Kidney Cancer Clinical Trial

A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)

Summary

The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC)
Has had disease progression on or after having received systemic treatment for locally advanced or metastatic RCC with both Programmed cell death 1 ligand 1 (PD-1/L1) checkpoint inhibitor and a vascular endothelial growth factor - tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination
Has received no more than 3 prior systemic regimens for locally advanced or metastatic RCC
A male participant is eligible to participate if he is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 7 days after the last dose of study intervention
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a (woman of childbearing potential) WOCBP OR A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention for those randomized to belzutifan and for at least 8 weeks after the last dose of study intervention for those randomized to everolimus
The participant (or legally acceptable representative if applicable) has provided documented informed consent for the study
Has adequate organ function

Exclusion Criteria:

Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. (Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ [e.g., breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy are not excluded)
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis. (Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks (28 days) by repeat imaging)
Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study medication administration, or New York Heart Association Class III or IV congestive heart failure. (Medically controlled arrhythmia stable on medication is permitted)
Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or diastolic blood pressure (DBP) ≥90 mm Hg
Has moderate to severe hepatic impairment (Child-Pugh B or C)
Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study
Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption)
Has known hypersensitivity or allergy to the active pharmaceutical ingredient or any component of the study intervention (belzutifan or everolimus) formulations
Has received prior treatment with belzutifan or another hypoxia inducible factor 2α (HIF-2α inhibitor)
Has received prior treatment with everolimus or any other specific or selective target of rapamycin complex 1 (TORC1)/ phosphatidylinositol 3-kinase (PI3K)/ protein kinase B (AKT) inhibitor (e.g., temsirolimus) in the advanced disease setting
Has received any type of systemic anticancer antibody (including investigational antibody) within 4 weeks before randomization
Has received prior radiotherapy within 2 weeks prior to randomization
Has had major surgery within 3 weeks prior to randomization
Has received a live vaccine within 30 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed
Is currently receiving either strong (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study
Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g., bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study
Is currently participating in a study of an investigational agent or is currently using an investigational device
Has an active infection requiring systemic therapy
Has active bacillus tuberculosis (TB)
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
Has a known history of human immunodeficiency virus (HIV) infection. (Testing for HIV at screening is only required if mandated by local health authority
Has a known history of Hepatitis B virus (HBV) (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (HCV) (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

736

Study ID:

NCT04195750

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 166 Locations for this study

