Taking people in United StatesPhase 2

Testing immunotherapy with radiation to avoid bladder removal in bladder cancer

Tests pembrolizumab with radiation in adults with muscle invasive bladder cancer after chemotherapy.

Plain-language title generated from the registry record
Registry title: Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

Key facts

Where: Ames, Ankeny, Appleton, Aurora, Bemidji, Beverly Hills, Billings, Birmingham, Bloomington, Boone, Boston, Brookfield, Canton, Cape Girardeau, Carthage, Cherry Hill, Cheyenne, Chicago, Chilton, Cincinnati, Cleveland, Clive, Coeur d'Alene, Columbus, Corona, Dallas, Danville, Decatur, DeKalb, Denver, Derby, Des Moines, Dixon, Duarte, Edina, Edwards, Effingham, Eureka, Evanston, Fairfield, Fargo, Fayetteville, Flemington, Flushing, Fort Collins, Fort Dodge, Fort Worth, Franklin, Galesburg, Geneva, Germantown, Gilbert, Glenview, Grayslake, Great Falls, Greeley, Green Bay, Greenwich, Guilford, Highland Park, Highlands Ranch, Houston, Irvine, Jackson, Jacksonville, Jefferson, Jersey City, Kewanee, Lake Forest, Lancaster, Lebanon, Lexington, Livingston, Lone Tree, Long Branch, Los Angeles, Louisville, Loveland, Macomb, Marshalltown, Mattoon, Mequon, Milwaukee, Minneapolis, Missoula, Morgantown, New Brunswick, New Haven, New Orleans, New York, Newnan, North Haven, O'Fallon, Oak Brook, Oconto Falls, Oklahoma City, Orland Park, Oshkosh, Ottawa, Parkersburg, Pekin, Peoria, Peru, Philadelphia, Phoenix, Post Falls, Princeton, Racine, Richardson, Richmond, Rogers, Ruskin, Sacramento, Saint Johnsbury, Saint Louis Park, Salt Lake City, San Antonio, Sandpoint, Seattle, Sewell, Sheboygan, Sioux Falls, South Pasadena, Springdale, Springfield, Stamford, Stony Brook, Sturgeon Bay, Tampa, Tarzana, Temple, Toms River, Torrington, Trumbull, Upland, Urbana, Warrenville, Washington, Waterbury, Waterford, Waukee, Wauwatosa, Wesley Chapel, West Chester, West Des Moines, Westerly, Willow Grove, and Worcester, United StatesSee the 182 sites
Phase: Phase 2

