Melanoma Clinical Trial

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

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 has spread to other places in 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.

View Full Description

Full Description

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 the overall study (Stage I and Stage II).

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 the study treatment, patients are followed for up to 3 years.

View Eligibility Criteria

Eligibility Criteria

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 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 known history of congenital long QT syndrome and must not have experienced unstable angina pectoris, clinically significant cardiac arrhythmias, or stroke (transient ischemic attack [TIA] or other ischemic event) within 90 days prior to Step 1 registration
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 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 have been eligible for step 1 registration 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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

150

Study ID:

NCT05136196

Recruitment Status:

Recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 157 Locations for this study

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Mayo Clinic Hospital in Arizona
Phoenix Arizona, 85054, United States More Info
Site Public Contact
Contact
855-776-0015
Arkadiusz Z. Dudek
Principal Investigator
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States More Info
Site Public Contact
Contact
501-686-8274
Omar T. Atiq
Principal Investigator
Rocky Mountain Regional VA Medical Center
Aurora Colorado, 80045, United States More Info
Site Public Contact
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888-336-8262
Jessica D. McDermott
Principal Investigator
UCHealth Memorial Hospital Central
Colorado Springs Colorado, 80909, United States More Info
Site Public Contact
Contact
719-365-2406
Robert J. Hoyer
Principal Investigator
Memorial Hospital North
Colorado Springs Colorado, 80920, United States More Info
Site Public Contact
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719-364-6700
Robert J. Hoyer
Principal Investigator
Poudre Valley Hospital
Fort Collins Colorado, 80524, United States More Info
Site Public Contact
Contact
970-297-6150
Robert J. Hoyer
Principal Investigator
Cancer Care and Hematology-Fort Collins
Fort Collins Colorado, 80528, United States More Info
Site Public Contact
Contact
[email protected]
Robert J. Hoyer
Principal Investigator
UCHealth Greeley Hospital
Greeley Colorado, 80631, United States More Info
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Contact
[email protected]
Robert J. Hoyer
Principal Investigator
Medical Center of the Rockies
Loveland Colorado, 80538, United States More Info
Site Public Contact
Contact
970-203-7083
Robert J. Hoyer
Principal Investigator
Helen F Graham Cancer Center
Newark Delaware, 19713, United States More Info
Site Public Contact
Contact
302-623-4450
[email protected]
Gregory A. Masters
Principal Investigator
Medical Oncology Hematology Consultants PA
Newark Delaware, 19713, United States More Info
Site Public Contact
Contact
302-623-4450
[email protected]
Gregory A. Masters
Principal Investigator
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States More Info
Site Public Contact
Contact
855-776-0015
Arkadiusz Z. Dudek
Principal Investigator
Saint Alphonsus Cancer Care Center-Boise
Boise Idaho, 83706, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
John M. Schallenkamp
Principal Investigator
Saint Luke's Cancer Institute - Boise
Boise Idaho, 83712, United States More Info
Site Public Contact
Contact
208-381-2774
[email protected]
Charles W. Drescher
Principal Investigator
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell Idaho, 83605, United States More Info
Site Public Contact
Contact
734-712-3671
[email protected]
John M. Schallenkamp
Principal Investigator
Kootenai Health - Coeur d'Alene
Coeur d'Alene Idaho, 83814, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Saint Luke's Cancer Institute - Fruitland
Fruitland Idaho, 83619, United States More Info
Site Public Contact
Contact
208-381-2774
[email protected]
Charles W. Drescher
Principal Investigator
Saint Luke's Cancer Institute - Meridian
Meridian Idaho, 83642, United States More Info
Site Public Contact
Contact
208-381-2774
[email protected]
Charles W. Drescher
Principal Investigator
Saint Luke's Cancer Institute - Nampa
Nampa Idaho, 83686, United States More Info
Site Public Contact
