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

A Randomized Phase II Trial of Adjuvant Nivolumab With or Without Cabozantinib in Patients With Resected Mucosal Melanoma

INTRODUCTION

  • Org Study ID: NCI-2021-11794
  • Secondary ID: N/A
  • NCT ID: NCT05111574
  • Sponsor: National Cancer Institute (NCI)

BRIEF SUMMARY

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.

DETAILED DESCRIPTION

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.

  • Overall Status
    Recruiting
  • Start Date
    August 11, 2022
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • 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

ELIGIBILITY

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Alexander N Shoushtari

Role: Principal Investigator

Affiliation: Alliance for Clinical Trials in Oncology

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: Sutter Auburn Faith Hospital
Auburn, California 95602
United States
Status: Recruiting Contact: Contact
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Principal Investigator
Ari D. Baron

Facility: Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
United States
Status: Recruiting Contact: Contact
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Principal Investigator
Ari D. Baron

Facility: Palo Alto Medical Foundation-Fremont
Fremont, California 94538
United States
Status: Recruiting Contact: Contact
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Principal Investigator
Ari D. Baron

Facility: Keck Medicine of USC Koreatown
Los Angeles, California 90020
United States
Status: Recruiting Contact: Contact
Site Public Contact
213-388-0908

Principal Investigator
Gino K. In

Facility: Los Angeles General Medical Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: Contact
Site Public Contact
323-865-0451
uscnorrisinfo@med.usc.edu

Principal Investigator
Gino K. In

Facility: USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Status: Recruiting Contact: Contact
Site Public Contact
323-865-0451

Principal Investigator
Gino K. In

Facility: Memorial Medical Center
Modesto, California 95355
United States
Status: Recruiting Contact: Contact
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Principal Investigator
Ari D. Baron

Facility: USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California 92663
United States
Status: Recruiting Contact: Contact
Site Public Contact
323-865-0451

Principal Investigator
Gino K. In

Facility: Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
United States
Status: Recruiting Contact: Contact
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Principal Investigator
Ari D. Baron

Facility: Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
United States
Status: Recruiting Contact: Contact
Site Public Contact
650-498-7061
ccto-office@stanford.edu

Principal Investigator
Sunil A. Reddy

Facility: Sutter Roseville Medical Center
Roseville, California 95661
United States
Status: Recruiting Contact: Contact
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Principal Investigator
Ari D. Baron

Facility: Sutter Medical Center Sacramento
Sacramento, California 95816
United States
Status: Recruiting Contact: Contact
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Principal Investigator
Ari D. Baron

Facility: California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
United States
Status: Recruiting Contact: Contact
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Principal Investigator
Ari D. Baron

Facility: Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
United States
Status: Recruiting Contact: Contact
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Principal Investigator
Ari D. Baron

Facility: Sutter Solano Medical Center/Cancer Center
Vallejo, California 94589
United States
Status: Recruiting Contact: Contact
Site Public Contact
NCIclinicaltrials@sutterhealth.org

Principal Investigator
Ari D. Baron

Facility: UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida 33180
United States
Status: Recruiting Contact: Contact
Site Public Contact
954-461-2180

Principal Investigator
Leonel F. Hernandez-Aya

Facility: UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
United States
Status: Recruiting Contact: Contact
Site Public Contact
305-243-2647

Principal Investigator
Leonel F. Hernandez-Aya

Facility: UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
United States
Status: Recruiting Contact: Contact
Site Public Contact
305-243-2647

Principal Investigator
Leonel F. Hernandez-Aya

Facility: University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
United States
Status: Recruiting Contact: Contact
Site Public Contact
305-243-2647

Principal Investigator
Leonel F. Hernandez-Aya

Facility: UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida 33324
United States
Status: Recruiting Contact: Contact
Site Public Contact
305-243-2647

Principal Investigator
Leonel F. Hernandez-Aya

Facility: Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Principal Investigator
John M. Schallenkamp

Facility: Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
United States
Status: Recruiting Contact: Contact
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Principal Investigator
John M. Schallenkamp

Facility: Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Kootenai Cancer Clinic
Sandpoint, Idaho 83864
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Rush - Copley Medical Center
Aurora, Illinois 60504
United States
Status: Recruiting Contact: Contact
Site Public Contact
630-978-6212
Cancer.Research@rushcopley.com

Principal Investigator
Pratima Chalasani

Facility: Centralia Oncology Clinic
Centralia, Illinois 62801
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Principal Investigator
Bryan A. Faller

Facility: Northwestern University
Chicago, Illinois 60611
United States
Status: Recruiting Contact: Contact
Site Public Contact
312-695-1301
cancer@northwestern.edu

Principal Investigator
Sunandana Chandra

Facility: Carle at The Riverfront
Danville, Illinois 61832
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-446-5532
Research@Carle.com

