Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)

NCT ID: NCT05096663

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-15

Study Completion Date

2027-12-01

Brief Summary

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This phase II/III Lung-MAP trial studies how well immunotherapy treatment with N-803 (ALT-803) and pembrolizumab working in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Natural killer cells, part of our immune system, are always on alert and ready to defend our bodies from many kinds of infection or rogue cells, such as those that cause cancer. N-803 (ALT-803) may activate natural killer cells so that they can stimulate an immune response to help fight cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving N-803 (ALT-803) and pembrolizumab may help shrink and stabilize lung cancer or prevent it from returning.

Detailed Description

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PRIMARY OBJECTIVES:

I. To compare overall survival (OS) between participants randomized to nogapendekin alfa (N-803 \[ALT-803\]) + pembrolizumab versus standard of care therapy. (Primary Resistance Cohort) II. To compare overall survival (OS) between participants randomized to N-803 (ALT-803) + pembrolizumab versus standard of care therapy. (Acquired Resistance Cohort)

SECONDARY OBJECTIVES:

I. To compare investigator assessed progression-free survival (IA-PFS) with confirmation of progression by immune response criteria between the treatment arms.

II. To compare investigator assessed progression-free survival (IA-PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between the treatment arms.

III. To compare the response rates between the arms. IV. To evaluate duration of response (DoR) among responders. V. To evaluate the frequency and severity of toxicities within each treatment arm.

TRANSLATIONAL MEDICINE OBJECTIVE:

I. To establish a blood repository to pursue future studies.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive standard of care consisting of docetaxel intravenously (IV) over 30-60 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; pemetrexed IV over 10 minutes on day 1; or ramucirumab IV over 30-60 minutes and docetaxel IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive pembrolizumab IV over 30 minutes and nogapendekin alfa subcutaneously (SC) on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients then receive nogapendekin alfa SC on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years.

Conditions

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Advanced Lung Non-Small Cell Carcinoma Recurrent Lung Non-Small Cell Carcinoma Stage III Lung Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A (standard of care)

Patients receive standard of care consisting of docetaxel IV over 30-60 minutes on day 1; gemcitabine IV over 30 minutes on days 1 and 8; pemetrexed IV over 10 minutes on day 1; or ramucirumab IV over 30-60 minutes and docetaxel IV over 30-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group Type ACTIVE_COMPARATOR

Cobalamin

Intervention Type DIETARY_SUPPLEMENT

Given intramuscularly

Dexamethasone

Intervention Type DRUG

Given orally (PO)

Docetaxel

Intervention Type DRUG

Given IV

Folic Acid

Intervention Type DIETARY_SUPPLEMENT

Given PO

Gemcitabine

Intervention Type DRUG

Given IV

Pemetrexed

Intervention Type DRUG

Given IV

Ramucirumab

Intervention Type BIOLOGICAL

Given IV

Arm B (pembrolizumab, nogapendekin alfa)

Patients receive pembrolizumab IV over 30 minutes and nogapendekin alfa SC on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients then receive nogapendekin alfa SC on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Nogapendekin Alfa

Intervention Type DRUG

Given SC

Pembrolizumab

Intervention Type BIOLOGICAL

Given IV

Interventions

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Cobalamin

Given intramuscularly

Intervention Type DIETARY_SUPPLEMENT

Dexamethasone

Given orally (PO)

