Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial
Purpose
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.
Conditions
- Advanced Melanoma
- Clinical Stage III Cutaneous Melanoma AJCC v8
- Clinical Stage IV Cutaneous Melanoma AJCC v8
- Melanoma of Unknown Primary
- Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
- Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
- Pathologic Stage IIID Cutaneous Melanoma AJCC v8
- Pathologic Stage IV Cutaneous Melanoma AJCC v8
- Unresectable Acral Lentiginous Melanoma
- Unresectable Melanoma
- Unresectable Mucosal Melanoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 - 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 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 restaging scans obtained at week 52 (+/- 2 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 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 >= 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 - Patient must not have brain metastases - Women 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 females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A female of childbearing potential is defined as any woman, 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) - Women of childbearing potential and sexually active males 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 until at least 5 months after the last dose of anti-PD-1 treatment for female patients and for at least 7 months after the last dose of anti-PD-1 treatment for male patients who are sexually active with a women of childbearing potential (WOCBP)
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A (active surveillance) |
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. |
|
|
Active Comparator Arm B (nivolumab, pembrolizumab, ipilimumab) |
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 continue their standard of care anti-PD-1 therapy for 12 months in the absence of disease progression or unacceptable toxicity. |
|
|
Other Standard of Care (nivolumab, pembrolizumab, ipilimumab) |
Patients continue their standard of care anti-PD-1 therapy. Treatment may consist of the following regimens: 1) nivolumab IV over 30 minutes Q2W or Q4W; 2) pembrolizumab IV over 30 minutes Q3W or 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. |
|
Recruiting Locations
Fairbanks Memorial Hospital
Fairbanks, Alaska 99701
Fairbanks, Alaska 99701
Cancer Center at Saint Joseph's
Phoenix, Arizona 85004
Phoenix, Arizona 85004
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
Fort Smith, Arkansas 72903
Contact:
Site Public Contact
800-378-9373
Site Public Contact
800-378-9373
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274
Site Public Contact
501-686-8274
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California 93420
Arroyo Grande, California 93420
Cedars Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
Contact:
Site Public Contact
310-423-8965
Site Public Contact
310-423-8965
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401
San Luis Obispo, California 93401
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California 93444
Santa Maria, California 93444
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012
Aurora, Colorado 80012
The Medical Center of Aurora
Aurora, Colorado 80012
Aurora, Colorado 80012
Boulder Community Foothills Hospital
Boulder, Colorado 80303
Boulder, Colorado 80303
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304
Boulder, Colorado 80304
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado 80112
Centennial, Colorado 80112
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907
Colorado Springs, Colorado 80907
Saint Francis Cancer Center
Colorado Springs, Colorado 80923
Colorado Springs, Colorado 80923
The Women's Imaging Center
Denver, Colorado 80209
Denver, Colorado 80209
Porter Adventist Hospital
Denver, Colorado 80210
Denver, Colorado 80210
Colorado Blood Cancer Institute
Denver, Colorado 80218
Denver, Colorado 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado 80218
Denver, Colorado 80218
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado 80218
Denver, Colorado 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado 80220
Denver, Colorado 80220
Rose Medical Center
Denver, Colorado 80220
Denver, Colorado 80220
Western Surgical Care
Denver, Colorado 80220
Denver, Colorado 80220
Contact:
Site Public Contact
303-777-2663
Site Public Contact
303-777-2663
Mercy Medical Center
Durango, Colorado 81301
Durango, Colorado 81301
Southwest Oncology PC
Durango, Colorado 81301
Durango, Colorado 81301
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado 80113
