Clinical Stage III Cutaneous Melanoma AJCC v8Phase 2NCT05136196
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Cabozantinib S-malate in people with Clinical Stage III Cutaneous Melanoma AJCC v8 and Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, run by National Cancer Institute (NCI) at 231 sites in United States.
Trial summary
This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
- What is being tested?
- Biopsy Procedure, Biospecimen Collection and Cabozantinib S-malate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 231 sitesUnited States
- Study dates
- 6 Dec 2022to 1 Jan 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEP 1 - SPECIMEN SUBMISSION
- Participants must have histologically confirmed melanoma that is stage III or IV, unresectable, recurrent, or metastatic non-uveal melanoma OR Participants must have histologically confirmed squamous cell carcinoma of the head and neck (HNSCC) that is either locally recurrent and non-amendable to curative therapy (e.g., radiation, surgery) or metastatic. The primary tumor location must be the oropharynx, oral cavity, hypopharynx, or larynx. Primary tumor site of nasopharynx (any histology) or unknown primary tumor are not eligible
- Note: For participants with primary oropharyngeal cancer, human papillomavirus (HPV) or p16 status must be known prior to step 1 registration
- Participants must have disease presentation consistent with measurable disease. Note: Current disease measurements will not be required until step 2 registration
- Participants must have had documented progression during or within 12 weeks after the last dose of PD-1 checkpoint inhibition-based therapy. Participants must have been receiving checkpoint inhibition for a minimum of 6 weeks. Participants who recur during adjuvant anti-PD1 treatment or within 12 weeks of completion of adjuvant anti-PD1 treatment are eligible if they have measurable disease and are considered unresectable
- Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test within 6 months prior to step 1 registration
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- Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to step 1 registration
- Participants with a history of hepatitis C virus (HCV) infection must have no detectable viral load within 28 days prior to step 1 registration
- Participants must not have an active infection requiring systemic therapy (except HBV, HCV or HIV as mentioned above)
- Participants must not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 90 days prior to step 1 registration, unless clinically stable with ongoing medical management
- Participants must have recovered to baseline or =< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 toxicities related to any prior treatments, unless adverse events are deemed clinically nonsignificant by the treating investigator or stable on supportive therapy
- Participants must not have received more than one prior primary radiotherapy regimen, curative or adjuvant, to the mucosal surfaces of the head and neck, with the additional following criteria:
- If the primary radiation is combined with chemotherapy, a minimum of 16 weeks will be required to have elapsed between the end of radiotherapy and step 1 registration. If the radiation is given alone, a minimum of 8 weeks will be required to have elapsed between the end of radiotherapy and step 1 registration
- Additional palliative radiotherapy regimens are permitted but cannot have been administered to previously treated tissue (i.e., overlapping fields are excluded) with the exception of central nervous system (CNS) radiation and must be completed at least 4 weeks prior to step 1 registration
- Treatment areas should be healed with no sequelae from radiation therapy (RT) that would predispose to fistula formation
- Participants must not have received prior treatment with anti-VEGF therapies for any reason
- Participants must be >= 18 years of age
- Participants must have a Zubrod Performance Status 0 or 1
- Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better to be eligible for this trial
- Participants must not have any known significant organ disfunction that, in the opinion of the treating investigator, may impact suitability for receiving combination nivolumab/cabozantinib treatment
- Participants must be able to take oral medication without breaking, opening, crushing, dissolving or chewing capsules
- Participants must not have malabsorption syndrome
- Participants must not have active autoimmune disease requiring systemic steroids (equivalent of > 10mg of prednisone) or other immune suppression. Exceptions:
- Type 1 diabetes mellitus
- Endocrinopathy only requiring hormone replacement
- Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment
- Conditions not expected to recur in the absence of an external trigger
- Participants must not have received an organ allograft
- Participants must not have a history of hemoptysis (defined as >= 1/2 tsp of bright red blood per day) or tumor bleeding within 90 days prior to step 1 registration
- Participants must not have any of the following criteria due to the possibility of increased risk for tumor bleeding with cabozantinib therapy:
- Prior carotid bleeding
- Tumors that invade major vessels (e.g., the carotid) as shown unequivocally by imaging studies
- Central (e.g., within 2 cm from the hilum) lung metastases that are cavitary as shown unequivocally by imaging studies
- Any prior history of bleeding related to the current head and neck cancer
- History of gross hemoptysis (bright red blood of 1/2 teaspoon or more per episode of coughing) within 3 months
- Participants must not require concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel)
- Participants must not require anticoagulants except for the following:
- Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).
- Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors, rivaroxaban, edoxaban, or apixaban in participants without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to step 1 registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
- Participants must not have evidence of preexisting uncontrolled hypertension 28 days prior to step 1 registration as documented by baseline blood pressure reading with systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg. Participants on antihypertensive therapies with controlled blood pressure are eligible
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- Participants must not be pregnant or nursing due to the known safety profiles of the drugs in this study. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential". In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion and vasectomy with testing showing no sperm in the semen
- Have an adequate archival tissue specimen verified by the local pathologist and documented on the Pathology Review Form from a procedure obtained after the development of resistance to anti-PD-1/L1 therapy. Archival tissue must consist of tumor block or at least 1 hematoxylin and eosin (H\&E)-stained 4-5 micron slide and 20 freshly cut serially sectioned and numbered 4-5 micron unstained, uncharged slides OR
- Be willing to undergo research biopsy AND have tumor accessible for biopsy based on the following criteria:
- Mediastinal, laparoscopic, gastrointestinal, or bronchial endoscopic biopsies can be obtained incidentally to a clinically necessary procedure and NOT for the sole purpose of the clinical trial
- Acceptable biopsy procedures are:
- Percutaneous biopsy with local anesthetic and/or sedation with an expected risk of severe complications < 2%
- Direct transoral biopsy (with or without local anesthetic and/or sedation) with an expected risk of severe complications < 2%
- Excisional cutaneous biopsy with local anesthetic and/or sedation with an expected risk of severe complications < 2%
- Biopsy with removal of additional tumor tissue during a medically necessary mediastinoscopy, laparoscopy, gastrointestinal endoscopy, bronchoscopy or craniotomy. No open surgical, laparoscopic or endoscopic procedure should be performed solely to obtain a biopsy for this protocol
- Removal of additional tumor tissue during a medically necessary surgical procedure
- Participants must submit whole blood for germline genomic analysis
- Participants must have been offered the opportunity to participate in specimen banking
- Note: As a part of the Oncology Patient Enrollment Network (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 informed consent in accordance with institutional and federal guidelines
- Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)
- STEP 2 TREATMENT REGISTRATION
- Note: No tests or exams are required to be repeated for step 2 registration (Treatment). However, participants who are known to have a change in eligibility status after step 1 registration are not eligible for step 2 registration
- Participants must continue to meet eligibility for step 1 registration prior to step 2 registration
- Participants must have had their tumor tissue submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System prior to step 2 registration
- Participants registered during stage II of the protocol must have received assignment to an open cohort from the SWOG Statistics and Data Management Center based on their biomarker screening profile (not applicable for patients registered during stage I of the protocol)
- Participants must have measurable disease. All measurable disease must be assessed within 28 days prior to step 2 registration. All non-measurable disease must be assessed within 42 days prior to step 2 registration. Note: All disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
- For melanoma participants, CT chest, abdomen and pelvis must be obtained. For HNSCC participants, CT neck and chest must be obtained. Further imaging (i.e., MR brain, CT abdomen/pelvis or extremities, bone scan) will be performed as deemed appropriate by the treating physician
- Participants with treated brain metastases must have no evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy
- Participants must not have experienced any significant health changes that, in the opinion of the treating investigator, may impact continued suitability for receiving combination nivolumab/cabozantinib treatment
- Participants with treated brain metastases must have discontinued steroid treatment at least 14 days prior to step 2 registration
- Participants must not have received investigational agents or monoclonal antibodies (except Food and Drug Administration [FDA] approved supportive care antibodies, such as denosumab) within 28 days prior to step 2 registration
- Participants must not have received surgery, chemotherapy, radiation therapy, biologic agents, or steroids within 14 days prior to step 2 registration
