Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery

Study Purpose

This phase II trial tests whether nivolumab in combination with cabozantinib works in patients with mucosal melanoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving nivolumab in combination with cabozantinib could prevent cancer from returning.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - STEP 0 INCLUSION CRITERIA.
  • - Histologically proven mucosal melanoma by local pathology.
  • - Central PD-L1 tumor tissue submission.
  • - STEP 1 INCLUSION CRITERIA.
  • - Receipt of the central PD-L1 testing results available.
  • - Disease status-Resected R0 or R1 disease patients.
Patients eligible for randomization have resected R0 or R1 disease (with negative margins or positive microscopic margins) that must meet one of the following 4 criteria as defined below:
  • - Regional lymph node (LN) involvement; OR.
  • - In-transit metastases/satellite primary disease; OR.
  • - Single localized, primary disease meeting one of the following site-specific requirements: - Head/neck - Sinonasal (including nasopharynx): any primary lesion; Nasal or oral cavity; pT4a or above, given slightly improved OS.
  • - NOTE: Conjunctival: does not meet the qualification for eligibility.
  • - Anorectal - any primary lesion.
  • - Vaginal/cervical - any primary, as they have 5 year OS rates of 5-25.
  • - Urinary tract - any primary urethral or bladder tumor.
  • - Penile.
  • - Vulvar- AJCC cutaneous stage IIB or higher.
  • - Esophageal/gallbladder - any primary.
  • - Locoregionally recurrent following prior resection, meeting at least one of the above criteria.
  • - In addition, patients must have undergone cross-sectional imaging of the brain, chest, abdomen and pelvis with no evidence of distant metastatic disease.
  • - Disease status-Non-resected R2 or metastatic disease patients.
  • - Non-resected R2 or metastatic disease that is assessable and measurable radiographically or by physical examination.
  • - Prior Treatment: - No prior systemic checkpoint inhibitor therapy of mucosal melanoma, including in the adjuvant setting, is allowed.
Prior adjuvant chemotherapy or interferon is allowed.
  • - No other active, concurrent malignancy that requires ongoing systemic treatment or interferes with radiographic assessment of melanoma response as determined by the investigator.
Exceptions may allow for adjuvant no evidence of disease (NED) cancers undergoing hormone based therapy may be eligible pending the other eligibility criteria are met and the principal investigator (PI) affirms the hormonal agent would not change the melanoma response.
  • - Any radiation must have completed 28 days prior to randomization and the patient must have adequately recovered from its effects.
  • - For resectable patients only: Surgery must have completed 28 days prior to randomization.
  • - For resectable patients only: Surgery must have completed no more than 84 days prior to randomization.
  • - Not pregnant and not nursing, because this study has an agent that has known genotoxic, mutagenic and teratogenic effects.
Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required.
  • - Age >= 18 years.
  • - Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • - Absolute neutrophil count (ANC) >= 1,500/mm^3.
  • - Platelet count >= 100,000/mm^3.
  • - Creatinine =< 1.5 x upper limit of normal (ULN) OR creatinine clearance (CrCl) >= 50mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
  • - Albumin >= 2.8 g/dL.
  • - Total bilirubin =< 1.5 x upper limit of normal (ULN) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN) - No cardiovascular disease, including: - No history of acute coronary syndromes (including myocardial infarction and unstable angina), coronary artery bypass graft (CABG) coronary angioplasty, or stenting within 6 months prior to study entry.
  • - No history of current class II or higher congestive heart failure as defined by the New York Heart Association (NYHA) functional classification system.
  • - No refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg despite adequate attempts at anti-hypertensive therapy.
  • - No history of myocarditis.
  • - No history of syncope of cardiovascular etiology, uncontrolled cardiac arrhythmia, history of Mobitz II second degree or third degree heart block without a permanent pacemaker in Association (NYHA) class II to IV heart failure, or stroke/transient ischemic attack (TIA) within the past 3 months.