Englewood, Colorado 80113
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado 80113
Englewood, Colorado 80113
Swedish Medical Center
Englewood, Colorado 80113
Englewood, Colorado 80113
The Melanoma and Skin Cancer Institute
Englewood, Colorado 80113
Englewood, Colorado 80113
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado 80228
Lakewood, Colorado 80228
Saint Anthony Hospital
Lakewood, Colorado 80228
Lakewood, Colorado 80228
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado 80120
Littleton, Colorado 80120
Littleton Adventist Hospital
Littleton, Colorado 80122
Littleton, Colorado 80122
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado 80124
Lone Tree, Colorado 80124
Sky Ridge Medical Center
Lone Tree, Colorado 80124
Lone Tree, Colorado 80124
Longmont United Hospital
Longmont, Colorado 80501
Longmont, Colorado 80501
Parker Adventist Hospital
Parker, Colorado 80138
Parker, Colorado 80138
Saint Mary Corwin Medical Center
Pueblo, Colorado 81004
Pueblo, Colorado 81004
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado 80260
Thornton, Colorado 80260
MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Washington, District of Columbia 20007
Contact:
Site Public Contact
202-444-2223
Site Public Contact
202-444-2223
MedStar Washington Hospital Center
Washington, District of Columbia 20010
Washington, District of Columbia 20010
Contact:
Site Public Contact
202-877-8839
Site Public Contact
202-877-8839
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida 33180
Aventura, Florida 33180
Contact:
Site Public Contact
954-461-2180
Site Public Contact
954-461-2180
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
Coral Gables, Florida 33146
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
Deerfield Beach, Florida 33442
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
Holy Cross Hospital
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
Contact:
Site Public Contact
954-267-7748
Site Public Contact
954-267-7748
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
Miami, Florida 33136
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida 33176
Miami, Florida 33176
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
Plantation, Florida 33324
Contact:
Site Public Contact
305-243-2647
Site Public Contact
305-243-2647
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Contact:
Site Public Contact
404-778-1868
Site Public Contact
404-778-1868
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
Savannah, Georgia 31405
Saint Anthony's Health
Alton, Illinois 62002
Alton, Illinois 62002
Contact:
Site Public Contact
618-463-5623
Site Public Contact
618-463-5623
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Illinois CancerCare-Canton
Canton, Illinois 61520
Canton, Illinois 61520
Memorial Hospital of Carbondale
Carbondale, Illinois 62902
Carbondale, Illinois 62902
SIH Cancer Institute
Carterville, Illinois 62918
Carterville, Illinois 62918
Illinois CancerCare-Carthage
Carthage, Illinois 62321
Carthage, Illinois 62321
Centralia Oncology Clinic
Centralia, Illinois 62801
Centralia, Illinois 62801
Northwestern University
Chicago, Illinois 60611
Chicago, Illinois 60611
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Illinois CancerCare-Dixon
Dixon, Illinois 61021
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800
Site Public Contact
815-285-7800
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Illinois CancerCare-Eureka
Eureka, Illinois 61530
Eureka, Illinois 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-344-2831
Site Public Contact
309-344-2831
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Kewanee, Illinois 61443
Illinois CancerCare-Macomb
Macomb, Illinois 61455
Macomb, Illinois 61455
Good Samaritan Regional Health Center
Mount Vernon, Illinois 62864
Mount Vernon, Illinois 62864
Contact:
Site Public Contact
618-242-4600
Site Public Contact
618-242-4600
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Ottawa, Illinois 61350
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Peoria, Illinois 61615
Methodist Medical Center of Illinois
Peoria, Illinois 61636
Peoria, Illinois 61636
Illinois CancerCare-Peru
Peru, Illinois 61354
Peru, Illinois 61354
Valley Radiation Oncology
Peru, Illinois 61354
Peru, Illinois 61354
Contact:
Site Public Contact
815-664-4141
Site Public Contact
815-664-4141
Illinois CancerCare-Princeton
Princeton, Illinois 61356
Princeton, Illinois 61356
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Memorial Medical Center
Springfield, Illinois 62781
Springfield, Illinois 62781
Illinois CancerCare - Washington
