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RecruitingNCT05136196Updated Sep 25, 2026

BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study

A Phase 2 interventional study of Biopsy Procedure and Biospecimen Collection in Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage IV Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI). Recruiting at 229 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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 may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine how quickly patients can be divided into groups based on biomarkers in their tumors. A biomarker is a biological molecule found in the blood, other body fluids, or in tissues that is a sign of a normal or abnormal process or a sign of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. The two biomarkers that this trial is studying are "tumor mutational burden" and "tumor inflammation signature." Another purpose of this trial is to help doctors learn if cabozantinib and nivolumab shrink or stabilize the cancer, and whether patients respond differently to the combination depending on the status of the biomarkers.

Read the detailed description

PRIMARY OBJECTIVES:

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 Nanostring IO360 gene expression profiling assay for tumor inflammation score (TIS) for stratification, as assessed by the proportion of participants with less than or equal to a 21-day turnaround time for biopsy results in Stage II of the study.

III. To evaluate the efficacy by overall response rate (ORR - defined as confirmed and unconfirmed partial responses plus complete responses) of cabozantinib S-malate (cabozantinib) plus nivolumab in each disease cohort, stratified by TIS.

SECONDARY OBJECTIVES:

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

VII. To evaluate the ORR in participants receiving cabozantinib plus nivolumab in each disease cohort, stratified by TIS and TMB.

VIII. To evaluate the association of TMB as a continuous variable with ORR within each disease cohort.

ADDITIONAL OBJECTIVE:

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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    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.

    Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Drug: Cabozantinib S-malate · Procedure: Computed Tomography · Procedure: Magnetic Resonance Imaging · Biological: Nivolumab

Interventions

  • ProcedureBiopsy Procedure

    Undergo tumor biopsies

    Also known as: Biopsy, BIOPSY_TYPE, Bx

  • ProcedureBiospecimen Collection

    Undergo collection of blood samples

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • DrugCabozantinib S-malate

    Given PO

    Also known as: BMS-907351, Cabometyx, Cometriq, XL 184, XL-184, XL184

  • ProcedureComputed Tomography

    Undergo CT scans

    Also known as: 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

  • ProcedureMagnetic Resonance Imaging

    Undergo MRI scans

    Also known as: 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

  • BiologicalNivolumab

    Given IV

    Also known as: 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

05

What researchers measure

Primary outcomes

  1. Biomarker results turnaround time

    A biomarker turnaround time estimate of at least 75% less than or equal to 21 days will be considered successful with respect to feasibility. For melanoma participants prior to Revision #7, turnaround time is defined as the time-period between date of tissue submission by the site to central repository and date the site was sent notification of participant molecular group determination. For head and neck squamous cell carcinoma (HNSCC) and melanoma participants after Revision #7, turnaround time is defined as the time-period between date of tissue submission by the site to central repository and one day after results have been received from the initial tissue submission by the Southwest Oncology Group Statistics and Data Management Center to simulate when the site would have received notification of participant molecular group determination.

    Time frame: Up to 21 days

  2. Objective response rate

    Confirmed and unconfirmed complete and partial responses in tumor inflammation score subgroups. Will assess biomarker response association. To test this association, will consider combination of biomarkers coded as 0 = Lo/Lo, 1 = Lo/Hi or Hi/Lo, and 2 = Hi/Hi. Assume each biomarker level is associated with an odds-ratio of approximately 3.1 (for example, corresponding to a difference in response rate of 5 percent to 14 percent from Lo/Lo to Lo/Hi or Hi/Lo). For the melanoma cohort, with approximately equal sized biomarker combination subgroups, a one-sided 0.10 level test for trend using (0,1,2) coding with logistic regression has a power of 80%. The same analysis for HNSCC will have lower power for the same effect size due to the unequal frequencies in the subgroups defined by the biomarkers. We will also conduct disease-by-biomarker interaction tests; however, there will be limited power to detect even to detect relatively large interaction parameters.

    Time frame: At the end of stage I

Secondary outcomes

  1. Rate and profile of >= grade 3 treatment-related adverse events

    Per Common Terminology Criteria for Adverse Events 5.0. With respect to overall disease group, 60 participants are sufficient to estimate the probability of a particular toxicity to within +/- 13 percent. Any toxicity occurring with at least a 5 percent probability is likely to be seen at least once (95 percent chance).