Contact
208-381-2774
[email protected]
Charles W. Drescher
Principal Investigator
Saint Alphonsus Cancer Care Center-Nampa
Nampa Idaho, 83687, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Kootenai Clinic Cancer Services - Post Falls
Post Falls Idaho, 83854, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Kootenai Cancer Clinic
Sandpoint Idaho, 83864, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Saint Luke's Cancer Institute - Twin Falls
Twin Falls Idaho, 83301, United States More Info
Site Public Contact
Contact
208-381-2774
[email protected]
Charles W. Drescher
Principal Investigator
Rush - Copley Medical Center
Aurora Illinois, 60504, United States More Info
Site Public Contact
Contact
630-978-6212
[email protected]
Prem Sobti
Principal Investigator
Illinois CancerCare-Bloomington
Bloomington Illinois, 61704, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Canton
Canton Illinois, 61520, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Carthage
Carthage Illinois, 62321, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Centralia Oncology Clinic
Centralia Illinois, 62801, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Northwestern University
Chicago Illinois, 60611, United States More Info
Site Public Contact
Contact
312-695-1301
[email protected]
Jeffrey A. Sosman
Principal Investigator
Carle at The Riverfront
Danville Illinois, 61832, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Prem Sobti
Principal Investigator
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Decatur Memorial Hospital
Decatur Illinois, 62526, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Northwestern Medicine Cancer Center Kishwaukee
DeKalb Illinois, 60115, United States More Info
Site Public Contact
Contact
630-352-5360
[email protected]
Jeffrey A. Sosman
Principal Investigator
Illinois CancerCare-Dixon
Dixon Illinois, 61021, United States More Info
Site Public Contact
Contact
815-285-7800
Bryan A. Faller
Principal Investigator
Carle Physician Group-Effingham
Effingham Illinois, 62401, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Prem Sobti
Principal Investigator
Crossroads Cancer Center
Effingham Illinois, 62401, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Eureka
Eureka Illinois, 61530, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Galesburg
Galesburg Illinois, 61401, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Northwestern Medicine Cancer Center Delnor
Geneva Illinois, 60134, United States More Info
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Contact
630-352-5360
[email protected]
Jeffrey A. Sosman
Principal Investigator
Illinois CancerCare-Kewanee Clinic
Kewanee Illinois, 61443, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Northwestern Medicine Lake Forest Hospital
Lake Forest Illinois, 60045, United States More Info
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Contact
[email protected]
Jeffrey A. Sosman
Principal Investigator
Illinois CancerCare-Macomb
Macomb Illinois, 61455, United States More Info
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Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Carle Physician Group-Mattoon/Charleston
Mattoon Illinois, 61938, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Prem Sobti
Principal Investigator
Cancer Care Center of O'Fallon
O'Fallon Illinois, 62269, United States More Info
Site Public Contact
Contact
217-876-4762
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Ottawa Clinic
Ottawa Illinois, 61350, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Pekin
Pekin Illinois, 61554, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Peru
Peru Illinois, 61354, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Illinois CancerCare-Princeton
Princeton Illinois, 61356, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States More Info
Site Public Contact
Contact
217-545-7929
Bryan A. Faller
Principal Investigator
Springfield Clinic
Springfield Illinois, 62702, United States More Info
Site Public Contact
Contact
800-444-7541
Bryan A. Faller
Principal Investigator
Memorial Medical Center
Springfield Illinois, 62781, United States More Info
Site Public Contact
Contact
217-528-7541
[email protected]
Bryan A. Faller
Principal Investigator
Carle Cancer Center
Urbana Illinois, 61801, United States More Info
Site Public Contact
Contact
800-446-5532
[email protected]
Prem Sobti
Principal Investigator
Northwestern Medicine Cancer Center Warrenville
Warrenville Illinois, 60555, United States More Info
Site Public Contact
Contact
630-352-5360
[email protected]
Jeffrey A. Sosman
Principal Investigator