Washington, Illinois 61571
Washington, Illinois 61571
Reid Health
Richmond, Indiana 47374
Richmond, Indiana 47374
Mary Greeley Medical Center
Ames, Iowa 50010
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic PC - Ames
Ames, Iowa 50010
Ames, Iowa 50010
McFarland Clinic PC-Boone
Boone, Iowa 50036
Boone, Iowa 50036
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
Saint Anthony Regional Hospital
Carroll, Iowa 51401
Carroll, Iowa 51401
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa 50325
Clive, Iowa 50325
Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Clive, Iowa 50325
Alegent Health Mercy Hospital
Council Bluffs, Iowa 51503
Council Bluffs, Iowa 51503
Greater Regional Medical Center
Creston, Iowa 50801
Creston, Iowa 50801
Iowa Methodist Medical Center
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727
Site Public Contact
515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-282-2921
Site Public Contact
515-282-2921
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Iowa Lutheran Hospital
Des Moines, Iowa 50316
Des Moines, Iowa 50316
Contact:
Site Public Contact
515-241-8704
Site Public Contact
515-241-8704
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa 50501
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
Trinity Regional Medical Center
Fort Dodge, Iowa 50501
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-574-8302
Site Public Contact
515-574-8302
McFarland Clinic PC-Jefferson
Jefferson, Iowa 50129
Jefferson, Iowa 50129
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa 50158
Marshalltown, Iowa 50158
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
Methodist West Hospital
West Des Moines, Iowa 50266-7700
West Des Moines, Iowa 50266-7700
Contact:
Site Public Contact
515-343-1000
Site Public Contact
515-343-1000
Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
West Des Moines, Iowa 50266
Central Care Cancer Center - Garden City
Garden City, Kansas 67846
Garden City, Kansas 67846
Central Care Cancer Center - Great Bend
Great Bend, Kansas 67530
Great Bend, Kansas 67530
Flaget Memorial Hospital
Bardstown, Kentucky 40004
Bardstown, Kentucky 40004
Commonwealth Cancer Center-Corbin
Corbin, Kentucky 40701
Corbin, Kentucky 40701
Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky 40504
Lexington, Kentucky 40504
Saint Joseph Hospital East
Lexington, Kentucky 40509
Lexington, Kentucky 40509
Saint Joseph London
London, Kentucky 40741
London, Kentucky 40741
MedStar Franklin Square Medical Center/Weinberg Cancer Institute
Baltimore, Maryland 21237
Baltimore, Maryland 21237
Contact:
Site Public Contact
443-777-7364
Site Public Contact
443-777-7364
Boston Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Contact:
Site Public Contact
617-638-8265
Site Public Contact
617-638-8265
Hickman Cancer Center
Adrian, Michigan 49221
Adrian, Michigan 49221
Contact:
Site Public Contact
517-265-0116
Site Public Contact
517-265-0116
Saint Joseph Mercy Hospital
Ann Arbor, Michigan 48106
Ann Arbor, Michigan 48106
Bronson Battle Creek
Battle Creek, Michigan 49017
Battle Creek, Michigan 49017
Saint Joseph Mercy Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Brighton, Michigan 48114
Saint Joseph Mercy Canton
Canton, Michigan 48188
Canton, Michigan 48188
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Canton, Michigan 48188
Caro Cancer Center
Caro, Michigan 48723
Caro, Michigan 48723
Saint Joseph Mercy Chelsea
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Chelsea, Michigan 48118
Hematology Oncology Consultants-Clarkston
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Newland Medical Associates-Clarkston
Clarkston, Michigan 48346
Clarkston, Michigan 48346
Ascension Saint John Hospital
Detroit, Michigan 48236
Detroit, Michigan 48236
Great Lakes Cancer Management Specialists-Doctors Park
East China Township, Michigan 48054
East China Township, Michigan 48054
Genesee Cancer and Blood Disease Treatment Center
Flint, Michigan 48503
Flint, Michigan 48503
Genesee Hematology Oncology PC
Flint, Michigan 48503
Flint, Michigan 48503
Genesys Hurley Cancer Institute
Flint, Michigan 48503
Flint, Michigan 48503
Hurley Medical Center
Flint, Michigan 48503
Flint, Michigan 48503
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Mercy Health Saint Mary's
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Academic Hematology Oncology Specialists
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, Michigan 48236
Grosse Pointe Woods, Michigan 48236
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
West Michigan Cancer Center