- Participants must not have received administration of a live, attenuated vaccine within 30 days prior to step 2 registration. Note: Participants may have received a messenger ribonucleic acid (mRNA) or viral vector-based coronavirus disease 2019 (COVID-19) vaccine within 30 days prior to step 2 registration
- Participants must not have received administration of any strong CYP3A4 inducers, such as but not limited to rifampin, carbamazepine, enzalutamide, mitotane, phenytoin and St. John's wort, within 14 days prior to step 2 registration
- Participants must not have received administration of any strong CYP3A4 inhibitors, such as but not limited to clarithromycin, itraconazole, ketoconazole, grapefruit juice, indinavir, nelfinavir, ritonavir, nefazodone, saquinavir, and telithromycin, within 5 times the half-life of the CYP3A inhibitor prior to step 2 registration
- Participants must have a history and physical examination performed within 28 days prior to step 2 registration
- Leukocytes >= 3,000/uL (within 28 days prior to step 2 registration)
- Absolute neutrophil count >= 1,500/uL (within 28 days prior to step 2 registration)
- Platelets >= 100,000/uL (within 28 days prior to step 2 registration)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) or =< 3 x ULN for participants with Gilbert's disease (within 28 days prior to step 2 registration)
- Aspartate aminotransferase (AST) =< 3 x institutional ULN (within 28 days prior to step 2 registration)
- Alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to step 2 registration)
- Urinalysis: For baseline value (no required value for eligibility)
- Measured (OR calculated) creatinine clearance >= 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to step 2 registration
Who cannot join
None listed.
Trial locations and contacts
231 sites in 1 country. Contact the study team or a site near you to ask about taking part.
231 sites in 1 country
United States231 sites, 209 recruiting
- Suspended
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, 96701
- Recruiting
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Site Public Contact, 505-925-0348, HSC-ClinicalTrialInfo@salud.unm.edu
Moises Harari-Turquie
- Recruiting
Inova Alexandria Hospital
Alexandria, Virginia, 22304
Site Public Contact, 703-776-2580, Stephanie.VanBebber@inova.org
Sekwon Jang
- Recruiting
Mary Greeley Medical Center
Ames, Iowa, 50010
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
McFarland Clinic - Ames
Ames, Iowa, 50010
Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com
Joseph J. Merchant
- Recruiting
Community Hospital of Anaconda
Anaconda, Montana, 59711
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, 50023
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
Site Public Contact, 800-865-1125, CancerAnswerLine@med.umich.edu
Paul L. Swiecicki
- Recruiting
Duluth Clinic Ashland
Ashland, Wisconsin, 54806
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Active, not recruiting
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
- Suspended
Rush-Copley Medical Center
Aurora, Illinois, 60504
- Recruiting
Bronson Battle Creek
Battle Creek, Michigan, 49017
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Alissa S. Marr
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Saint Charles Health System
Bend, Oregon, 97701
Site Public Contact, 541-706-2909, nosall@stcharleshealthcare.org
Charles W. Drescher
- Recruiting
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Site Public Contact, towercancerresearch@toweroncology.com
Inderjit Mehmi
- Recruiting
Billings Clinic Cancer Center
Billings, Montana, 59101
Site Public Contact, 800-996-2663, research@billingsclinic.org
John M. Schallenkamp
- Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Suspended
McFarland Clinic - Boone
Boone, Iowa, 50036
- Active, not recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
- Recruiting
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605
Site Public Contact, 734-712-3671, stephanie.couch@stjoeshealth.org
Elie G. Dib
- Recruiting
Illinois CancerCare-Canton
Canton, Illinois, 61520
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health Medical Center - Canton
Canton, Michigan, 48188
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
Site Public Contact, 573-334-2230, sfmc@sfmc.net
Bryan A. Faller
- Recruiting
Illinois CancerCare-Carthage
Carthage, Illinois, 62321
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Mercy Hospital
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-365-4673
Deborah W. Wilbur
- Recruiting
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403
Site Public Contact, 319-363-2690
Deborah W. Wilbur
- Recruiting
Miami Valley Hospital South
Centerville, Ohio, 45459
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Centralia Oncology Clinic
Centralia, Illinois, 62801
