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Набира участници Фаза 2/3 NCT05058651

Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung

Фаза 2/3 – комбинирано изпитване
Заболявания: Advanced Extrapulmonary Neuroendocrine Carcinoma Metastatic Extrapulmonary Neuroendocrine Carcinoma Recurrent Extrapulmonary Neuroendocrine Carcinoma Unresectable Extrapulmonary Neuroendocrine Carcinoma

Спонсор: National Cancer Institute (NCI)

Налично на: БГ
Обобщение
This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone.
Описание
PRIMARY OBJECTIVES: I. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus induction platinum/etoposide alone (Arm 3). II. Compare the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2) versus induction platinum/etoposide alone (Arm 3). III. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2). SECONDARY OBJECTIVES: I. To compare overall survival (OS), measured from start of observation/maintenance, across arms. II. To compare progression free survival (PFS) (measured from randomization and measured from start of observation/maintenance) across arms. III. To compare objective response rate (ORR = confirmed and unconfirmed partial response \[PR\] + confirmed and unconfirmed complete response \[CR\]) across arms among patients with measurable disease at randomization. IV. To compare clinical benefit rate (CBR = confirmed and unconfirmed PR + confirmed and unconfirmed CR + stable disease \[SD\]) across arms among patients with measurable disease at randomization. V. To compare duration of response (DOR) across arms. VI. To evaluate the safety and tolerability of each arm. ADDITIONAL OBJECTIVE: I. To bank tumor and blood samples for future biomarker correlative studies. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: During induction phase, patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. During maintenance phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. ARM II: During induction phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year. ARM III: During induction phase, patients receive carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year. Patients in all arms also undergo compute tomography (CT) scan and/or magnetic resonance imaging (MRI) throughout the trial and blood sample collection on s
Кой може да участва
Inclusion Criteria: * Participants must have histologically-confirmed (local site pathological confirmation sufficient) extrapulmonary poorly differentiated, neuroendocrine carcinoma (NEC) * Participants must have disease that is unresectable or metastatic and not eligible for definitive therapy as deemed per the treating investigator * Participants must have radiologically evaluable disease, measurable or non-measurable, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. All measurable and nonmeasurable lesions must be assessed by CT scan with IV contrast of the chest/abdomen/and pelvis (or CT chest without contrast and MRI abdomen/pelvis with gadolinium contrast, if contraindication to CT iodinated contrast) within 28 days prior to registration. While may be used for routine clinical evaluation, PET scans and bone scans alone are not acceptable for disease assessment while participating in this study. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form * Participants must have brain MRI (or CT head with contrast if there is contraindication to MRI brain) if clinically indicated within 28 days prior to registration. Note: Brain imaging is not required in participants without known and/or clinical concern for brain metastases. Participants with asymptomatic central nervous system (CNS) metastases are eligible if one or more of the following apply: * Participants who have received treatment for brain metastases must have: * No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration * Discontinued all corticosteroids at least 14 days prior to registration * Participants with treatment-naive brain lesions must have: * No lesion measuring \> 2.0 cm in size in any axis * MRI brain or CT head with contrast (if there is contraindication to MRI brain) demonstrating no evidence for mass effect, edema, or other impending neurological compromise within 28 days prior to registration * No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration * No need for \> 2 mg of dexamethasone (or equivalent of \> 10 mg prednisone) per day at time of registration * Participants must not have symptomatic central nervous system (CNS) metastases * Participants must not have known or suspected leptomeningeal disease * Participants with prior history of non-metastatic (localized/locally advanced disease) extrapulmonary poorly differentiated