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Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients with Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial

Trial Status: Active

This phase II trial investigates how well biomarkers on PET / CT imaging drive early discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy option for patients with unresectable melanoma. This trial is being done to determine if doctors can safely shorten the use of standard of care anti-PD1 therapy for melanoma by using biomarkers seen on PET / CT imaging and tumor biopsy.

Inclusion Criteria

  • STEP 0 PRE-REGISTRATION INCLUSION CRITERIA
  • Patient must have active advanced melanoma, defined as unresectable stage IIIB-IV by American Joint Committee on Cancer (AJCC) 8th edition. Patients with mucosal melanoma defined as unresectable stage III or regional/distant metastatic disease are eligible
  • Patient must have melanoma originating from cutaneous, acral-lentiginous, or mucosal primary sites. Patients with melanoma of unknown primary site are eligible. Patients must not have melanoma from an ocular primary site
  • Patient must have had measurable disease by immune related Response Evaluation Criteria in Solid Tumors (imRECIST) prior to start of initial anti-PD-1 therapy
  • Patient must be actively receiving standard of care anti-PD-1 therapy, currently be 52 weeks (+/- 2 weeks) from start of anti-PD-1 therapy, and have not experienced a toxicity that prevents them from continuing on therapy. Permitted systemic anti-PD-1 therapy regimens include: * Nivolumab 240 mg IV every (Q)2weeks or 480 mg IV Q4weeks * Pembrolizumab 200 mg IV Q3weeks or 400 mg IV Q6weeks * Nivolumab 1 mg/kg plus ipilimumab 3 mg/kg IV Q3weeks induction x 4 doses, followed by nivolumab 240 mg IV Q2weeks or 480 mg IV Q4weeks maintenance * Nivolumab 3 mg/kg plus Ipilimumab 1 mg/kg IV Q3weeks induction x 4 doses, followed by nivolumab 240 mg IV Q2weeks or 480 mg IV Q4weeks maintenance * Pembrolizumab 2 mg/kg (or 200 mg flat dose) plus Ipilimumab 1 mg/kg IV Q3weeks induction x 4 doses, followed by pembrolizumab 200 mg IV Q3weeks or 400 mg IV Q6weeks maintenance
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients with detectable viral loads are excluded as it is unclear if these patients have a low risk of melanoma progression off anti-PD-1 treatment
  • 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 an undetectable HCV viral load
  • Patients with baseline brain metastases must have been treated with surgery and/or stereotactic radiosurgery and demonstrate disease control or response. Alternatively, patients with baseline brain metastases primarily treated with systemic therapy must demonstrate ongoing response/disease control. Patients with emergent or progressive brain metastases after start of systemic therapy are not eligible. Brain imaging (magnetic resonance imaging [MRI] with IV contrast preferred; non-contrast MRI or computed tomography [CT] scan are acceptable) at week 48 (+/- 6 weeks) to confirm disease control/response required
  • 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
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • Patient must have experienced complete response, partial response, or stable disease on restaging CT scans by imRECIST that is maintained on diagnostic restaging CT scan at week 48 (+/- 6 weeks) from start of initial anti-PD-1 therapy
  • Patient must have completed an FDG-PET/CT scan at week 52 (+/- 2 weeks) from start of initial anti-PD-1 therapy * Patients with FDG PET/CT positive for hypermetabolic lesions: If a core needle, punch or excisional biopsy and pathological review of a representative lesion was not performed prior to pre-registration (Step 0) must either: ** Be amenable to undergo a biopsy. Patient must not be on anticoagulation therapy or, if on anti-coagulation therapy, patient must be able to hold treatment for a biopsy procedure (core needle, punch or excisional biopsy). Anti-coagulation therapy is defined as low molecular weight heparin, warfarin, factor Xa inhibitor, or direct thrombin inhibitor ** Have documentation of inability to perform the biopsy due to feasibility or safety concerns
  • Leukocytes >= 3,000/mcL (obtained =< 4 weeks prior to protocol registration)
  • Absolute neutrophil count (ANC) >= 1,500/mcL (obtained =< 4 weeks prior to protocol registration)
  • Platelets >= 100,000/mcL (obtained =< 4 weeks prior to protocol registration)
  • Total bilirubin =< institutional upper limit of normal (ULN) (patients with history of Gilbert’s syndrome are permitted to have a total bilirubin > 1.5 x institutional ULN) (obtained =< 4 weeks prior to protocol registration)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained =< 4 weeks prior to protocol registration)
  • Creatinine =< 1.5 x institutional ULN (obtained =< 4 weeks prior to protocol registration)
  • STEP 1 REGISTRATION INCLUSION CRITERIA
  • Patient met all eligibility criteria outlined above
  • Patient must register to Step 1 within 4 weeks of registration to Step 0
  • Patients must meet one of the following criteria: * Patient had no positive hypermetabolic lesions on the week 52 FDG-PET/CT. * Patients with positive hypermetabolic lesion(s) on the week 52 FDG-PET/CT (positive hypermetabolic = standard uptake volume [SUV] > pooled mediastinal blood), one of the following must have occurred: ** A representative lesion was biopsied (core needle, punch or excisional biopsy) within 14 days of registration to Step 0 and subsequent pathology review performed to determine the presence or absence of viable tumor ** Documentation is present that the patient is not able to undergo biopsy of a hypermetabolic lesion due to feasibility or safety concerns, i.e., the lesion location that is not amenable to biopsy

