Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study
Study Details
Study Description
Brief Summary
This phase III trial compares the effect of adding cabozantinib to avelumab versus avelumab alone in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and avelumab together may further shrink the cancer or prevent it from returning/progressing.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Phase 3 |
Detailed Description
PRIMARY OBJECTIVE:
- To evaluate the effect of cabozantinib S-malate (cabozantinib) in combination with avelumab on overall survival (OS) compared to avelumab alone in patients with metastatic urothelial cancer (mUC) who did not progress during first-line platinum-based chemotherapy therapy, i.e. patients who had complete response (CR), partial response (PR) or stable disease (SD) after completion of first line platinum-based chemotherapy.
SECONDARY OBJECTIVES:
-
To evaluate the effect of cabozantinib in combination with avelumab on progression-free survival (PFS) compared to avelumab alone for maintenance treatment following initial first-line treatment in patients who had a CR, PR or SD upon completion of first-line platinum-based chemotherapy.
-
To evaluate the safety and tolerability of cabozantinib in combination with avelumab in mUC compared to avelumab alone for maintenance treatment following initial first-line treatment in patients who had a CR, PR or SD upon completion of first-line platinum-based chemotherapy.
-
To evaluate activity of cabozantinib in combination with avelumab based on Response Evaluation Criteria in Solid Tumors (RECIST) compared to avelumab alone for maintenance treatment following initial first-line treatment in patients who had a CR, PR or SD upon completion of first-line platinum-based chemotherapy.
-
Results of the primary analysis will be examined for consistency, while accounting for the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue.
-
To evaluate the activity of cabozantinib in combination with avelumab compared to avelumab alone based on PD-L1 status of patients' tumors.
QUALITY OF LIFE (QOL) OBJECTIVES:
-
To compare quality-adjusted survival between patients randomized to receive cabozantinib and avelumab versus (vs.) avelumab alone using the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).
-
To compare patient-reported fatigue as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 4a from baseline through 12 months between patients randomized to receive cabozantinib and avelumab vs. avelumab alone.
-
To compare patient-reported global health status/quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core (C)30 from baseline through 12 months between patients randomized to receive cabozantinib and avelumab vs. avelumab alone.
-
To compare scale scores of the EORTC QLQ-Bladder Cancer Muscle-Invasive (BLM)30 (urinary symptoms, urostomy problems, catheter problems, future perspectives, abdominal bloating and flatulence, body image, sexual function) at 3, 6, 12, 18, and 24 months between patients randomized to receive cabozantinib and avelumab vs. avelumab alone.
-
To compare scale scores of the EORTC QLQ-C30 (global health status/quality of life; physical, role, emotional, cognitive, and social function; symptoms) at 3, 6, 12, 18, and 24 months between patients randomized to receive cabozantinib and avelumab vs. avelumab alone.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive avelumab intravenously (IV) over 60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive avelumab IV over 60 minutes on days 1 and 15 of each cycle and cabozantinib orally (PO) daily on days 1-28 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 30 days through 90 days, then every 3 months for 5 years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm A (avelumab) Patients receive avelumab IV over 60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. |
Drug: Avelumab
Given IV
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
| Experimental: Arm B (avelumab, cabozantinib) Patients receive avelumab IV over 60 minutes on days 1 and 15 of each cycle and cabozantinib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. |
Drug: Avelumab
Given IV
Other Names:
Drug: Cabozantinib S-malate
Given PO
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Overall survival (OS) [Time from randomization until death due to any cause, assessed up to 5 years]
Subgroup analyses will be done using a stratified Cox model that includes the treatment arm assignment as an explanatory variable and a separate model will be generated for each level for the subgroup of interest.
Secondary Outcome Measures
- Progression free survival (PFS) [Time from randomization until disease progression as assessed by the treating physician using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, assessed up to 5 years]
A stratified Cox model will be used to compare the outcomes between the two treatment groups. The subgroup analyses will be done using a stratified Cox model that includes the treatment arm assignment as an explanatory variable and a separate model will be generated for each level for the subgroup of interest.