  • - No corrected QT interval by Fridericia's formula (QTcF) > 500 msec.
Note: if initial QTcF is found to be > 500 ms, two additional EKGs separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard.
  • - No underlying hematologic issues, including: - Congenital bleeding diathesis.
  • - Gastrointestinal (GI) bleeding requiring intervention within the past 6 months, unless directly related to mucosal melanoma.
  • - Active hemoptysis within 42 days prior to study enrollment.
  • - Active tumor lesions with cavitations or tumor lesions which invade, encase, or abut major blood vessels.
The anatomic location and characteristics of primary tumors or metastases as well as the medical history should be carefully reviewed in the selection of subjects for treatment with cabozantinib/placebo.
  • - Pulmonary emboli or deep vein thromboses (DVT) that require an active anticoagulation regimen.
  • - No known or suspected history of cytopenia (low white blood cell [WBC], hemoglobin or platelet count) of greater than 3 months duration with an unknown cause, myelodysplastic syndrome, or hematologic malignancies.
  • - No clinical, laboratory or radiographic evidence of an active bacterial, fungal, or viral infection requiring treatment at the time of pre-registration (e.g., active symptoms of COVID-19 infection or a post-infectious symptomatic autoimmune syndrome, serious bacterial infections requiring antibiotics).
  • - No known or suspected gastrointestinal disorder affecting absorption of oral medications.
  • - Comorbid conditions: - No active autoimmune disease or any condition requiring systemic treatment with either corticosteroids (> 10 mg daily of prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • - No history of autoimmune motor neuropathy (e.g., Guillain-Barre syndrome, myasthenia gravis) or non-infectious pneumonitis.
  • - No history of severe allergic reactions to an unknown allergen or any components of the study drugs or its excipients.
  • - No history of gastrointestinal perforation or abdominal fistula.
  • - No clinically suspected central nervous system (CNS) (leptomeningeal or parenchymal) metastases.
Patients with a history of CNS metastasis(s) will be allowed as long as.
  • - The metastatic site(s) were adequately treated as demonstrated by clinical and radiographic improvement, AND.
  • - The patient has recovered from the intervention (no residual adverse events > Common Terminology Criteria for Adverse Events [CTCAE] grade 1), AND.
  • - The patient has remained without occurrence of new or worsening CNS symptoms for a period of 28 days prior to enrollment.
  • - No history of seizure or any condition that may increase the patient's seizure risk (e.g., prior cortical stroke, significant brain trauma) within 2 years.
  • - No clinically active or chronic liver disease resulting in moderate/severe hepatic impairment (Child-Pugh class B or C), ascites, coagulopathy or bleeding due to liver dysfunction.
  • - No untreated spinal cord compression or evidence of spinal metastases with a risk of impending fracture or spinal cord compression.
Spinal metastases must have completed planned radiation or surgical therapy prior to registration.
  • - Concomitant medications: - Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study.
Patients on strong CYP3A4 inhibitors must discontinue the drug for 5 days prior to the start of study treatment.
  • - Chronic concomitant treatment with strong CYP3A4 inducers is not allowed.
Patients must discontinue the drug 5 days prior to the start of study treatment.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05111574
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Alexander N Shoushtari
Principal Investigator Affiliation Alliance for Clinical Trials in Oncology
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Anal Melanoma, Bladder Melanoma, Cervical Melanoma, Esophageal Melanoma, Gallbladder Melanoma, Mucosal Melanoma, Mucosal Melanoma of the Head and Neck, Mucosal Melanoma of the Urinary System, Nasopharyngeal Melanoma, Oral Cavity Mucosal Melanoma, Penile Mucosal Melanoma, Rectal Melanoma, Recurrent Mucosal Melanoma, Sinonasal Mucosal Melanoma, Stage II Vulvar Cancer AJCC v8, Stage III Vulvar Cancer AJCC v8, Stage IV Vulvar Cancer AJCC v8, Urethral Melanoma, Vaginal Melanoma, Vulvar Melanoma
Additional Details