Intervention Type DRUG

Docetaxel

Given IV

Intervention Type DRUG

Folic Acid

Given PO

Intervention Type DIETARY_SUPPLEMENT

Gemcitabine

Given IV

Intervention Type DRUG

Nogapendekin Alfa

Given SC

Intervention Type DRUG

Pembrolizumab

Given IV

Intervention Type BIOLOGICAL

Pemetrexed

Given IV

Intervention Type DRUG

Ramucirumab

Given IV

Intervention Type BIOLOGICAL

Other Intervention Names

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B12 Vitamin Cobalamin (1+) VIT B12 Vitamin B-12 Vitamin B12 Vitamin-B12 Aacidexam Adexone Aknichthol Dexa Alba-Dex Alin Alin Depot Alin Oftalmico Amplidermis Anemul mono Auricularum Auxiloson Baycadron Baycuten Baycuten N Cortidexason Cortisumman Decacort Decadrol Decadron Decadron DP Decalix Decameth Decasone R.p. Dectancyl Dekacort Deltafluorene Deronil Desamethasone Desameton Dexa-Mamallet Dexa-Rhinosan Dexa-Scheroson Dexa-sine Dexacortal Dexacortin Dexafarma Dexafluorene Dexalocal Dexamecortin Dexameth Dexamethasone Intensol Dexamethasonum Dexamonozon Dexapos Dexinoral Dexone Dinormon Dxevo Fluorodelta Fortecortin Gammacorten Hemady Hexadecadrol Hexadrol Lokalison-F Loverine Methylfluorprednisolone Millicorten Mymethasone Orgadrone Spersadex TaperDex Visumetazone ZoDex Docecad RP56976 Taxotere Taxotere Injection Concentrate 2-[4-[(2-amino-4-oxo-1H-pteridin-6-yl)methylamino]benzoyl]aminopentanedioic acid FA Folacin Pteroylmonoglutamic Acid Vitamin B9 Vitamin Bc dFdC dFdCyd Difluorodeoxycytidine ALT 803 ALT-803 ALT803 Fusion Protein Consisting of IL-15N72D and IL-15RaSu/FC IL-15N72D/IL-15Ra-Fc IL-15N72D:IL-15RaSu/Fc Fusion Complex N 803 N-803 N803 Superagonist Interleukin-15:Interleukin-15 Receptor AlphaSu/Fc Fusion Complex Alt-803 Keytruda Lambrolizumab MK-3475 SCH 900475 MTA Multitargeted Antifolate Pemfexy Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B Cyramza IMC-1121B LY3009806 Monoclonal Antibody HGS-ETR2

Eligibility Criteria

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Inclusion Criteria

* Participants must have been assigned to S1800D by the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC). Assignment to S1800D is determined by the LUNGMAP or S1400 protocol
* Participants must have measurable or non-measurable disease documented by computed tomography (CT) or magnetic resonance imaging (MRI). Measurable disease must be assessed within 28 days prior to randomization. Non-measurable disease must be assessed within 42 days prior to randomization. The CT from a combined positron emission tomography (PET)/CT may be used only if it is of diagnostic quality. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)
* Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to sub-study randomization
* Participants with spinal cord compression or brain metastases must have received local treatment to these metastases and remained clinically controlled and asymptomatic for at least 7 days following stereotactic radiation and/or 14 days following whole brain radiation, and prior to sub-study randomization
* Participants with spinal cord compression or brain metastases must not have residual neurological dysfunction, unless no further recovery is expected, and the participant has been stable on weaning doses of corticosteroids (=\< 10 mg daily prednisone or equivalent) prior to sub-study randomization
* Participants must have progressed (in the opinion of the treating investigator) following the most recent line of therapy for non-small cell lung cancer (NSCLC)
* Participants with a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists (e.g. EGFR, ALK gene fusions, ROS1, BRAF, RET, NTRK, and MET sensitizing mutations), must have previously received at least one of the approved therapy(s)
* Participants must have received exactly one line of anti-PD-1 or anti-PD-L1 therapy for advanced disease (stage IV or recurrent, or stage III in certain circumstances outlined below) given alone or in combination with platinum-based chemotherapy. Participants must have experienced disease progression during or after this regimen

* Continuing the same agent(s) after progression counts as a single line of therapy. However, a change or addition in agent(s) after progression (e.g. the addition of chemotherapy to anti-PD-1 monotherapy after progression) counts as a subsequent line of therapy and would exclude the participant
* For participants who received consolidation anti-PD-1 or anti-PD-L1 therapy following concurrent chemoradiation for Stage III disease as their only line of anti-PD-1 or anti-PD-L1 therapy:

