Bladder Cancer Clinical Trial
Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study
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.
Full Description
PRIMARY OBJECTIVE:
I. 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:
I. 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.
II. 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.
III. 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.
IV. 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.
V. 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:
I. 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).
II. 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.
III. 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.
IV. 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.
V. 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. Patients also undergo bone scan at screening and undergo computed tomography (CT) or magnetic resonance imaging (MRI) and biospecimen collection throughout the trial.
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. Patients also undergo bone scan at screening and undergo CT or MRI and biospecimen collection throughout the trial.
After completion of study treatment, patients are followed every 30 days through 90 days, then every 3 months for 5 years.
Eligibility 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
None of the following:
Active autoimmune disease that might deteriorate when receiving the anti PD-L1 agent, avelumab.
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 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 (eg. 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 (eg, 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, diverticultis, 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 (eg, 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
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
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
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.
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There are 244 Locations for this study
Phoenix Arizona, 85054, United States
Auburn California, 95602, United States
Berkeley California, 94704, United States
Fremont California, 94538, United States
Modesto California, 95355, United States
Mountain View California, 94040, United States
Palo Alto California, 94301, United States
Roseville California, 95661, United States
Sacramento California, 95816, United States
Sacramento California, 95817, United States
San Francisco California, 94115, United States
Santa Cruz California, 95065, United States
Sunnyvale California, 94086, United States
Vallejo California, 94589, United States
Frankford Delaware, 19945, United States
Newark Delaware, 19713, United States
Newark Delaware, 19713, United States
Rehoboth Beach Delaware, 19971, United States
Washington District of Columbia, 20010, United States
Gainesville Florida, 32610, United States
Jacksonville Florida, 32224, United States
Weston Florida, 33331, United States
Aurora Illinois, 60504, United States
Barrington Illinois, 60010, United States
Bloomington Illinois, 61704, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Centralia Illinois, 62801, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60657, United States
Crystal Lake Illinois, 60014, United States
Danville Illinois, 61832, United States
Decatur Illinois, 62526, United States
DeKalb Illinois, 60115, United States
Dixon Illinois, 61021, United States
Downers Grove Illinois, 60515, United States
Effingham Illinois, 62401, United States
Effingham Illinois, 62401, United States
Elgin Illinois, 60123, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Geneva Illinois, 60134, United States
Hazel Crest Illinois, 60429, United States
Kewanee Illinois, 61443, United States
Lake Forest Illinois, 60045, United States
Libertyville Illinois, 60048, United States
Libertyville Illinois, 60048, United States
Macomb Illinois, 61455, United States
Mattoon Illinois, 61938, United States
O'Fallon Illinois, 62269, United States
Oak Lawn Illinois, 60453, United States
Ottawa Illinois, 61350, United States
Park Ridge Illinois, 60068, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61615, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Rockford Illinois, 61114, United States
Shiloh Illinois, 62269, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62702, United States
Springfield Illinois, 62781, United States
Urbana Illinois, 61801, United States
Warrenville Illinois, 60555, United States
Washington Illinois, 61571, United States
Yorkville Illinois, 60560, United States
Crown Point Indiana, 46307, United States
Dyer Indiana, 46311, United States
Hobart Indiana, 46342, United States
Hobart Indiana, 46342, United States
Indianapolis Indiana, 46312, United States
Munster Indiana, 46321, United States
Munster Indiana, 46321, United States
Valparaiso Indiana, 46383, United States
Ames Iowa, 50010, United States
Ames Iowa, 50010, United States
Boone Iowa, 50036, United States
Fort Dodge Iowa, 50501, United States
Iowa City Iowa, 52242, United States
Jefferson Iowa, 50129, United States
Marshalltown Iowa, 50158, United States
Louisville Kentucky, 40207, United States
Augusta Maine, 04330, United States
Bethesda Maryland, 20892, United States
Worcester Massachusetts, 01655, United States
Ann Arbor Michigan, 48106, United States
Battle Creek Michigan, 49017, United States
Brighton Michigan, 48114, United States
Brighton Michigan, 48114, United States
Canton Michigan, 48188, United States
Canton Michigan, 48188, United States
Chelsea Michigan, 48118, United States
Chelsea Michigan, 48118, United States
Clarkston Michigan, 48346, United States
Clarkston Michigan, 48346, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49009, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Macomb Michigan, 48044, United States
Muskegon Michigan, 49444, United States
Norton Shores Michigan, 49444, United States
Pontiac Michigan, 48341, United States
Pontiac Michigan, 48341, United States
Pontiac Michigan, 48341, United States
Pontiac Michigan, 48341, United States
Reed City Michigan, 49677, United States