PRIMARY OBJECTIVE:

  • I. To compare the efficacy of adjuvant nivolumab (480 mg every [q]4 weeks) versus nivolumab plus cabozantinib s-malate (cabozantinib) (40 mg daily) in patients with mucosal melanoma.
SECONDARY OBJECTIVES:
  • I. To compare overall survival between the two adjuvant therapies.
  • II. To evaluate the adverse effects in each arm.
  • III. To assess the correlation between PD-L1 expression in tumor cells with survival (recurrence free survival [RFS] and overall survival [OS]).
  • IV. To evaluate the overall response rate (ORR), duration of response (DOR), progression free survival (PFS), and OS of nivolumab plus cabozantinib in patients who cannot undergo gross total resection of disease or have metastatic disease at baseline.
  • V. Results of the primary analysis will be examined for consistency, while taking into account the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue.
OUTLINE: Patients whose tumor has been fully removed by surgery are randomized to Arm 1 or Arm 2. Patients whose tumor has not been fully removed by surgery or has spread are assigned to Arm 3. ARM 1: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 and cabozantinib orally (PO) once daily (QD) of each cycle. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. ARM 2: Patients receive nivolumab IV over 30 minutes on day 1 and placebo PO QD of each cycle. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. ARM 3: Patients receive nivolumab IV over 30 minutes and cabozantinib PO QD of each cycle. Treatment repeats every 28 days for up to 26 cycle in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiogram (ECHO) during screening and as clinically indicated throughout the trial. Patients may undergo computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT at baseline, CT and MRI may be repeated every 6 months on study. Additionally, patients may undergo stool sample collection at baseline, and blood and tissue sample collection at baseline and on the trial. After completion of study treatment, patients are followed up every 3 months until disease progression, and then every 6 months for up to 5 years from registration or until death.

Arms & Interventions

Arms

Experimental: Arm 1 (nivolumab, cabozantinib)

Patients receive nivolumab IV over 30 minutes on day 1 and cabozantinib PO QD of each cycle. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated throughout the trial. Patients may undergo CT, MRI, or PET/CT at baseline, CT and MRI may be repeated every 6 months on study. Additionally, patients may undergo stool sample collection at baseline, and blood and tissue sample collection at baseline and on the trial.

Active Comparator: Arm 2 (nivolumab, placebo)

Patients receive nivolumab IV over 30 minutes on day 1 and placebo PO QD of each cycle. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated throughout the trial. Patients may undergo CT, MRI, or PET/CT at baseline, CT and MRI may be repeated every 6 months on study. Additionally, patients may undergo stool sample collection at baseline, and blood and tissue sample collection at baseline and on the trial.

Experimental: Arm 3 (nivolumab, cabozantinib)

Patients receive nivolumab IV over 30 minutes and cabozantinib PO QD of each cycle. Treatment repeats every 28 days for up to 26 cycle in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO during screening and as clinically indicated throughout the trial. Patients may undergo CT, MRI, or PET/CT at baseline, CT and MRI may be repeated every 6 months on study. Additionally, patients may undergo stool sample collection at baseline, and blood and tissue sample collection at baseline and on the trial.

Interventions

Procedure: - Biospecimen Collection

Undergo blood, stool and tissue sample collection

Drug: - Cabozantinib S-malate

Given PO

Procedure: - Computed Tomography

Undergo CT

Procedure: - Echocardiography

Undergo ECHO

Procedure: - Magnetic Resonance Imaging

Undergo MRI

Biological: - Nivolumab

Given IV

Drug: - Placebo Administration

Given PO

Procedure: - Positron Emission Tomography

Undergo PET

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sutter Auburn Faith Hospital, Auburn, California