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Ascension Borgess Cancer Center
Kalamazoo, Michigan 49009
Kalamazoo, Michigan 49009
Borgess Medical Center
Kalamazoo, Michigan 49048
Kalamazoo, Michigan 49048
Sparrow Hospital
Lansing, Michigan 48912
Lansing, Michigan 48912
Contact:
Site Public Contact
517-364-9400
Site Public Contact
517-364-9400
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Livonia, Michigan 48154
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, Michigan 48044
Macomb, Michigan 48044
Michigan Breast Specialists-Macomb Township
Macomb, Michigan 48044
Macomb, Michigan 48044
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan 48453
Marlette, Michigan 48453
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan 48162
Monroe, Michigan 48162
Contact:
Site Public Contact
800-444-3561
Site Public Contact
800-444-3561
Mercy Health Mercy Campus
Muskegon, Michigan 49444
Muskegon, Michigan 49444
Lakeland Hospital Niles
Niles, Michigan 49120
Niles, Michigan 49120
Contact:
Site Public Contact
616-391-1230
Site Public Contact
616-391-1230
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Norton Shores, Michigan 49444
21st Century Oncology-Pontiac
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Hope Cancer Center
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Newland Medical Associates-Pontiac
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Saint Joseph Mercy Oakland
Pontiac, Michigan 48341
Pontiac, Michigan 48341
Spectrum Health Reed City Hospital
Reed City, Michigan 49677
Reed City, Michigan 49677
Ascension Saint Mary's Hospital
Saginaw, Michigan 48601
Saginaw, Michigan 48601
Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
Saginaw, Michigan 48604
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, Michigan 48312
Sterling Heights, Michigan 48312
Ascension Saint Joseph Hospital
Tawas City, Michigan 48764
Tawas City, Michigan 48764
Munson Medical Center
Traverse City, Michigan 49684
Traverse City, Michigan 49684
Advanced Breast Care Center PLLC
Warren, Michigan 48088
Warren, Michigan 48088
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, Michigan 48093
Warren, Michigan 48093
Macomb Hematology Oncology PC
Warren, Michigan 48093
Warren, Michigan 48093
Michigan Breast Specialists-Warren
Warren, Michigan 48093
Warren, Michigan 48093
Saint John Macomb-Oakland Hospital
Warren, Michigan 48093
Warren, Michigan 48093
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan 48661
West Branch, Michigan 48661
Metro Health Hospital
Wyoming, Michigan 49519
Wyoming, Michigan 49519
Huron Gastroenterology PC
Ypsilanti, Michigan 48106
Ypsilanti, Michigan 48106
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Riverwood Healthcare Center
Aitkin, Minnesota 56431
Aitkin, Minnesota 56431
Essentia Health - Baxter Clinic
Baxter, Minnesota 56425
Baxter, Minnesota 56425
Contact:
Site Public Contact
218-828-2880
Site Public Contact
218-828-2880
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Bemidji, Minnesota 56601
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota 56401
Brainerd, Minnesota 56401
Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
Deer River, Minnesota 56636
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota 56501
Detroit Lakes, Minnesota 56501
Essentia Health Cancer Center
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Miller-Dwan Hospital
Duluth, Minnesota 55805
Duluth, Minnesota 55805
Essentia Health - Ely Clinic
Ely, Minnesota 55731
Ely, Minnesota 55731
Contact:
Site Public Contact
218-365-7900
Site Public Contact
218-365-7900
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota 56537
Fergus Falls, Minnesota 56537
Essentia Health - Fosston
Fosston, Minnesota 56542
Fosston, Minnesota 56542
Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
Hibbing, Minnesota 55746
Contact:
Site Public Contact
218-786-3308
Site Public Contact
218-786-3308
Essentia Health - International Falls Clinic
International Falls, Minnesota 56649
International Falls, Minnesota 56649
Contact:
Site Public Contact
218-283-9431
Site Public Contact
218-283-9431
Essentia Health - Moose Lake Clinic
Moose Lake, Minnesota 55767
Moose Lake, Minnesota 55767
Contact:
Site Public Contact
218-485-4481
Site Public Contact
218-485-4481
Essentia Health - Park Rapids
Park Rapids, Minnesota 56470
Park Rapids, Minnesota 56470
Essentia Health Sandstone
Sandstone, Minnesota 55072
Sandstone, Minnesota 55072
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota 56701
Thief River Falls, Minnesota 56701
Contact:
Site Public Contact
605-312-3320
Site Public Contact
605-312-3320
Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Virginia, Minnesota 55792