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Minnesota Oncology Hematology PA-Chaska
Chaska, Minnesota, 55318
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, 48118
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Site Public Contact, 312-695-1301, cancer@northwestern.edu
Jacob Choi
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Site Public Contact, 312-355-3046
Ryan Nguyen
- Recruiting
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Brendan J. Knapp
- Recruiting
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909
Site Public Contact, 719-365-2406
Stacey Parker-Brueggemann
- Recruiting
Memorial Hospital North
Colorado Springs, Colorado, 80920
Site Public Contact, 719-364-6700
Stacey Parker-Brueggemann
- Recruiting
Mercy Hospital
Coon Rapids, Minnesota, 55433
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Brendan J. Knapp
- Recruiting
Carle at The Riverfront
Danville, Illinois, 61832
Site Public Contact, 800-446-5532, Research@Carle.com
Prem Sobti
- Recruiting
Premier Blood and Cancer Center
Dayton, Ohio, 45409
Site Public Contact, 937-276-8320
Tarek M. Sabagh
- Recruiting
Miami Valley Hospital North
Dayton, Ohio, 45415
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Decatur Memorial Hospital
Decatur, Illinois, 62526
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
Essentia Health - Deer River Clinic
Deer River, Minnesota, 56636
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Jacob Choi
- Recruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Richard L. Deming
- Recruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Active, not recruiting
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota, 56501
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Illinois CancerCare-Dixon
Dixon, Illinois, 61021
Site Public Contact, 815-285-7800
Bryan A. Faller
- Recruiting
Essentia Health Cancer Center
Duluth, Minnesota, 55805
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Kareem H. Abdelhadi
- Recruiting
Fairview Southdale Hospital
Edina, Minnesota, 55435
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Carle Physician Group-Effingham
Effingham, Illinois, 62401
Site Public Contact, 800-446-5532, Research@carle.com
Prem Sobti
- Recruiting
Crossroads Cancer Center
Effingham, Illinois, 62401
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
OSF Saint Francis Hospital and Medical Group
Escanaba, Michigan, 49829
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Illinois CancerCare-Eureka
Eureka, Illinois, 61530
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Sekwon Jang
- Recruiting
Inova Fair Oaks Hospital
Fairfax, Virginia, 22033
Site Public Contact, 703-720-5210, Stephanie.VanBebber@inova.org
Sekwon Jang
- Recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Site Public Contact, 703-208-6650, Stephanie.VanBebber@inova.org
Sekwon Jang
- Recruiting
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, 58103
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org
Daniel Almquist
- Active, not recruiting
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
- Recruiting
Cancer Hematology Centers - Flint
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Suspended
Genesee Hematology Oncology PC
Flint, Michigan, 48503
- Recruiting
Genesys Hurley Cancer Institute
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Hurley Medical Center
Flint, Michigan, 48503
Site Public Contact, 810-762-8038, wstrong@ghci.org
Elie G. Dib
- Recruiting
Poudre Valley Hospital
Fort Collins, Colorado, 80524
Site Public Contact, 970-297-6150
Stacey Parker-Brueggemann
- Recruiting
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528
Site Public Contact, protocols@swog.org
Stacey Parker-Brueggemann
- Recruiting
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa, 50501
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Essentia Health - Fosston
Fosston, Minnesota, 56542
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Active, not recruiting
Unity Hospital
Fridley, Minnesota, 55432
- Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Jacob Choi
- Recruiting
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois, 60026
Site Public Contact, 312-695-1102
Jacob Choi
- Recruiting
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534
Site Public Contact, 919-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Elie G. Dib
- Recruiting
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois, 60030
Site Public Contact, 312-695-1102
Jacob Choi
- Recruiting
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
UCHealth Greeley Hospital
Greeley, Colorado, 80631
Site Public Contact, protocols@swog.org
Stacey Parker-Brueggemann
- Recruiting
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331
Site Public Contact, 937-569-7515
Tarek M. Sabagh
- Recruiting
Essentia Health Hibbing Clinic
Hibbing, Minnesota, 55746
Site Public Contact, 218-786-3308
Bret E. Friday
- Suspended