    Time frame: Up to 2 years

  2. Disease control rate

    Will be estimated using the method of Kaplan-Meier.

    Time frame: Up to 2 years

  3. Progression-free survival

    Will be estimated using the method of Kaplan-Meier.

    Time frame: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 2 years

  4. Overall survival

    Will be estimated using the method of Kaplan-Meier.

    Time frame: From date of registration to date of death due to any cause, assessed up to 2 years

  5. Turnaround time for the Tumor Inflammation Score in stage II

    Time frame: Assessed within 21 days

Other outcomes

  1. Additional markers of response or resistance

    Explore additional markers of response or resistance through hypothesis generating analysis. Tumor mutational burden (TMB) will be evaluated as an exploratory biomarker within each disease cohort. Both the binary cut-point of TMB high/low will be considered as well as TMB as a continuous variable (including log-transformed) will be assessed in a logistic regression model.

    Time frame: Up to 2 years

06

Study locations

204 of 229 sites recruiting
  • Mayo Clinic Hospital in Arizona
    Phoenix, Arizona 85054, United States
    • Site Public Contact · Contact · 855-776-0015
    • Arkadiusz Z. Dudek · Principal investigator
    Recruiting
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
    • Site Public Contact · Contact · 501-686-8274
    • Omar T. Atiq · Principal investigator
    Recruiting
  • Tower Cancer Research Foundation
    Beverly Hills, California 90211, United States
    Recruiting
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
    Irvine, California 92612, United States
    • Site Public Contact · Contact · ucstudy@uci.edu · 877-827-8839
    • Poorva Vaidya · Principal investigator
    Recruiting
  • The Angeles Clinic and Research Institute - West Los Angeles Office
    Los Angeles, California 90025, United States
    • Site Public Contact · Contact · protocols@swog.org
    • Inderjit Mehmi · Principal investigator
    Recruiting
  • Los Angeles General Medical Center
    Los Angeles, California 90033, United States
    Recruiting
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
    • Site Public Contact · Contact · 323-865-0451
    • Gino K. In · Principal investigator
    Recruiting
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
    Recruiting
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
    • Site Public Contact · Contact · ucstudy@uci.edu · 877-827-8839
    • Poorva Vaidya · Principal investigator
    Recruiting
  • Rocky Mountain Regional VA Medical Center
    Aurora, Colorado 80045, United States
    Active, not recruiting
  • UCHealth Memorial Hospital Central
    Colorado Springs, Colorado 80909, United States
    • Site Public Contact · Contact · 719-365-2406
    • Stacey Parker-Brueggemann · Principal investigator
    Recruiting
  • Memorial Hospital North
    Colorado Springs, Colorado 80920, United States
    • Site Public Contact · Contact · 719-364-6700
    • Stacey Parker-Brueggemann · Principal investigator
    Recruiting
  • Poudre Valley Hospital
    Fort Collins, Colorado 80524, United States
    • Site Public Contact · Contact · 970-297-6150
    • Stacey Parker-Brueggemann · Principal investigator
    Recruiting
  • Cancer Care and Hematology-Fort Collins
    Fort Collins, Colorado 80528, United States
    • Site Public Contact · Contact · protocols@swog.org
    • Stacey Parker-Brueggemann · Principal investigator
    Recruiting
  • UCHealth Greeley Hospital
    Greeley, Colorado 80631, United States
    • Site Public Contact · Contact · protocols@swog.org
    • Stacey Parker-Brueggemann · Principal investigator
    Recruiting
  • Medical Center of the Rockies
    Loveland, Colorado 80538, United States
    • Site Public Contact · Contact · 970-203-7083
    • Stacey Parker-Brueggemann · Principal investigator
    Recruiting
  • Helen F Graham Cancer Center
    Newark, Delaware 19713, United States
    Recruiting
  • Medical Oncology Hematology Consultants PA
    Newark, Delaware 19713, United States
    Recruiting