Status

Recruiting

Address

Sutter Auburn Faith Hospital

Auburn, California, 95602

Site Contact

Site Public Contact

NCIclinicaltrials@sutterhealth.org

Berkeley, California

Status

Recruiting

Address

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704

Site Contact

Site Public Contact

NCIclinicaltrials@sutterhealth.org

Palo Alto Medical Foundation-Fremont, Fremont, California

Status

Recruiting

Address

Palo Alto Medical Foundation-Fremont

Fremont, California, 94538

Site Contact

Site Public Contact

NCIclinicaltrials@sutterhealth.org

Keck Medicine of USC Koreatown, Los Angeles, California

Status

Recruiting

Address

Keck Medicine of USC Koreatown

Los Angeles, California, 90020

Site Contact

Site Public Contact

213-388-0908

Los Angeles General Medical Center, Los Angeles, California

Status

Recruiting

Address

Los Angeles General Medical Center

Los Angeles, California, 90033

Site Contact

Site Public Contact

uscnorrisinfo@med.usc.edu

323-865-0451

USC / Norris Comprehensive Cancer Center, Los Angeles, California

Status

Recruiting

Address

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

Site Contact

Site Public Contact

323-865-0451

Memorial Medical Center, Modesto, California

Status

Recruiting

Address

Memorial Medical Center

Modesto, California, 95355

Site Contact

Site Public Contact

NCIclinicaltrials@sutterhealth.org

Newport Beach, California

Status

Recruiting

Address

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663

Site Contact

Site Public Contact

323-865-0451

Palo Alto Medical Foundation Health Care, Palo Alto, California

Status

Recruiting

Address

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301

Site Contact

Site Public Contact

NCIclinicaltrials@sutterhealth.org

Stanford Cancer Institute Palo Alto, Palo Alto, California

Status

Recruiting

Address

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304

Site Contact

Site Public Contact

ccto-office@stanford.edu

650-498-7061

Sutter Roseville Medical Center, Roseville, California

Status

Recruiting

Address

Sutter Roseville Medical Center

Roseville, California, 95661

Site Contact

Site Public Contact

NCIclinicaltrials@sutterhealth.org

Sutter Medical Center Sacramento, Sacramento, California

Status

Recruiting

Address

Sutter Medical Center Sacramento

Sacramento, California, 95816

Site Contact

Site Public Contact

NCIclinicaltrials@sutterhealth.org

San Francisco, California

Status

Recruiting

Address

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94115

Site Contact

Site Public Contact

NCIclinicaltrials@sutterhealth.org

Palo Alto Medical Foundation-Santa Cruz, Santa Cruz, California

Status

Recruiting

Address

Palo Alto Medical Foundation-Santa Cruz

Santa Cruz, California, 95065

Site Contact

Site Public Contact

NCIclinicaltrials@sutterhealth.org

Palo Alto Medical Foundation-Sunnyvale, Sunnyvale, California

Status

Recruiting

Address

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, 94086

Site Contact

Site Public Contact

NCIclinicaltrials@sutterhealth.org

Vallejo, California

Status

Recruiting

Address

Sutter Solano Medical Center/Cancer Center

Vallejo, California, 94589

Site Contact

Site Public Contact

NCIclinicaltrials@sutterhealth.org

Aventura, Florida

Status

Recruiting

Address

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180

Site Contact

Site Public Contact

954-461-2180

Coral Gables, Florida

Status

Recruiting

Address

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146

Site Contact

Site Public Contact

305-243-2647

Deerfield Beach, Florida

Status

Recruiting

Address

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442

Site Contact

Site Public Contact

305-243-2647

Miami, Florida

Status

Recruiting

Address

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

Site Contact

Site Public Contact

305-243-2647

Plantation, Florida

Status

Recruiting

Address

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324

Site Contact

Site Public Contact

305-243-2647

Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho

Status

Suspended

Address

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706

Caldwell, Idaho

Status