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
- Suspended
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii, 96813
- Suspended
Queen's Medical Center
Honolulu, Hawaii, 96813
- Suspended
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
- Recruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Poorva Vaidya
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Site Public Contact, 855-776-0015
Arkadiusz Z. Dudek
- Recruiting
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546
Site Public Contact, 910-587-9084, jfields@cancersmoc.com
Samer S. Kasbari
- Recruiting
Essentia Health - Jamestown Clinic
Jamestown, North Dakota, 58401
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Suspended
McFarland Clinic - Jefferson
Jefferson, Iowa, 50129
- Recruiting
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Suspended
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan, 49009
- Recruiting
Logan Health Medical Center
Kalispell, Montana, 59901
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Site Public Contact, 608-775-2385, cancerctr@gundersenhealth.org
David E. Marinier
- Recruiting
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045
Site Public Contact, cancertrials@northwestern.edu
Jacob Choi
- Active, not recruiting
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
- Recruiting
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org
Elie G. Dib
- Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Site Public Contact, 800-639-6918, cancer.research.nurse@dartmouth.edu
Garrett T. Wasp
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Site Public Contact, 501-686-8274
Omar T. Atiq
- Recruiting
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, 90025
Site Public Contact, protocols@swog.org
Inderjit Mehmi
- Recruiting
Los Angeles General Medical Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451, uscnorrisinfo@med.usc.edu
Gino K. In
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Site Public Contact, 323-865-0451
Gino K. In
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org
Inderjit Mehmi
- Recruiting
Medical Center of the Rockies
Loveland, Colorado, 80538
Site Public Contact, 970-203-7083
Stacey Parker-Brueggemann
- Recruiting
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia, 24501
Site Public Contact, 434-200-1495, Kevin.Patel@centrahealth.com
Andrew Poklepovic
- Recruiting
Illinois CancerCare-Macomb
Macomb, Illinois, 61455
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
McFarland Clinic - Marshalltown
Marshalltown, Iowa, 50158
Site Public Contact, 515-956-4132
Joseph J. Merchant
- Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Kareem H. Abdelhadi
- Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
Site Public Contact, 800-446-5532, Research@carle.com
Prem Sobti
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Site Public Contact, 708-226-4357
Joseph I. Clark
- Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Site Public Contact, 414-805-3666
Callisia N. Clarke
- Recruiting
NYU Langone Hospital - Long Island
Mineola, New York, 11501
Site Public Contact, 212-263-4432, cancertrials@nyulangone.org
Ruth A. White
- Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Kareem H. Abdelhadi
- Recruiting
Community Medical Center
Missoula, Montana, 59804
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149
Site Public Contact, research.institute@phci.org
Timothy R. Wassenaar
- Suspended
Trinity Health Muskegon Hospital
Muskegon, Michigan, 49444
- Recruiting
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Elie G. Dib
- Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016
Site Public Contact, CancerTrials@nyulangone.org
Ruth A. White
- Recruiting
Helen F Graham Cancer Center
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
Site Public Contact, 302-623-4450, lbarone@christianacare.org
Gregory A. Masters
- Recruiting
Providence Newberg Medical Center
Newberg, Oregon, 97132
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120
Site Public Contact, 616-391-1230
Kathleen Y. Butler
- Recruiting
Carle BroMenn Medical Center
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Prem Sobti
- Recruiting
Carle Cancer Institute Normal
Normal, Illinois, 61761
Site Public Contact, 800-446-5532, Research@Carle.com
Prem Sobti
- Recruiting
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
Site Public Contact, 616-391-1230, connie.szczepanek@crcwm.org
Elie G. Dib
- Recruiting
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com
Bryan A. Faller
- Recruiting
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066
Site Public Contact, 262-928-7878
Timothy R. Wassenaar
- Recruiting
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154
Site Public Contact, 920-433-8889, WI_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu
Vishnu Nagalapuram
- Recruiting
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118
Site Public Contact, 402-559-5600
Alissa S. Marr