  • Mayo Clinic in Florida
    Jacksonville, Florida 32224-9980, United States
    • Site Public Contact · Contact · 855-776-0015
    • Arkadiusz Z. Dudek · Principal investigator
    Recruiting
  • Hawaii Cancer Care Inc - Waterfront Plaza
    Honolulu, Hawaii 96813, United States
    Suspended
  • Queen's Cancer Cenrer - POB I
    Honolulu, Hawaii 96813, United States
    Suspended
  • Queen's Medical Center
    Honolulu, Hawaii 96813, United States
    Suspended
  • Queen's Cancer Center - Kuakini
    Honolulu, Hawaii 96817, United States
    Suspended
  • Hawaii Cancer Care - Westridge
    ‘Aiea, Hawaii 96701, United States
    Suspended
  • Saint Alphonsus Cancer Care Center-Boise
    Boise, Idaho 83706, United States
    Recruiting
  • Saint Luke's Cancer Institute - Boise
    Boise, Idaho 83712, United States
    • Site Public Contact · Contact · eslinget@slhs.org · 208-381-2774
    • Charles W. Drescher · Principal investigator
    Recruiting
  • Saint Alphonsus Cancer Care Center-Caldwell
    Caldwell, Idaho 83605, United States
    Recruiting
  • Kootenai Health - Coeur d'Alene
    Coeur d'Alene, Idaho 83814, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Saint Luke's Cancer Institute - Fruitland
    Fruitland, Idaho 83619, United States
    • Site Public Contact · Contact · eslinget@slhs.org · 208-381-2774
    • Charles W. Drescher · Principal investigator
    Recruiting
  • Saint Luke's Cancer Institute - Meridian
    Meridian, Idaho 83642, United States
    • Site Public Contact · Contact · eslinget@slhs.org · 208-381-2774
    • Charles W. Drescher · Principal investigator
    Recruiting
  • Saint Alphonsus Cancer Care Center-Nampa
    Nampa, Idaho 83687, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • Elie G. Dib · Principal investigator
    Recruiting
  • Saint Luke's Cancer Institute - Nampa
    Nampa, Idaho 83687, United States
    • Site Public Contact · Contact · eslinget@slhs.org · 208-381-2774
    • Charles W. Drescher · Principal investigator
    Recruiting
  • Kootenai Clinic Cancer Services - Post Falls
    Post Falls, Idaho 83854, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Kootenai Clinic Cancer Services - Sandpoint
    Sandpoint, Idaho 83864, United States
    • Site Public Contact · Contact · mccinfo@mtcancer.org · 406-969-6060
    • John M. Schallenkamp · Principal investigator
    Recruiting
  • Saint Luke's Cancer Institute - Twin Falls
    Twin Falls, Idaho 83301, United States
    • Site Public Contact · Contact · eslinget@slhs.org · 208-381-2774
    • Charles W. Drescher · Principal investigator
    Recruiting
  • Rush-Copley Medical Center
    Aurora, Illinois 60504, United States
    Recruiting
  • Illinois CancerCare-Bloomington
    Bloomington, Illinois 61704, United States
    Recruiting
  • Illinois CancerCare-Canton
    Canton, Illinois 61520, United States
    Recruiting
  • Illinois CancerCare-Carthage
    Carthage, Illinois 62321, United States
    Recruiting
  • Centralia Oncology Clinic
    Centralia, Illinois 62801, United States
    Recruiting
  • Northwestern University
    Chicago, Illinois 60611, United States
    Recruiting
  • University of Illinois
    Chicago, Illinois 60612, United States
    • Site Public Contact · Contact · 312-355-3046
    • Ryan Nguyen · Principal investigator
    Recruiting
  • Carle at The Riverfront
    Danville, Illinois 61832, United States
    • Site Public Contact · Contact · Research@Carle.com · 800-446-5532
    • Prem Sobti · Principal investigator
    Recruiting
  • Cancer Care Specialists of Illinois - Decatur
    Decatur, Illinois 62526, United States
    Recruiting
  • Decatur Memorial Hospital
    Decatur, Illinois 62526, United States
    Recruiting
  • Northwestern Medicine Cancer Center Kishwaukee
    DeKalb, Illinois 60115, United States
    • Site Public Contact · Contact · Donald.Smith3@nm.org · 630-352-5360
    • Jacob Choi · Principal investigator
    Recruiting
  • Illinois CancerCare-Dixon
    Dixon, Illinois 61021, United States
    • Site Public Contact · Contact · 815-285-7800
    • Bryan A. Faller · Principal investigator
    Recruiting