Sanford Cancer Center Worthington
Worthington, Minnesota 56187
Worthington, Minnesota 56187
Contact:
Site Public Contact
605-312-3320
Site Public Contact
605-312-3320
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri 63011
Ballwin, Missouri 63011
Contact:
Site Public Contact
314-251-7058
Site Public Contact
314-251-7058
Central Care Cancer Center - Bolivar
Bolivar, Missouri 65613
Bolivar, Missouri 65613
Cox Cancer Center Branson
Branson, Missouri 65616
Branson, Missouri 65616
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Southeast Cancer Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-651-5550
Site Public Contact
573-651-5550
Parkland Health Center - Farmington
Farmington, Missouri 63640
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Capital Region Southwest Campus
Jefferson City, Missouri 65109
Jefferson City, Missouri 65109
Freeman Health System
Joplin, Missouri 64804
Joplin, Missouri 64804
Mercy Hospital Joplin
Joplin, Missouri 64804
Joplin, Missouri 64804
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Rolla, Missouri 65401
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-6379
Site Public Contact
573-458-6379
Heartland Regional Medical Center
Saint Joseph, Missouri 64506
Saint Joseph, Missouri 64506
Saint Louis Cancer and Breast Institute-South City
Saint Louis, Missouri 63109
Saint Louis, Missouri 63109
Contact:
Site Public Contact
314-353-1870
Site Public Contact
314-353-1870
Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066
Site Public Contact
314-251-7066
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Springfield
Springfield, Missouri 65804
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
CoxHealth South Hospital
Springfield, Missouri 65807
Springfield, Missouri 65807
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Washington
Washington, Missouri 63090
Washington, Missouri 63090
Contact:
Site Public Contact
636-390-1600
Site Public Contact
636-390-1600
CHI Health Saint Francis
Grand Island, Nebraska 68803
Grand Island, Nebraska 68803
Contact:
Site Public Contact
402-334-4773
Site Public Contact
402-334-4773
CHI Health Good Samaritan
Kearney, Nebraska 68847
Kearney, Nebraska 68847
Saint Elizabeth Regional Medical Center
Lincoln, Nebraska 68510
Lincoln, Nebraska 68510
Alegent Health Immanuel Medical Center
Omaha, Nebraska 68122
Omaha, Nebraska 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska 68124
Omaha, Nebraska 68124
Alegent Health Lakeside Hospital
Omaha, Nebraska 68130
Omaha, Nebraska 68130
Creighton University Medical Center
Omaha, Nebraska 68131
Omaha, Nebraska 68131
Midlands Community Hospital
Papillion, Nebraska 68046
Papillion, Nebraska 68046
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Basking Ridge, New Jersey 07920
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Hackensack University Medical Center
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Contact:
Site Public Contact
201-996-2879
Site Public Contact
201-996-2879
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Middletown, New Jersey 07748
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Montvale, New Jersey 07645
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Commack
Commack, New York 11725
Commack, New York 11725
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Glens Falls Hospital
Glens Falls, New York 12801
Glens Falls, New York 12801
Contact:
Site Public Contact
518-926-6700
Site Public Contact
518-926-6700
Memorial Sloan Kettering Westchester
Harrison, New York 10604
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
New York, New York 10016
Memorial Sloan Kettering Cancer Center
New York, New York 10065
New York, New York 10065
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
Uniondale, New York 11553
Contact:
Site Public Contact
212-639-7592
Site Public Contact
212-639-7592
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Bismarck, North Dakota 58501
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Sanford South University Medical Center
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Contact:
Site Public Contact
701-234-6161
Site Public Contact
701-234-6161
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota 58103
Fargo, North Dakota 58103
Contact:
Site Public Contact
605-312-3320
Site Public Contact
605-312-3320
Sanford Medical Center Fargo
Fargo, North Dakota 58104
Fargo, North Dakota 58104
Contact:
Site Public Contact
800-437-4010
Site Public Contact
800-437-4010
Sanford Broadway Medical Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Essentia Health - Jamestown Clinic
