A Randomized Phase III Trial of Chemo-Immunotherapy vs Immunotherapy Alone for the Vulnerable Older Adult With Advanced Non-Small Cell Lung Cancer: The ACHIEVE Study

Status: Recruiting
Location: See all (302) locations...
Intervention Type: Procedure, Drug, Other, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• STEP 1 REGISTRATION

• Patient must be ≥ 70 years of age

• Patient must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with PD-L1 Tumor Proportion Score (TPS) range of 1-49%

• Patient must have Stage IIIB, IIIC or IV disease and not be candidates for combined chemo-radiation. NOTE: Prior chemo-radiation therapy (RT) for stage III with recurrence is allowed

• Patient must have a tumor that is negative for EGFR mutation/ALK translocations or other actionable first line mutations in which patients would receive first-line oral tyrosine kinase inhibitors

• Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 2

• Patient must agree not to father children while on study and for 6 months after the last dose of protocol treatment

• Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

• Absolute neutrophil count (ANC) ≥ 1,500/uL (obtained within 14 days prior to Step 1 registration)

• Platelets ≥ 75,000/uL (obtained within 14 days prior to Step 1 registration)

• Hemoglobin (Hgb) ≥ 8.0 g/dL (obtained within 14 days prior to Step 1 registration)

• Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to Step 1 registration)

• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 3.0 × institutional ULN (obtained within 14 days prior to Step 1 registration)

• Creatinine clearance (CrCL) ≥ 45 mL/min (estimated using Cockcroft-Gault method with actual body weight or measured) (obtained within 14 days prior to Step 1 registration)

• Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months of Step 1 registration are eligible for this trial

• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have undetectable HCV viral

• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

• Patient must be English or Spanish speaking to be eligible for the QOL component of the study

⁃ NOTE: Sites cannot translate the associated GA or QOL forms

• Patient must not have symptomatic central nervous system disease (CNS) metastases. Patients with a clinical history of CNS metastases or cord compression are eligible if they have been definitively treated and are clinically stable for at least 14 days prior to Step 1 registration and off all steroids for at least 24 hours prior to Step 1 registration. Patients with asymptomatic CNS metastases are eligible

• Patient must not have had any prior cytotoxic chemotherapy regimen for metastatic disease. Chemotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed, and they have fully recovered from treatment related adverse events prior to Step 1 registration

• Patient must not have had any prior immunotherapy for metastatic disease. Immunotherapy given in the setting of adjuvant therapy or locally advanced disease is allowed as long as treatment was completed greater than 6 months prior to Step 1 registration

• Patient must not have a history of uncontrolled autoimmune conditions with the following exceptions, which are allowed: alopecia, vitiligo, rheumatoid arthritis, psoriasis/psoriatic arthritis, Hashimoto's thyroiditis, lupus, inflammatory bowel disease

• Patient must not be on immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal and/or topical steroids are eligible

• Patient must have baseline imaging done assessing all measurable or non-measurable sites of disease within 45 days prior to Step 1 registration

• Investigator must declare their intended chemotherapy regimen should their patient be randomized to Arm B (doublet versus\[vs\] singlet)

• STEP 2 RANDOMIZATION

• Patient must have completed the baseline Geriatric Assessment (GA) after Step 1 registration and prior to Step 2 randomization