  • Carle Physician Group-Effingham
    Effingham, Illinois 62401, United States
    • Site Public Contact · Contact · Research@carle.com · 800-446-5532
    • Prem Sobti · Principal investigator
    Recruiting
  • Crossroads Cancer Center
    Effingham, Illinois 62401, United States
    Recruiting
  • Illinois CancerCare-Eureka
    Eureka, Illinois 61530, United States
    Recruiting
  • Illinois CancerCare-Galesburg
    Galesburg, Illinois 61401, United States
    Recruiting
  • Northwestern Medicine Cancer Center Delnor
    Geneva, Illinois 60134, United States
    • Site Public Contact · Contact · Donald.Smith3@nm.org · 630-352-5360
    • Jacob Choi · Principal investigator
    Recruiting
  • Northwestern Medicine Glenview Outpatient Center
    Glenview, Illinois 60026, United States
    • Site Public Contact · Contact · 312-695-1102
    • Jacob Choi · Principal investigator
    Recruiting
  • Northwestern Medicine Grayslake Outpatient Center
    Grayslake, Illinois 60030, United States
    • Site Public Contact · Contact · 312-695-1102
    • Jacob Choi · Principal investigator
    Recruiting
  • Illinois CancerCare-Kewanee Clinic
    Kewanee, Illinois 61443, United States
    Recruiting
  • Northwestern Medicine Lake Forest Hospital
    Lake Forest, Illinois 60045, United States
    Recruiting
  • Illinois CancerCare-Macomb
    Macomb, Illinois 61455, United States
    Recruiting
  • Carle Physician Group-Mattoon/Charleston
    Mattoon, Illinois 61938, United States
    • Site Public Contact · Contact · Research@carle.com · 800-446-5532
    • Prem Sobti · Principal investigator
    Recruiting
  • Loyola University Medical Center
    Maywood, Illinois 60153, United States
    • Site Public Contact · Contact · 708-226-4357
    • Joseph I. Clark · Principal investigator
    Recruiting
  • Carle BroMenn Medical Center
    Normal, Illinois 61761, United States
    • Site Public Contact · Contact · Research@Carle.com · 800-446-5532
    • Prem Sobti · Principal investigator
    Recruiting
  • Carle Cancer Institute Normal
    Normal, Illinois 61761, United States
    • Site Public Contact · Contact · Research@Carle.com · 800-446-5532
    • Prem Sobti · Principal investigator
    Recruiting
  • Cancer Care Center of O'Fallon
    O'Fallon, Illinois 62269, United States
    Recruiting
  • Northwestern Medicine Orland Park
    Orland Park, Illinois 60462, United States
    Recruiting
  • Illinois CancerCare-Ottawa Clinic
    Ottawa, Illinois 61350, United States
    Recruiting
  • Illinois CancerCare-Pekin
    Pekin, Illinois 61554, United States
    Recruiting
  • Illinois CancerCare-Peoria
    Peoria, Illinois 61615, United States
    Recruiting
  • Illinois CancerCare-Peru
    Peru, Illinois 61354, United States
    Recruiting
  • Illinois CancerCare-Princeton
    Princeton, Illinois 61356, United States
    Recruiting
  • Memorial Hospital East
    Shiloh, Illinois 62269, United States
    • Site Public Contact · Contact · dschwab@wustl.edu · 314-747-9912
    • Brendan J. Knapp · Principal investigator
    Recruiting
  • Southern Illinois University School of Medicine
    Springfield, Illinois 62702, United States
    • Site Public Contact · Contact · 217-545-7929
    • Bryan A. Faller · Principal investigator
    Recruiting
  • Springfield Clinic
    Springfield, Illinois 62702, United States
    • Site Public Contact · Contact · 800-444-7541
    • Bryan A. Faller · Principal investigator
    Recruiting
  • Springfield Memorial Hospital
    Springfield, Illinois 62781, United States
    Recruiting
  • Carle Cancer Center
    Urbana, Illinois 61801, United States
    • Site Public Contact · Contact · Research@carle.com · 800-446-5532
    • Prem Sobti · Principal investigator
    Recruiting
  • Northwestern Medicine Cancer Center Warrenville
    Warrenville, Illinois 60555, United States
    • Site Public Contact · Contact · Donald.Smith3@nm.org · 630-352-5360
    • Jacob Choi · Principal investigator
    Recruiting
  • Illinois CancerCare - Washington
    Washington, Illinois 61571, United States
    Recruiting
  • Rush-Copley Healthcare Center
    Yorkville, Illinois 60560, United States