* If they experienced disease progression less than (\<) 365 days from the first date of anti-PD-1 or anti-PD-L1 therapy, this counts as the single line of anti-PD-1 or anti-PD-L1 therapy for advanced disease
* If they experienced disease progression more than or equal to (\>=) 365 days from the first date of anti-PD-1 or anti-PD-L1 therapy, this is not considered a line of anti-PD-1 or anti-PD-L1 therapy for advanced disease
* Participants must have recovered (=\< grade 1) from any side effects of prior therapy, except for alopecia
* Participants must be able to safely receive at least one of the investigator's choice of standard of care regimens, per the current FDA-approved package insert

* Note: Pemetrexed is not FDA-approved for squamous cell NSCLC and must not be used to treat participants with squamous cell NSCLC
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^3/uL (obtained within 28 days prior to sub-study randomization)
* Platelet count \>= 100 x 10\^3/uL(obtained within 28 days prior to sub-study randomization)
* Hemoglobin \>= 9 g/dL (obtained within 28 days prior to sub-study randomization)
* Serum bilirubin =\< institutional upper limit of normal (IULN) (within 28 days prior to sub-study randomization). For participants with liver metastases, bilirubin must be =\< 5 x IULN
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2 x IULN (within 28 days prior to sub-study randomization). For participants with liver metastases, ALT and AST must be =\< 5 x IULN
* Serum creatinine =\< the IULN or calculated creatinine clearance \>= 50 mL/min using Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to sub-study randomization
* Participants' most recent Zubrod performance status must be 0-1 and be documented within 28 days prior to sub-study randomization
* Participants must have history and physical exam must be obtained within 28 days prior to sub-study randomization
* Participants with known human immunodeficiency virus (HIV) infection must be receiving anti-retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to sub-study randomization
* Participants must also be offered participation in banking and in the correlative studies for collection and future use of specimens
* Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

* Participants must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines

Exclusion Criteria

* Participants must not have leptomeningeal disease that requires CNS-specific treatment prior to registration and must not be planning to receive the CNS-specific treatment through the first cycle of the protocol therapy
* Participants must not have experienced the following:

* Any grade 3 or worse immune-related adverse event (irAE). Exception: asymptomatic nonbullous/nonexfoliative rash
* Any unresolved grade 2 irAE
* Any toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy
* Exception to the above: Toxicities of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are allowed
* Participants must not have any history of organ transplant that requires use of immunosuppressives
* Participants must not have history of (non-infectious) pneumonitis that required steroids or current pneumonitis/interstitial lung disease
* Participants must not have any known allergy or reaction to any component of the investigational formulations. If there is a known allergy or reaction to standard of care formulations, participants must be able to safely receive at least one of the standard of care options
* Participants must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., participants with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months prior to sub-study randomization, or serious uncontrolled cardiac arrhythmia
* Participants must not have experienced any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to sub-study randomization
* Participants must not have an active or uncontrolled infection in the opinion of the treating investigator
* Participants must not have a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participants must not have any of following:

* Cirrhosis at a level of Child-Pugh B (or worse)
* Cirrhosis (any degree) and a history of hepatic encephalopathy
* Or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
* Participants must not have received anti-CTLA4 therapy (e.g. ipilimumab, tremelimumab), or other immune-modulatory therapy (e.g. anti-TIM-3, anti-LAG-3, anti-GITR, IL-2, IL-15)
* Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 21 days prior to sub-study randomization
* Participants must not have received any radiation therapy within 14 days prior to sub-study randomization
* Participants must not have received nitrosoureas or mitomycin-c within 42 days prior to sub-study randomization
* Participants must not have received systemic treatment with corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 7 days prior to sub-study randomization. Inhaled or topical steroids, and adrenal replacement doses =\< 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease
* Participants must not have received a live attenuated vaccination within 28 days prior to sub-study randomization. All COVID-19 vaccines that have received Food and Drug Administration (FDA) approval or FDA emergency use authorization are acceptable
* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study
* Participants must not have had a major surgery within 14 days prior to sub-study randomization. Participant must have fully recovered from the effects of prior surgery in the opinion of the treating investigator
* Participants must not have an active autoimmune disease that has required systemic treatment within two years prior to sub-study randomization (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
* Participants must not have any history of primary immunodeficiency
* Participants must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method during the study and 4 months after completion of study treatment. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures during the study and 4 months after study completion
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John M Wrangle