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Site Public Contact, 402-559-6941, unmcrsa@unmc.edu
Alissa S. Marr
- Recruiting
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
Elie G. Dib
- Recruiting
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868
Site Public Contact, 877-827-8839, ucstudy@uci.edu
Poorva Vaidya
- Recruiting
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462
Site Public Contact, nctnprogram_rhlccc@northwestern.edu
Jacob Choi
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
Site Public Contact, 407-303-2090, FH.Cancer.Research@flhosp.org
Sajeve S. Thomas
- Recruiting
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Essentia Health - Park Rapids
Park Rapids, Minnesota, 56470
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Illinois CancerCare-Peru
Peru, Illinois, 61354
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Active, not recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
- Active, not recruiting
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114
- Recruiting
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
Site Public Contact, 855-776-0015
Arkadiusz Z. Dudek
- Recruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org
Charles W. Drescher
- Recruiting
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Illinois CancerCare-Princeton
Princeton, Illinois, 61356
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
Rapid City Regional Hospital
Rapid City, South Dakota, 57701
Site Public Contact, 605-755-2370, research@monument.health
Abdel-Ghani Azzouqa
- Recruiting
Corewell Health Reed City Hospital
Reed City, Michigan, 49677
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Kareem H. Abdelhadi
- Recruiting
Virginia Cancer Institute
Richmond, Virginia, 23229
Site Public Contact, 804-287-3000, smoore@vacancer.com
Andrew Poklepovic
- Recruiting
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Site Public Contact, ctoclinops@vcu.edu
Andrew Poklepovic
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
Site Public Contact, 804-628-6430, CTOclinops@vcu.edu
Andrew Poklepovic
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Site Public Contact, 855-776-0015
Arkadiusz Z. Dudek
- Recruiting
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819
Site Public Contact, 800-639-6918, cancer.research.nurse@hitchcock.org
Garrett T. Wasp
- Recruiting
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
United Hospital
Saint Paul, Minnesota, 55102
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
Site Public Contact, 888-424-2100, cancerinfo@hci.utah.edu
Kathleen C. Kerrigan
- Recruiting
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864
Site Public Contact, 406-969-6060, mccinfo@mtcancer.org
John M. Schallenkamp
- Recruiting
Essentia Health Sandstone
Sandstone, Minnesota, 55072
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin, 53081
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Memorial Hospital East
Shiloh, Illinois, 62269
Site Public Contact, 314-747-9912, dschwab@wustl.edu
Brendan J. Knapp
- Recruiting
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
Site Public Contact, 605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org
Daniel Almquist
- Recruiting
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org
Daniel Almquist
- Recruiting
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Site Public Contact, 217-545-7929
Bryan A. Faller
- Recruiting
Springfield Clinic
Springfield, Illinois, 62702
Site Public Contact, 800-444-7541
Bryan A. Faller
- Recruiting
Springfield Memorial Hospital
Springfield, Illinois, 62781
Site Public Contact, 217-528-7541, pallante.beth@mhsil.com
Bryan A. Faller
- Recruiting
Baystate Medical Center
Springfield, Massachusetts, 01199
Site Public Contact, 413-794-3565, tamara.wrenn@baystatehealth.org
John C. McCann
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Brendan J. Knapp
- Recruiting
Mercy Hospital South
St Louis, Missouri, 63128
Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net
Jay W. Carlson
- Recruiting
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Brendan J. Knapp
- Recruiting
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
Site Public Contact, 800-600-3606, info@siteman.wustl.edu
Brendan J. Knapp
- Recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Kareem H. Abdelhadi
- Active, not recruiting
Tufts Medical Center Cancer Center Stoneham
Stoneham, Massachusetts, 02180
- Recruiting
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
Site Public Contact, 920-433-8889, wi_research_admin@hshs.org
Matthew L. Ryan
- Recruiting
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880
Site Public Contact, 701-364-6272
Bret E. Friday
- Recruiting
VCU Health Tappahannock Hospital
Tappahannock, Virginia, 22560
Site Public Contact, klcampbell@vcu.edu
Andrew Poklepovic
- Recruiting
Munson Medical Center
Traverse City, Michigan, 49684