    Recruiting
  • Mary Greeley Medical Center
    Ames, Iowa 50010, United States
    • Site Public Contact · Contact · 515-956-4132
    • Joseph J. Merchant · Principal investigator
    Recruiting
  • McFarland Clinic - Ames
    Ames, Iowa 50010, United States
    Recruiting
  • UI Health Care Mission Cancer and Blood - Ankeny Clinic
    Ankeny, Iowa 50023, United States
    • Site Public Contact · Contact · 515-241-3305
    • Seema Harichand-Herdt · Principal investigator
    Recruiting
  • McFarland Clinic - Boone
    Boone, Iowa 50036, United States
    Suspended
  • Mercy Hospital
    Cedar Rapids, Iowa 52403, United States
    • Site Public Contact · Contact · 319-365-4673
    • Deborah W. Wilbur · Principal investigator
    Recruiting
  • Oncology Associates at Mercy Medical Center
    Cedar Rapids, Iowa 52403, United States
    • Site Public Contact · Contact · 319-363-2690
    • Deborah W. Wilbur · Principal investigator
    Recruiting
  • Mercy Cancer Center-West Lakes
    Clive, Iowa 50325, United States
    • Site Public Contact · Contact · 515-241-3305
    • Richard L. Deming · Principal investigator
    Recruiting
  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
    Clive, Iowa 50325, United States
    • Site Public Contact · Contact · 515-241-3305
    • Seema Harichand-Herdt · Principal investigator
    Recruiting
  • UI Health Care Mission Cancer and Blood - Des Moines Clinic
    Des Moines, Iowa 50309, United States
    • Site Public Contact · Contact · 515-241-3305
    • Seema Harichand-Herdt · Principal investigator
    Recruiting
  • Mercy Medical Center - Des Moines
    Des Moines, Iowa 50314, United States
    • Site Public Contact · Contact · 515-241-3305
    • Richard L. Deming · Principal investigator
    Recruiting
  • UI Health Care Mission Cancer and Blood - Laurel Clinic
    Des Moines, Iowa 50314, United States
    • Site Public Contact · Contact · 515-241-3305
    • Seema Harichand-Herdt · Principal investigator
    Recruiting
  • McFarland Clinic - Trinity Cancer Center
    Fort Dodge, Iowa 50501, United States
    • Site Public Contact · Contact · 515-956-4132
    • Joseph J. Merchant · Principal investigator
    Recruiting
  • McFarland Clinic - Jefferson
    Jefferson, Iowa 50129, United States
    Suspended
  • McFarland Clinic - Marshalltown
    Marshalltown, Iowa 50158, United States
    • Site Public Contact · Contact · 515-956-4132
    • Joseph J. Merchant · Principal investigator
    Recruiting
  • UI Health Care Mission Cancer and Blood - Waukee Clinic
    Waukee, Iowa 50263, United States
    • Site Public Contact · Contact · 515-241-3305
    • Seema Harichand-Herdt · Principal investigator
    Recruiting
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
    Active, not recruiting
  • Baystate Medical Center
    Springfield, Massachusetts 01199, United States
    Recruiting
  • Tufts Medical Center Cancer Center Stoneham
    Stoneham, Massachusetts 02180, United States
    Active, not recruiting
  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
    Ann Arbor, Michigan 48106, United States
    Recruiting
  • University of Michigan Rogel Cancer Center
    Ann Arbor, Michigan 48109, United States
    Recruiting
  • Bronson Battle Creek
    Battle Creek, Michigan 49017, United States
    Recruiting
  • Trinity Health IHA Medical Group Hematology Oncology - Brighton
    Brighton, Michigan 48114, United States
    Recruiting
  • Trinity Health Medical Center - Brighton
    Brighton, Michigan 48114, United States
    Recruiting
  • Trinity Health IHA Medical Group Hematology Oncology - Canton
    Canton, Michigan 48188, United States
    Recruiting

Showing the first 100 of 229 sites.

07

References and documents

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05136196
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 29, 2021
Start date
Dec 6, 2022
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Siwen Hu-Lieskovan
principal investigator · SWOG Cancer Research Network

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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