Principal Investigator
Pratima Chalasani

Facility: Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Principal Investigator
Bryan A. Faller

Facility: Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Principal Investigator
Bryan A. Faller

Facility: Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-446-5532
Research@carle.com

Principal Investigator
Pratima Chalasani

Facility: Crossroads Cancer Center
Effingham, Illinois 62401
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Principal Investigator
Bryan A. Faller

Facility: Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-446-5532
Research@carle.com

Principal Investigator
Pratima Chalasani

Facility: Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Principal Investigator
Bryan A. Faller

Facility: Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-545-7929

Principal Investigator
Bryan A. Faller

Facility: Springfield Clinic
Springfield, Illinois 62702
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-444-7541

Principal Investigator
Bryan A. Faller

Facility: Memorial Medical Center
Springfield, Illinois 62781
United States
Status: Recruiting Contact: Contact
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

Principal Investigator
Bryan A. Faller

Facility: Carle Cancer Center
Urbana, Illinois 61801
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-446-5532
Research@carle.com

Principal Investigator
Pratima Chalasani

Facility: Rush-Copley Healthcare Center
Yorkville, Illinois 60560
United States
Status: Recruiting Contact: Contact
Site Public Contact
630-978-6212
Cancer.Research@rushcopley.com

Principal Investigator
Pratima Chalasani

Facility: Mary Greeley Medical Center
Ames, Iowa 50010
United States
Status: Recruiting Contact: Contact
Site Public Contact
515-956-4132

Principal Investigator
Joseph J. Merchant

Facility: McFarland Clinic - Ames
Ames, Iowa 50010
United States
Status: Recruiting Contact: Contact
Site Public Contact
515-239-4734
ksoder@mcfarlandclinic.com

Principal Investigator
Joseph J. Merchant

Facility: McFarland Clinic - Boone
Boone, Iowa 50036
United States
Status: Recruiting Contact: Contact
Site Public Contact
515-956-4132

Principal Investigator
Joseph J. Merchant

Facility: McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa 50501
United States
Status: Recruiting Contact: Contact
Site Public Contact
515-956-4132

Principal Investigator
Joseph J. Merchant

Facility: McFarland Clinic - Jefferson
Jefferson, Iowa 50129
United States
Status: Recruiting Contact: Contact
Site Public Contact
515-956-4132

Principal Investigator
Joseph J. Merchant

Facility: McFarland Clinic - Marshalltown
Marshalltown, Iowa 50158
United States
Status: Recruiting Contact: Contact
Site Public Contact
515-956-4132

Principal Investigator
Joseph J. Merchant

Facility: Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Site Public Contact
877-442-3324

Principal Investigator
Elizabeth I. Buchbinder

Facility: Bronson Battle Creek
Battle Creek, Michigan 49017
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Bronson Methodist Hospital
Kalamazoo, Michigan 49007
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: West Michigan Cancer Center
Kalamazoo, Michigan 49007
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Ascension Borgess Cancer Center
Kalamazoo, Michigan 49009
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
connie.szczepanek@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Corewell Health Reed City Hospital
Reed City, Michigan 49677
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Munson Medical Center
Traverse City, Michigan 49684
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: University of Michigan Health - West
Wyoming, Michigan 49519
United States
Status: Recruiting Contact: Contact
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Principal Investigator
Kathleen J. Yost

Facility: Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
United States
Status: Recruiting Contact: Contact
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Principal Investigator
Daniel M. Anderson

Facility: Mercy Hospital
Coon Rapids, Minnesota 55433
United States
Status: Recruiting Contact: Contact
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Principal Investigator
Daniel M. Anderson

Facility: Fairview Southdale Hospital
Edina, Minnesota 55435
United States
Status: Recruiting Contact: Contact
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Principal Investigator
Daniel M. Anderson

Facility: Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
United States
Status: Recruiting Contact: Contact
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Principal Investigator
Daniel M. Anderson

Facility: Mayo Clinic in Rochester
Rochester, Minnesota 55905
United States
Status: Recruiting Contact: Contact
Site Public Contact
855-776-0015

Principal Investigator
Robert R. McWilliams

Facility: Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
United States
Status: Recruiting Contact: Contact
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Principal Investigator
Daniel M. Anderson

Facility: Regions Hospital
Saint Paul, Minnesota 55101
United States
Status: Recruiting Contact: Contact
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Principal Investigator
Daniel M. Anderson

Facility: United Hospital
Saint Paul, Minnesota 55102
United States
Status: Recruiting Contact: Contact
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Principal Investigator
Daniel M. Anderson

Facility: Parkland Health Center - Farmington
Farmington, Missouri 63640
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-996-5569

Principal Investigator
Bryan A. Faller

Facility: Missouri Baptist Medical Center
Saint Louis, Missouri 63131
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-996-5569

