Bay Hematology Oncology | Easton | Maryland |
United States | Minnesota Oncology Hematology, P.A. | Edina | Minnesota |
United States | Texas Oncology | El Paso | Texas |
United States | Erie Regional Cancer Center | Erie | Pennsylvania |
United States | Oncology Associates Of Oregon, Pc | Eugene | Oregon |
United States | Providence Regional Cancer Partnership | Everett | Washington |
United States | Virginia Cancer Specialists, Pc | Fairfax | Virginia |
United States | Sanford Health | Fargo | North Dakota |
United States | San Juan Oncology Associates | Farmington | New Mexico |
United States | Hunterdon Medical Center | Flemington | New Jersey |
United States | Texas Oncology | Flower Mound | Texas |
United States | Florida Cancer Specialists S. | Fort Myers | Florida |
United States | Brooke Army Medical Center | Fort Sam Houston | Texas |
United States | Ft. Wayne Med Onco-Hema Inc | Fort Wayne | Indiana |
United States | Texas Oncology | Fort Worth | Texas |
United States | The Center For Cancer And Blood Disorders | Fort Worth | Texas |
United States | St. Joseph Heritage Medical Group | Fullerton | California |
United States | University of Florida at Shands | Gainesville | Florida |
United States | The Jones Clinic, PC | Germantown | Tennessee |
United States | West Cancer Center | Germantown | Tennessee |
United States | Arizona Oncology Assoc, Pc-Hal | Glendale | Arizona |
United States | Glens Falls Hospital | Glens Falls | New York |
United States | St. Mary's Hospital Regional Cancer Center | Grand Junction | Colorado |
United States | Cancer & Hematology Centers Of Western Michigan | Grand Rapids | Michigan |
United States | Cone Health Cancer Center | Greensboro | North Carolina |
United States | Moses Cone Health System | Greensboro | North Carolina |
United States | Randolph Cancer Center | Greensboro | North Carolina |
United States | Greenville Health System | Greenville | South Carolina |
United States | Forrest General Cancer Center | Hattiesburg | Mississippi |
United States | Memorial Cancer Institute | Hollywood | Florida |
United States | Abington Hematology Oncology Associates, Inc | Horsham | Pennsylvania |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Texas Oncology | Houston | Texas |
United States | Edwards Comprehensive Cancer Center | Huntington | West Virginia |
United States | Jackson Oncology Associates, Pllc | Jackson | Mississippi |
United States | Broome Oncology | Johnson City | New York |
United States | Scripps Cancer Center | La Jolla | California |
United States | Rocky Mountain Cancer Centers | Lakewood | Colorado |
United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
United States | Southeast Nebraska Cancer Center | Lincoln | Nebraska |
United States | UCLA Hematology/Oncology Clinic | Los Angeles | California |
United States | Hematology Oncology Associates | Medford | Oregon |
United States | Texas Cancer Center Of Mesquite | Mesquite | Texas |
United States | East Jefferson General Hospital | Metairie | Louisiana |
United States | Baptist Health Medical Group Oncology | Miami | Florida |
United States | Texas Oncology, Pa | Midland | Texas |
United States | Southern Cancer Center Pc | Mobile | Alabama |
United States | Summit Medical Group | Morristown | New Jersey |
United States | Northern Westchester Hospital | Mount Kisco | New York |
United States | Tennessee Oncology, PLLC - SCRI - PPDS | Nashville | Tennessee |
United States | Texas Oncology | New Braunfels | Texas |
United States | Columbia University Medical Center (Cumc) | New York | New York |
United States | Cancer Treatment Centers Of America | Newnan | Georgia |
United States | Illinois Cancer Specialists | Niles | Illinois |
United States | Virginia Oncology Associates | Norfolk | Virginia |
United States | Eastern Ct Hem Onc Assoc | Norwich | Connecticut |
United States | Hematology-Oncology Associates Of Rockland | Nyack | New York |
United States | Ocala Oncology Center | Ocala | Florida |
United States | Nebraska Cancer Specialists | Omaha | Nebraska |
United States | West KY Hematology Oncology Group PSC | Paducah | Kentucky |
United States | Texas Oncology | Paris | Texas |
United States | First Health Of The Carolinas | Pinehurst | North Carolina |
United States | Texas Oncology Plano West Cancer Center | Plano | Texas |
United States | Texas Oncology-Plano East | Plano | Texas |
United States | Hematology Oncology Associates Of The Treasure Coast | Port Saint Lucie | Florida |
United States | Virginia Cancer Institute | Richmond | Virginia |
United States | Florida Cancer Specialists | Saint Petersburg | Florida |
United States | W.G. Bill Hefner VA Medical Center | Salisbury | North Carolina |
United States | Cancer Centers of South Texas | San Antonio | Texas |
United States | Coastal Integrative Cancer Care | San Luis Obispo | California |
United States | Central Coast Med Oncology | Santa Maria | California |
United States | Summit Cancer Care | Savannah | Georgia |
United States | New England Cancer Specialists | Scarborough | Maine |