Locations
United States
Arkansas
Highlands Oncology Group - Fayetteville
RECRUITING
Fayetteville
Mercy Hospital Fort Smith
RECRUITING
Fort Smith
Highlands Oncology Group - Rogers
RECRUITING
Rogers
Highlands Oncology Group
RECRUITING
Springdale
California
Kaiser Permanente Dublin
RECRUITING
Dublin
Kaiser Permanente-Fremont
RECRUITING
Fremont
Kaiser Permanente Fresno Orchard Plaza
RECRUITING
Fresno
Kaiser Permanente-Fresno
RECRUITING
Fresno
Kaiser Permanente-Modesto
RECRUITING
Modesto
Kaiser Permanente-Oakland
RECRUITING
Oakland
VA Palo Alto Health Care System
RECRUITING
Palo Alto
Kaiser Permanente-Roseville
RECRUITING
Roseville
Kaiser Permanente Downtown Commons
RECRUITING
Sacramento
Kaiser Permanente-South Sacramento
RECRUITING
Sacramento
Kaiser Permanente-San Francisco
RECRUITING
San Francisco
Kaiser Permanente-Santa Teresa-San Jose
RECRUITING
San Jose
Kaiser Permanente San Leandro
RECRUITING
San Leandro
Kaiser San Rafael-Gallinas
RECRUITING
San Rafael
Kaiser Permanente Medical Center - Santa Clara
RECRUITING
Santa Clara
Kaiser Permanente-Santa Rosa
RECRUITING
Santa Rosa
Kaiser Permanente-South San Francisco
RECRUITING
South San Francisco
Kaiser Permanente-Vallejo
RECRUITING
Vallejo
Kaiser Permanente-Walnut Creek
RECRUITING
Walnut Creek
Connecticut
Stamford Hospital/Bennett Cancer Center
RECRUITING
Stamford
Veterans Affairs Connecticut Healthcare System-West Haven Campus
RECRUITING
West Haven
Florida
UM Sylvester Comprehensive Cancer Center at Aventura
RECRUITING
Aventura
UM Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITING
Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
RECRUITING
Deerfield Beach
Holy Cross Hospital
RECRUITING
Fort Lauderdale
Malcom Randall Veterans Administration Medical Center
RECRUITING
Gainesville
UM Sylvester Comprehensive Cancer Center at Kendall
RECRUITING
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITING
Miami
Sacred Heart Hospital
RECRUITING
Pensacola
UM Sylvester Comprehensive Cancer Center at Plantation
RECRUITING
Plantation
Moffitt Cancer Center
SUSPENDED
Tampa
Moffitt Cancer Center - McKinley Campus
SUSPENDED
Tampa
Moffitt Cancer Center-International Plaza
RECRUITING
Tampa
Moffitt Cancer Center at Wesley Chapel
RECRUITING
Wesley Chapel
Georgia
CTCA at Southeastern Regional Medical Center
RECRUITING
Newnan
Hawaii
Kaiser Permanente Moanalua Medical Center
RECRUITING
Honolulu
Iowa
UI Health Care Mission Cancer and Blood - Ankeny Clinic
RECRUITING
Ankeny
Mercy Hospital
RECRUITING
Cedar Rapids
Oncology Associates at Mercy Medical Center
RECRUITING
Cedar Rapids
Mercy Cancer Center-West Lakes
RECRUITING
Clive
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
RECRUITING
Clive
Mercy Medical Center - Des Moines
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Des Moines Clinic
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Waukee Clinic
RECRUITING
Waukee
Idaho
Saint Alphonsus Cancer Care Center-Boise
RECRUITING
Boise
Saint Alphonsus Cancer Care Center-Caldwell
RECRUITING
Caldwell
Kootenai Health - Coeur d'Alene
RECRUITING
Coeur D'alene
Saint Alphonsus Cancer Care Center-Nampa
RECRUITING
Nampa
Kootenai Clinic Cancer Services - Post Falls
RECRUITING
Post Falls
Kootenai Clinic Cancer Services - Sandpoint
RECRUITING
Sandpoint
Illinois
Rush-Copley Medical Center
RECRUITING
Aurora
Advocate Good Shepherd Hospital
RECRUITING
Barrington
Advocate Illinois Masonic Medical Center
RECRUITING
Chicago
University of Illinois
RECRUITING
Chicago
AMG Crystal Lake - Oncology
RECRUITING
Crystal Lake
Carle at The Riverfront
RECRUITING
Danville
Cancer Care Specialists of Illinois - Decatur