Suspended

Address

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605

Kootenai Health - Coeur d'Alene, Coeur d'Alene, Idaho

Status

Recruiting

Address

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814

Site Contact

Site Public Contact

mccinfo@mtcancer.org

406-969-6060

Saint Alphonsus Cancer Care Center-Nampa, Nampa, Idaho

Status

Suspended

Address

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687

Post Falls, Idaho

Status

Recruiting

Address

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854

Site Contact

Site Public Contact

mccinfo@mtcancer.org

406-969-6060

Kootenai Cancer Clinic, Sandpoint, Idaho

Status

Recruiting

Address

Kootenai Cancer Clinic

Sandpoint, Idaho, 83864

Site Contact

Site Public Contact

mccinfo@mtcancer.org

406-969-6060

Rush - Copley Medical Center, Aurora, Illinois

Status

Recruiting

Address

Rush - Copley Medical Center

Aurora, Illinois, 60504

Site Contact

Site Public Contact

Cancer.Research@rushcopley.com

630-978-6212

Centralia Oncology Clinic, Centralia, Illinois

Status

Recruiting

Address

Centralia Oncology Clinic

Centralia, Illinois, 62801

Site Contact

Site Public Contact

morganthaler.jodi@mhsil.com

217-876-4762

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

Site Contact

Site Public Contact

cancer@northwestern.edu

312-695-1301

Carle at The Riverfront, Danville, Illinois

Status

Recruiting

Address

Carle at The Riverfront

Danville, Illinois, 61832

Site Contact

Site Public Contact

Research@Carle.com

800-446-5532

Decatur, Illinois

Status

Recruiting

Address

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

Site Contact

Site Public Contact

morganthaler.jodi@mhsil.com

217-876-4762

Decatur Memorial Hospital, Decatur, Illinois

Status

Recruiting

Address

Decatur Memorial Hospital

Decatur, Illinois, 62526

Site Contact

Site Public Contact

morganthaler.jodi@mhsil.com

217-876-4762

Carle Physician Group-Effingham, Effingham, Illinois

Status

Recruiting

Address

Carle Physician Group-Effingham

Effingham, Illinois, 62401

Site Contact

Site Public Contact

Research@carle.com

800-446-5532

Crossroads Cancer Center, Effingham, Illinois

Status

Recruiting

Address

Crossroads Cancer Center

Effingham, Illinois, 62401

Site Contact

Site Public Contact

morganthaler.jodi@mhsil.com

217-876-4762

Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois

Status

Recruiting

Address

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

Site Contact

Site Public Contact

Research@carle.com

800-446-5532

Cancer Care Center of O'Fallon, O'Fallon, Illinois

Status

Recruiting

Address

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

Site Contact

Site Public Contact

morganthaler.jodi@mhsil.com

217-876-4762

Springfield, Illinois

Status

Recruiting

Address

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

Site Contact

Site Public Contact

217-545-7929

Springfield Clinic, Springfield, Illinois

Status

Recruiting

Address

Springfield Clinic

Springfield, Illinois, 62702

Site Contact

Site Public Contact

800-444-7541

Memorial Medical Center, Springfield, Illinois

Status

Recruiting

Address

Memorial Medical Center

Springfield, Illinois, 62781

Site Contact

Site Public Contact

pallante.beth@mhsil.com

217-528-7541

Carle Cancer Center, Urbana, Illinois

Status

Recruiting

Address

Carle Cancer Center

Urbana, Illinois, 61801

Site Contact

Site Public Contact

Research@carle.com

800-446-5532

Rush-Copley Healthcare Center, Yorkville, Illinois

Status

Recruiting

Address

Rush-Copley Healthcare Center

Yorkville, Illinois, 60560

Site Contact

Site Public Contact

Cancer.Research@rushcopley.com

630-978-6212

Mary Greeley Medical Center, Ames, Iowa

Status

Recruiting

Address

Mary Greeley Medical Center

Ames, Iowa, 50010

Site Contact

Site Public Contact

515-956-4132

McFarland Clinic - Ames, Ames, Iowa

Status

Recruiting

Address

McFarland Clinic - Ames

Ames, Iowa, 50010

Site Contact

Site Public Contact

ksoder@mcfarlandclinic.com

515-239-4734

McFarland Clinic - Boone, Boone, Iowa

Status

Recruiting

Address

McFarland Clinic - Boone

Boone, Iowa, 50036

Site Contact

Site Public Contact

515-956-4132