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

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Veterans Administration Medical Center - Birmingham

Birmingham, Alabama, United States

Site Status

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Kaiser Permanente-Anaheim

Anaheim, California, United States

Site Status

PCR Oncology

Arroyo Grande, California, United States

Site Status

Sutter Auburn Faith Hospital

Auburn, California, United States

Site Status

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Site Status

Kaiser Permanente-Bellflower

Bellflower, California, United States

Site Status

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Site Status

Tower Cancer Research Foundation

Beverly Hills, California, United States

Site Status

Kaiser Permanente-Fontana

Fontana, California, United States

Site Status

Palo Alto Medical Foundation-Fremont

Fremont, California, United States

Site Status

Kaiser Permanente - Harbor City

Harbor City, California, United States

Site Status

Kaiser Permanente-Irvine

Irvine, California, United States

Site Status

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status

Kaiser Permanente West Los Angeles

Los Angeles, California, United States

Site Status

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Memorial Medical Center

Modesto, California, United States

Site Status

Kaiser Permanente-Oakland

Oakland, California, United States

Site Status

Kaiser Permanente-Ontario

Ontario, California, United States

Site Status

Palo Alto Medical Foundation Health Care

Palo Alto, California, United States

Site Status

Kaiser Permanente - Panorama City

Panorama City, California, United States

Site Status

Eisenhower Medical Center

Rancho Mirage, California, United States

Site Status

Kaiser Permanente-Riverside

Riverside, California, United States

Site Status

Kaiser Permanente-Roseville

Roseville, California, United States

Site Status

Sutter Roseville Medical Center

Roseville, California, United States

Site Status

Kaiser Permanente Downtown Commons

Sacramento, California, United States

Site Status

Sutter Medical Center Sacramento

Sacramento, California, United States

Site Status

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

Kaiser Permanente-San Diego Zion

San Diego, California, United States

Site Status

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Site Status

Kaiser Permanente-San Francisco

San Francisco, California, United States

Site Status

Veterans Affairs Medical Center - San Francisco

San Francisco, California, United States

Site Status

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Site Status

Kaiser Permanente San Leandro

San Leandro, California, United States

Site Status

Kaiser Permanente-San Marcos

San Marcos, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, United States

Site Status

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Site Status

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Site Status

Torrance Memorial Physician Network - Cancer Care

Torrance, California, United States

Site Status

Kaiser Permanente-Vallejo

Vallejo, California, United States

Site Status

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Site Status

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

Site Status

Presbyterian Intercommunity Hospital

Whittier, California, United States

Site Status

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

Site Status

Veterans Affairs Connecticut Healthcare System-West Haven Campus

West Haven, Connecticut, United States

Site Status

Bayhealth Hospital Kent Campus

Dover, Delaware, United States

Site Status

Beebe South Coastal Health Campus

Frankford, Delaware, United States

Site Status

Bayhealth Hospital Sussex Campus

Milford, Delaware, United States

Site Status

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Site Status

Kaiser Permanente-Capitol Hill Medical Center

Washington D.C., District of Columbia, United States

Site Status

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

Northside Hospital

Atlanta, Georgia, United States

Site Status

Northside Hospital - Duluth

Duluth, Georgia, United States

Site Status

Northeast Georgia Medical Center-Gainesville

Gainesville, Georgia, United States

Site Status

Northside Hospital - Gwinnett

Lawrenceville, Georgia, United States

Site Status

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Site Status

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Site Status

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

Site Status

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status

Centralia Oncology Clinic

Centralia, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Carle on Vermilion