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Advocate Good Samaritan Hospital
RECRUITING
Downers Grove
Carle Physician Group-Effingham
RECRUITING
Effingham
Crossroads Cancer Center
RECRUITING
Effingham
Advocate Sherman Hospital
RECRUITING
Elgin
Advocate South Suburban Hospital
RECRUITING
Hazel Crest
AMG Libertyville - Oncology
RECRUITING
Libertyville
Condell Memorial Hospital
RECRUITING
Libertyville
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
Loyola University Medical Center
RECRUITING
Maywood
SSM Health Good Samaritan
SUSPENDED
Mount Vernon
Cancer Care Center of O'Fallon
RECRUITING
O'fallon
Advocate Christ Medical Center
RECRUITING
Oak Lawn
Advocate Lutheran General Hospital
RECRUITING
Park Ridge
UW Health Carbone Cancer Center Rockford
RECRUITING
Rockford
Memorial Hospital East
ACTIVE_NOT_RECRUITING
Shiloh
Southern Illinois University School of Medicine
RECRUITING
Springfield
Springfield Clinic
RECRUITING
Springfield
Springfield Memorial Hospital
RECRUITING
Springfield
Carle Cancer Center
RECRUITING
Urbana
Indiana
Northwest Cancer Center - Main Campus
RECRUITING
Crown Point
Northwest Oncology LLC
RECRUITING
Dyer
Northwest Cancer Center - Hobart
RECRUITING
Hobart
Saint Mary Medical Center
RECRUITING
Hobart
Saint Catherine Hospital
RECRUITING
Indianapolis
The Community Hospital
RECRUITING
Munster
Women's Diagnostic Center - Munster
RECRUITING
Munster
Northwest Cancer Center - Valparaiso
RECRUITING
Valparaiso
Kansas
University of Kansas Clinical Research Center
RECRUITING
Fairway
HaysMed
RECRUITING
Hays
University of Kansas Cancer Center
RECRUITING
Kansas City
Lawrence Memorial Hospital
RECRUITING
Lawrence
The University of Kansas Cancer Center - Olathe
RECRUITING
Olathe
University of Kansas Cancer Center-Overland Park
RECRUITING
Overland Park
University of Kansas Hospital-Indian Creek Campus
RECRUITING
Overland Park
Salina Regional Health Center
RECRUITING
Salina
University of Kansas Health System Saint Francis Campus
RECRUITING
Topeka
University of Kansas Hospital-Westwood Cancer Center
RECRUITING
Westwood
Kentucky
University of Kentucky/Markey Cancer Center
RECRUITING
Lexington
The James Graham Brown Cancer Center at University of Louisville
RECRUITING
Louisville
UofL Health Medical Center Northeast
RECRUITING
Louisville
Massachusetts
Tufts Medical Center
SUSPENDED
Boston
Dana-Farber Cancer Institute at Boston Medical Center - Brighton
RECRUITING
Brighton
Dana-Farber Cancer Institute at Foxborough
RECRUITING
Foxborough
Dana Farber-Merrimack Valley
RECRUITING
Methuen
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
RECRUITING
Milford
Dana-Farber/Brigham and Women's Cancer Center at South Shore
RECRUITING
South Weymouth
UMass Memorial Medical Center - University Campus
SUSPENDED
Worcester
Maryland
Sinai Hospital of Baltimore
RECRUITING
Baltimore
University of Maryland/Greenebaum Cancer Center
RECRUITING
Baltimore
William E Kahlert Regional Cancer Center/Sinai Hospital
RECRUITING
Westminster
Maine
Lafayette Family Cancer Center-EMMC
RECRUITING
Brewer
Michigan
Bronson Battle Creek
RECRUITING
Battle Creek
Trinity Health IHA Medical Group Hematology Oncology - Brighton
RECRUITING
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Canton
RECRUITING
Canton
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
RECRUITING
Chelsea
Cancer Hematology Centers - Flint
RECRUITING
Flint
Genesee Hematology Oncology PC
SUSPENDED
Flint
Genesys Hurley Cancer Institute
RECRUITING
Flint
Hurley Medical Center
RECRUITING
Flint
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
RECRUITING
Grand Rapids
Trinity Health Grand Rapids Hospital
RECRUITING
Grand Rapids
Bronson Methodist Hospital