Principal Investigator
Bryan A. Faller

Facility: Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-996-5569

Principal Investigator
Bryan A. Faller

Facility: Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-996-5569

Principal Investigator
Bryan A. Faller

Facility: BJC Outpatient Center at Sunset Hills
Sunset Hills, Missouri 63127
United States
Status: Recruiting Contact: Contact
Site Public Contact
314-996-5569

Principal Investigator
Bryan A. Faller

Facility: Community Hospital of Anaconda
Anaconda, Montana 59711
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Billings Clinic Cancer Center
Billings, Montana 59101
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-996-2663
research@billingsclinic.org

Principal Investigator
John M. Schallenkamp

Facility: Bozeman Deaconess Hospital
Bozeman, Montana 59715
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Kalispell Regional Medical Center
Kalispell, Montana 59901
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Community Medical Hospital
Missoula, Montana 59804
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United States
Status: Recruiting Contact: Contact
Site Public Contact
212-639-7592

Principal Investigator
Alexander N. Shoushtari

Facility: Memorial Sloan Kettering Westchester
Harrison, New York 10604
United States
Status: Recruiting Contact: Contact
Site Public Contact
212-639-7592

Principal Investigator
Alexander N. Shoushtari

Facility: NYU Winthrop Hospital
Mineola, New York 11501
United States
Status: Recruiting Contact: Contact
Site Public Contact
212-263-4432
cancertrials@nyulangone.org

Principal Investigator
Maya Dimitrova

Facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
United States
Status: Recruiting Contact: Contact
Site Public Contact
CancerTrials@nyulangone.org

Principal Investigator
Maya Dimitrova

Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Status: Recruiting Contact: Contact
Site Public Contact
212-639-7592

Principal Investigator
Alexander N. Shoushtari

Facility: Case Western Reserve University
Cleveland, Ohio 44106
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Principal Investigator
Ankit Mangla

Facility: Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio 45415
United States
Status: Recruiting Contact: Contact
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Principal Investigator
Howard M. Gross

Facility: Kettering Medical Center
Kettering, Ohio 45429
United States
Status: Recruiting Contact: Contact
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Principal Investigator
Howard M. Gross

Facility: Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma 73505
United States
Status: Recruiting Contact: Contact
Site Public Contact
877-231-4440

Principal Investigator
Adam S. Asch

Facility: University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: Contact
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Principal Investigator
Adam S. Asch

Facility: Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
United States
Status: Recruiting Contact: Contact
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Principal Investigator
John M. Schallenkamp

Facility: Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Status: Recruiting Contact: Contact
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Principal Investigator
Rino Seedor

Facility: University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact: Contact
Site Public Contact
412-647-8073

Principal Investigator
Jason J. Luke

Facility: Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
United States
Status: Recruiting Contact: Contact
Site Public Contact
215-600-9151
ONCTrialNow@jefferson.edu

Principal Investigator
Rino Seedor

Facility: Avera Cancer Institute
Sioux Falls, South Dakota 57105
United States
Status: Recruiting Contact: Contact
Site Public Contact
605-322-3095
OncRegulatory@avera.org

Principal Investigator
Benjamin M. Solomon

Facility: M D Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Site Public Contact
877-632-6789
askmdanderson@mdanderson.org

Principal Investigator
Sapna P. Patel

Facility: VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
United States
Status: Recruiting Contact: Contact
Site Public Contact
ctoclinops@vcu.edu

Principal Investigator
Andrew Poklepovic

Facility: Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
United States
Status: Recruiting Contact: Contact
Site Public Contact
CTOclinops@vcu.edu

Principal Investigator
Andrew Poklepovic

Facility: HSHS Sacred Heart Hospital
Eau Claire, Wisconsin 54701
United States
Status: Recruiting Contact: Contact
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Principal Investigator
Anthony J. Jaslowski

Facility: Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Principal Investigator
Adedayo A. Onitilo

Facility: Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
United States
Status: Recruiting Contact: Contact
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Principal Investigator
Anthony J. Jaslowski

Facility: Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
United States
Status: Recruiting Contact: Contact
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Principal Investigator
Anthony J. Jaslowski

Facility: University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-622-8922
clinicaltrials@cancer.wisc.edu

Principal Investigator
Vincent T. Ma

Facility: Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
United States
Status: Recruiting Contact: Contact
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Principal Investigator
Adedayo A. Onitilo

Facility: Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin 54154
United States
Status: Recruiting Contact: Contact
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Principal Investigator
Anthony J. Jaslowski

Facility: Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin 53081
United States
Status: Recruiting Contact: Contact
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Principal Investigator
Anthony J. Jaslowski

Facility: Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
United States
Status: Recruiting Contact: Contact
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Principal Investigator
Anthony J. Jaslowski