NEC may have had prior platinum-based therapy +/- radiation +/- surgery provided that all therapy was completed \>= 6 months prior to registration * Participants must discontinue denosumab prior to study registration and plan to replace with a bisphosphonate while on the study * Participants must not have had prior treatment for advanced or metastatic NEC EXCEPT one cycle of platinum (carboplatin/cisplatin) + etoposide is allowed prior to registration. Other chemotherapy regimens are not allowed. For participants with prostate or urothelial NEC, prior chemotherapy for the non-NEC component (e.g. adenocarcinoma or urothelial) is allowed as long as such therapy was completed \>= 24 weeks prior to registration and participants have recovered from all prior toxicities to =\< grade 1. * Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, antiPD-L2, CD137 agonists, anti-CTLA-4 agent, or any other immune checkpoint inhibitors for any neuroendocrine neoplasm. Immune checkpoint inhibitors given for other cancer indications are allowed provided last therapy was given at least 12 months prior to study registration * Participants must not have received treatment with systemic immunostimulatory agents including, but not limited to, interferon and interleukin2 \[IL-2\] within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to registration * Participants must not have had history of known severe allergy, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies, including to Chinese hamster ovary cell products or to any component of the atezolizumab formulation, cisplatin, carboplatin, or etoposide * Participants must not be on active systemic therapy for another cancer with the exception of hormonal therapy including androgen deprivation therapy (e.g., gonadotropin-releasing hormone \[GnRH\] agonists or antagonists), which can be continued while participants are receiving protocol therapy. Use of enzalutamide or apalutamide is permitted after completion of chemotherapy and must be held during chemotherapy for participants receiving prior to enrollment. Use of darolutamide is permitted during chemotherapy. Glucocorticoid-containing regimens, including abiraterone, are not permitted. * Participants must be \>= 18 years of age * Participants must have a Zubrod performance status of =\< 2 within 28 days prior to registration * Participants must have a complete medical history and physical exam within 28 days prior to registration * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9 /L (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests) * Hemoglobin \>= 9.0 g/dl (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests) * Platelet count \>= 100 x 10\^9/L (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests) * Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests) * Serum total bilirubin =\< 1.5 x ULN (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests) * Adequate renal function as defined by any 1 of the following: 1) Measured creatinine clearance (CL) \> 50 mL/min OR 2) Calculated creatinine CL \> 50 mL/min by the Cockcroft-Gault formula OR by 24-hour urine collection for determination of creatinine clearance (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests) * Participants must not have uncontrolled or symptomatic hypercalcemia (\> 1.5 mmol/L ionized calcium or calcium \> 12 mg/dL or corrected serum calcium \> ULN) within 14 days prior to registration. Participants who have asymptomatic hypercalcemia are eligible provided that medical therapy to treat the hypercalcemia is planned * Participants must not have a diagnosis of immunodeficiency nor be receiving systemic steroid therapy (equivalent of \> 20 mg of hydrocortisone per day) or any other form of immunosuppressive therapy within 14 days prior to registration * Participants must not have active or history of autoimmune disease or immune deficiency, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis with the following exceptions: * Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study * Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met: * Rash must cover \< 10% of body surface area * Disease is well controlled at baseline and requires only low-potency topical corticosteroids * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months * Participants must not have history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. NOTE: History of radiation pneumonitis in the radiation field (fibrosis) is permitted * Participants must not have significant cardiovascular disease, such as New York Heart Association class II or greater cardiac disease, myocardial infarction within 3 months prior to registration, unstable