Jamestown, North Dakota 58401
Jamestown, North Dakota 58401
Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
Beavercreek, Ohio 45431
Strecker Cancer Center-Belpre
Belpre, Ohio 45714
Belpre, Ohio 45714
Saint Elizabeth Boardman Hospital
Boardman, Ohio 44512
Boardman, Ohio 44512
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
Centerville, Ohio 45459
Adena Regional Medical Center
Chillicothe, Ohio 45601
Chillicothe, Ohio 45601
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
Cincinnati, Ohio 45220
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio 45236
Cincinnati, Ohio 45236
Bethesda North Hospital
Cincinnati, Ohio 45242
Cincinnati, Ohio 45242
TriHealth Cancer Institute-Westside
Cincinnati, Ohio 45247
Cincinnati, Ohio 45247
TriHealth Cancer Institute-Anderson
Cincinnati, Ohio 45255
Cincinnati, Ohio 45255
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Columbus, Ohio 43210
Mount Carmel East Hospital
Columbus, Ohio 43213
Columbus, Ohio 43213
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio 43214
Columbus, Ohio 43214
Riverside Methodist Hospital
Columbus, Ohio 43214
Columbus, Ohio 43214
Grant Medical Center
Columbus, Ohio 43215
Columbus, Ohio 43215
The Mark H Zangmeister Center
Columbus, Ohio 43219
Columbus, Ohio 43219
Mount Carmel Health Center West
Columbus, Ohio 43222
Columbus, Ohio 43222
Doctors Hospital
Columbus, Ohio 43228
Columbus, Ohio 43228
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio 45415
Dayton, Ohio 45415
Delaware Health Center-Grady Cancer Center
Delaware, Ohio 43015
Delaware, Ohio 43015
Grady Memorial Hospital
Delaware, Ohio 43015
Delaware, Ohio 43015
Columbus Oncology and Hematology Associates
Dublin, Ohio 43016
Dublin, Ohio 43016
Dublin Methodist Hospital
Dublin, Ohio 43016
Dublin, Ohio 43016
Armes Family Cancer Center
Findlay, Ohio 45840
Findlay, Ohio 45840
Blanchard Valley Hospital
Findlay, Ohio 45840
Findlay, Ohio 45840
Orion Cancer Care
Findlay, Ohio 45840
Findlay, Ohio 45840
Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
Franklin, Ohio 45005
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio 43230
Gahanna, Ohio 43230
Dayton Physicians LLC-Wayne
Greenville, Ohio 45331
Greenville, Ohio 45331
Wayne Hospital
Greenville, Ohio 45331
Greenville, Ohio 45331
Mount Carmel Grove City Hospital
Grove City, Ohio 43123
Grove City, Ohio 43123
Greater Dayton Cancer Center
Kettering, Ohio 45409
Kettering, Ohio 45409
Kettering Medical Center
Kettering, Ohio 45429
Kettering, Ohio 45429
Fairfield Medical Center
Lancaster, Ohio 43130
Lancaster, Ohio 43130
Saint Rita's Medical Center
Lima, Ohio 45801
Lima, Ohio 45801
Contact:
Site Public Contact
419-226-9617
Site Public Contact
419-226-9617
OhioHealth Mansfield Hospital
Mansfield, Ohio 44903
Mansfield, Ohio 44903
Marietta Memorial Hospital
Marietta, Ohio 45750
Marietta, Ohio 45750
OhioHealth Marion General Hospital
Marion, Ohio 43302
Marion, Ohio 43302
Knox Community Hospital
Mount Vernon, Ohio 43050
Mount Vernon, Ohio 43050
Licking Memorial Hospital
Newark, Ohio 43055
Newark, Ohio 43055
Newark Radiation Oncology
Newark, Ohio 43055
Newark, Ohio 43055
Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio 43551
Perrysburg, Ohio 43551
Southern Ohio Medical Center
Portsmouth, Ohio 45662
Portsmouth, Ohio 45662
Springfield Regional Cancer Center
Springfield, Ohio 45504
Springfield, Ohio 45504
Springfield Regional Medical Center
Springfield, Ohio 45505
Springfield, Ohio 45505
Saint Vincent Mercy Medical Center
Toledo, Ohio 43608
Toledo, Ohio 43608
Mercy Health - Saint Anne Hospital
Toledo, Ohio 43623
Toledo, Ohio 43623
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio 43623
Toledo, Ohio 43623
Contact:
Site Public Contact
800-444-3561
Site Public Contact
800-444-3561
Dayton Physicians LLC-Upper Valley
Troy, Ohio 45373
Troy, Ohio 45373
Saint Joseph Warren Hospital
Warren, Ohio 44484
Warren, Ohio 44484
Saint Ann's Hospital
Westerville, Ohio 43081
Westerville, Ohio 43081
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio 44501
Youngstown, Ohio 44501
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio 43701
Zanesville, Ohio 43701
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Oklahoma City, Oklahoma 73120
Contact:
Site Public Contact
405-752-3402
Site Public Contact
405-752-3402
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
Allentown, Pennsylvania 18103
Lehigh Valley Hospital - Muhlenberg
Bethlehem, Pennsylvania 18017
Bethlehem, Pennsylvania 18017
Geisinger Medical Center
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
Pocono Medical Center
East Stroudsburg, Pennsylvania 18301