- Tumor response [Up to 5 years]
Will be defined as a complete response or partial response (PR) as measured with Immune-Modified RECIST. Will be compared between the arms using a Mantel-Haenszel test (that accounts for the randomization stratification factors) comparing the response rates between the two treatment arms. This analysis will only include patients who had a PR or stable disease (SD) response to first-line therapy. An additional analysis will be conducted using logistic regression analysis that includes treatment arm and any baseline variables that are imbalanced between the arms as explanatory variable.
- Incidence of adverse events (AE) [Up to 5 years]
Will be assessed by Common Terminology Criteria for Adverse Events 5.0. Will be summarized with frequencies and relative frequencies. The maximum grade for an AE will be recorded for each patient by treatment arm. The number (percent) of patients that experience each observed adverse event will be summarized by treatment arm. In addition, the proportion of patients that experience a grade 3+, grade 4+, and grade 5 adverse event will be summarized as the number and percent of patients by treatment arm. The primary summary will be regardless of attribution. Will also do an analogous summary for the adverse events that were deemed at least possibly related to treatment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically or cytologically-confirmed diagnosis of advanced or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell and mixed transitional/non-transitional cell histologies except for small-cell histology), including N3 only disease prior to start of first-line platinum-based chemotherapy
-
Prior first-line treatment must have consisted of 4-6 cycles of 1st-line therapy (platinum-based chemotherapy; gemcitabine-cisplatin, gemcitabine-carboplatin, methotrexate, vinblastine, doxorubicin and cisplatin [MVAC] or dose-dense [dd]MVAC)
-
No more than 1 line of prior chemotherapy for metastatic or locally advanced disease (neoadjuvant or adjuvant chemotherapy will be allowed if given 12 or more months prior to registration)
-
Tumor objective response of CR, PR, or SD upon completion of first line platinum-based chemotherapy by treating physician's assessment
-
The last dose of first-line chemotherapy must have been received no less than 3 weeks, and no more than 10 weeks, prior to randomization in the present study
-
No prior immunotherapy with IL-2, IFN-alpha, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
-
Age >= 18 years
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
-
Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
-
Women of childbearing potential must have a negative pregnancy test =< 14 days prior to registration.
-
Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Post menopause is defined as amenorrhea >= 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason
-
No use of immunosuppressive medication within 7 days prior to randomization except:
-
Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection);
-
Systemic corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent;
-
Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication)
-
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
-
Patients with diabetes type I, vitiligo, psoriasis, or hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible
-
Absolute neutrophil count (ANC) >= 1,000/mm^3
-
Platelet count >= 100,000/mm^3
-
Hemoglobin >= 8 g/dL
-
Calculated (Calc.) creatinine clearance >= 30 mL/min using the Cockcroft-Gault equation: (140 - age) × weight (kg)/(serum creatinine [mg/dL] × 72)
-
Total serum bilirubin =< 1.5 x upper limit of normal (ULN)
-
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN (or =< 5 x ULN for patients with liver metastases or Gilbert's disease)
-
Urine protein creatinine (UPC) ratio =< 1 or 24-hour protein < 1 g
Exclusion Criteria:
-
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
-
No known symptomatic central nervous system (CNS) metastases. Patients with previously diagnosed CNS metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to randomization, have discontinued corticosteroid treatment for at least 2 weeks, and are neurologically stable. Baseline brain imaging with contrast-enhanced CT or magnetic resonance imaging (MRI) scans for subjects with known brain metastases is required to confirm eligibility
-
No major surgery within 4 weeks prior to randomization. Subjects must have complete wound healing from surgery before randomization. Subjects with clinically relevant ongoing complications from prior surgery are not eligible
-
No palliative radiotherapy within 48 hours prior to patient randomization
-
No hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood, clinically significant hematuria, hematemesis, coagulopathy, or other history of significant bleeding (e.g. pulmonary hemorrhage) within 3 months before randomization
-
No known cavitating pulmonary lesion(s) or known endobronchial disease manifestation
-
No administration of a live, attenuated vaccine within 30 days prior to randomization. The use of inactivated (killed) vaccines for the prevention of infectious disease is permitted. The use of COVID-19 vaccines is permitted
-
No uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
-
Cardiovascular disorders including:
-
Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening
-
Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment
-
The patient has a known history of corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms and confirmed by electrocardiogram (ECG) within 28 days before randomization. Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is =< 500 ms, the subject meets eligibility in this regard
-
Any history of congenital long QT syndrome
-
Stroke, transient ischemic attack (TIA), myocardial infarction, or other symptomatic ischemic event or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism (DVT/PE) within 6 months before randomization. Subjects with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if asymptomatic and stable at screening and treated with low molecular weight heparin (LMWH) or the direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban for at least 1 week before randomization. Non-symptomatic white matter disease in the brain is acceptable
-
No significant gastrointestinal disorders, particularly those associated with a high risk of perforation or fistula formation including unresolved active peptic ulcer disease, cholecystitis, diverticulitis, symptomatic cholangitis or appendicitis, or malabsorption syndrome within 28 days of randomization
-
No other clinically significant disorders such as:
-
Any active infection requiring systemic treatment within 14 days before randomization. Subjects receiving oral (including prophylactic) antibiotics with no symptoms of infection at randomization are eligible
-
Serious non-healing wound/ulcer/bone fracture within 28 days before randomization
-
History of organ or allogeneic stem cell transplant
-
No persisting toxicity related to prior therapy grade > 2 constituting a safety risk based on the investigator's judgment
-
No diagnosis of any other malignancy within 3 years prior to randomization, except for locally curable cancers that have been adequately treated such as basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, Gleason < 7 prostate cancer on surveillance without any plans for treatment intervention (e.g., surgery, radiation, or castration), or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms and no indication for treatment
-
No 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)
-
Allowed anticoagulants are 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 subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor
-
Physicians should consider whether any of the following may render the patient inappropriate for this protocol:
-
Psychiatric illness which would prevent the patient from giving informed consent.
-
Uncontrolled medical conditions which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
-
Patients who cannot swallow oral formulations of the agent(s).
In addition:
-
Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Include as applicable: Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom).
-
Patients with rheumatoid arthritis and other rheumatologic arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and or steroids equivalent to < 10 mg prednisone daily, not on immunosuppressive medications and patients with positive serology are eligible. Patients with vitiligo, endocrine deficiencies including hypo or hyper thyroid disease managed with replacement, diabetes type 1 are eligible.
-
Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the study and continue for 4 months after the last dose of study drugs, even if oral contraceptives are also used.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sutter Auburn Faith Hospital | Auburn | California | United States | 95602 |
| 2 | Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | United States | 94704 |
| 3 | Palo Alto Medical Foundation-Fremont | Fremont | California | United States | 94538 |
| 4 | Palo Alto Medical Foundation-Camino Division | Mountain View | California | United States | 94040 |
| 5 | Sutter Roseville Medical Center | Roseville | California | United States | 95661 |
| 6 | Sutter Medical Center Sacramento | Sacramento | California | United States | 95816 |
| 7 | California Pacific Medical Center-Pacific Campus | San Francisco | California | United States | 94115 |