arrythmias, or unstable angina * Participants must not have had a major surgical procedure other than for diagnosis within 28 days prior to registration. Participant must not plan to receive a major surgical procedure during the course of protocol treatment. NOTE: Patient port placement is not considered a major surgery * Participants must not have severe infections (i.e., Common Terminology Criteria for Adverse Events \[CTCAE\] grade \>= 2) at time of registration, including but not limited to hospitalization for complications for infection, bacteremia, or severe pneumonia * Participants must not have known active tuberculosis * Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load, with testing performed as clinically indicated * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load, with testing performed as clinically indicated * Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load within 6 months of registration * Participants must not have prior allogeneic bone marrow transplantation or solid organ transplant * Participants must not have received administration of a live, attenuated vaccine (e.g., FluMist \[registered trademark\]) within 28 days prior to initiation of study treatment, during treatment with atezolizumab, and not plan to receive for 5 months after the last dose of atezolizumab * Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method (with details provided as a part of the consent process) during the treatment period and for 5 months after the final dose of atezolizumab. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a sideeffect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen * Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
Интервенции
Atezolizumab
BIOLOGICAL
Biospecimen Collection
PROCEDURE
Carboplatin
DRUG
Cisplatin
DRUG
Computed Tomography
PROCEDURE
Etoposide
DRUG
Magnetic Resonance Imaging
PROCEDURE
Patient Observation
OTHER
Места на провеждане 243
САЩ (243)
Hawaii Cancer Care - Westridge
‘Aiea , Hawaii
Pali Momi Medical Center
‘Aiea , Hawaii
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The Queen's Medical Center - West Oahu
‘Ewa Beach , Hawaii
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Mary Greeley Medical Center
Ames , Iowa
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McFarland Clinic - Ames
Ames , Iowa
Kaiser Permanente-Anaheim
Anaheim , California
Alaska Women's Cancer Care
Anchorage , Alaska
SUSPENDED
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny , Iowa
Site Public Contact
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor , Michigan
University of Michigan Rogel Cancer Center
Ann Arbor , Michigan
Sutter Auburn Faith Hospital
Auburn , California
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn , California
Rush-Copley Medical Center
Aurora , Illinois
Kaiser Permanente-Baldwin Park
Baldwin Park , California
LSU Health Baton Rouge-North Clinic
Baton Rouge , Louisiana
Our Lady of the Lake Physician Group
Baton Rouge , Louisiana
Bronson Battle Creek
Battle Creek , Michigan
Kaiser Permanente-Bellflower
Bellflower , California
Saint Charles Health System
Bend , Oregon
Alta Bates Summit Medical Center-Herrick Campus
Berkeley , California
Saint Vincent Frontier Cancer Center
Billings , Montana
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McFarland Clinic - Boone
Boone , Iowa
SUSPENDED
United Hospital Center
Bridgeport , West Virginia
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton , Michigan
Trinity Health Medical Center - Brighton
Brighton , Michigan
Henry Ford Cancer Institute-Downriver
Brownstown , Michigan
Roswell Park Cancer Institute
Buffalo , New York
ACTIVE_NOT_RECRUITING
Lahey Hospital and Medical Center
Burlington , Massachusetts
Minnesota Oncology - Burnsville
Burnsville , Minnesota
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park , California
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton , Michigan
Trinity Health Medical Center - Canton
Canton , Michigan
Saint Francis Medical Center
Cape Girardeau , Missouri
Mercy Cancer Center - Carmichael
Carmichael , California
Mercy San Juan Medical Center
Carmichael , California
Saint Anthony Regional Hospital
Carroll , Iowa
Duke Cancer Center Cary
Cary , North Carolina
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Centralia Oncology Clinic
Centralia , Illinois
WellSpan Medical Oncology and Hematology
Chambersburg , Pennsylvania
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Medical University of South Carolina
Charleston , South Carolina
SUSPENDED
Carolinas Medical Center/Levine Cancer Institute
Charlotte , North Carolina
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Levine Cancer Institute-SouthPark