Exclusion Criteria

  • STEP 0 PRE-REGISTRATION EXCLUSION CRITERIA
  • Patient must not be receiving concurrent anti-tumor therapies in addition to the standard of care anti-PD-1 regimens. Patients who are receiving bisphosphonates and RANKL inhibitors for management of bone metastases are eligible
  • Patients must not be pregnant or breast-feeding due to potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the anti-PD-1 regimens being used. All patients of childbearing potential must have a blood test or urine study within 28 days prior to Step 0 pre-registration to rule out pregnancy. A second pregnancy test for patients registered to Arm A may be done as clinically indicated. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Patients must not conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of study registration and continuing (for patients of childbearing potential) until at least 5 months after the last dose of anti-PD-1 treatment. Patients of childbearing potential must also not donate eggs during this same time period

Arizona

Phoenix
Cancer Center at Saint Joseph's
Status: ACTIVE
Contact: Site Public Contact
Phone: 602-406-0777

Arkansas

Ft. Smith
Mercy Hospital Fort Smith
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-378-9373
Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-313-2409

California

Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
Status: ACTIVE
Contact: Site Public Contact
Phone: 805-219-4673
Los Angeles
Cedars Sinai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 310-423-8965
San Luis Obispo
Pacific Central Coast Health Center-San Luis Obispo
Status: ACTIVE
Contact: Site Public Contact
Phone: 805-219-4673
Santa Maria
Mission Hope Medical Oncology - Santa Maria
Status: ACTIVE
Contact: Site Public Contact
Phone: 805-219-4673

Colorado

Colorado Springs
Penrose-Saint Francis Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550
Rocky Mountain Cancer Centers-Penrose
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550
Saint Francis Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550
Denver
Porter Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550
Durango
Mercy Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550
Southwest Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550
Lakewood
Saint Anthony Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550
Littleton
Littleton Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550
Longmont
Longmont United Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550
Rocky Mountain Cancer Centers-Longmont
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 719-776-6550
Parker
Parker Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550
Pueblo
Saint Mary Corwin Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 719-776-6550

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 202-444-2223
MedStar Washington Hospital Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 202-877-8839

Florida

Aventura
UM Sylvester Comprehensive Cancer Center at Aventura
Status: ACTIVE
Contact: Site Public Contact
Phone: 954-461-2180
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Fort Lauderdale
Holy Cross Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 954-267-7748
Miami
UM Sylvester Comprehensive Cancer Center at Kendall
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-778-1868
Savannah
Lewis Cancer and Research Pavilion at Saint Joseph's / Candler
Status: ACTIVE
Contact: Site Public Contact
Phone: 912-819-5704