Illinois CancerCare - Washington
Washington Illinois, 61571, United States More Info
Site Public Contact
Contact
309-243-3605
[email protected]
Bryan A. Faller
Principal Investigator
Rush-Copley Healthcare Center
Yorkville Illinois, 60560, United States More Info
Site Public Contact
Contact
630-978-6212
[email protected]
Prem Sobti
Principal Investigator
Mary Greeley Medical Center
Ames Iowa, 50010, United States More Info
Site Public Contact
Contact
515-956-4132
Joseph J. Merchant
Principal Investigator
McFarland Clinic - Ames
Ames Iowa, 50010, United States More Info
Site Public Contact
Contact
515-239-4734
[email protected]
Joseph J. Merchant
Principal Investigator
Mission Cancer and Blood - Ankeny
Ankeny Iowa, 50023, United States More Info
Site Public Contact
Contact
515-282-2921
Richard L. Deming
Principal Investigator
McFarland Clinic - Boone
Boone Iowa, 50036, United States More Info
Site Public Contact
Contact
515-956-4132
Joseph J. Merchant
Principal Investigator
Mercy Hospital
Cedar Rapids Iowa, 52403, United States More Info
Site Public Contact
Contact
319-365-4673
Deborah W. Wilbur
Principal Investigator
Oncology Associates at Mercy Medical Center
Cedar Rapids Iowa, 52403, United States More Info
Site Public Contact
Contact
319-363-2690
Deborah W. Wilbur
Principal Investigator
Medical Oncology and Hematology Associates-West Des Moines
Clive Iowa, 50325, United States More Info
Site Public Contact
Contact
515-241-3305
Richard L. Deming
Principal Investigator
Mercy Cancer Center-West Lakes
Clive Iowa, 50325, United States More Info
Site Public Contact
Contact
515-358-6613
[email protected]
Richard L. Deming
Principal Investigator
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States More Info
Site Public Contact
Contact
515-241-3305
Joshua Lukenbill
Principal Investigator
Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States More Info
Site Public Contact
Contact
515-358-6613
[email protected]
Richard L. Deming
Principal Investigator
Mission Cancer and Blood - Laurel
Des Moines Iowa, 50314, United States More Info
Site Public Contact
Contact
515-241-3305
Richard L. Deming
Principal Investigator
McFarland Clinic - Trinity Cancer Center
Fort Dodge Iowa, 50501, United States More Info
Site Public Contact
Contact
515-956-4132
Joseph J. Merchant
Principal Investigator
McFarland Clinic - Jefferson
Jefferson Iowa, 50129, United States More Info
Site Public Contact
Contact
515-956-4132
Joseph J. Merchant
Principal Investigator
McFarland Clinic - Marshalltown
Marshalltown Iowa, 50158, United States More Info
Site Public Contact
Contact
515-956-4132
Joseph J. Merchant
Principal Investigator
Tufts Medical Center
Boston Massachusetts, 02111, United States More Info
Site Public Contact
Contact
617-636-5000
[email protected]
Lori H. Pai
Principal Investigator
Baystate Medical Center
Springfield Massachusetts, 01199, United States More Info
Site Public Contact
Contact
413-794-3565
[email protected]
John C. McCann
Principal Investigator
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Elie G. Dib
Principal Investigator
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States More Info
Site Public Contact
Contact
800-865-1125
Paul L. Swiecicki
Principal Investigator
Bronson Battle Creek
Battle Creek Michigan, 49017, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Saint Joseph Mercy Brighton
Brighton Michigan, 48114, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Elie G. Dib
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton Michigan, 48114, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Elie G. Dib
Principal Investigator
Saint Joseph Mercy Canton
Canton Michigan, 48188, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Elie G. Dib
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton Michigan, 48188, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Elie G. Dib
Principal Investigator
Saint Joseph Mercy Chelsea
Chelsea Michigan, 48118, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Elie G. Dib
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea Michigan, 48118, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Elie G. Dib
Principal Investigator
Wayne State University/Karmanos Cancer Institute
Detroit Michigan, 48201, United States More Info
Site Public Contact
Contact
313-576-9790
[email protected]
Ammar Sukari
Principal Investigator
Weisberg Cancer Treatment Center
Farmington Hills Michigan, 48334, United States More Info
Site Public Contact
Contact
313-576-9790
[email protected]
Ammar Sukari
Principal Investigator
Genesee Cancer and Blood Disease Treatment Center