United States | Northern Arizona Hematology & Oncology Associates | Sedona | Arizona |
United States | Texas Cancer Center - Sherman | Sherman | Texas |
United States | Sanford Research | Sioux Falls | South Dakota |
United States | Local Institution | Solvang | California |
United States | Cancer Care Northwest | Spokane Valley | Washington |
United States | Stamford Hospital | Stamford | Connecticut |
United States | Texas Oncology Cancer Center - Sugar Land | Sugar Land | Texas |
United States | Atlantic Health System | Summit | New Jersey |
United States | Morristown Medical Center | Summit | New Jersey |
United States | Tallahassee Memorial Cancer Center | Tallahassee | Florida |
United States | Lewis Hall Singletary Oncology Center | Thomasville | Georgia |
United States | Cotton-O-Neil Clinical Research Center | Topeka | Kansas |
United States | Florida Cancer Affiliates | Trinity | Florida |
United States | Arizona Clinical Research Center, Inc. | Tucson | Arizona |
United States | Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope | Tucson | Arizona |
United States | Oklahoma Cancer Specialists and Research Institute, LLC-Clinical Research | Tulsa | Oklahoma |
United States | Texas Oncology-Tyler | Tyler | Texas |
United States | Northwest Cancer Specialists, Pc | Vancouver | Washington |
United States | Texas Oncology Cancer Care And Research Center | Waco | Texas |
United States | Texas Oncology, P.A. | Webster | Texas |
United States | Texas Oncology | Weslaco | Texas |
United States | Va Ct Healthcare System | West Haven | Connecticut |
United States | White Plains Hospital | White Plains | New York |
United States | Texas Oncology-Wichita Falls | Wichita Falls | Texas |
United States | Shenandoah Oncology | Winchester | Virginia |
United States | Yakima Valley Memorial Hospital/North Star Lodge | Yakima | Washington |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-Free Survival (PFS), Groups A-D Only | Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first. | up to approximately 48 months | |
Primary | Overall Survival (OS), Groups A-C Only | Overall survival (OS) is defined as the time from randomization to the date of death. | up to approximately 60 months | |
Primary | Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only | Percentage of participants who experienced a treatment-related AE during the course of the study that lead to discontinuation of both study drugs. | up to approximately 60 months | |
Secondary | Duration of Response (DOR), Groups A-D Only | Duration of response (DOR) is defined as the time from first confirmed response (complete response (CR) or partial response (PR)) to the date of the initial objectively documented tumor progression as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Median computed using Kaplan-Meier method. |
up to approximately 48 months | |
Secondary | Objective Response Rate (ORR), Groups A-E | Objective response rate (ORR) is defined as the number and percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation, recorded between the date of first dose and the date of the initial objectively documented tumor progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first. Confidence interval based on the Clopper and Pearson method. |
up to approximately 48 months | |
Secondary | Overall Survival (OS), Group D Only | Overall survival (OS) is defined as the time from randomization to the date of death. | up to approximately 60 months | |
Secondary | Progression-Free Survival (PFS), Group E Only | Progression-free survival (PFS) is defined as the time from randomization to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first. | up to approximately 48 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03087448 -
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1 | |
Recruiting |
NCT05042375 -
A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Terminated |
NCT05414123 -
A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
|
||
Recruiting |
NCT05059444 -
ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
|
||
Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
Recruiting |
NCT05009836 -
Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
|
Phase 3 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03219970 -
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
|
||
Recruiting |
NCT05949619 -
A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04054531 -
Study of KN046 With Chemotherapy in First Line Advanced NSCLC
|
Phase 2 | |
Withdrawn |
NCT03519958 -
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
|
||
Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
Terminated |
NCT02580708 -
Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01871805 -
A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC)
|
Phase 1/Phase 2 | |
Terminated |
NCT04042480 -
A Study of SGN-CD228A in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05919641 -
LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
|
||
Completed |
NCT03656705 -
CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma
|
Phase 1 |