Danville, Illinois, United States

Site Status

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Site Status

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status

Edward Hines Jr VA Hospital

Hines, Illinois, United States

Site Status

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Site Status

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status

Mercyhealth Javon Bea Hospital - Rockton

Rockford, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Springfield Clinic

Springfield, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

The Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

Illinois CancerCare - Washington

Washington, Illinois, United States

Site Status

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Mary Greeley Medical Center

Ames, Iowa, United States

Site Status

McFarland Clinic PC - Ames

Ames, Iowa, United States

Site Status

University of Iowa Healthcare Cancer Services Quad Cities

Bettendorf, Iowa, United States

Site Status

McFarland Clinic PC-Boone

Boone, Iowa, United States

Site Status

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Site Status

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Site Status

Greater Regional Medical Center

Creston, Iowa, United States

Site Status

Mission Cancer and Blood - Laurel

Des Moines, Iowa, United States

Site Status

McFarland Clinic PC-Trinity Cancer Center

Fort Dodge, Iowa, United States

Site Status

McFarland Clinic PC-Jefferson

Jefferson, Iowa, United States

Site Status

McFarland Clinic PC-Marshalltown

Marshalltown, Iowa, United States

Site Status

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

Site Status

HaysMed University of Kansas Health System

Hays, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Olathe Health Cancer Center

Olathe, Kansas, United States

Site Status

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

Site Status

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States

Site Status

Salina Regional Health Center

Salina, Kansas, United States

Site Status

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, United States

Site Status

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Site Status

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Site Status

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Site Status

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status

Owensboro Health Mitchell Memorial Cancer Center

Owensboro, Kentucky, United States

Site Status

Louisiana Hematology Oncology Associates LLC

Baton Rouge, Louisiana, United States

Site Status

Harold Alfond Center for Cancer Care

Augusta, Maine, United States

Site Status

MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford

Biddeford, Maine, United States

Site Status

Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States

Site Status

MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford

Sanford, Maine, United States

Site Status

Kaiser Permanente-Woodlawn Medical Center

Baltimore, Maryland, United States

Site Status

UPMC Western Maryland

Cumberland, Maryland, United States

Site Status

Kaiser Permanente-Gaithersburg Medical Center

Gaithersburg, Maryland, United States

Site Status

Kaiser Permanente - Kensington Medical Center

Kensington, Maryland, United States

Site Status

Kaiser Permanente - Largo Medical Center

Largo, Maryland, United States

Site Status

William E Kahlert Regional Cancer Center/Sinai Hospital

Westminster, Maryland, United States

Site Status

Beverly Hospital

Beverly, Massachusetts, United States

Site Status

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Site Status

Addison Gilbert Hospital

Gloucester, Massachusetts, United States

Site Status

Lahey Medical Center-Peabody

Peabody, Massachusetts, United States

Site Status

UMass Memorial Medical Center - University Campus

Worcester, Massachusetts, United States

Site Status

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

Bronson Battle Creek

Battle Creek, Michigan, United States

Site Status

Saint Joseph Mercy Brighton

Brighton, Michigan, United States

Site Status

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Site Status

Saint Joseph Mercy Canton

Canton, Michigan, United States

Site Status

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Site Status

Saint Joseph Mercy Chelsea

Chelsea, Michigan, United States

Site Status

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Site Status

Ascension Saint John Hospital

Detroit, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Doctors Park

East China Township, Michigan, United States

Site Status

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, United States

Site Status

Genesee Hematology Oncology PC

Flint, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Academic Hematology Oncology Specialists

Grosse Pointe Woods, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, United States

Site Status

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Ascension Borgess Cancer Center

Kalamazoo, Michigan, United States

Site Status

Sparrow Hospital

Lansing, Michigan, United States

Site Status

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Macomb Medical Campus

Macomb, Michigan, United States

Site Status

Ascension Providence Hospitals - Novi

Novi, Michigan, United States

Site Status

Ascension Saint Mary's Hospital

Saginaw, Michigan, United States

Site Status

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Site Status

Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Site Status

Ascension Providence Hospitals - Southfield

Southfield, Michigan, United States

Site Status

Bhadresh Nayak MD PC-Sterling Heights

Sterling Heights, Michigan, United States

Site Status

Ascension Saint Joseph Hospital

Tawas City, Michigan, United States

Site Status

Great Lakes Cancer Management Specialists-Macomb Professional Building

Warren, Michigan, United States

Site Status

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Site Status

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Site Status

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Site Status

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Site Status

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Site Status

Essentia Health Cancer Center

Duluth, Minnesota, United States

Site Status

Unity Hospital

Fridley, Minnesota, United States

Site Status

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Site Status

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Minneapolis VA Medical Center