McFarland Clinic - Trinity Cancer Center, Fort Dodge, Iowa

Status

Recruiting

Address

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501

Site Contact

Site Public Contact

515-956-4132

McFarland Clinic - Jefferson, Jefferson, Iowa

Status

Recruiting

Address

McFarland Clinic - Jefferson

Jefferson, Iowa, 50129

Site Contact

Site Public Contact

515-956-4132

McFarland Clinic - Marshalltown, Marshalltown, Iowa

Status

Recruiting

Address

McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158

Site Contact

Site Public Contact

515-956-4132

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Recruiting

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Site Contact

Site Public Contact

877-442-3324

Bronson Battle Creek, Battle Creek, Michigan

Status

Recruiting

Address

Bronson Battle Creek

Battle Creek, Michigan, 49017

Site Contact

Site Public Contact

crcwm-regulatory@crcwm.org

616-391-1230

Spectrum Health at Butterworth Campus, Grand Rapids, Michigan

Status

Recruiting

Address

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, 49503

Site Contact

Site Public Contact

crcwm-regulatory@crcwm.org

616-391-1230

Trinity Health Grand Rapids Hospital, Grand Rapids, Michigan

Status

Recruiting

Address

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503

Site Contact

Site Public Contact

crcwm-regulatory@crcwm.org

616-391-1230

Bronson Methodist Hospital, Kalamazoo, Michigan

Status

Recruiting

Address

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

Site Contact

Site Public Contact

crcwm-regulatory@crcwm.org

616-391-1230

West Michigan Cancer Center, Kalamazoo, Michigan

Status

Recruiting

Address

West Michigan Cancer Center

Kalamazoo, Michigan, 49007

Site Contact

Site Public Contact

crcwm-regulatory@crcwm.org

616-391-1230

Ascension Borgess Cancer Center, Kalamazoo, Michigan

Status

Recruiting

Address

Ascension Borgess Cancer Center

Kalamazoo, Michigan, 49009

Site Contact

Site Public Contact

crcwm-regulatory@crcwm.org

616-391-1230

Trinity Health Muskegon Hospital, Muskegon, Michigan

Status

Recruiting

Address

Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444

Site Contact

Site Public Contact

crcwm-regulatory@crcwm.org

616-391-1230

Norton Shores, Michigan

Status

Recruiting

Address

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, 49444

Site Contact

Site Public Contact

connie.szczepanek@crcwm.org

616-391-1230

Corewell Health Reed City Hospital, Reed City, Michigan

Status

Recruiting

Address

Corewell Health Reed City Hospital

Reed City, Michigan, 49677

Site Contact

Site Public Contact

crcwm-regulatory@crcwm.org

616-391-1230

Saint Joseph, Michigan

Status

Recruiting

Address

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085

Site Contact

Site Public Contact

crcwm-regulatory@crcwm.org

616-391-1230

Munson Medical Center, Traverse City, Michigan

Status

Recruiting

Address

Munson Medical Center

Traverse City, Michigan, 49684

Site Contact

Site Public Contact

crcwm-regulatory@crcwm.org

616-391-1230

University of Michigan Health - West, Wyoming, Michigan

Status

Recruiting

Address

University of Michigan Health - West

Wyoming, Michigan, 49519

Site Contact

Site Public Contact

crcwm-regulatory@crcwm.org

616-391-1230

Minnesota Oncology - Burnsville, Burnsville, Minnesota

Status

Recruiting

Address

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337

Site Contact

Site Public Contact

mmcorc@healthpartners.com

952-993-1517

Mercy Hospital, Coon Rapids, Minnesota

Status

Recruiting

Address

Mercy Hospital

Coon Rapids, Minnesota, 55433

Site Contact

Site Public Contact

mmcorc@healthpartners.com

952-993-1517

Fairview Southdale Hospital, Edina, Minnesota

Status

Recruiting

Address

Fairview Southdale Hospital

Edina, Minnesota, 55435

Site Contact

Site Public Contact

mmcorc@healthpartners.com

952-993-1517

Abbott-Northwestern Hospital, Minneapolis, Minnesota

Status

Recruiting

Address

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

Site Contact

Site Public Contact

mmcorc@healthpartners.com

952-993-1517

Mayo Clinic in Rochester, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Site Public Contact