| 8 | Palo Alto Medical Foundation-Sunnyvale | Sunnyvale | California | United States | 94086 |
| 9 | Sutter Solano Medical Center/Cancer Center | Vallejo | California | United States | 94589 |
| 10 | University of Florida Health Science Center - Gainesville | Gainesville | Florida | United States | 32610 |
| 11 | Illinois CancerCare-Bloomington | Bloomington | Illinois | United States | 61704 |
| 12 | Illinois CancerCare-Canton | Canton | Illinois | United States | 61520 |
| 13 | Illinois CancerCare-Carthage | Carthage | Illinois | United States | 62321 |
| 14 | Centralia Oncology Clinic | Centralia | Illinois | United States | 62801 |
| 15 | Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | United States | 62526 |
| 16 | Illinois CancerCare-Dixon | Dixon | Illinois | United States | 61021 |
| 17 | Crossroads Cancer Center | Effingham | Illinois | United States | 62401 |
| 18 | Illinois CancerCare-Eureka | Eureka | Illinois | United States | 61530 |
| 19 | Illinois CancerCare-Galesburg | Galesburg | Illinois | United States | 61401 |
| 20 | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | United States | 61443 |
| 21 | Illinois CancerCare-Macomb | Macomb | Illinois | United States | 61455 |
| 22 | Cancer Care Center of O'Fallon | O'Fallon | Illinois | United States | 62269 |
| 23 | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | United States | 61350 |
| 24 | Illinois CancerCare-Pekin | Pekin | Illinois | United States | 61554 |
| 25 | Illinois CancerCare-Peoria | Peoria | Illinois | United States | 61615 |
| 26 | Illinois CancerCare-Peru | Peru | Illinois | United States | 61354 |
| 27 | Illinois CancerCare-Princeton | Princeton | Illinois | United States | 61356 |
| 28 | Southern Illinois University School of Medicine | Springfield | Illinois | United States | 62702 |
| 29 | Springfield Clinic | Springfield | Illinois | United States | 62702 |
| 30 | Memorial Medical Center | Springfield | Illinois | United States | 62781 |
| 31 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 32 | Illinois CancerCare - Washington | Washington | Illinois | United States | 61571 |
| 33 | Mary Greeley Medical Center | Ames | Iowa | United States | 50010 |
| 34 | McFarland Clinic PC - Ames | Ames | Iowa | United States | 50010 |
| 35 | McFarland Clinic PC-Boone | Boone | Iowa | United States | 50036 |
| 36 | McFarland Clinic PC-Trinity Cancer Center | Fort Dodge | Iowa | United States | 50501 |
| 37 | McFarland Clinic PC-Jefferson | Jefferson | Iowa | United States | 50129 |
| 38 | McFarland Clinic PC-Marshalltown | Marshalltown | Iowa | United States | 50158 |
| 39 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
| 40 | Saint Joseph Mercy Brighton | Brighton | Michigan | United States | 48114 |
| 41 | Trinity Health IHA Medical Group Hematology Oncology - Brighton | Brighton | Michigan | United States | 48114 |
| 42 | Saint Joseph Mercy Canton | Canton | Michigan | United States | 48188 |
| 43 | Trinity Health IHA Medical Group Hematology Oncology - Canton | Canton | Michigan | United States | 48188 |
| 44 | Saint Joseph Mercy Chelsea | Chelsea | Michigan | United States | 48118 |
| 45 | Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital | Chelsea | Michigan | United States | 48118 |
| 46 | Hematology Oncology Consultants-Clarkston | Clarkston | Michigan | United States | 48346 |
| 47 | Newland Medical Associates-Clarkston | Clarkston | Michigan | United States | 48346 |
| 48 | Genesee Cancer and Blood Disease Treatment Center | Flint | Michigan | United States | 48503 |
| 49 | Genesee Hematology Oncology PC | Flint | Michigan | United States | 48503 |
| 50 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
| 51 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 52 | Trinity Health Saint Mary Mercy Livonia Hospital | Livonia | Michigan | United States | 48154 |
| 53 | 21st Century Oncology-Pontiac | Pontiac | Michigan | United States | 48341 |
| 54 | Hope Cancer Center | Pontiac | Michigan | United States | 48341 |
| 55 | Newland Medical Associates-Pontiac | Pontiac | Michigan | United States | 48341 |
| 56 | Saint Joseph Mercy Oakland | Pontiac | Michigan | United States | 48341 |
| 57 | Huron Gastroenterology PC | Ypsilanti | Michigan | United States | 48106 |
| 58 | Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus | Ypsilanti | Michigan | United States | 48197 |
| 59 | Sanford Joe Lueken Cancer Center | Bemidji | Minnesota | United States | 56601 |
| 60 | Abbott-Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 61 | Coborn Cancer Center at Saint Cloud Hospital | Saint Cloud | Minnesota | United States | 56303 |
| 62 | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | United States | 55416 |