Illinois

Alton
Saint Anthony's Health
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-463-5623
Aurora
Rush - Copley Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212
Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Carbondale
Memorial Hospital of Carbondale
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-457-5200
Carterville
SIH Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-985-3333
Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Chicago
Northwestern University
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-695-1301
Danville
Carle on Vermilion
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Dixon
Illinois CancerCare-Dixon
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-285-7800
Effingham
Carle Physician Group-Effingham
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Western Illinois Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-344-2831
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Lake Forest
Northwestern Medicine Lake Forest Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Mount Vernon
Good Samaritan Regional Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 618-242-4600
O'Fallon
Cancer Care Center of O'Fallon
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4762
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Valley Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-528-7541
Southern Illinois University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-7541
Swansea
Southwest Illinois Health Services LLP
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 618-236-1000
Urbana
Carle Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-446-5532
Washington
Illinois CancerCare - Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Yorkville
Rush-Copley Healthcare Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 630-978-6212

Indiana

Richmond
Reid Health
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900

Iowa

Ames
Mary Greeley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
McFarland Clinic PC - Ames
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-239-4734
Boone
McFarland Clinic PC-Boone
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Carroll
Saint Anthony Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-689-7658
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Mercy Cancer Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Council Bluffs
Alegent Health Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-717-1510
Creston
Greater Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Lutheran Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2921
Medical Oncology and Hematology Associates-Laurel
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Mercy Medical Center - Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Trinity Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-574-8302
Jefferson
McFarland Clinic PC-Jefferson
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
Marshalltown
McFarland Clinic PC-Marshalltown
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-956-4132
West Des Moines
Mercy Medical Center-West Lakes
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-358-6613
Methodist West Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-343-1000

Kansas

Garden City
Central Care Cancer Center - Garden City
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-948-5588
Great Bend
Central Care Cancer Center - Great Bend
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-948-5588

Kentucky

Bardstown
Flaget Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-629-7169
Corbin
Commonwealth Cancer Center-Corbin
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-629-7169
Lexington
Saint Joseph Hospital East
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-629-7169
Saint Joseph Radiation Oncology Resource Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-629-7169
London
Saint Joseph London
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-629-7169
Louisville
Jewish Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-629-7169
Saints Mary and Elizabeth Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-629-7169
UofL Health Medical Center Northeast
Status: ACTIVE
Contact: Site Public Contact
Phone: 502-852-2755
Shepherdsville
Jewish Hospital Medical Center South
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-629-7169

Maryland

Baltimore
MedStar Franklin Square Medical Center / Weinberg Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 443-777-7364

Massachusetts

Boston
Boston Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 617-638-8265

Michigan

Adrian
Hickman Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 517-265-0116
Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Battle Creek
Bronson Battle Creek
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Brighton
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Canton
Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Trinity Health IHA Medical Group Hematology Oncology - Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Caro
Caro Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 989-907-8411
Chelsea
Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Clarkston
Hematology Oncology Consultants-Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Newland Medical Associates-Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Detroit
Ascension Saint John Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
East China
Great Lakes Cancer Management Specialists-Doctors Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
Flint
Genesee Cancer and Blood Disease Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 810-762-8038
Genesee Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 810-762-8038
Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 810-762-8038
Hurley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 810-762-8038
Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Mercy Health Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Grosse Pointe Woods
Academic Hematology Oncology Specialists
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
Michigan Breast Specialists-Grosse Pointe Woods
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
Kalamazoo
Ascension Borgess Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Borgess Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Bronson Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
West Michigan Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Lansing
Sparrow Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 517-364-9400
Livonia
Hope Cancer Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Trinity Health Saint Mary Mercy Livonia Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
Michigan Breast Specialists-Macomb Township
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
Marlette
Saint Mary's Oncology / Hematology Associates of Marlette
Status: ACTIVE
Contact: Site Public Contact
Phone: 989-907-8411
Monroe
Toledo Clinic Cancer Centers-Monroe
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-3561
Muskegon
Mercy Health Mercy Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Niles
Lakeland Hospital Niles
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Pontiac
21st Century Oncology-Pontiac
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Hope Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Newland Medical Associates-Pontiac
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Saint Joseph Mercy Oakland
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Reed City
Spectrum Health Reed City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Rochester Hills
Great Lakes Cancer Management Specialists-Rochester Hills
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 734-712-3671
Saginaw
Ascension Saint Mary's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 989-907-8411
Oncology Hematology Associates of Saginaw Valley PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 989-907-8411
Saint Joseph
Lakeland Medical Center Saint Joseph
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Marie Yeager Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
Tawas City
Ascension Saint Joseph Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 989-907-8411
Traverse City
Munson Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Warren
Advanced Breast Care Center PLLC
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
Great Lakes Cancer Management Specialists-Macomb Professional Building
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
Macomb Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
Michigan Breast Specialists-Warren
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
Saint John Macomb-Oakland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-343-3166
West Branch
Saint Mary's Oncology / Hematology Associates of West Branch
Status: ACTIVE
Contact: Site Public Contact
Phone: 989-907-8411
Wyoming
Metro Health Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Ypsilanti
Huron Gastroenterology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-7251