East Stroudsburg, Pennsylvania 18301
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania 18201
Hazleton, Pennsylvania 18201
Lehigh Valley Hospital-Hazleton
Hazleton, Pennsylvania 18201
Hazleton, Pennsylvania 18201
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Lewisburg, Pennsylvania 17837
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania 17901
Pottsville, Pennsylvania 17901
Community Medical Center
Scranton, Pennsylvania 18510
Scranton, Pennsylvania 18510
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina 29341
Gaffney, South Carolina 29341
Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
Greer, South Carolina 29651
North Grove Medical Park
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
Contact:
Site Public Contact
864-560-6812
Site Public Contact
864-560-6812
Spartanburg Medical Center
Spartanburg, South Carolina 29303
Spartanburg, South Carolina 29303
Spartanburg Medical Center - Mary Black Campus
Spartanburg, South Carolina 29307
Spartanburg, South Carolina 29307
Contact:
Site Public Contact
864-560-6812
Site Public Contact
864-560-6812
MGC Hematology Oncology-Union
Union, South Carolina 29379
Union, South Carolina 29379
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Sioux Falls, South Dakota 57117-5134
Saint Joseph Regional Cancer Center
Bryan, Texas 77802
Bryan, Texas 77802
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont 05602
Berlin, Vermont 05602
Contact:
Site Public Contact
802-225-5400
Site Public Contact
802-225-5400
University of Vermont Medical Center
Burlington, Vermont 05401
Burlington, Vermont 05401
University of Vermont and State Agricultural College
Burlington, Vermont 05405
Burlington, Vermont 05405
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington 98310
Bremerton, Washington 98310
Harrison Medical Center
Bremerton, Washington 98310
Bremerton, Washington 98310
Highline Medical Center-Main Campus
Burien, Washington 98166
Burien, Washington 98166
Saint Elizabeth Hospital
Enumclaw, Washington 98022
Enumclaw, Washington 98022
Saint Francis Hospital
Federal Way, Washington 98003
Federal Way, Washington 98003
Saint Clare Hospital
Lakewood, Washington 98499
Lakewood, Washington 98499
Jefferson Healthcare
Port Townsend, Washington 98368
Port Townsend, Washington 98368
Contact:
Site Public Contact
360-344-3091
Site Public Contact
360-344-3091
Franciscan Research Center-Northwest Medical Plaza
Tacoma, Washington 98405
Tacoma, Washington 98405
Duluth Clinic Ashland
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Northwest Wisconsin Cancer Center
Ashland, Wisconsin 54806
Ashland, Wisconsin 54806
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin 54729
Chippewa Falls, Wisconsin 54729
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Essentia Health-Hayward Clinic
Hayward, Wisconsin 54843
Hayward, Wisconsin 54843
Marshfield Clinic - Ladysmith Center
Ladysmith, Wisconsin 54848
Ladysmith, Wisconsin 54848
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Marshfield, Wisconsin 54449
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
Minocqua, Wisconsin 54548
ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
Mukwonago, Wisconsin 53149
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
Oconomowoc, Wisconsin 53066
Contact:
Site Public Contact
262-928-7878
Site Public Contact
262-928-7878
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
Rice Lake, Wisconsin 54868
Essentia Health-Spooner Clinic
Spooner, Wisconsin 54801
Spooner, Wisconsin 54801
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Stevens Point, Wisconsin 54482
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin 54880
Superior, Wisconsin 54880
Contact:
Site Public Contact
701-364-6272
Site Public Contact
701-364-6272
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin 53188
Waukesha, Wisconsin 53188
Contact:
Site Public Contact
262-928-7632
Site Public Contact
262-928-7632
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
Waukesha, Wisconsin 53188
Marshfield Clinic-Wausau Center
Wausau, Wisconsin 54401
Wausau, Wisconsin 54401
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Weston, Wisconsin 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin 54494
Wisconsin Rapids, Wisconsin 54494
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming 82001
Cheyenne, Wyoming 82001
More Details
- NCT ID
- NCT04462406
- Status
- Recruiting
- Sponsor
- ECOG-ACRIN Cancer Research Group
Detailed Description
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 continue their standard of care anti-PD-1 therapy for 12 months 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.