855-776-0015

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota

Status

Recruiting

Address

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416

Site Contact

Site Public Contact

mmcorc@healthpartners.com

952-993-1517

Regions Hospital, Saint Paul, Minnesota

Status

Recruiting

Address

Regions Hospital

Saint Paul, Minnesota, 55101

Site Contact

Site Public Contact

mmcorc@healthpartners.com

952-993-1517

United Hospital, Saint Paul, Minnesota

Status

Recruiting

Address

United Hospital

Saint Paul, Minnesota, 55102

Site Contact

Site Public Contact

mmcorc@healthpartners.com

952-993-1517

Parkland Health Center - Farmington, Farmington, Missouri

Status

Recruiting

Address

Parkland Health Center - Farmington

Farmington, Missouri, 63640

Site Contact

Site Public Contact

314-996-5569

Missouri Baptist Medical Center, Saint Louis, Missouri

Status

Recruiting

Address

Missouri Baptist Medical Center

Saint Louis, Missouri, 63131

Site Contact

Site Public Contact

314-996-5569

Sainte Genevieve, Missouri

Status

Recruiting

Address

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

Site Contact

Site Public Contact

314-996-5569

Missouri Baptist Sullivan Hospital, Sullivan, Missouri

Status

Recruiting

Address

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

Site Contact

Site Public Contact

314-996-5569

BJC Outpatient Center at Sunset Hills, Sunset Hills, Missouri

Status

Recruiting

Address

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127

Site Contact

Site Public Contact

314-996-5569

Community Hospital of Anaconda, Anaconda, Montana

Status

Recruiting

Address

Community Hospital of Anaconda

Anaconda, Montana, 59711

Site Contact

Site Public Contact

mccinfo@mtcancer.org

406-969-6060

Billings Clinic Cancer Center, Billings, Montana

Status

Recruiting

Address

Billings Clinic Cancer Center

Billings, Montana, 59101

Site Contact

Site Public Contact

research@billingsclinic.org

800-996-2663

Bozeman Deaconess Hospital, Bozeman, Montana

Status

Recruiting

Address

Bozeman Deaconess Hospital

Bozeman, Montana, 59715

Site Contact

Site Public Contact

mccinfo@mtcancer.org

406-969-6060

Great Falls, Montana

Status

Recruiting

Address

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, 59405

Site Contact

Site Public Contact

mccinfo@mtcancer.org

406-969-6060

Kalispell Regional Medical Center, Kalispell, Montana

Status

Recruiting

Address

Kalispell Regional Medical Center

Kalispell, Montana, 59901

Site Contact

Site Public Contact

mccinfo@mtcancer.org

406-969-6060

Community Medical Hospital, Missoula, Montana

Status

Recruiting

Address

Community Medical Hospital

Missoula, Montana, 59804

Site Contact

Site Public Contact

mccinfo@mtcancer.org

406-969-6060

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

Site Contact

Site Public Contact

212-639-7592

Memorial Sloan Kettering Westchester, Harrison, New York

Status

Recruiting

Address

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

Site Contact

Site Public Contact

212-639-7592

NYU Winthrop Hospital, Mineola, New York

Status

Recruiting

Address

NYU Winthrop Hospital

Mineola, New York, 11501

Site Contact

Site Public Contact

cancertrials@nyulangone.org

212-263-4432

New York, New York

Status

Recruiting

Address

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

Site Contact

Site Public Contact

CancerTrials@nyulangone.org

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Site Contact

Site Public Contact

212-639-7592

Case Western Reserve University, Cleveland, Ohio

Status

Recruiting

Address

Case Western Reserve University

Cleveland, Ohio, 44106

Site Contact

Site Public Contact

CTUReferral@UHhospitals.org

800-641-2422

Dayton, Ohio

Status

Recruiting

Address

Dayton Physician LLC-Miami Valley Hospital North

Dayton, Ohio, 45415

Site Contact

Site Public Contact