Where in United States

Mary Greeley Medical CenterAmes, United StatesTaking people
McFarland Clinic - AmesAmes, United StatesTaking people
UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, United StatesTaking people
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-AppletonAppleton, United StatesTaking people
UCHealth University of Colorado HospitalAurora, United StatesTaking people
Rush-Copley Medical CenterAurora, United StatesNo longer taking part
Sanford Joe Lueken Cancer CenterBemidji, United StatesTaking people
Tower Cancer Research FoundationBeverly Hills, United StatesTaking people
Billings Clinic Cancer CenterBillings, United StatesTaking people
University of Alabama at Birmingham Cancer CenterBirmingham, United StatesTaking people
Illinois CancerCare-BloomingtonBloomington, United StatesTaking people
OSF Saint Joseph Medical CenterBloomington, United StatesTaking people
McFarland Clinic - BooneBoone, United StatesNo longer taking part
Dana-Farber Cancer InstituteBoston, United StatesTaking people
Tufts Medical CenterBoston, United StatesTaking people
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-BrookfieldBrookfield, United StatesTaking people
Illinois CancerCare-CantonCanton, United StatesTaking people
Saint Francis Medical CenterCape Girardeau, United StatesTaking people
Illinois CancerCare-CarthageCarthage, United StatesTaking people
Jefferson Cherry Hill HospitalCherry Hill, United StatesTaking people
Memorial Hospital of Laramie CountyCheyenne, United StatesTaking people
Northwestern Medicine Cancer Center Old Irving ParkChicago, United StatesTaking people
Northwestern UniversityChicago, United StatesTaking people
Ascension Calumet Hospital-ChiltonChilton, United StatesTaking people
University of Cincinnati Cancer Center-UC Medical CenterCincinnati, United StatesTaking people
MetroHealth Medical CenterCleveland, United StatesTaking people
Mercy Cancer Center-West LakesClive, United StatesTaking people
UI Health Care Mission Cancer and Blood - West Des Moines ClinicClive, United StatesTaking people
Kootenai Health - Coeur d'AleneCoeur d'Alene, United StatesNo longer taking part
Ohio State University Comprehensive Cancer CenterColumbus, United StatesTaking people
City of Hope CoronaCorona, United StatesTaking people
Parkland Memorial HospitalDallas, United StatesTaking people
UT Southwestern Simmons Cancer Center - RedBirdDallas, United StatesTaking people
UT Southwestern/Simmons Cancer Center-DallasDallas, United StatesTaking people
Carle at The RiverfrontDanville, United StatesTaking people
Cancer Care Specialists of Illinois - DecaturDecatur, United StatesTaking people
Decatur Memorial HospitalDecatur, United StatesTaking people
Northwestern Medicine Cancer Center KishwaukeeDeKalb, United StatesTaking people
UCHealth - Cherry CreekDenver, United StatesTaking people
Smilow Cancer Hospital-Derby Care CenterDerby, United StatesTaking people
Iowa Methodist Medical CenterDes Moines, United StatesTaking people
Mercy Medical Center - Des MoinesDes Moines, United StatesTaking people
UI Health Care Mission Cancer and Blood - Des Moines ClinicDes Moines, United StatesTaking people
UI Health Care Mission Cancer and Blood - Laurel ClinicDes Moines, United StatesTaking people
Illinois CancerCare-DixonDixon, United StatesNo longer taking part
City of Hope Comprehensive Cancer CenterDuarte, United StatesTaking people
Fairview Southdale HospitalEdina, United StatesTaking people
Shaw Cancer CenterEdwards, United StatesTaking people
Carle Physician Group-EffinghamEffingham, United StatesTaking people
Crossroads Cancer CenterEffingham, United StatesNo longer taking part
Illinois CancerCare-EurekaEureka, United StatesTaking people
NorthShore University HealthSystem-Evanston HospitalEvanston, United StatesTaking people
Smilow Cancer Hospital Care Center-FairfieldFairfield, United StatesTaking people
Sanford Broadway Medical CenterFargo, United StatesTaking people
Sanford Roger Maris Cancer CenterFargo, United StatesTaking people
Highlands Oncology Group - FayettevilleFayetteville, United StatesTaking people
Hunterdon Medical CenterFlemington, United StatesTaking people
The New York Hospital Medical Center of QueensFlushing, United StatesTaking people
Cancer Care and Hematology-Fort CollinsFort Collins, United StatesTaking people
Poudre Valley HospitalFort Collins, United StatesTaking people
McFarland Clinic - Trinity Cancer CenterFort Dodge, United StatesNo longer taking part
UT Southwestern/Simmons Cancer Center-Fort WorthFort Worth, United StatesTaking people
Reiman Cancer Center-Ascension Wisconsin Health Center-RawsonFranklin, United StatesTaking people
Illinois CancerCare-GalesburgGalesburg, United StatesTaking people
Northwestern Medicine Cancer Center DelnorGeneva, United StatesTaking people
The West Clinic - Wolf RiverGermantown, United StatesTaking people
Banner MD Anderson Cancer CenterGilbert, United StatesTaking people
NorthShore University HealthSystem-Glenbrook HospitalGlenview, United StatesTaking people
Northwestern Medicine Glenview Outpatient CenterGlenview, United StatesTaking people
Northwestern Medicine Grayslake Outpatient CenterGrayslake, United StatesTaking people
Benefis Sletten Cancer InstituteGreat Falls, United StatesTaking people
UCHealth Greeley HospitalGreeley, United StatesTaking people
Saint Vincent Hospital Cancer Center at Saint Mary'sGreen Bay, United StatesTaking people
Saint Vincent Hospital Cancer Center Green BayGreen Bay, United StatesTaking people
Smilow Cancer Hospital Care Center at GreenwichGreenwich, United StatesTaking people
Smilow Cancer Hospital Care Center - GuilfordGuilford, United StatesTaking people
NorthShore University HealthSystem-Highland Park HospitalHighland Park, United StatesTaking people
UCHealth Highlands Ranch HospitalHighlands Ranch, United StatesTaking people
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, United StatesTaking people
City of Hope at Irvine LennarIrvine, United StatesTaking people
University of Mississippi Medical CenterJackson, United StatesTaking people
Mayo Clinic in FloridaJacksonville, United StatesTaking people
McFarland Clinic - JeffersonJefferson, United StatesNo longer taking part
Jersey City Medical CenterJersey City, United StatesTaking people
Illinois CancerCare-Kewanee ClinicKewanee, United StatesTaking people
Northwestern Medicine Lake Forest HospitalLake Forest, United StatesTaking people
City of Hope Antelope ValleyLancaster, United StatesTaking people
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesTaking people
University of Kentucky/Markey Cancer CenterLexington, United StatesTaking people
Cooperman Barnabas Medical CenterLivingston, United StatesTaking people
UCHealth Lone Tree Health CenterLone Tree, United StatesTaking people
Monmouth Medical CenterLong Branch, United StatesTaking people
Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
Los Angeles General Medical CenterLos Angeles, United StatesTaking people
The Angeles Clinic and Research Institute - West Los Angeles OfficeLos Angeles, United StatesTaking people
USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesTaking people
The James Graham Brown Cancer Center at University of LouisvilleLouisville, United StatesTaking people
UofL Health Medical Center NortheastLouisville, United StatesTaking people
Medical Center of the RockiesLoveland, United StatesTaking people
Illinois CancerCare-MacombMacomb, United StatesTaking people
McFarland Clinic - MarshalltownMarshalltown, United StatesNo longer taking part
Carle Physician Group-Mattoon/CharlestonMattoon, United StatesTaking people
Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-MequonMequon, United StatesTaking people
Ascension Columbia Saint Mary's Hospital-Milwaukee CampusMilwaukee, United StatesTaking people
Abbott-Northwestern HospitalMinneapolis, United StatesTaking people
Community Medical CenterMissoula, United StatesNo longer taking part
West Virginia University HealthcareMorgantown, United StatesTaking people
Rutgers Cancer Institute of New JerseyNew Brunswick, United StatesTaking people
Yale UniversityNew Haven, United StatesTaking people
Ochsner Medical Center JeffersonNew Orleans, United StatesTaking people
University Medical Center New OrleansNew Orleans, United StatesTaking people
NYP/Weill Cornell Medical CenterNew York, United StatesTaking people
CTCA at Southeastern Regional Medical CenterNewnan, United StatesTaking people
Yale-New Haven Hospital North Haven Medical CenterNorth Haven, United StatesTaking people
Cancer Care Center of O'FallonO'Fallon, United StatesTaking people
HSHS Saint Elizabeth's HospitalO'Fallon, United StatesTaking people
Northwestern Medicine Oak BrookOak Brook, United StatesTaking people
Saint Vincent Hospital Cancer Center at Oconto FallsOconto Falls, United StatesTaking people
University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
Northwestern Medicine Orland ParkOrland Park, United StatesTaking people
Ascension Northeast Wisconsin-Mercy Hospital-OshkoshOshkosh, United StatesTaking people
Illinois CancerCare-Ottawa ClinicOttawa, United StatesTaking people
Camden Clark Medical CenterParkersburg, United StatesTaking people
Illinois CancerCare-PekinPekin, United StatesTaking people
Illinois CancerCare-PeoriaPeoria, United StatesTaking people
OSF Saint Francis Medical CenterPeoria, United StatesTaking people
OSF Saint Francis Radiation Oncology at Peoria Cancer CenterPeoria, United StatesTaking people
Illinois CancerCare-PeruPeru, United StatesTaking people
Thomas Jefferson University HospitalPhiladelphia, United StatesTaking people
University of Pennsylvania/Abramson Cancer CenterPhiladelphia, United StatesTaking people
Mayo Clinic Hospital in ArizonaPhoenix, United StatesTaking people
Kootenai Clinic Cancer Services - Post FallsPost Falls, United StatesNo longer taking part
Illinois CancerCare-PrincetonPrinceton, United StatesTaking people
Ascension All Saints Hospital-Spring Street-RacineRacine, United StatesTaking people
UT Southwestern Clinical Center at Richardson/PlanoRichardson, United StatesTaking people
VCU Massey Cancer Center at Stony PointRichmond, United StatesTaking people
VCU Massey Comprehensive Cancer CenterRichmond, United StatesTaking people
Highlands Oncology Group - RogersRogers, United StatesTaking people
Moffitt Cancer Center at SouthShoreRuskin, United StatesTaking people
University of California Davis Comprehensive Cancer CenterSacramento, United StatesTaking people
Dartmouth Cancer Center - NorthSaint Johnsbury, United StatesTaking people
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United StatesTaking people
Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesTaking people
University of Texas Health Science Center at San AntonioSan Antonio, United StatesTaking people
Kootenai Clinic Cancer Services - SandpointSandpoint, United StatesNo longer taking part
Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
Swedish Medical Center-First HillSeattle, United StatesTaking people
University of Washington Medical Center - MontlakeSeattle, United StatesTaking people
Sidney Kimmel Cancer Center Washington TownshipSewell, United StatesTaking people
Saint Vincent Hospital Cancer Center at SheboyganSheboygan, United StatesTaking people
Sanford Cancer Center Oncology ClinicSioux Falls, United StatesTaking people
Sanford USD Medical Center - Sioux FallsSioux Falls, United StatesTaking people
City of Hope South PasadenaSouth Pasadena, United StatesTaking people
Highlands Oncology GroupSpringdale, United StatesTaking people
Southern Illinois University School of MedicineSpringfield, United StatesTaking people
Springfield ClinicSpringfield, United StatesTaking people
Springfield Memorial HospitalSpringfield, United StatesTaking people
Smilow Cancer Hospital Care Center at Long RidgeStamford, United StatesTaking people
Stony Brook University Medical CenterStony Brook, United StatesTaking people
Saint Vincent Hospital Cancer Center at Sturgeon BaySturgeon Bay, United StatesTaking people
Moffitt Cancer CenterTampa, United StatesTaking people
Moffitt Cancer Center - McKinley CampusTampa, United StatesTaking people
Moffitt Cancer Center-International PlazaTampa, United StatesTaking people
Cedars-Sinai Cancer - TarzanaTarzana, United StatesTaking people
Scott and White Memorial HospitalTemple, United StatesTaking people
Community Medical CenterToms River, United StatesTaking people
Smilow Cancer Hospital-Torrington Care CenterTorrington, United StatesTaking people
Smilow Cancer Hospital Care Center-TrumbullTrumbull, United StatesTaking people
City of Hope UplandUpland, United StatesTaking people
Carle Cancer CenterUrbana, United StatesTaking people
Northwestern Medicine Cancer Center WarrenvilleWarrenville, United StatesTaking people
Illinois CancerCare - WashingtonWashington, United StatesTaking people
Smilow Cancer Hospital-Waterbury Care CenterWaterbury, United StatesTaking people
Smilow Cancer Hospital Care Center - WaterfordWaterford, United StatesTaking people
UI Health Care Mission Cancer and Blood - Waukee ClinicWaukee, United StatesTaking people
Ascension Southeast Wisconsin Hospital-Mayfair Road-WauwatosaWauwatosa, United StatesTaking people
Moffitt Cancer Center at Wesley ChapelWesley Chapel, United StatesTaking people
University of Cincinnati Cancer Center-West ChesterWest Chester, United StatesTaking people
The Iowa Clinic PCWest Des Moines, United StatesTaking people
Smilow Cancer Hospital Care Center - WesterlyWesterly, United StatesTaking people
Asplundh Cancer PavilionWillow Grove, United StatesTaking people
UMass Memorial Medical Center - University CampusWorcester, United StatesTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

