RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study

Quick Facts

Study Start:2022-12-06

Study Completion:2027-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05136196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 * 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	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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
* 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

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Siwen Hu-Lieskovan

PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Study Locations (Sites)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, 80045

United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909

United States

Memorial Hospital North

Colorado Springs, Colorado, 80920

United States

Poudre Valley Hospital

Fort Collins, Colorado, 80524

United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, 80528

United States

UCHealth Greeley Hospital

Greeley, Colorado, 80631

United States

Medical Center of the Rockies

Loveland, Colorado, 80538

United States

Helen F Graham Cancer Center

Newark, Delaware, 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713

United States

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

United States

Hawaii Cancer Care - Westridge

'Aiea, Hawaii, 96701

United States

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813

United States

Queen's Medical Center

Honolulu, Hawaii, 96813

United States

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817

United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605

United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814

United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619

United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642

United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687

United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854

United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, 83864

United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301

United States

Rush - Copley Medical Center

Aurora, Illinois, 60504

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

United States

Illinois CancerCare-Canton

Canton, Illinois, 61520

United States

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

United States

Centralia Oncology Clinic

Centralia, Illinois, 62801

United States

Northwestern University

Chicago, Illinois, 60611

United States

University of Illinois

Chicago, Illinois, 60612

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115

United States

Illinois CancerCare-Dixon

Dixon, Illinois, 61021

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134

United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045

United States

Illinois CancerCare-Macomb

Macomb, Illinois, 61455

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

United States

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

United States

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

United States

Illinois CancerCare-Peru

Peru, Illinois, 61354

United States

Illinois CancerCare-Princeton

Princeton, Illinois, 61356

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Springfield Memorial Hospital

Springfield, Illinois, 62781

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

United States

Illinois CancerCare - Washington

Washington, Illinois, 61571

United States

Rush-Copley Healthcare Center

Yorkville, Illinois, 60560

United States

Mary Greeley Medical Center

Ames, Iowa, 50010

United States

McFarland Clinic - Ames

Ames, Iowa, 50010

United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023

United States

McFarland Clinic - Boone

Boone, Iowa, 50036

United States

Mercy Hospital

Cedar Rapids, Iowa, 52403

United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403

United States

Mercy Cancer Center-West Lakes

Clive, Iowa, 50325

United States

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

Clive, Iowa, 50325

United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309

United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314

United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314

United States

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501

United States

McFarland Clinic - Jefferson

Jefferson, Iowa, 50129

United States

McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158

United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263

United States

Tufts Medical Center

Boston, Massachusetts, 02111

United States

Baystate Medical Center

Springfield, Massachusetts, 01199

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

United States

Bronson Battle Creek

Battle Creek, Michigan, 49017

United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

United States

Trinity Health Medical Center - Canton

Canton, Michigan, 48188

United States

Chelsea Hospital

Chelsea, Michigan, 48118

United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334

United States

Cancer Hematology Centers - Flint

Flint, Michigan, 48503

United States

Genesee Hematology Oncology PC

Flint, Michigan, 48503

United States

Genesys Hurley Cancer Institute

Flint, Michigan, 48503

United States

Hurley Medical Center

Flint, Michigan, 48503

United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503

United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503

United States

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

United States

West Michigan Cancer Center

Kalamazoo, Michigan, 49007

United States

Ascension Borgess Cancer Center

Kalamazoo, Michigan, 49009

United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444

United States

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, 49120

United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, 49444

United States

Corewell Health Reed City Hospital

Reed City, Michigan, 49677

United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085

United States

Munson Medical Center

Traverse City, Michigan, 49684

United States

University of Michigan Health - West

Wyoming, Michigan, 49519

United States

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, 56601

United States

Essentia Health Saint Joseph's Medical Center

Brainerd, Minnesota, 56401

United States

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Essentia Health - Deer River Clinic

Deer River, Minnesota, 56636

United States

Essentia Health Saint Mary's - Detroit Lakes Clinic

Detroit Lakes, Minnesota, 56501

United States

Essentia Health Cancer Center

Duluth, Minnesota, 55805

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Essentia Health - Fosston

Fosston, Minnesota, 56542

United States

Unity Hospital

Fridley, Minnesota, 55432

United States

Essentia Health Hibbing Clinic

Hibbing, Minnesota, 55746

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Essentia Health - Park Rapids

Park Rapids, Minnesota, 56470

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

United Hospital

Saint Paul, Minnesota, 55102

United States

Essentia Health Sandstone

Sandstone, Minnesota, 55072

United States

Essentia Health Virginia Clinic

Virginia, Minnesota, 55792

United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

Mercy Hospital South

Saint Louis, Missouri, 63128

United States

Community Hospital of Anaconda

Anaconda, Montana, 59711

United States

Billings Clinic Cancer Center

Billings, Montana, 59101

United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Logan Health Medical Center

Kalispell, Montana, 59901

United States

Community Medical Center

Missoula, Montana, 59804

United States

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123

United States

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042

United States

NYU Langone Hospital - Long Island

Mineola, New York, 11501

United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016

United States

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, 28328

United States

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, 27534

United States

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, 28546

United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501

United States

Essentia Health Cancer Center-South University Clinic

Fargo, North Dakota, 58103

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

United States

Essentia Health - Jamestown Clinic

Jamestown, North Dakota, 58401

United States

Miami Valley Hospital South

Centerville, Ohio, 45459

United States

Premier Blood and Cancer Center

Dayton, Ohio, 45409

United States

Miami Valley Hospital North

Dayton, Ohio, 45415

United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066

United States

Miami Valley Cancer Care and Infusion

Greenville, Ohio, 45331

United States

Upper Valley Medical Center

Troy, Ohio, 45373

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Saint Charles Health System

Bend, Oregon, 97701

United States

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015

United States

Providence Newberg Medical Center

Newberg, Oregon, 97132

United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, 97914

United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon, 97225

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114

United States

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, 19090

United States

Rapid City Regional Hospital

Rapid City, South Dakota, 57701

United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112

United States

Inova Alexandria Hospital

Alexandria, Virginia, 22304

United States

Inova Schar Cancer Institute

Fairfax, Virginia, 22031

United States

Inova Fair Oaks Hospital

Fairfax, Virginia, 22033

United States

Inova Fairfax Hospital

Falls Church, Virginia, 22042

United States

Centra Alan B Pearson Regional Cancer Center

Lynchburg, Virginia, 24501

United States

Virginia Cancer Institute

Richmond, Virginia, 23229

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

Duluth Clinic Ashland

Ashland, Wisconsin, 54806

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548

United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149

United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066

United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

United States

Essentia Health Saint Mary's Hospital - Superior

Superior, Wisconsin, 54880

United States

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, 53188

United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188

United States

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Siwen Hu-Lieskovan, PRINCIPAL_INVESTIGATOR, SWOG Cancer Research Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-06

Study Completion Date2027-01-01

Study Record Updates

Study Start Date2022-12-06

Study Completion Date2027-01-01

Terms related to this study

Additional Relevant MeSH Terms

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