Saint Joseph Michigan, 49085, United States
Traverse City Michigan, 49684, United States
Wyoming Michigan, 49519, United States
Ypsilanti Michigan, 48106, United States
Ypsilanti Michigan, 48197, United States
Bemidji Minnesota, 56601, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Rochester Minnesota, 55905, United States
Saint Cloud Minnesota, 56303, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Willmar Minnesota, 56201, United States
Cape Girardeau Missouri, 63703, United States
Columbia Missouri, 65212, United States
Creve Coeur Missouri, 63141, United States
Kansas City Missouri, 64111, United States
Lee's Summit Missouri, 64086, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63129, United States
Saint Louis Missouri, 63136, United States
Saint Louis Missouri, 63141, United States
Saint Peters Missouri, 63376, United States
Henderson Nevada, 89052, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89148, United States
Concord New Hampshire, 03301, United States
Manchester New Hampshire, 03103, United States
Basking Ridge New Jersey, 07920, United States
Hackensack New Jersey, 07601, United States
Middletown New Jersey, 07748, United States
Montvale New Jersey, 07645, United States
Morristown New Jersey, 07960, United States
Paterson New Jersey, 07503, United States
Summit New Jersey, 07902, United States
Albuquerque New Mexico, 87106, United States
Las Cruces New Mexico, 88011, United States
Commack New York, 11725, United States
Elmira New York, 14905, United States
Glens Falls New York, 12801, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Oswego New York, 13126, United States
Stony Brook New York, 11794, United States
Syracuse New York, 13210, United States
Syracuse New York, 13215, United States
Uniondale New York, 11553, United States
Verona New York, 13478, United States
Charlotte North Carolina, 28203, United States
Charlotte North Carolina, 28211, United States
Charlotte North Carolina, 28262, United States
Charlotte North Carolina, 28277, United States
Clinton North Carolina, 28328, United States
Concord North Carolina, 28025, United States
Goldsboro North Carolina, 27534, United States
Jacksonville North Carolina, 28546, United States
Lincolnton North Carolina, 28092, United States
Shelby North Carolina, 28150, United States
Winston-Salem North Carolina, 27157, United States
Bismarck North Dakota, 58501, United States
Fargo North Dakota, 58122, United States
Fargo North Dakota, 58122, United States
Akron Ohio, 44307, United States
Centerville Ohio, 45459, United States
Cleveland Ohio, 44111, United States
Cleveland Ohio, 44195, United States
Dayton Ohio, 45409, United States
Dayton Ohio, 45415, United States
Dayton Ohio, 45415, United States
Franklin Ohio, 45005, United States
Greenville Ohio, 45331, United States
Kettering Ohio, 45429, United States
Mansfield Ohio, 44906, United States
Mayfield Heights Ohio, 44124, United States
Sandusky Ohio, 44870, United States
Strongsville Ohio, 44136, United States
Toledo Ohio, 43623, United States
Troy Ohio, 45373, United States
Warrensville Heights Ohio, 44122, United States
Wooster Ohio, 44691, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Gresham Oregon, 97030, United States
Portland Oregon, 97210, United States
Tualatin Oregon, 97062, United States
Allentown Pennsylvania, 18103, United States
Bethlehem Pennsylvania, 18017, United States
Harrisburg Pennsylvania, 17111, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19148, United States
Boiling Springs South Carolina, 29316, United States
Charleston South Carolina, 29425, United States
Easley South Carolina, 29640, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Greer South Carolina, 29650, United States
Rock Hill South Carolina, 29732, United States
Seneca South Carolina, 29672, United States
Aberdeen South Dakota, 57401, United States
Sioux Falls South Dakota, 57104, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
Yankton South Dakota, 57078, United States
Alcoa Tennessee, 37701, United States
Knoxville Tennessee, 37920, United States
Dallas Texas, 75237, United States
Dallas Texas, 75390, United States
Fort Worth Texas, 76104, United States
Richardson Texas, 75080, United States
Mechanicsville Virginia, 23116, United States
Midlothian Virginia, 23114, United States
Richmond Virginia, 23226, United States
Richmond Virginia, 23229, United States
Richmond Virginia, 23235, United States
Richmond Virginia, 23298, United States
South Hill Virginia, 23970, United States
Winchester Virginia, 22601, United States
Renton Washington, 98055, United States
Vancouver Washington, 98684, United States
Vancouver Washington, 98686, United States
Charleston West Virginia, 25304, United States
Burlington Wisconsin, 53105, United States
Eau Claire Wisconsin, 54701, United States
Germantown Wisconsin, 53022, United States
Grafton Wisconsin, 53024, United States
Green Bay Wisconsin, 54311, United States
Kenosha Wisconsin, 53142, United States
Marinette Wisconsin, 54143, United States
Marshfield Wisconsin, 54449, United States
Menomonee Falls Wisconsin, 53051, United States
Milwaukee Wisconsin, 53209, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53233, United States
Minocqua Wisconsin, 54548, United States
Mukwonago Wisconsin, 53149, United States
New Richmond Wisconsin, 54017, United States
Oak Creek Wisconsin, 53154, United States
Oconomowoc Wisconsin, 53066, United States
Oshkosh Wisconsin, 54904, United States
Racine Wisconsin, 53406, United States
Rice Lake Wisconsin, 54868, United States
Sheboygan Wisconsin, 53081, United States
Stevens Point Wisconsin, 54482, United States
Summit Wisconsin, 53066, United States
Two Rivers Wisconsin, 54241, United States
Waukesha Wisconsin, 53188, United States
Waukesha Wisconsin, 53188, United States
Wauwatosa Wisconsin, 53226, United States
West Allis Wisconsin, 53227, United States
West Bend Wisconsin, 53095, United States
Weston Wisconsin, 54476, United States
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M5G 2, Canada
Regina Saskatchewan, S4T 7, Canada
Saskatoon Saskatchewan, S7N 4, Canada
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