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Recruiting
Upper Valley Medical Center
Troy, Ohio, 45373
Site Public Contact, 937-528-2900, clinical.trials@daytonncorp.org
Tarek M. Sabagh
- Recruiting
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301
Site Public Contact, 208-381-2774, eslinget@slhs.org
Charles W. Drescher
- Recruiting
Carle Cancer Center
Urbana, Illinois, 61801
Site Public Contact, 800-446-5532, Research@carle.com
Prem Sobti
- Recruiting
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792
Site Public Contact, 218-786-3308, CancerTrials@EssentiaHealth.org
Bret E. Friday
- Recruiting
Ridgeview Medical Center
Waconia, Minnesota, 55387
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555
Site Public Contact, 630-352-5360, Donald.Smith3@nm.org
Jacob Choi
- Recruiting
Illinois CancerCare - Washington
Washington, Illinois, 61571
Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com
Bryan A. Faller
- Recruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, 50263
Site Public Contact, 515-241-3305
Seema Harichand-Herdt
- Recruiting
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
Site Public Contact, 262-928-7632
Timothy R. Wassenaar
- Recruiting
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
Site Public Contact, 262-928-5539, Chanda.miller@phci.org
Timothy R. Wassenaar
- Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476
Site Public Contact, 800-782-8581, oncology.clinical.trials@marshfieldresearch.org
Kareem H. Abdelhadi
- Active, not recruiting
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090
- Recruiting
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
Site Public Contact, 952-993-1517, mmcorc@healthpartners.com
David M. King
- Recruiting
University of Michigan Health - West
Wyoming, Michigan, 49519
Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org
Kathleen Y. Butler
- Suspended
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560
- Recruiting
Huron Gastroenterology PC
Ypsilanti, Michigan, 48106
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
- Recruiting
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, 48197
Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org
Elie G. Dib
About this study
Official title: Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study
This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. This trial may help doctors determine how quickly patients can be divided into groups based on biomarkers in their tumors. A biomarker is a biological molecule found in the blood, other body fluids, or in tissues that is a sign of a normal or abnormal process or a sign of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. The two biomarkers that this trial is studying are "tumor mutational burden" and "tumor inflammation signature." Another purpose of this trial is to help doctors learn if cabozantinib and nivolumab shrink or stabilize the cancer, and whether patients respond differently to the combination depending on the status of the biomarkers.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of molecular characterization based on tumor mutation burden (TMB) for participant stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in Stage I of the study.
II. To evaluate the feasibility of molecular characterization based on TMB and Nanostring IO360 gene expression profiling assay for tumor inflammation score (TIS) for stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in Stage II of the study.
III. To evaluate the efficacy by overall response rate (ORR - defined as confirmed and unconfirmed partial responses plus complete responses) of cabozantinib S-malate (cabozantinib) plus nivolumab in each disease cohort, stratified by TIS.
SECONDARY OBJECTIVES:
- To assess the difference in ORR in each disease cohort between tumor marker subgroups separately for each disease cohort.
II. To assess safety and tolerability of this treatment in these populations. III. To estimate disease control rate (DCR) in participants receiving cabozantinib plus nivolumab in each disease cohort, stratified by tumor biomarkers.
IV. To estimate progression-free survival (PFS) in participants receiving cabozantinib plus nivolumab in each disease cohort, stratified by tumor biomarkers.
- To estimate overall survival (OS) in participants receiving cabozantinib plus nivolumab in each disease cohort, stratified by tumor biomarkers.
VI. To assess the proportion of participants with assay failure, and the time from the date of tissue collection to molecular group determination at the end of Stage I.
VII. To evaluate the ORR in participants receiving cabozantinib plus nivolumab in each disease cohort, stratified by TIS and TMB.
VIII. To evaluate the association of TMB as a continuous variable with ORR within each disease cohort.
ADDITIONAL OBJECTIVE:
- To identify candidate biomarkers predictive of response and toxicity to the cabozantinib and nivolumab combination.