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University of Alabama - Birmingham ( Site 1538)
Birmingham Alabama, 35294, United States
University of California San Diego Moores Cancer Center ( Site 1546)
La Jolla California, 92093, United States
St Joseph Heritage Healthcare ( Site 1531)
Santa Rosa California, 95403, United States
University Of Colorado ( Site 1540)
Aurora Colorado, 80045, United States
UCHealth Highlands Ranch Hospital ( Site 1560)
Highlands Ranch Colorado, 80129, United States
Sibley Memorial Hospital ( Site 1559)
Washington District of Columbia, 20016, United States
Northwest Georgia Oncology Centers PC ( Site 1520)
Marietta Georgia, 30060, United States
The University of Chicago Medical Center ( Site 1539)
Chicago Illinois, 60637, United States
Ochsner Medical Center ( Site 1522)
New Orleans Louisiana, 70121, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1514)
Baltimore Maryland, 21231, United States
Massachusetts General Hospital ( Site 1558)
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center ( Site 1501)
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute ( Site 1505)
Boston Massachusetts, 02215, United States
Henry Ford Cancer Center ( Site 1511)
Detroit Michigan, 48202, United States
Hattiesburg Clinic ( Site 1509)
Hattiesburg Mississippi, 39401, United States
St. Vincent Frontier Cancer Center ( Site 1549)
Billings Montana, 59102, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1513)
Hackensack New Jersey, 07601, United States
University of Rochester Medical Center ( Site 1543)
Rochester New York, 14620, United States
University of North Carolina at Chapel Hill ( Site 1537)
Chapel Hill North Carolina, 27514, United States
Oncology Hematology Care, Inc. ( Site 1524)
Cincinnati Ohio, 45242, United States
Cleveland Clinic ( Site 1504)
Cleveland Ohio, 44195, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1523)
Tulsa Oklahoma, 74146, United States
Oregon Health & Science University ( Site 1553)
Portland Oregon, 97232, United States
Abramson Cancer Center ( Site 1525)
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center ( Site 1506)
Philadelphia Pennsylvania, 19111, United States
Medical University of South Carolina ( Site 1518)
Charleston South Carolina, 29425, United States
Henry Joyce Cancer Clinic ( Site 1544)
Nashville Tennessee, 37232, United States
Texas Oncology-Austin Central ( Site 1533)
Austin Texas, 78731, United States
Texas Oncology, P.A.-Dallas ( Site 1534)
Dallas Texas, 75230, United States
Centro Avancado de Tratamento Oncologico ( Site 1657)
Belo Horizonte Minas Gerais, 30130, Brazil
Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1650)
Curitiba Parana, 80510, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 1651)
Natal Rio Grande Do Norte, 59075, Brazil
Hospital de Clinicas de Porto Alegre ( Site 1655)
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 1653)
Sao Paulo , 01321, Brazil
BC Cancer - Vancouver Center ( Site 0155)
Vancouver British Columbia, V5Z 4, Canada
Nova Scotia Health Authority QEII-HSC ( Site 0150)
Halifax Nova Scotia, B3H 1, Canada
Juravinski Cancer Centre ( Site 0154)
Hamilton Ontario, L8V 5, Canada
Sunnybrook Research Institute ( Site 0153)
Toronto Ontario, M4N 3, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0151)
Montreal Quebec, H2X 3, Canada
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0152)
Quebec , G1R 2, Canada
Centro Investigación del Cáncer James Lind ( Site 0004)
Temuco Araucania, Temuc, Chile
Bradfordhill ( Site 0003)
Santiago Region M. De Santiago, 84203, Chile
Fundacion Centro de Investigacion Clinica CIC ( Site 1703)
Medellin Antioquia, 05002, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1709)
Valledupar Cesar, 20000, Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1702)
Bogota Cundinamarca, 11132, Colombia
Administradora Country SA - Clinica del Country ( Site 1701)
Bogota Distrito Capital De Bogota, 11022, Colombia
Oncologos del Occidente S.A. ( Site 1708)
Pereira Risaralda, 66000, Colombia
Masarykuv onkologicky ustav ( Site 0105)
Brno Brno-mesto, 656 5, Czechia
Fakultni nemocnice Ostrava ( Site 0103)
Ostrava Ostrava Mesto, 708 5, Czechia
Fakultni nemocnice Hradec Kralove ( Site 0106)
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice Olomouc ( Site 0104)
Olomouc , 779 0, Czechia
Fakultni nemocnice Kralovske Vinohrady ( Site 0102)
Praha 10 , 100 3, Czechia
Fakultni Thomayerova nemocnice ( Site 0107)
Praha 4 , 140 5, Czechia
Herlev Hospital ( Site 0251)
Herlev Hovedstaden, 2730, Denmark
Aarhus University Hospital Skejby ( Site 0250)
Aarhus Midtjylland, 8200, Denmark
Tampereen yliopistollinen sairaala ( Site 0300)
Tampere Pirkanmaa, 33520, Finland
Kuopion Yliopistollinen Sairaala ( Site 0304)
Kuopio Pohjois-Savo, 70210, Finland