Charlotte , North Carolina
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Atrium Health University City/LCI-University
Charlotte , North Carolina
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Levine Cancer Institute-Ballantyne
Charlotte , North Carolina
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Chelsea Hospital
Chelsea , Michigan
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea , Michigan
Northwestern University
Chicago , Illinois
University of Chicago Comprehensive Cancer Center
Chicago , Illinois
Providence Cancer Institute Clackamas Clinic
Clackamas , Oregon
SUSPENDED
Southeastern Medical Oncology Center-Clinton
Clinton , North Carolina
Henry Ford Macomb Hospital-Clinton Township
Clinton Township , Michigan
Mercy Cancer Center-West Lakes
Clive , Iowa
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UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive , Iowa
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Ohio State University Comprehensive Cancer Center
Columbus , Ohio
Atrium Health Cabarrus/LCI-Concord
Concord , North Carolina
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Greater Regional Medical Center
Creston , Iowa
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UChicago Medicine Northwest Indiana
Crown Point , Indiana
UT Southwestern/Simmons Cancer Center-Dallas
Dallas , Texas
Parkland Memorial Hospital
Dallas , Texas
UT Southwestern Simmons Cancer Center - RedBird
Dallas , Texas
Carle at The Riverfront
Danville , Illinois
Corewell Health Dearborn Hospital
Dearborn , Michigan
Site Public Contact
Henry Ford Medical Center-Fairlane
Dearborn , Michigan
Cancer Care Specialists of Illinois - Decatur
Decatur , Illinois
Decatur Memorial Hospital
Decatur , Illinois
Northwestern Medicine Cancer Center Kishwaukee
DeKalb , Illinois
AdventHealth Porter
Denver , Colorado
Smilow Cancer Hospital-Derby Care Center
Derby , Connecticut
Iowa Methodist Medical Center
Des Moines , Iowa
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UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines , Iowa
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Broadlawns Medical Center
Des Moines , Iowa
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Mercy Medical Center - Des Moines
Des Moines , Iowa
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UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines , Iowa
Site Public Contact
Wayne State University/Karmanos Cancer Institute
Detroit , Michigan
ACTIVE_NOT_RECRUITING
Henry Ford Hospital
Detroit , Michigan
Henry Ford Health Saint John Hospital
Detroit , Michigan
Saint Luke's Hospital of Duluth
Duluth , Minnesota
ACTIVE_NOT_RECRUITING
Duke University Medical Center
Durham , North Carolina
Site Public Contact
Marshfield Medical Center-EC Cancer Center
Eau Claire , Wisconsin
Fairview Southdale Hospital
Edina , Minnesota
Carle Physician Group-Effingham
Effingham , Illinois
Crossroads Cancer Center
Effingham , Illinois
Mercy Cancer Center - Elk Grove
Elk Grove , California
Ephrata Cancer Center
Ephrata , Pennsylvania
Site Public Contact
Smilow Cancer Hospital Care Center-Fairfield
Fairfield , Connecticut
Weisberg Cancer Treatment Center
Farmington Hills , Michigan
ACTIVE_NOT_RECRUITING
Corewell Health Farmington Hills Hospital
Farmington Hills , Michigan
Site Public Contact
Cancer Hematology Centers - Flint
Flint , Michigan
Genesee Hematology Oncology PC
Flint , Michigan
SUSPENDED
Genesys Hurley Cancer Institute
Flint , Michigan
Hurley Medical Center
Flint , Michigan
Kaiser Permanente-Fontana
Fontana , California
McFarland Clinic - Trinity Cancer Center
Fort Dodge , Iowa
Site Public Contact
Holy Cross Hospital
Fort Lauderdale , Florida
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UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth , Texas
Palo Alto Medical Foundation-Fremont
Fremont , California
Levine Cancer Institute-Gaston
Gastonia , North Carolina
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Northwestern Medicine Cancer Center Delnor
Geneva , Illinois
Adams Cancer Center
Gettysburg , Pennsylvania
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Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury , Connecticut
Northwestern Medicine Glenview Outpatient Center
Glenview , Illinois
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Southeastern Medical Oncology Center-Goldsboro
Goldsboro , North Carolina
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids , Michigan
Trinity Health Grand Rapids Hospital
Grand Rapids , Michigan
Northwestern Medicine Grayslake Outpatient Center
Grayslake , Illinois
Site Public Contact
Smilow Cancer Hospital Care Center at Greenwich