RECRUITING
Kalamazoo
West Michigan Cancer Center
RECRUITING
Kalamazoo
University of Michigan Health - Sparrow Lansing
RECRUITING
Lansing
Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITING
Livonia
Trinity Health Muskegon Hospital
RECRUITING
Muskegon
Corewell Health Lakeland Hospitals - Niles Hospital
RECRUITING
Niles
Cancer and Hematology Centers of Western Michigan - Norton Shores
RECRUITING
Norton Shores
Michigan Healthcare Professionals Pontiac
RECRUITING
Pontiac
Trinity Health Saint Joseph Mercy Oakland Hospital
RECRUITING
Pontiac
Corewell Health Reed City Hospital
RECRUITING
Reed City
MyMichigan Medical Center Saginaw
RECRUITING
Saginaw
Oncology Hematology Associates of Saginaw Valley PC
SUSPENDED
Saginaw
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
RECRUITING
Saint Joseph
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
RECRUITING
Saint Joseph
MyMichigan Medical Center Tawas
RECRUITING
Tawas City
Munson Medical Center
RECRUITING
Traverse City
Saint Mary's Oncology/Hematology Associates of West Branch
SUSPENDED
West Branch
University of Michigan Health - West
RECRUITING
Wyoming
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
RECRUITING
Ypsilanti
Minnesota
Sanford Joe Lueken Cancer Center
RECRUITING
Bemidji
Minnesota Oncology - Burnsville
RECRUITING
Burnsville
Mercy Hospital
RECRUITING
Coon Rapids
Essentia Health - Deer River Clinic
RECRUITING
Deer River
Essentia Health Cancer Center
RECRUITING
Duluth
Fairview Southdale Hospital
RECRUITING
Edina
Essentia Health Hibbing Clinic
RECRUITING
Hibbing
Mayo Clinic Health Systems-Mankato
RECRUITING
Mankato
Abbott-Northwestern Hospital
RECRUITING
Minneapolis
New Ulm Medical Center
RECRUITING
New Ulm
Park Nicollet Clinic - Saint Louis Park
RECRUITING
Saint Louis Park
Regions Hospital
RECRUITING
Saint Paul
United Hospital
RECRUITING
Saint Paul
Essentia Health Sandstone
RECRUITING
Sandstone
Saint Francis Regional Medical Center
RECRUITING
Shakopee
Essentia Health Virginia Clinic
RECRUITING
Virginia
Missouri
Saint Francis Medical Center
RECRUITING
Cape Girardeau
Siteman Cancer Center at Saint Peters Hospital
ACTIVE_NOT_RECRUITING
City Of Saint Peters
Siteman Cancer Center at West County Hospital
ACTIVE_NOT_RECRUITING
Creve Coeur
Kansas City Veterans Affairs Medical Center
RECRUITING
Kansas City
University Health Truman Medical Center
RECRUITING
Kansas City
University of Kansas Cancer Center - North
RECRUITING
Kansas City
University of Kansas Cancer Center - Lee's Summit
RECRUITING
Lee's Summit
Lake Regional Hospital
RECRUITING
Osage Beach
Mercy Hospital South
RECRUITING
St Louis
Siteman Cancer Center at Christian Hospital
ACTIVE_NOT_RECRUITING
St Louis
Siteman Cancer Center-South County
ACTIVE_NOT_RECRUITING
St Louis
Washington University School of Medicine
ACTIVE_NOT_RECRUITING
St Louis
Montana
Community Hospital of Anaconda
RECRUITING
Anaconda
Billings Clinic Cancer Center
RECRUITING
Billings
Bozeman Health Deaconess Hospital
RECRUITING
Bozeman
Benefis Sletten Cancer Institute
RECRUITING
Great Falls
Logan Health Medical Center
RECRUITING
Kalispell
Community Medical Center
RECRUITING
Missoula
North Carolina
Durham VA Medical Center
RECRUITING
Durham
North Dakota
Sanford Bismarck Medical Center
RECRUITING
Bismarck
Sanford Broadway Medical Center
RECRUITING
Fargo
Sanford Roger Maris Cancer Center
RECRUITING
Fargo
New Hampshire
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
RECRUITING
Lebanon
The Dana-Farber Cancer Institute at Londonderry
RECRUITING
Londonderry
New Jersey
Jefferson Cherry Hill Hospital
RECRUITING
Cherry Hill
Inspira Medical Center Mullica Hill
SUSPENDED
Mullica Hill
