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

NCT ID: NCT05136196

Last Updated: 2025-11-10

Study Results

Results pending

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

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-06

Study Completion Date

2027-01-01

Brief Summary

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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.

Detailed Description

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PRIMARY OBJECTIVES:

I. 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 gene expression profiling (GEP) (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, both across and within tumor biomarker subgroups.

SECONDARY OBJECTIVES:

I. 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.

V. 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 patients with assay failure, and the time from the date of tissue collection to molecular group determination at the end of Stage I.

ADDITIONAL OBJECTIVE:

I. To identify candidate biomarkers predictive of response and toxicity to the cabozantinib and nivolumab combination.

BANKING OBJECTIVE:

I. 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

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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 Locally Recurrent Laryngeal Squamous Cell Carcinoma Locally Recurrent Oral Cavity Squamous Cell Carcinoma Locally Recurrent Oropharyngeal Squamous Cell Carcinoma Metastatic Head and Neck Squamous Cell Carcinoma Metastatic Hypopharyngeal Squamous Cell Carcinoma Metastatic Laryngeal Squamous Cell Carcinoma Metastatic Melanoma Metastatic Oral Cavity Squamous Cell Carcinoma Metastatic Oropharyngeal Squamous Cell Carcinoma Recurrent Melanoma Stage III Hypopharyngeal Carcinoma AJCC v8 Stage III Laryngeal Cancer AJCC v8 Stage III Lip and Oral Cavity Cancer AJCC v8 Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Stage IV Hypopharyngeal Carcinoma AJCC v8 Stage IV Laryngeal Cancer AJCC v8 Stage IV Lip and Oral Cavity Cancer AJCC v8 Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8 Unresectable Melanoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (nivolumab and cabozantinib)

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.

Group Type EXPERIMENTAL

Biopsy Procedure

Intervention Type PROCEDURE

Undergo tumor biopsies

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Cabozantinib S-malate

Intervention Type DRUG

Given PO

Computed Tomography

Intervention Type PROCEDURE

Undergo CT scans

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI scans

Nivolumab

Intervention Type BIOLOGICAL

Given IV

Interventions

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Biopsy Procedure

Undergo tumor biopsies

Intervention Type PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

Intervention Type PROCEDURE

Cabozantinib S-malate

Given PO

Intervention Type DRUG

Computed Tomography

Undergo CT scans

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo MRI scans

Intervention Type PROCEDURE

Nivolumab

Given IV

Intervention Type BIOLOGICAL

Other Intervention Names

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Biopsy BIOPSY_TYPE Bx Biological Sample Collection Biospecimen Collected Specimen Collection BMS-907351 Cabometyx Cometriq XL 184 XL-184 XL184 CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized axial tomography (procedure) Computerized Tomography Computerized Tomography (CT) scan CT CT Scan Diagnostic CAT Scan Diagnostic CAT Scan Service Type tomography Magnetic Resonance Magnetic Resonance Imaging (MRI) Magnetic resonance imaging (procedure) Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan MRIs NMR Imaging NMRI Nuclear Magnetic Resonance Imaging sMRI Structural MRI ABP 206 BCD-263 BMS 936558 BMS-936558 BMS936558 CMAB819 MDX 1106 MDX-1106 MDX1106 NIVO Nivolumab Biosimilar ABP 206 Nivolumab Biosimilar BCD-263 Nivolumab Biosimilar CMAB819 ONO 4538 ONO-4538 ONO4538 Opdivo

Eligibility Criteria

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Inclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Siwen Hu-Lieskovan

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

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Inova Schar Cancer Institute

Fairfax, Virginia, United States

Site Status RECRUITING

Inova Fair Oaks Hospital

Fairfax, Virginia, United States

Site Status RECRUITING

Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status RECRUITING

Centra Alan B Pearson Regional Cancer Center

Lynchburg, Virginia, United States

Site Status RECRUITING

Virginia Cancer Institute

Richmond, Virginia, United States

Site Status RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

Site Status RECRUITING

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

Site Status RECRUITING

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status RECRUITING

Tower Cancer Research Foundation

Beverly Hills, California, United States

Site Status RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Site Status RECRUITING

The Angeles Clinic and Research Institute - West Los Angeles Office

Los Angeles, California, United States

Site Status RECRUITING

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status RECRUITING

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Site Status ACTIVE_NOT_RECRUITING

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Site Status RECRUITING

Memorial Hospital North

Colorado Springs, Colorado, United States

Site Status RECRUITING

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status RECRUITING

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

Site Status RECRUITING

UCHealth Greeley Hospital

Greeley, Colorado, United States

Site Status RECRUITING

Medical Center of the Rockies

Loveland, Colorado, United States

Site Status RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Site Status RECRUITING

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, United States

Site Status RECRUITING

Queen's Medical Center

Honolulu, Hawaii, United States

Site Status RECRUITING

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, United States

Site Status RECRUITING

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Site Status RECRUITING

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Site Status RECRUITING

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Site Status RECRUITING

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

Site Status RECRUITING

Rush-Copley Medical Center

Aurora, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status RECRUITING

Centralia Oncology Clinic

Centralia, Illinois, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

University of Illinois

Chicago, Illinois, United States

Site Status RECRUITING

Carle at The Riverfront

Danville, Illinois, United States

Site Status RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status RECRUITING

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status RECRUITING

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status RECRUITING

Memorial Hospital East

Shiloh, Illinois, United States

Site Status RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status RECRUITING