HYKS. ( Site 0302)
Helsinki Uusimaa, 00290, Finland
TYKS T-sairaala Syopatautien pkl ( Site 0301)
Turku Varsinais-Suomi, 20521, Finland
CHU de Bordeaux Hop St ANDRE ( Site 0359)
Bordeaux Aquitaine, 33075, France
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0350)
Strasbourg Bas-Rhin, 67200, France
Centre Francois Baclesse ( Site 0360)
Caen Calvados, 14076, France
CHU Besancon - Hopital Jean Minjoz ( Site 0351)
Besancon Doubs, 25000, France
Institut de Cancerologie du Gard - CHU Caremeau ( Site 0352)
Nimes Gard, 30029, France
Centre Alexis Vautrin Institut de Cancerologie de Lorraine ( Site 0356)
Vandoeuvre les Nancy Meurthe-et-Moselle, 54519, France
Centre Hospitalier Lyon Sud ( Site 0354)
Pierre Benite Rhone, 69310, France
Gustave Roussy ( Site 0353)
Villejuif Val-de-Marne, 94800, France
Universitaetsklinik fuer Urologie ( Site 0405)
Tuebingen Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Duesseldorf ( Site 0410)
Duesseldorf Nordrhein-Westfalen, 40225, Germany
Universitaetsklinikum Essen ( Site 0401)
Essen Nordrhein-Westfalen, 45122, Germany
Universitaetsklinikum Magdeburg A.o.R. ( Site 0404)
Magdeburg Sachsen-Anhalt, 39120, Germany
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0403)
Dresden Sachsen, 01307, Germany
Universitaetsklinikum Jena ( Site 0402)
Jena Thuringen, 07747, Germany
Universitaetsmedizin Berlin ( Site 0400)
Berlin , 10117, Germany
Universitatsklinikum Hamburg-Eppendorf ( Site 0408)
Hamburg , 20246, Germany
Prince of Wales Hospital ( Site 1050)
Hong Kong , , Hong Kong
Queen Mary Hospital ( Site 1051)
Hong Kong , , Hong Kong
Queen Elizabeth Hospital. ( Site 1052)
Kowloon , , Hong Kong
Princess Margaret Hospital. ( Site 1053)
Lai Chi Kok , , Hong Kong
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0505)
Gyula Bekes, H-570, Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce
Miskolc Borsod-Abauj-Zemplen, 3526, Hungary
Semmelweis Egyetem ( Site 0501)
Budapest , 1085, Hungary
Orszagos Onkologiai Intezet ( Site 0503)
Budapest , 1122, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 0504)
Debrecen , 4032, Hungary
Zala Megyei Szent Rafael Korhaz ( Site 0509)
Zalaegerszeg , 8900, Hungary
Istituto Oncologico Veneto IRCCS ( Site 0603)
Padova Veneto, 35128, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 0605
Verona Veneto, 37126, Italy
Medical Oncology Ospedale San Donato ( Site 0609)
Arezzo , 52100, Italy
Azienda Ospedaliera Policlinico di Bari ( Site 0610)
Bari , 70124, Italy
Policlinico S. Orsola-Malpighi ( Site 0606)
Bologna , 40138, Italy
Istituto Nazionale dei Tumori ( Site 0601)
Milano , 20133, Italy
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0604)
Modena , 41125, Italy
Fondazione Salvatore Maugeri clinica del lavoro ( Site 0600)
Pavia , 27100, Italy
Fondazione Policlinico Universitario A. Gemelli ( Site 0607)
Roma , 00168, Italy
Azienda Ospedaliera Santa Maria ( Site 0602)
Terni , 05100, Italy
Fujita Health University ( Site 1016)
Toyoake Aichi, 470-1, Japan
National Cancer Center Hospital East ( Site 1001)
Kashiwa Chiba, 277-8, Japan
Ehime University Hospital ( Site 1014)
Toon Ehime, 791-0, Japan
Sapporo Medical University Hospital ( Site 1008)
Sapporo Hokkaido, 060-8, Japan
Yokohama City University Hospital ( Site 1015)
Yokohama Kanagawa, 236-0, Japan
Kanagawa cancer center ( Site 1021)
Yokohama Kanagawa, 241-8, Japan
Nara Medical University Hospital ( Site 1009)
Kashihara Nara, 634-0, Japan
Kindai University Hospital- Osakasayama Campus-Urology ( Site 1011)
Osakasayama Osaka, 589-8, Japan
Osaka University Hospital ( Site 1006)
Suita Osaka, 565-0, Japan
Saitama Medical University International Medical Center ( Site 1012)
Hidaka-city Saitama, 350-1, Japan
Hamamatsu University Hospital ( Site 1005)
Hamamatsu Shizuoka, 431-3, Japan
Toyama University Hospital ( Site 1013)
Toyoma Toyama, 930-0, Japan
Yamaguchi University Hospital ( Site 1018)
Ube Yamaguchi, 755-8, Japan
Kyushu University Hospital ( Site 1007)
Fukuoka , 812-8, Japan
Hiroshima University Hospital-Hiroshima University Hospital ( Site 1019)
Hiroshima , 734-8, Japan
Niigata University Medical & Dental Hospital ( Site 1022)
Niigata , 951-8, Japan
Okayama University Hospital ( Site 1020)
Okayama , 700-8, Japan
Tokushima University Hospital-Department of Urology ( Site 1017)
Tokushima , 770-8, Japan
National Cancer Center Hospital ( Site 1003)
Tokyo , 104-0, Japan
Toranomon Hospital ( Site 1004)
Tokyo , 105-8, Japan
Nippon Medical School Hospital ( Site 1010)
Tokyo , 113-8, Japan
The Cancer Institute Hospital of JFCR ( Site 1000)
Tokyo , 135-8, Japan
Keio University Hospital ( Site 1002)
Tokyo , 160-8, Japan
National Cancer Center ( Site 1204)
Gyeonggi-do Kyonggi-do, 10408, Korea, Republic of
Chungnam National University Hospital ( Site 1205)
Daejeon Taejon-Kwangyokshi, 35015, Korea, Republic of