Greenwich , Connecticut
Smilow Cancer Hospital Care Center - Guilford
Guilford , Connecticut
Kaiser Permanente South Bay
Harbor City , California
Smilow Cancer Hospital Care Center at Saint Francis
Hartford , Connecticut
Ingalls Memorial Hospital
Harvey , Illinois
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu , Hawaii
Queen's Cancer Cenrer - POB I
Honolulu , Hawaii
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Queen's Medical Center
Honolulu , Hawaii
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Straub Clinic and Hospital
Honolulu , Hawaii
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Queen's Cancer Center - Kuakini
Honolulu , Hawaii
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Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston , Texas
Ben Taub General Hospital
Houston , Texas
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Kaiser Permanente-Irvine
Irvine , California
Allegiance Health
Jackson , Michigan
Mayo Clinic in Florida
Jacksonville , Florida
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Southeastern Medical Oncology Center-Jacksonville
Jacksonville , North Carolina
McFarland Clinic - Jefferson
Jefferson , Iowa
SUSPENDED
Mercy Hospital Joplin
Joplin , Missouri
Bronson Methodist Hospital
Kalamazoo , Michigan
West Michigan Cancer Center
Kalamazoo , Michigan
Gundersen Lutheran Medical Center
La Crosse , Wisconsin
Northwestern Medicine Lake Forest Hospital
Lake Forest , Illinois
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing , Michigan
ACTIVE_NOT_RECRUITING
Cancer Centers of Southwest Oklahoma Research
Lawton , Oklahoma
Site Public Contact
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon , New Hampshire
Sechler Family Cancer Center
Lebanon , Pennsylvania
AdventHealth Littleton
Littleton , Colorado
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia , Michigan
Kaiser Permanente Los Angeles Medical Center
Los Angeles , California
Kaiser Permanente West Los Angeles
Los Angeles , California
McFarland Clinic - Marshalltown
Marshalltown , Iowa
Site Public Contact
Marshfield Medical Center-Marshfield
Marshfield , Wisconsin
Carle Physician Group-Mattoon/Charleston
Mattoon , Illinois
East Jefferson General Hospital
Metairie , Louisiana
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie , Louisiana
Medical College of Wisconsin
Milwaukee , Wisconsin
Site Public Contact
Abbott-Northwestern Hospital
Minneapolis , Minnesota
Hennepin County Medical Center
Minneapolis , Minnesota
Marshfield Medical Center - Minocqua
Minocqua , Wisconsin
Memorial Medical Center
Modesto , California
West Virginia University Healthcare
Morgantown , West Virginia
Palo Alto Medical Foundation-Camino Division
Mountain View , California
Trinity Health Muskegon Hospital
Muskegon , Michigan
Saint Alphonsus Cancer Care Center-Nampa
Nampa , Idaho
Vanderbilt University/Ingram Cancer Center
Nashville , Tennessee
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Yale University
New Haven , Connecticut
UC Comprehensive Cancer Center at Silver Cross
New Lenox , Illinois
University Medical Center New Orleans
New Orleans , Louisiana
Mount Sinai Hospital
New York , New York
ACTIVE_NOT_RECRUITING
Providence Newberg Medical Center
Newberg , Oregon
Corewell Health Lakeland Hospitals - Niles Hospital
Niles , Michigan
Site Public Contact
Carle BroMenn Medical Center
Normal , Illinois
Carle Cancer Institute Normal
Normal , Illinois
Yale-New Haven Hospital North Haven Medical Center
North Haven , Connecticut
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores , Michigan
Henry Ford Medical Center-Columbus
Novi , Michigan
Cancer Care Center of O'Fallon
O'Fallon , Illinois
University of Oklahoma Health Sciences Center
Oklahoma City , Oklahoma
Mercy Hospital Oklahoma City
Oklahoma City , Oklahoma
Site Public Contact
Kaiser Permanente-Ontario
Ontario , California
Providence Willamette Falls Medical Center
Oregon City , Oregon
Northwestern Medicine Orland Park
Orland Park , Illinois
University of Chicago Medicine-Orland Park
Orland Park , Illinois
Palo Alto Medical Foundation Health Care
Palo Alto , California
SUSPENDED
Kaiser Permanente - Panorama City
Panorama City , California
AdventHealth Parker
Parker , Colorado
Lahey Medical Center-Peabody
Peabody , Massachusetts
Cancer Center at Saint Joseph's
Phoenix , Arizona
Mayo Clinic Hospital in Arizona
Phoenix , Arizona
Site Public Contact
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst , North Carolina
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac , Michigan
Providence Portland Medical Center
Portland , Oregon
Providence Saint Vincent Medical Center
Portland , Oregon
Duke Cancer Center Raleigh