Minnesota

Aitkin
Riverwood Healthcare Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Baxter
Essentia Health - Baxter Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-828-2880
Bemidji
Sanford Joe Lueken Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-333-5000
Brainerd
Essentia Health Saint Joseph's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Deer River
Essentia Health - Deer River Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Detroit Lakes
Essentia Health Saint Mary's - Detroit Lakes Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Duluth
Essentia Health Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Essentia Health Saint Mary's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Miller-Dwan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Ely
Essentia Health - Ely Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-365-7900
Fergus Falls
Lake Region Healthcare Corporation-Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Fosston
Essentia Health - Fosston
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Hibbing
Essentia Health Hibbing Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
International Falls
Essentia Health - International Falls Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-283-9431
Moose Lake
Essentia Health - Moose Lake Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-485-4481
Park Rapids
Essentia Health - Park Rapids
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Sandstone
Essentia Health Sandstone
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Thief River Falls
Sanford Thief River Falls Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320
Virginia
Essentia Health Virginia Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Worthington
Sanford Cancer Center Worthington
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7058
Bolivar
Central Care Cancer Center - Bolivar
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-948-5588
Branson
Cox Cancer Center Branson
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-651-5550
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Farmington
Parkland Health Center - Farmington
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Jefferson City
Capital Region Southwest Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-632-4814
Joplin
Freeman Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-347-4030
Mercy Hospital Joplin
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-556-3074
Rolla
Delbert Day Cancer Institute at PCRMC
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-7504
Mercy Clinic-Rolla-Cancer and Hematology
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-458-6379
Saint Joseph
Heartland Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 816-271-7937
Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-251-7066
Mercy Hospital South
Status: ACTIVE
Contact: Site Public Contact
Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Saint Louis Cancer and Breast Institute-South City
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-353-1870
Siteman Cancer Center at Christian Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Siteman Cancer Center-South County
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Washington University School of Medicine
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-600-3606
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
CoxHealth South Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520
Sullivan
Missouri Baptist Sullivan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Washington
Mercy Hospital Washington
Status: ACTIVE
Contact: Site Public Contact
Phone: 636-390-1600

Nebraska

Grand Island
CHI Health Saint Francis
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-334-4773
Kearney
CHI Health Good Samaritan
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-865-7963
Lincoln
Saint Elizabeth Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-313-2409
Omaha
Alegent Health Bergan Mercy Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-717-1510
Alegent Health Immanuel Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-717-1510
Alegent Health Lakeside Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-717-1510
Creighton University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-717-1510
Papillion
Midlands Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-717-1510

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Hackensack
Hackensack University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 201-996-2879
Middletown
Memorial Sloan Kettering Monmouth
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Montvale
Memorial Sloan Kettering Bergen
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-767-9355
Commack
Memorial Sloan Kettering Commack
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Glens Falls
Glens Falls Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 518-926-6700
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE
Contact: Site Public Contact
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Uniondale
Memorial Sloan Kettering Nassau
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
West Harrison
Memorial Sloan Kettering Westchester
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Essentia Health Cancer Center-South University Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Sanford Medical Center Fargo
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-437-4010
Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161
Sanford South University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161
Southpointe-Sanford Medical Center Fargo
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320
Jamestown
Essentia Health - Jamestown Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308