clinical.trials@daytonncorp.org

937-528-2900

Kettering Medical Center, Kettering, Ohio

Status

Recruiting

Address

Kettering Medical Center

Kettering, Ohio, 45429

Site Contact

Site Public Contact

clinical.trials@daytonncorp.org

937-528-2900

Lawton, Oklahoma

Status

Recruiting

Address

Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505

Site Contact

Site Public Contact

877-231-4440

Oklahoma City, Oklahoma

Status

Recruiting

Address

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Site Contact

Site Public Contact

ou-clinical-trials@ouhsc.edu

405-271-8777

Saint Alphonsus Medical Center-Ontario, Ontario, Oregon

Status

Suspended

Address

Saint Alphonsus Medical Center-Ontario

Ontario, Oregon, 97914

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

Status

Recruiting

Address

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

Site Contact

Site Public Contact

ONCTrialNow@jefferson.edu

215-600-9151

Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

Site Contact

Site Public Contact

412-647-8073

Asplundh Cancer Pavilion, Willow Grove, Pennsylvania

Status

Recruiting

Address

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090

Site Contact

Site Public Contact

ONCTrialNow@jefferson.edu

215-600-9151

Avera Cancer Institute, Sioux Falls, South Dakota

Status

Recruiting

Address

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

Site Contact

Site Public Contact

OncRegulatory@avera.org

605-322-3095

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Site Public Contact

askmdanderson@mdanderson.org

877-632-6789

VCU Massey Cancer Center at Stony Point, Richmond, Virginia

Status

Recruiting

Address

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

Site Contact

Site Public Contact

ctoclinops@vcu.edu

Richmond, Virginia

Status

Recruiting

Address

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

Site Contact

Site Public Contact

CTOclinops@vcu.edu

HSHS Sacred Heart Hospital, Eau Claire, Wisconsin

Status

Recruiting

Address

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin, 54701

Site Contact

Site Public Contact

ewd_research_admin@hshs.org

920-433-8889

Eau Claire, Wisconsin

Status

Recruiting

Address

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

Green Bay, Wisconsin

Status

Recruiting

Address

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, 54301

Site Contact

Site Public Contact

ewd_research_admin@hshs.org

920-433-8889

Green Bay, Wisconsin

Status

Recruiting

Address

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, 54303

Site Contact

Site Public Contact

ewd_research_admin@hshs.org

920-433-8889

Madison, Wisconsin

Status

Recruiting

Address

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792

Site Contact

Site Public Contact

clinicaltrials@cancer.wisc.edu

800-622-8922

Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin

Status

Recruiting

Address

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, 54548

Oconto Falls, Wisconsin

Status

Recruiting

Address

Saint Vincent Hospital Cancer Center at Oconto Falls

Oconto Falls, Wisconsin, 54154

Site Contact

Site Public Contact

ewd_research_admin@hshs.org

920-433-8889

Sheboygan, Wisconsin

Status

Recruiting

Address

Saint Vincent Hospital Cancer Center at Sheboygan

Sheboygan, Wisconsin, 53081

Site Contact

Site Public Contact

ewd_research_admin@hshs.org

920-433-8889

Sturgeon Bay, Wisconsin

Status

Recruiting

Address

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, 54235-1495

Site Contact

Site Public Contact

ewd_research_admin@hshs.org

920-433-8889

International Sites

Toronto, Ontario, Canada

Status

Suspended

Address

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9

Jewish General Hospital, Montreal, Quebec, Canada

Status

Suspended

Address

Jewish General Hospital

Montreal, Quebec, H3T 1E2

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