Minneapolis, Minnesota, United States

Site Status

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

Essentia Health Sandstone

Sandstone, Minnesota, United States

Site Status

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status

Parkland Health Center - Farmington

Farmington, Missouri, United States

Site Status

Truman Medical Centers

Kansas City, Missouri, United States

Site Status

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

Site Status

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

Site Status

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, United States

Site Status

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Site Status

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

Site Status

Missouri Baptist Outpatient Center-Sunset Hills

Sunset Hills, Missouri, United States

Site Status

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Site Status

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Site Status

Renown Regional Medical Center

Reno, Nevada, United States

Site Status

New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Solinsky Center for Cancer Care

Manchester, New Hampshire, United States

Site Status

Virtua Samson Cancer Center

Moorestown, New Jersey, United States

Site Status

Virtua Voorhees

Voorhees Township, New Jersey, United States

Site Status

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status

Presbyterian Kaseman Hospital

Albuquerque, New Mexico, United States

Site Status

Memorial Medical Center - Las Cruces

Las Cruces, New Mexico, United States

Site Status

Presbyterian Rust Medical Center/Jorgensen Cancer Center

Rio Rancho, New Mexico, United States

Site Status

Mary Imogene Bassett Hospital

Cooperstown, New York, United States

Site Status

Cancer Institute at Saint Francis Hospital

East Hills, New York, United States

Site Status

Arnot Ogden Medical Center/Falck Cancer Center

Elmira, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Good Samaritan Hospital Medical Center

West Islip, New York, United States

Site Status

Randolph Hospital

Asheboro, North Carolina, United States

Site Status

AdventHealth Infusion Center Asheville

Asheville, North Carolina, United States

Site Status

Cone Health Cancer Center at Alamance Regional

Burlington, North Carolina, United States

Site Status

AdventHealth Infusion Center Haywood

Clyde, North Carolina, United States

Site Status

Durham VA Medical Center

Durham, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Cone Health Cancer Center

Greensboro, North Carolina, United States

Site Status

AdventHealth Hendersonville

Hendersonville, North Carolina, United States

Site Status

Cone Heath Cancer Center at Mebane

Mebane, North Carolina, United States

Site Status

FirstHealth of the Carolinas-Moore Regional Hospital

Pinehurst, North Carolina, United States

Site Status

Duke Women's Cancer Care Raleigh

Raleigh, North Carolina, United States

Site Status

Duke Raleigh Hospital

Raleigh, North Carolina, United States

Site Status

Annie Penn Memorial Hospital

Reidsville, North Carolina, United States

Site Status

AdventHealth Infusion Center Weaverville

Weaverville, North Carolina, United States

Site Status

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Site Status

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Site Status

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Site Status

Cleveland Clinic Mercy Hospital

Canton, Ohio, United States

Site Status

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Grant Medical Center

Columbus, Ohio, United States

Site Status

The Mark H Zangmeister Center

Columbus, Ohio, United States

Site Status

Doctors Hospital

Columbus, Ohio, United States

Site Status

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, United States

Site Status

Cleveland Clinic Cancer Center Mansfield

Mansfield, Ohio, United States

Site Status

OhioHealth Marion General Hospital

Marion, Ohio, United States

Site Status

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

Site Status

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status

Licking Memorial Hospital

Newark, Ohio, United States

Site Status

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Site Status

North Coast Cancer Care

Sandusky, Ohio, United States

Site Status

Springfield Regional Cancer Center

Springfield, Ohio, United States

Site Status

Springfield Regional Medical Center

Springfield, Ohio, United States

Site Status

Trinity's Tony Teramana Cancer Center

Steubenville, Ohio, United States

Site Status

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, United States

Site Status

ProMedica Flower Hospital

Sylvania, Ohio, United States

Site Status

South Pointe Hospital

Warrensville Heights, Ohio, United States

Site Status

Saint Ann's Hospital

Westerville, Ohio, United States

Site Status

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, United States

Site Status

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

Site Status

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status

Kaiser Permanente Northwest

Portland, Oregon, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

UPMC Altoona

Altoona, Pennsylvania, United States

Site Status

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center at Butler Health System