Penn Medicine Princeton Health
RECRUITING
Plainsboro
Sidney Kimmel Cancer Center Washington Township
RECRUITING
Sewell
New York
Glens Falls Hospital
RECRUITING
Glens Falls
Upstate Cancer Center at Oswego
RECRUITING
Oswego
University of Rochester
RECRUITING
Rochester
Stony Brook University Medical Center
RECRUITING
Stony Brook
State University of New York Upstate Medical University
RECRUITING
Syracuse
SUNY Upstate Medical Center-Community Campus
RECRUITING
Syracuse
Montefiore Medical Center - Moses Campus
RECRUITING
The Bronx
Montefiore Medical Center-Einstein Campus
RECRUITING
The Bronx
Upstate Cancer Center at Verona
RECRUITING
Verona
Wilmot Cancer Institute at Webster
RECRUITING
Webster
Ohio
UH Seidman Cancer Center at UH Avon Health Center
RECRUITING
Avon
UHHS-Chagrin Highlands Medical Center
RECRUITING
Beachwood
Strecker Cancer Center-Belpre
RECRUITING
Belpre
Aultman Health Foundation
RECRUITING
Canton
Miami Valley Hospital South
RECRUITING
Centerville
Adena Regional Medical Center
RECRUITING
Chillicothe
Case Western Reserve University
RECRUITING
Cleveland
MetroHealth Medical Center
RECRUITING
Cleveland
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
The Mark H Zangmeister Center
RECRUITING
Columbus
Miami Valley Hospital
RECRUITING
Dayton
Miami Valley Hospital North
RECRUITING
Dayton
Premier Blood and Cancer Center
RECRUITING
Dayton
Atrium Medical Center-Middletown Regional Hospital
RECRUITING
Franklin
Miami Valley Cancer Care and Infusion
RECRUITING
Greenville
Mount Carmel Grove City Hospital
RECRUITING
Grove City
Memorial Hospital
RECRUITING
Marysville
UH Seidman Cancer Center at Lake Health Mentor Campus
RECRUITING
Mentor
Knox Community Hospital
RECRUITING
Mount Vernon
Licking Memorial Hospital
RECRUITING
Newark
Mercy Health - Perrysburg Hospital
RECRUITING
Perrysburg
Springfield Regional Cancer Center
RECRUITING
Springfield
Mercy Health - Saint Anne Hospital
RECRUITING
Toledo
Upper Valley Medical Center
RECRUITING
Troy
Genesis Healthcare System Cancer Care Center
RECRUITING
Zanesville
Oklahoma
Mercy Hospital Oklahoma City
RECRUITING
Oklahoma City
Oregon
Saint Alphonsus Cancer Care Center-Ontario
RECRUITING
Ontario
Pennsylvania
Bryn Mawr Hospital
RECRUITING
Bryn Mawr
Penn State Milton S Hershey Medical Center
RECRUITING
Hershey
Lancaster General Ann B Barshinger Cancer Institute
RECRUITING
Lancaster
Riddle Memorial Hospital
RECRUITING
Media
Paoli Memorial Hospital
RECRUITING
Paoli
ECOG-ACRIN Cancer Research Group
RECRUITING
Philadelphia
Jefferson Torresdale Hospital
RECRUITING
Philadelphia
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Reading Hospital McGlinn Cancer Institute at Phoenixville
RECRUITING
Phoenixville
Guthrie Medical Group PC-Robert Packer Hospital
RECRUITING
Sayre
Reading Hospital
RECRUITING
West Reading
Asplundh Cancer Pavilion
RECRUITING
Willow Grove
Lankenau Medical Center
RECRUITING
Wynnewood
South Carolina
Medical University of South Carolina
SUSPENDED
Charleston
Ralph H Johnson VA Medical Center
RECRUITING
Charleston
South Dakota
Rapid City Regional Hospital
SUSPENDED
Rapid City
Sanford Cancer Center Oncology Clinic
RECRUITING
Sioux Falls
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Texas
Parkland Memorial Hospital
RECRUITING
Dallas
UT Southwestern Simmons Cancer Center - RedBird
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth
RECRUITING
Fort Worth
UT Southwestern Clinical Center at Richardson/Plano
RECRUITING
Richardson
Virginia
University of Virginia Cancer Center
RECRUITING
Charlottesville
VCU Massey Cancer Center at Stony Point
RECRUITING
Richmond
VCU Massey Comprehensive Cancer Center
RECRUITING