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Elie G. Dib
Principal Investigator
Genesee Hematology Oncology PC
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Elie G. Dib
Principal Investigator
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Elie G. Dib
Principal Investigator
Hurley Medical Center
Flint Michigan, 48503, United States More Info
Site Public Contact
Contact
810-762-8038
[email protected]
Elie G. Dib
Principal Investigator
Spectrum Health at Butterworth Campus
Grand Rapids Michigan, 49503, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Trinity Health Grand Rapids Hospital
Grand Rapids Michigan, 49503, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Ascension Borgess Cancer Center
Kalamazoo Michigan, 49009, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
University of Michigan Health - Sparrow Lansing
Lansing Michigan, 48912, United States More Info
Site Public Contact
Contact
517-364-3712
[email protected]
Elie G. Dib
Principal Investigator
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia Michigan, 48154, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Elie G. Dib
Principal Investigator
Trinity Health Muskegon Hospital
Muskegon Michigan, 49444, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores Michigan, 49444, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Corewell Health Reed City Hospital
Reed City Michigan, 49677, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph Michigan, 49085, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Munson Medical Center
Traverse City Michigan, 49684, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
University of Michigan Health - West
Wyoming Michigan, 49519, United States More Info
Site Public Contact
Contact
616-391-1230
[email protected]
Kathleen J. Yost
Principal Investigator
Huron Gastroenterology PC
Ypsilanti Michigan, 48106, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Elie G. Dib
Principal Investigator
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti Michigan, 48197, United States More Info
Site Public Contact
Contact
734-712-7251
[email protected]
Elie G. Dib
Principal Investigator
Sanford Joe Lueken Cancer Center
Bemidji Minnesota, 56601, United States More Info
Site Public Contact
Contact
218-333-5000
[email protected]
Daniel Almquist
Principal Investigator
Essentia Health Saint Joseph's Medical Center
Brainerd Minnesota, 56401, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Mercy Hospital
Coon Rapids Minnesota, 55433, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
David M. King
Principal Investigator
Essentia Health - Deer River Clinic
Deer River Minnesota, 56636, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes Minnesota, 56501, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Essentia Health Cancer Center
Duluth Minnesota, 55805, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Fairview Southdale Hospital
Edina Minnesota, 55435, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
David M. King
Principal Investigator
Essentia Health - Fosston
Fosston Minnesota, 56542, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Unity Hospital
Fridley Minnesota, 55432, United States
Essentia Health Hibbing Clinic
Hibbing Minnesota, 55746, United States More Info
Site Public Contact
Contact
218-786-3308
Bret E. Friday
Principal Investigator
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
David M. King
Principal Investigator
Essentia Health - Park Rapids
Park Rapids Minnesota, 56470, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States More Info
Site Public Contact
Contact
855-776-0015
Arkadiusz Z. Dudek
Principal Investigator
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
David M. King
Principal Investigator
Regions Hospital
Saint Paul Minnesota, 55101, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
David M. King
Principal Investigator
United Hospital
Saint Paul Minnesota, 55102, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
David M. King
Principal Investigator
Essentia Health Sandstone
Sandstone Minnesota, 55072, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Essentia Health Virginia Clinic
Virginia Minnesota, 55792, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Minnesota Oncology Hematology PA-Woodbury
Woodbury Minnesota, 55125, United States More Info
Site Public Contact
Contact
952-993-1517
[email protected]
David M. King
Principal Investigator
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States More Info
Site Public Contact
Contact
573-334-2230
[email protected]
Bryan A. Faller
Principal Investigator