Ohio

Beavercreek
Indu and Raj Soin Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Belpre
Strecker Cancer Center-Belpre
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-523-3977
Boardman
Saint Elizabeth Boardman Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Centerville
Dayton Physicians LLC-Miami Valley South
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Miami Valley Hospital South
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Chillicothe
Adena Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-779-7585
Cincinnati
Bethesda North Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-853-1300
Good Samaritan Hospital - Cincinnati
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-853-1300
Oncology Hematology Care Inc-Kenwood
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
TriHealth Cancer Institute-Anderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-853-1300
TriHealth Cancer Institute-Westside
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-853-1300
University of Cincinnati Cancer Center-UC Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-584-7698
Columbus
Columbus Oncology and Hematology Associates Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Doctors Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-3275
Grant Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
Mount Carmel East Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Mount Carmel Health Center West
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-234-5433
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066
Riverside Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
The Mark H Zangmeister Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Dayton
Dayton Physician LLC-Miami Valley Hospital North
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Miami Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Miami Valley Hospital North
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Delaware
Delaware Health Center-Grady Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-615-0227
Grady Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-615-2403
Dublin
Columbus Oncology and Hematology Associates
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-3275
Dublin Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-752-9119
Findlay
Armes Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Blanchard Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Orion Cancer Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Franklin
Atrium Medical Center-Middletown Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Dayton Physicians LLC-Atrium
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Gahanna
Central Ohio Breast and Endocrine Surgery
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2745
Greenville
Dayton Physicians LLC-Wayne
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Wayne Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Grove City
Mount Carmel Grove City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-779-7585
Kettering
Greater Dayton Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Kettering Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Lancaster
Fairfield Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-687-8863
Lima
Saint Rita's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-226-9617
Mansfield
OhioHealth Mansfield Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 419-526-8018
Marietta
Marietta Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-523-3977
Marion
OhioHealth Marion General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Mount Vernon
Knox Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-393-9000
Newark
Licking Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-348-4000
Newark Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Perrysburg
Mercy Health Perrysburg Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Portsmouth
Southern Ohio Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Springfield
Springfield Regional Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Springfield Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 937-528-2900
Toledo
Mercy Health - Saint Anne Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Saint Vincent Mercy Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-488-2118
Toledo Clinic Cancer Centers-Toledo
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-444-3561
Troy
Dayton Physicians LLC-Upper Valley
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Upper Valley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Warren
Saint Joseph Warren Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
West Chester
University of Cincinnati Cancer Center-West Chester
Status: ACTIVE
Contact: Site Public Contact
Phone: 513-584-7698
Westerville
Saint Ann's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-234-5433
Youngstown
Saint Elizabeth Youngstown Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-528-2900
Zanesville
Genesis Healthcare System Cancer Care Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-454-5232

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: ACTIVE
Contact: Site Public Contact
Phone: 610-402-9543
Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: ACTIVE
Contact: Site Public Contact
Phone: 610-402-9543
Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
East Stroudsburg
Pocono Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 610-402-9543
Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-459-2901
Lehigh Valley Hospital-Hazleton
Status: ACTIVE
Contact: Site Public Contact
Phone: 610-402-9543
Hershey
Penn State Milton S Hershey Medical Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 717-531-3779
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-374-8555
Pottsville
Geisinger Cancer Services-Pottsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-275-6401
Scranton
Community Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-703-4768
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251

South Carolina

Gaffney
Gibbs Cancer Center-Gaffney
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Greer
Gibbs Cancer Center-Pelham
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Spartanburg
North Grove Medical Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6812
Spartanburg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Spartanburg Medical Center - Mary Black Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6812
Union
MGC Hematology Oncology-Union
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104

South Dakota

Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Texas

Bryan
Saint Joseph Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-313-2409

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-424-2100

Vermont

Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: ACTIVE
Contact: Site Public Contact
Phone: 802-225-5400
Burlington
University of Vermont Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 802-656-4101
Email: rpo@uvm.edu
University of Vermont and State Agricultural College
Status: ACTIVE
Contact: Site Public Contact
Phone: 802-656-8990
Email: rpo@uvm.edu

Virginia

Charlottesville
University of Virginia Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 434-243-6303

Washington

Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Harrison Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-426-6882
Burien
Highline Medical Center-Main Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-426-6882
Enumclaw
Saint Elizabeth Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-426-6882
Federal Way
Saint Francis Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-426-6882
Lakewood
Saint Clare Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-426-6882
Poulsbo
Harrison HealthPartners Hematology and Oncology-Poulsbo
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 308-398-6518
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-426-6882
Northwest Medical Specialties PLLC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-306-0532