Richmond
VCU Health Tappahannock Hospital
RECRUITING
Tappahannock
Vermont
Dartmouth Cancer Center - North
RECRUITING
Saint Johnsbury
White River Junction Veteran Administration Medical Center
RECRUITING
White River Junction
Washington
Swedish Cancer Institute-Edmonds
RECRUITING
Edmonds
Swedish Cancer Institute-Issaquah
RECRUITING
Issaquah
Swedish Medical Center-First Hill
RECRUITING
Seattle
Wisconsin
Langlade Hospital and Cancer Center
RECRUITING
Antigo
ThedaCare Regional Cancer Center
RECRUITING
Appleton
Duluth Clinic Ashland
RECRUITING
Ashland
ThedaCare Cancer Care - Berlin
RECRUITING
Berlin
Aurora Cancer Care-Southern Lakes VLCC
RECRUITING
Burlington
Aurora Saint Luke's South Shore
RECRUITING
Cudahy
Marshfield Medical Center-EC Cancer Center
RECRUITING
Eau Claire
Mayo Clinic Health System-Eau Claire Clinic
RECRUITING
Eau Claire
Aurora Health Care Germantown Health Center
RECRUITING
Germantown
Aurora Cancer Care-Grafton
RECRUITING
Grafton
Aurora BayCare Medical Center
RECRUITING
Green Bay
Bellin Memorial Hospital
RECRUITING
Green Bay
Mercyhealth Hospital and Cancer Center - Janesville
RECRUITING
Janesville
Aurora Cancer Care-Kenosha South
RECRUITING
Kenosha
Gundersen Lutheran Medical Center
RECRUITING
La Crosse
Aurora Bay Area Medical Group-Marinette
RECRUITING
Marinette
Marshfield Medical Center-Marshfield
RECRUITING
Marshfield
Aspirus Medford Hospital
RECRUITING
Medford
Aurora Cancer Care-Milwaukee
RECRUITING
Milwaukee
Aurora Saint Luke's Medical Center
RECRUITING
Milwaukee
Aurora Sinai Medical Center
RECRUITING
Milwaukee
Marshfield Medical Center - Minocqua
RECRUITING
Minocqua
ProHealth D N Greenwald Center
RECRUITING
Mukwonago
ThedaCare Regional Medical Center - Neenah
RECRUITING
Neenah
ThedaCare Cancer Care - New London
RECRUITING
New London
ProHealth Oconomowoc Memorial Hospital
RECRUITING
Oconomowoc
ThedaCare Cancer Care - Oshkosh
RECRUITING
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
RECRUITING
Oshkosh
Aurora Cancer Care-Racine
RECRUITING
Racine
Aspirus Cancer Care - James Beck Cancer Center
RECRUITING
Rhinelander
Marshfield Medical Center-Rice Lake
RECRUITING
Rice Lake
ThedaCare Cancer Care - Shawano
RECRUITING
Shawano
Vince Lombardi Cancer Clinic-Sheboygan
RECRUITING
Sheboygan
Aspirus Cancer Care - Stevens Point
RECRUITING
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
RECRUITING
Stevens Point
Aurora Medical Center in Summit
RECRUITING
Summit
Vince Lombardi Cancer Clinic-Two Rivers
RECRUITING
Two Rivers
ProHealth Waukesha Memorial Hospital
RECRUITING
Waukesha
UW Cancer Center at ProHealth Care
RECRUITING
Waukesha
ThedaCare Cancer Care - Waupaca
RECRUITING
Waupaca
Aspirus Regional Cancer Center
RECRUITING
Wausau
Aurora Cancer Care-Milwaukee West
RECRUITING
Wauwatosa
Aurora West Allis Medical Center
RECRUITING
West Allis
Marshfield Medical Center - Weston
RECRUITING
Weston
Aspirus Cancer Care - Wisconsin Rapids
RECRUITING
Wisconsin Rapids
West Virginia
Edwards Comprehensive Cancer Center
RECRUITING
Huntington
Time Frame
Start Date: 2024-07-19
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 304
Treatments
Active_comparator: Arm A (pembrolizumab)
INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.~MAINTENANCE: Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 or 42 days for 2 years in the absence of disease progression or unacceptable toxicity.~Patients undergo MRI at baseline and CT and/or PET on the trial at baseline and throughout the trial.
Experimental: Arm B (pembrolizumab, chemotherapy)
See Detailed Description
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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