Community Hospital of Anaconda
Anaconda Montana, 59711, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Billings Clinic Cancer Center
Billings Montana, 59101, United States More Info
Site Public Contact
Contact
800-996-2663
[email protected]
John M. Schallenkamp
Principal Investigator
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Benefis Healthcare- Sletten Cancer Institute
Great Falls Montana, 59405, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Community Medical Hospital
Missoula Montana, 59804, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Nebraska Medicine-Bellevue
Bellevue Nebraska, 68123, United States More Info
Site Public Contact
Contact
402-559-6941
[email protected]
Alissa S. Marr
Principal Investigator
Nebraska Medicine-Village Pointe
Omaha Nebraska, 68118, United States More Info
Site Public Contact
Contact
402-559-5600
Alissa S. Marr
Principal Investigator
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States More Info
Site Public Contact
Contact
402-559-6941
[email protected]
Alissa S. Marr
Principal Investigator
University of New Mexico Cancer Center
Albuquerque New Mexico, 87102, United States More Info
Site Public Contact
Contact
505-925-0348
[email protected]
Moises Harari-Turquie
Principal Investigator
Northwell Health/Center for Advanced Medicine
Lake Success New York, 11042, United States More Info
Site Public Contact
Contact
516-734-8896
Craig E. Devoe
Principal Investigator
Southeastern Medical Oncology Center-Clinton
Clinton North Carolina, 28328, United States More Info
Site Public Contact
Contact
919-587-9084
[email protected]
Samer S. Kasbari
Principal Investigator
Southeastern Medical Oncology Center-Goldsboro
Goldsboro North Carolina, 27534, United States More Info
Site Public Contact
Contact
919-587-9084
[email protected]
Samer S. Kasbari
Principal Investigator
Southeastern Medical Oncology Center-Jacksonville
Jacksonville North Carolina, 28546, United States More Info
Site Public Contact
Contact
910-587-9084
[email protected]
Samer S. Kasbari
Principal Investigator
Sanford Bismarck Medical Center
Bismarck North Dakota, 58501, United States More Info
Site Public Contact
Contact
701-323-5760
[email protected]
Daniel Almquist
Principal Investigator
Essentia Health Cancer Center-South University Clinic
Fargo North Dakota, 58103, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Sanford Broadway Medical Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-323-5760
[email protected]
Daniel Almquist
Principal Investigator
Sanford Roger Maris Cancer Center
Fargo North Dakota, 58122, United States More Info
Site Public Contact
Contact
701-234-6161
[email protected]
Daniel Almquist
Principal Investigator
Essentia Health - Jamestown Clinic
Jamestown North Dakota, 58401, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Miami Valley Hospital South
Centerville Ohio, 45459, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Tarek M. Sabagh
Principal Investigator
Dayton Blood and Cancer Center
Dayton Ohio, 45409, United States More Info
Site Public Contact
Contact
937-276-8320
Tarek M. Sabagh
Principal Investigator
Miami Valley Hospital North
Dayton Ohio, 45415, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Tarek M. Sabagh
Principal Investigator
Atrium Medical Center-Middletown Regional Hospital
Franklin Ohio, 45005, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Tarek M. Sabagh
Principal Investigator
Miami Valley Cancer Care and Infusion
Greenville Ohio, 45331, United States More Info
Site Public Contact
Contact
937-569-7515
Tarek M. Sabagh
Principal Investigator
Upper Valley Medical Center
Troy Ohio, 45373, United States More Info
Site Public Contact
Contact
937-528-2900
[email protected]
Tarek M. Sabagh
Principal Investigator
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States More Info
Site Public Contact
Contact
405-271-8777
[email protected]
Minh Phan
Principal Investigator
Saint Charles Health System
Bend Oregon, 97701, United States More Info
Site Public Contact
Contact
541-706-2909
[email protected]
Charles W. Drescher
Principal Investigator
Clackamas Radiation Oncology Center
Clackamas Oregon, 97015, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Charles W. Drescher
Principal Investigator
Providence Newberg Medical Center
Newberg Oregon, 97132, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Charles W. Drescher
Principal Investigator
Saint Alphonsus Medical Center-Ontario
Ontario Oregon, 97914, United States More Info
Site Public Contact
Contact
406-969-6060
[email protected]
John M. Schallenkamp
Principal Investigator