Butler, Pennsylvania, United States

Site Status

UPMC Camp Hill

Camp Hill, Pennsylvania, United States

Site Status

Carlisle Regional Cancer Center

Carlisle, Pennsylvania, United States

Site Status

WellSpan Medical Oncology and Hematology

Chambersburg, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center - Passavant - Cranberry

Cranberry Township, Pennsylvania, United States

Site Status

Ephrata Cancer Center

Ephrata, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, United States

Site Status

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, United States

Site Status

Adams Cancer Center

Gettysburg, Pennsylvania, United States

Site Status

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, United States

Site Status

Oncology Hematology Associates

Greenville, Pennsylvania, United States

Site Status

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, United States

Site Status

IRMC Cancer Center

Indiana, Pennsylvania, United States

Site Status

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Johnstown, Pennsylvania, United States

Site Status

Sechler Family Cancer Center

Lebanon, Pennsylvania, United States

Site Status

UPMC Cancer Center at UPMC McKeesport

McKeesport, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center - Monroeville

Monroeville, Pennsylvania, United States

Site Status

UPMC-Coraopolis/Heritage Valley Radiation Oncology

Moon Township, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center - Part of Frick Hospital

Mount Pleasant, Pennsylvania, United States

Site Status

Arnold Palmer Cancer Center Medical Oncology Norwin

N. Huntingdon, Pennsylvania, United States

Site Status

UPMC Cancer Center-Natrona Heights

Natrona Heights, Pennsylvania, United States

Site Status

UPMC Hillman Cancer Center - New Castle

New Castle, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

Site Status

UPMC-Mercy Hospital

Pittsburgh, Pennsylvania, United States

Site Status

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, United States

Site Status

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Pottstown Hospital

Pottstown, Pennsylvania, United States

Site Status

UPMC Cancer Center at UPMC Northwest

Seneca, Pennsylvania, United States

Site Status

UPMC Cancer Center-Uniontown

Uniontown, Pennsylvania, United States

Site Status

UPMC Cancer Center-Washington

Washington, Pennsylvania, United States

Site Status

UPMC West Mifflin-Cancer Center Jefferson

West Mifflin, Pennsylvania, United States

Site Status

Divine Providence Hospital

Williamsport, Pennsylvania, United States

Site Status

Cancer Care Associates of York

York, Pennsylvania, United States

Site Status

WellSpan Health-York Cancer Center

York, Pennsylvania, United States

Site Status

WellSpan Health-York Hospital

York, Pennsylvania, United States

Site Status

UPMC Memorial

York, Pennsylvania, United States

Site Status

AnMed Health Cancer Center

Anderson, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina, United States

Site Status

Ralph H Johnson VA Medical Center

Charleston, South Carolina, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Easley

Easley, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Faris

Greenville, South Carolina, United States

Site Status

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Greer

Greer, South Carolina, United States

Site Status

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina, United States

Site Status

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Site Status

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, United States

Site Status

Parkland Memorial Hospital

Dallas, Texas, United States

Site Status

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, United States

Site Status

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, United States

Site Status

Kaiser Permanente-Burke Medical Center

Burke, Virginia, United States

Site Status

Kaiser Permanente Tysons Corner Medical Center

McLean, Virginia, United States

Site Status

West Virginia University Charleston Division

Charleston, West Virginia, United States

Site Status

Edwards Comprehensive Cancer Center

Huntington, West Virginia, United States

Site Status

West Virginia University Healthcare

Morgantown, West Virginia, United States

Site Status

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Site Status

Aurora Cancer Care-Grafton

Grafton, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Site Status

Mercyhealth Hospital and Cancer Center - Janesville

Janesville, Wisconsin, United States

Site Status

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Site Status

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, United States

Site Status

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

Site Status

Aurora Medical Center in Summit

Summit, Wisconsin, United States

Site Status

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, United States

Site Status

Aurora West Allis Medical Center

West Allis, Wisconsin, United States

Site Status

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2021-09852

Identifier Type: REGISTRY

Identifier Source: secondary_id

S1800D

Identifier Type: OTHER

Identifier Source: secondary_id

S1800D

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180888

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S1800D

Identifier Type: -

Identifier Source: org_study_id

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