BANKING OBJECTIVE:
- To bank specimens for future correlative studies.
OUTLINE:
Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle and cabozantinib orally (PO) daily. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) scans and collection of blood samples throughout the trial. Patients undergo a tumor biopsy during screening and optionally during follow-up.
After completion of study treatment, patients are followed up every 12 weeks for 1 year and then every 6 months until 3 years after step 2 registration.
- Conditions
- Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Locally Recurrent Head and Neck Squamous Cell Carcinoma, Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma
- Being tested
- Biopsy Procedure, Biospecimen Collection, Cabozantinib S-malate, Computed Tomography, Magnetic Resonance Imaging
- Medical subject headings
- Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, Melanoma, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo tumor biopsies
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo collection of blood samples
Cabozantinib S-malateDrug
Also called BMS-907351, Cabometyx, Cometriq, XL 184
Given PO
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT scans
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI scans
NivolumabBiological
Also called ABP 206, BCD-263, BMS 936558, BMS-936558
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (nivolumab and cabozantinib) | Experimental | Patients receive nivolumab IV over 30 minutes on day 1 of each cycle and cabozantinib PO daily. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans and collection of blood samples throughout the trial. Patients undergo a tumor biopsy during screening and optionally during follow-up. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Drug: Cabozantinib S-malate; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker results turnaround time
A biomarker turnaround time estimate of at least 75% less than or equal to 21 days will be considered successful with respect to feasibility. For melanoma participants prior to Revision #7, turnaround time is defined as the time-period between date of tissue submission by the site to central repository and date the site was sent notification of participant molecular group determination. For head and neck squamous cell carcinoma (HNSCC) and melanoma participants after Revision #7, turnaround time is defined as the time-period between date of tissue submission by the site to central repository and one day after results have been received from the initial tissue submission by the Southwest Oncology Group Statistics and Data Management Center to simulate when the site would have received notification of participant molecular group determination.
Measured: Up to 21 days
Objective response rate
Confirmed and unconfirmed complete and partial responses in tumor inflammation score subgroups. Will assess biomarker response association. To test this association, will consider combination of biomarkers coded as 0 = Lo/Lo, 1 = Lo/Hi or Hi/Lo, and 2 = Hi/Hi. Assume each biomarker level is associated with an odds-ratio of approximately 3.1 (for example, corresponding to a difference in response rate of 5 percent to 14 percent from Lo/Lo to Lo/Hi or Hi/Lo). For the melanoma cohort, with approximately equal sized biomarker combination subgroups, a one-sided 0.10 level test for trend using (0,1,2) coding with logistic regression has a power of 80%. The same analysis for HNSCC will have lower power for the same effect size due to the unequal frequencies in the subgroups defined by the biomarkers. We will also conduct disease-by-biomarker interaction tests; however, there will be limited power to detect even to detect relatively large interaction parameters.
Measured: At the end of stage I
Secondary outcomes (5)
Rate and profile of >= grade 3 treatment-related adverse events
Per Common Terminology Criteria for Adverse Events 5.0. With respect to overall disease group, 60 participants are sufficient to estimate the probability of a particular toxicity to within +/- 13 percent. Any toxicity occurring with at least a 5 percent probability is likely to be seen at least once (95 percent chance).
Measured: Up to 2 years
Disease control rate
Will be estimated using the method of Kaplan-Meier.
Measured: Up to 2 years
Progression-free survival
Will be estimated using the method of Kaplan-Meier.
Measured: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 2 years
Overall survival
Will be estimated using the method of Kaplan-Meier.
Measured: From date of registration to date of death due to any cause, assessed up to 2 years
Turnaround time for the Tumor Inflammation Score in stage II
Measured: Assessed within 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start6 Dec 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Stage III Cutaneous Melanoma AJCC v8Studies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Siwen Hu-Lieskovan, Principal investigator, SWOG Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136196
- Sponsor's protocol ID
- NCI-2021-12653
- Other IDs
- NCI-2021-12653, S2101, S2101, U10CA180888
- Status last verified
- Jul 2026
- First submitted
- 25 Nov 2021
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page