Providence Willamette Falls Medical Center
Oregon City Oregon, 97045, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Charles W. Drescher
Principal Investigator
Providence Portland Medical Center
Portland Oregon, 97213, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Charles W. Drescher
Principal Investigator
Providence Saint Vincent Medical Center
Portland Oregon, 97225, United States More Info
Site Public Contact
Contact
503-215-2614
[email protected]
Charles W. Drescher
Principal Investigator
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States More Info
Site Public Contact
Contact
215-600-9151
[email protected]
Jennifer M. Johnson
Principal Investigator
Jefferson Torresdale Hospital
Philadelphia Pennsylvania, 19114, United States More Info
Site Public Contact
Contact
215-600-9151
[email protected]
Jennifer M. Johnson
Principal Investigator
Asplundh Cancer Pavilion
Willow Grove Pennsylvania, 19090, United States More Info
Site Public Contact
Contact
215-600-9151
[email protected]
Jennifer M. Johnson
Principal Investigator
Sanford Cancer Center Oncology Clinic
Sioux Falls South Dakota, 57104, United States More Info
Site Public Contact
Contact
605-312-3320
[email protected]
Daniel Almquist
Principal Investigator
Sanford USD Medical Center - Sioux Falls
Sioux Falls South Dakota, 57117, United States More Info
Site Public Contact
Contact
605-312-3320
[email protected]
Daniel Almquist
Principal Investigator
Huntsman Cancer Institute/University of Utah
Salt Lake City Utah, 84112, United States More Info
Site Public Contact
Contact
888-424-2100
[email protected]
Jeffery S. Russell
Principal Investigator
Inova Alexandria Hospital
Alexandria Virginia, 22304, United States More Info
Site Public Contact
Contact
703-776-2580
[email protected]
Sekwon Jang
Principal Investigator
Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States More Info
Site Public Contact
Contact
703-720-5210
[email protected]
Sekwon Jang
Principal Investigator
Inova Fair Oaks Hospital
Fairfax Virginia, 22033, United States More Info
Site Public Contact
Contact
703-720-5210
[email protected]
Sekwon Jang
Principal Investigator
Inova Fairfax Hospital
Falls Church Virginia, 22042, United States More Info
Site Public Contact
Contact
703-208-6650
[email protected]
Sekwon Jang
Principal Investigator
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg Virginia, 24501, United States More Info
Site Public Contact
Contact
434-200-5925
[email protected]
Andrew Poklepovic
Principal Investigator
Virginia Cancer Institute
Richmond Virginia, 23229, United States More Info
Site Public Contact
Contact
804-287-3000
[email protected]
Andrew Poklepovic
Principal Investigator
VCU Massey Cancer Center at Stony Point
Richmond Virginia, 23235, United States More Info
Site Public Contact
Contact
[email protected]
Andrew Poklepovic
Principal Investigator
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States More Info
Site Public Contact
Contact
[email protected]
Andrew Poklepovic
Principal Investigator
Duluth Clinic Ashland
Ashland Wisconsin, 54806, United States More Info
Site Public Contact
Contact
218-786-3308
[email protected]
Bret E. Friday
Principal Investigator
Gundersen Lutheran Medical Center
La Crosse Wisconsin, 54601, United States More Info
Site Public Contact
Contact
608-775-2385
[email protected]
David E. Marinier
Principal Investigator
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Site Public Contact
Contact
414-805-3666
Callisia N. Clarke
Principal Investigator
ProHealth D N Greenwald Center
Mukwonago Wisconsin, 53149, United States More Info
Site Public Contact
Contact
[email protected]
Timothy R. Wassenaar
Principal Investigator
ProHealth Oconomowoc Memorial Hospital
Oconomowoc Wisconsin, 53066, United States More Info
Site Public Contact
Contact
262-928-7878
Timothy R. Wassenaar
Principal Investigator
Essentia Health Saint Mary's Hospital - Superior
Superior Wisconsin, 54880, United States More Info
Site Public Contact
Contact
701-364-6272
Bret E. Friday
Principal Investigator
ProHealth Waukesha Memorial Hospital
Waukesha Wisconsin, 53188, United States More Info
Site Public Contact
Contact
262-928-7632
Timothy R. Wassenaar
Principal Investigator
UW Cancer Center at ProHealth Care
Waukesha Wisconsin, 53188, United States More Info
Site Public Contact
Contact
262-928-5539
[email protected]
Timothy R. Wassenaar
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

150

Study ID:

NCT05136196

Recruitment Status:

Recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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