Raleigh , North Carolina
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Rapid City Regional Hospital
Rapid City , South Dakota
Corewell Health Reed City Hospital
Reed City , Michigan
Marshfield Medical Center-Rice Lake
Rice Lake , Wisconsin
UT Southwestern Clinical Center at Richardson/Plano
Richardson , Texas
Kaiser Permanente-Riverside
Riverside , California
Mayo Clinic in Rochester
Rochester , Minnesota
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Levine Cancer Institute-Rock Hill
Rock Hill , South Carolina
Site Public Contact
UW Health Carbone Cancer Center Rockford
Rockford , Illinois
Mercy Cancer Center - Rocklin
Rocklin , California
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville , California
Sutter Roseville Medical Center
Roseville , California
Corewell Health William Beaumont University Hospital
Royal Oak , Michigan
Site Public Contact
Mercy Cancer Center - Sacramento
Sacramento , California
Sutter Medical Center Sacramento
Sacramento , California
Dartmouth Cancer Center - North
Saint Johnsbury , Vermont
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph , Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph , Michigan
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park , Minnesota
Regions Hospital
Saint Paul , Minnesota
Huntsman Cancer Institute/University of Utah
Salt Lake City , Utah
Kaiser Permanente-San Diego Zion
San Diego , California
California Pacific Medical Center-Pacific Campus
San Francisco , California
Kaiser Permanente-San Marcos
San Marcos , California
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz , California
Sutter Pacific Medical Foundation
Santa Rosa , California
Fred Hutchinson Cancer Center
Seattle , Washington
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University of Washington Medical Center - Montlake
Seattle , Washington
Site Public Contact
Saint Francis Regional Medical Center
Shakopee , Minnesota
Atrium Health Cleveland/LCI-Cleveland
Shelby , North Carolina
Site Public Contact
Southern Illinois University School of Medicine
Springfield , Illinois
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Springfield Clinic
Springfield , Illinois
Site Public Contact
Springfield Memorial Hospital
Springfield , Illinois
CoxHealth South Hospital
Springfield , Missouri
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Mercy Hospital South
St Louis , Missouri
Smilow Cancer Hospital Care Center at Long Ridge
Stamford , Connecticut
Marshfield Medical Center-River Region at Stevens Point
Stevens Point , Wisconsin
Stony Brook University Medical Center
Stony Brook , New York
ACTIVE_NOT_RECRUITING
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale , California
Moffitt Cancer Center
Tampa , Florida
Toledo Clinic Cancer Centers-Toledo
Toledo , Ohio
SUSPENDED
Smilow Cancer Hospital-Torrington Care Center
Torrington , Connecticut
Munson Medical Center
Traverse City , Michigan
Corewell Health Beaumont Troy Hospital
Troy , Michigan
Site Public Contact
Smilow Cancer Hospital Care Center-Trumbull
Trumbull , Connecticut
Carle Cancer Center
Urbana , Illinois
Sutter Solano Medical Center/Cancer Center
Vallejo , California
Henry Ford Health Warren Hospital
Warren , Michigan
Northwestern Medicine Cancer Center Warrenville
Warrenville , Illinois
Smilow Cancer Hospital-Waterbury Care Center
Waterbury , Connecticut
Smilow Cancer Hospital Care Center - Waterford
Waterford , Connecticut
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee , Iowa
Site Public Contact
Henry Ford West Bloomfield Hospital
West Bloomfield , Michigan
Mercy Medical Center-West Lakes
West Des Moines , Iowa
Site Public Contact
Smilow Cancer Hospital Care Center - Westerly
Westerly , Rhode Island
Marshfield Medical Center - Weston
Weston , Wisconsin
Woodland Memorial Hospital
Woodland , California
Kaiser Permanente-Woodland Hills
Woodland Hills , California
Henry Ford Wyandotte Hospital
Wyandotte , Michigan
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University of Michigan Health - West
Wyoming , Michigan
Cancer Care Associates of York
York , Pennsylvania
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WellSpan Health-York Cancer Center
York , Pennsylvania
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Rush-Copley Healthcare Center
Yorkville , Illinois
Huron Gastroenterology PC
Ypsilanti , Michigan
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti , Michigan
Технически детайли
Статус
Набира участници
Фаза
Фаза 2/3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
28.06.2022
Крайна дата
01.10.2028
Регистрационен номер
NCT05058651
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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