Wisconsin

Ashland
Duluth Clinic Ashland
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Northwest Wisconsin Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Chippewa Falls
Marshfield Clinic-Chippewa Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Hayward
Essentia Health-Hayward Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Ladysmith
Marshfield Clinic - Ladysmith Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Marshfield
Marshfield Medical Center-Marshfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Minocqua
Marshfield Clinic-Minocqua Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Mukwonago
ProHealth D N Greenwald Center
Status: ACTIVE
Contact: Site Public Contact
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-7878
Rice Lake
Marshfield Medical Center-Rice Lake
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Spooner
Essentia Health-Spooner Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 218-786-3308
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Superior
Essentia Health Saint Mary's Hospital - Superior
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-364-6272
Waukesha
ProHealth Waukesha Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-7632
UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-5539
Wausau
Marshfield Clinic-Wausau Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Weston
Marshfield Medical Center - Weston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581

PRIMARY OBJECTIVE:

I. To determine the 12 month event free survival (EFS) rate following discontinuation of anti-PD-1 therapy in patients with disease control and negative fludeoxyglucose F-18 (FDG)- positron emission tomography (PET)/computed tomography (CT) scan or biopsy for residual disease after 12 months of anti-PD-1 therapy (Arm A).

SECONDARY OBJECTIVES:

I. To determine rates of pathologic response in patients with tumor biopsies where positive hypermetabolic activity was present on FDG-PET/CT scan after 12 months of anti-PD-1 therapy (Arm B).

II. To determine the overall 24 month EFS.

III. To determine overall survival from start of anti-PD-1 therapy.

IV. To determine percentage for patients who remain on treatment beyond 12 months because of positive FDG-PET/CT scan and positive biopsy for residual disease (or unable to obtain a biopsy).

V. To determine incidence rates of treatment-related adverse events beyond 12 months from start of treatment in patients who discontinue anti-PD-1 therapy at 12 months and in patients who continue anti-PD-1 therapy beyond 12 months (Arm A versus [vs.] Arm B).

EXPLORATORY OBJECTIVES:

I. To assess agreement in determining FDG-PET/CT positivity between the local site read and central review.

II. To determine if metabolic response on serial FDG-PET/CT from pre-therapy to 12 months of anti-PD-1 therapy, as determined centrally by various criteria, is associated with EFS.

III. To determine if metabolic response on serial FDG-PET/CT from 12 to 24 months after start of anti-PD-1 therapy, as determined centrally by various criteria, is associated with EFS.

BIOMARKER OBJECTIVE:

I. To bank tumor samples and peripheral blood for future biomarker studies.

OUTLINE: Patients continue their standard of care anti-PD-1 therapy and are then assigned to 1 of 2 arms.

STANDARD OF CARE: Treatment may consist of the following regimens: 1) nivolumab intravenously (IV) over 30 minutes every 2 weeks (Q2W) or every 4 weeks (Q4W); 2) pembrolizumab IV over 30 minutes every 3 weeks (Q3W) or every 6 weeks (Q6W); 3) nivolumab IV over 30 minutes and ipilimumab IV Q3W for 4 doses followed by nivolumab IV over 30 minutes Q2W or Q4W; or 4) pembrolizumab IV over 30 minutes and ipilimumab IV Q3W for 4 doses followed by pembrolizumab IV over 30 minutes Q3W or Q6W. Treatment continues until 52 weeks from start of standard of care anti-PD-1 therapy in the absence of disease progression or unacceptable toxicity.

ARM A: Patients with a negative FDG-PET/CT scan or a positive FDG-PET/CT scan but with a negative biopsy for viable tumor discontinue the anti-PD-1 therapy and undergo active surveillance.

ARM B: Patients with a positive FDG-PET/CT scan and positive biopsy for viable tumor or a positive FDG-PET/CT scan and biopsy not performed receive nivolumab IV over 30 minutes Q2W or Q4W, or pembrolizumab IV over 30 minutes Q3W or Q6W for 48 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up through week 97 and then every 3 months for up to 5 years.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Geoffrey Thomas Gibney

  • Primary ID EA6192
  • Secondary IDs NCI-2020-04463
  • Clinicaltrials.gov ID NCT04462406