| 63 | Regions Hospital | Saint Paul | Minnesota | United States | 55101 |
| 64 | Saint Francis Medical Center | Cape Girardeau | Missouri | United States | 63703 |
| 65 | University of Missouri - Ellis Fischel | Columbia | Missouri | United States | 65212 |
| 66 | New Hampshire Oncology Hematology PA-Concord | Concord | New Hampshire | United States | 03301 |
| 67 | Solinsky Center for Cancer Care | Manchester | New Hampshire | United States | 03103 |
| 68 | Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
| 69 | Memorial Sloan Kettering Monmouth | Middletown | New Jersey | United States | 07748 |
| 70 | Memorial Sloan Kettering Bergen | Montvale | New Jersey | United States | 07645 |
| 71 | Morristown Medical Center | Morristown | New Jersey | United States | 07960 |
| 72 | Overlook Hospital | Summit | New Jersey | United States | 07902 |
| 73 | Memorial Sloan Kettering Commack | Commack | New York | United States | 11725 |
| 74 | Glens Falls Hospital | Glens Falls | New York | United States | 12801 |
| 75 | Memorial Sloan Kettering Westchester | Harrison | New York | United States | 10604 |
| 76 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 77 | Stony Brook University Medical Center | Stony Brook | New York | United States | 11794 |
| 78 | Memorial Sloan Kettering Nassau | Uniondale | New York | United States | 11553 |
| 79 | Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina | United States | 28328 |
| 80 | Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina | United States | 27534 |
| 81 | Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina | United States | 28546 |
| 82 | Sanford Bismarck Medical Center | Bismarck | North Dakota | United States | 58501 |
| 83 | Sanford Broadway Medical Center | Fargo | North Dakota | United States | 58122 |
| 84 | Sanford Roger Maris Cancer Center | Fargo | North Dakota | United States | 58122 |
| 85 | Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland | Ohio | United States | 44111 |
| 86 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 87 | Cleveland Clinic Cancer Center Mansfield | Mansfield | Ohio | United States | 44906 |
| 88 | Hillcrest Hospital Cancer Center | Mayfield Heights | Ohio | United States | 44124 |
| 89 | North Coast Cancer Care | Sandusky | Ohio | United States | 44870 |
| 90 | Cleveland Clinic Cancer Center Strongsville | Strongsville | Ohio | United States | 44136 |
| 91 | South Pointe Hospital | Warrensville Heights | Ohio | United States | 44122 |
| 92 | Cleveland Clinic Wooster Family Health and Surgery Center | Wooster | Ohio | United States | 44691 |
| 93 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 94 | Legacy Mount Hood Medical Center | Gresham | Oregon | United States | 97030 |
| 95 | Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | United States | 97210 |
| 96 | Legacy Meridian Park Hospital | Tualatin | Oregon | United States | 97062 |
| 97 | Prisma Health Cancer Institute - Spartanburg | Boiling Springs | South Carolina | United States | 29316 |
| 98 | Prisma Health Cancer Institute - Easley | Easley | South Carolina | United States | 29640 |
| 99 | Prisma Health Cancer Institute - Butternut | Greenville | South Carolina | United States | 29605 |
| 100 | Prisma Health Cancer Institute - Faris | Greenville | South Carolina | United States | 29605 |
| 101 | Prisma Health Greenville Memorial Hospital | Greenville | South Carolina | United States | 29605 |
| 102 | Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | United States | 29615 |
| 103 | Prisma Health Cancer Institute - Greer | Greer | South Carolina | United States | 29650 |
| 104 | Prisma Health Cancer Institute - Seneca | Seneca | South Carolina | United States | 29672 |
| 105 | Sanford Cancer Center Oncology Clinic | Sioux Falls | South Dakota | United States | 57104 |
| 106 | Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | United States | 57117-5134 |
| 107 | University of Tennessee - Knoxville | Knoxville | Tennessee | United States | 37920 |
| 108 | Legacy Cancer Institute Medical Oncology and Day Treatment | Vancouver | Washington | United States | 98684 |
| 109 | Legacy Salmon Creek Hospital | Vancouver | Washington | United States | 98686 |
| 110 | ProHealth D N Greenwald Center | Mukwonago | Wisconsin | United States | 53149 |
| 111 | ProHealth Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | United States | 53066 |
| 112 | ProHealth Waukesha Memorial Hospital | Waukesha | Wisconsin | United States | 53188 |
| 113 | UW Cancer Center at ProHealth Care | Waukesha | Wisconsin | United States | 53188 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Shilpa Gupta, Alliance for Clinical Trials in Oncology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2021-11166
- NCI-2021-11166
- A032001
- A032001
- U10CA180821