Springfield Clinic

Springfield, Illinois, United States

Site Status RECRUITING

Springfield Memorial Hospital

Springfield, Illinois, United States

Site Status RECRUITING

Carle Cancer Center

Urbana, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Site Status RECRUITING

Illinois CancerCare - Washington

Washington, Illinois, United States

Site Status RECRUITING

Rush-Copley Healthcare Center

Yorkville, Illinois, United States

Site Status RECRUITING

Mary Greeley Medical Center

Ames, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Ames

Ames, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Boone

Boone, Iowa, United States

Site Status RECRUITING

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status RECRUITING

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status RECRUITING

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Site Status RECRUITING

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

Site Status RECRUITING

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, United States

Site Status RECRUITING

Tufts Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Site Status RECRUITING

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status RECRUITING

Bronson Battle Creek

Battle Creek, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Site Status RECRUITING

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Site Status RECRUITING

Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Cancer Hematology Centers - Flint

Flint, Michigan, United States

Site Status RECRUITING

Genesee Hematology Oncology PC

Flint, Michigan, United States

Site Status SUSPENDED

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status RECRUITING

Hurley Medical Center

Flint, Michigan, United States

Site Status RECRUITING

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Site Status RECRUITING

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Site Status RECRUITING

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status RECRUITING

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status RECRUITING

Beacon Kalamazoo Cancer Center

Kalamazoo, Michigan, United States

Site Status RECRUITING

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status RECRUITING

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States

Site Status RECRUITING

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, United States

Site Status RECRUITING

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Site Status RECRUITING

Corewell Health Reed City Hospital

Reed City, Michigan, United States

Site Status RECRUITING

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Site Status RECRUITING

Munson Medical Center

Traverse City, Michigan, United States

Site Status RECRUITING

University of Michigan Health - West

Wyoming, Michigan, United States

Site Status RECRUITING

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Site Status RECRUITING

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Site Status RECRUITING

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, United States

Site Status RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status RECRUITING

Essentia Health - Deer River Clinic

Deer River, Minnesota, United States

Site Status RECRUITING

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota, United States

Site Status RECRUITING

Essentia Health Cancer Center

Duluth, Minnesota, United States

Site Status RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status RECRUITING

Essentia Health - Fosston

Fosston, Minnesota, United States

Site Status RECRUITING

Unity Hospital

Fridley, Minnesota, United States

Site Status ACTIVE_NOT_RECRUITING

Essentia Health Hibbing Clinic

Hibbing, Minnesota, United States

Site Status RECRUITING

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status RECRUITING

Essentia Health - Park Rapids

Park Rapids, Minnesota, United States

Site Status RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status RECRUITING

Regions Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

United Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

Essentia Health Sandstone

Sandstone, Minnesota, United States

Site Status RECRUITING

Essentia Health Virginia Clinic

Virginia, Minnesota, United States

Site Status RECRUITING

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status RECRUITING

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital South

St Louis, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center-South County

St Louis, Missouri, United States

Site Status RECRUITING

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Site Status RECRUITING

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status RECRUITING

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status RECRUITING

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Site Status RECRUITING

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Site Status RECRUITING

Logan Health Medical Center

Kalispell, Montana, United States

Site Status RECRUITING

Community Medical Center

Missoula, Montana, United States

Site Status RECRUITING

Nebraska Medicine-Bellevue

Bellevue, Nebraska, United States

Site Status RECRUITING

Nebraska Medicine-Village Pointe

Omaha, Nebraska, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status RECRUITING

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States

Site Status ACTIVE_NOT_RECRUITING

NYU Langone Hospital - Long Island

Mineola, New York, United States

Site Status RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Site Status RECRUITING

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, United States

Site Status RECRUITING

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

Site Status RECRUITING

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, United States

Site Status RECRUITING

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Site Status RECRUITING

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, United States

Site Status RECRUITING

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Site Status RECRUITING

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status RECRUITING

Essentia Health - Jamestown Clinic

Jamestown, North Dakota, United States

Site Status RECRUITING

Miami Valley Hospital South

Centerville, Ohio, United States

Site Status RECRUITING

Premier Blood and Cancer Center

Dayton, Ohio, United States

Site Status RECRUITING

Miami Valley Hospital North

Dayton, Ohio, United States

Site Status RECRUITING

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Site Status RECRUITING

Miami Valley Cancer Care and Infusion

Greenville, Ohio, United States

Site Status RECRUITING

Upper Valley Medical Center

Troy, Ohio, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Saint Charles Health System

Bend, Oregon, United States

Site Status RECRUITING

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Site Status RECRUITING

Providence Newberg Medical Center

Newberg, Oregon, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States

Site Status RECRUITING

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Site Status RECRUITING

Providence Portland Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States

Site Status ACTIVE_NOT_RECRUITING

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status RECRUITING

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Inova Alexandria Hospital

Alexandria, Virginia, United States

Site Status RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

Duluth Clinic Ashland

Ashland, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Site Status RECRUITING

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Site Status RECRUITING

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

Site Status RECRUITING

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Site Status RECRUITING

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Site Status RECRUITING

Essentia Health Saint Mary's Hospital - Superior

Superior, Wisconsin, United States

Site Status RECRUITING

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Site Status RECRUITING

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

Site Status RECRUITING

Countries

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

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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Other Identifiers

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

NCI-2021-12653

Identifier Type: REGISTRY

Identifier Source: secondary_id

S2101

Identifier Type: OTHER

Identifier Source: secondary_id

S2101

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180888

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2021-12653

Identifier Type: -

Identifier Source: org_study_id