Korea University Anam Hospital ( Site 1203)
Seoul , 02841, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 1202)
Seoul , 03722, Korea, Republic of
Asan Medical Center ( Site 1200)
Seoul , 05505, Korea, Republic of
Samsung Medical Center ( Site 1201)
Seoul , 06351, Korea, Republic of
Akershus universitetssykehus ( Site 0851)
Lorenskog Akershus, 1478, Norway
Helse Bergen HF - Haukeland Universitetssykehus ( Site 0854)
Bergen Hordaland, 5021, Norway
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1151)
Krasnoyarsk Krasnoyarskiy Kray, 66013, Russian Federation
Hadassah Medical-Oncology department ( Site 1164)
Moscow Moskovskaya Oblast, 12120, Russian Federation
SBIH City clinical hospital named after D.D. Pletniov ( Site 1160)
Moscow Moskva, 10507, Russian Federation
N.N. Blokhin NMRCO ( Site 1156)
Moscow Moskva, 11547, Russian Federation
Russian Scientific Center of Roentgenoradiology ( Site 1155)
Moscow Moskva, 11799, Russian Federation
First Moscow State Medical University n.a. I.M.Sechenov ( Site 1163)
Moscow Moskva, 11914, Russian Federation
Central Clinical Hospital with Polyclinic ( Site 1157)
Moscow Moskva, 12135, Russian Federation
Omsk Clinical Oncology Dispensary ( Site 1150)
Omsk Omskaya Oblast, 64401, Russian Federation
SBHI SPb Clinical Research Centre of specialized types of medical care ( Site 1159)
Saint-Petersburg Sankt-Peterburg, 19775, Russian Federation
City clinical oncological dispensary ( Site 1154)
Sankt-Petersburg Sankt-Peterburg, 19825, Russian Federation
Russian Scientific Center of Radiology and Surgical Technologies ( Site 1153)
St. Petersburg Sankt-Peterburg, 19775, Russian Federation
Instituto Catalan de Oncologia - ICO ( Site 1251)
L Hospitalet De Llobregat Barcelona, 08908, Spain
Hospital Universitari Vall d Hebron ( Site 1250)
Barcelona Cataluna, 08035, Spain
Hospital General Universitario 12 de Octubre ( Site 1252)
Madrid Madrid, Comunidad De, 28041, Spain
Instituto Valenciano de Oncologia - IVO ( Site 1254)
Valencia Valenciana, Comunitat, 46009, Spain
Hospital Ramon y Cajal ( Site 1253)
Madrid , 28034, Spain
Laenssjukhuset Ryhov ( Site 1853)
Jönköping Jonkopings Lan, 551 8, Sweden
Malmo Universitetssjukhus ( Site 1851)
Malmo Skane Lan, 214 2, Sweden
Karolinska Universitetssjukhuset Solna ( Site 1850)
Stockholm Stockholms Lan, 171 7, Sweden
Norrlands Universitetssjukhus ( Site 1856)
Umeå Vasterbottens Lan, 901 8, Sweden
Chang Gung Medical Foundation - Kaohsiung ( Site 1104)
Kaohsiung , 83301, Taiwan
Taichung Veterans General Hospital ( Site 1105)
Taichung , 40705, Taiwan
National Cheng Kung University Hospital ( Site 1103)
Tainan , 704, Taiwan
National Taiwan University Hospital ( Site 1100)
Taipei , 10002, Taiwan
Taipei Veterans General Hospital ( Site 1101)
Taipei , 11217, Taiwan
Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1106)
Taoyuan , 333, Taiwan
Ankara Universitesi Tip Fakultesi ( Site 1311)
Ankara , 06100, Turkey
Hacettepe Universitesi Tip Fakultesi ( Site 1300)
Ankara , 06230, Turkey
Gazi Universitesi Tip Fakultesi ( Site 1308)
Ankara , 06560, Turkey
Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1302)
Edirne , 22030, Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1305)
Istanbul , 34098, Turkey
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1303)
Istanbul , 34722, Turkey
Ege Universitesi Tip Fakultesi Hastanesi ( Site 1304)
Izmir , 35100, Turkey
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 1306)
Izmir , 35360, Turkey
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 1453)
Dnipropetrovsk Dnipropetrovska Oblast, 49005, Ukraine
MI Precarpathian Clinical Oncology Center ( Site 1452)
Ivano-Frankivsk Ivano-Frankivska Oblast, 76018, Ukraine
Kyiv City Clinical Oncology Center ( Site 1450)
Kyiv Kyivska Oblast, 03115, Ukraine
Cambridge University Hospitals NHSFT ( Site 1405)
Cambridge Cambridgeshire, CB2 0, United Kingdom
Western General Hospital ( Site 1400)
Edinburgh Edinburgh, City Of, EH4 2, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1402)
Glasgow Glasgow City, G12 0, United Kingdom
Barts Health NHS Trust ( Site 1407)
London London, City Of, EC1A , United Kingdom
Royal Marsden NHS Foundation Trust ( Site 1403)
London London, City Of, SW3 6, United Kingdom
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1409)
London London, City Of, W6 8R, United Kingdom
Royal Marsden Hospital Sutton-Surrey ( Site 1411)
Sutton Surrey, SM2 5, United Kingdom
Medway Maritime Hospital ( Site 1406)
Gillingham , ME7 5, United Kingdom
The Christie NHS Foundation Trust ( Site 1401)
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 3

Estimated Enrollment:

736

Study ID:

NCT04195750

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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