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Trial details

Who runs it: National Cancer Institute (NCI)
Trial code: NCT07061964
Record updated: 3 November 2026
Original description: This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.Read full original descriptionShow less
Single Arm Phase II Study of Bladder Preservation With Immunoradiotherapy After a Clinically Meaningful Response to Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer (BRIGHT)
This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.
Inclusion: Participants must have histologic evidence of cT2-T4aN0M0 muscle invasive urothelial carcinoma of the bladder within 180 days prior to starting neoadjuvant therapy (NAT); Participants must have had CT chest/abdomen/pelvis (C/A/P), MRI C/A/P or PET within 60 days prior to starting NAT to determine cT2-T4aN0M0; Participants must have undergone TURBT with biopsy of areas of prior disease and systematic biopsies (left and right lateral, dome, posterior wall and trigone) and radiologic staging showing clinically T0-T1 disease within 60 days after the last dose of NAT. At least 4 out of 5 systematic biopsies must be performed; NOTE: This TURBT must be within 90 days prior to registration. Registration must be within 90 days after the last dose of NAT; Participants must have imaging of the chest, abdomen, and pelvis performed using CT or MRI preferably with contrast. Fludeoxyglucose F-18 (FDG) PET-CT can also be used for staging. If FDG PET-CT is used, then it is at the discretion of the investigator if they want to additionally obtain diagnostic CT or MRI with contrast within 60 days after the last dose of NAT; Participants with lymph nodes ≥ 1.0 cm in the shortest cross-sectional diameter on imaging (CT or MRI of abdomen and pelvis) after completion of NAT must have a PET-CT within 70 days prior to registration. A biopsy in the setting of negative PET-CT is not required unless there is strong clinical suspicion for nodal involvement with tumor. Participants with a positive PET are deemed ineligible unless a biopsy is performed and shows no evidence of tumor involvement; NOTE: For questions regarding the above eligibility criteria, please contact the study chairs in addition to the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC); Participants must not have evidence of ≥ T2, or N1-3, or M1 disease after NAT; Participants must not have the presence of small cell, neuroendocrine carcinoma, plasmacytoid variants on any pathology; Participants must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta/T1/carcinoma in situ (CIS) of the upper urinary tract, including renal pelvis or ureter if the participant underwent complete nephroureterectomy; NOTE: Participants with mixed variant histology will be eligible for the trial if the majority (> 50%) of the tumor is urothelial cell carcinoma; Participants will be allowed to continue PD-1/L-1 inhibitor therapy received as part of standard of care neoadjuvant therapy while they undergo pre-registration assessments (TURBT and imaging); Participants must have received at least 3 and no more than 6 cycles of Food and Drug Administration (FDA) approved NAT for MIBC. These include cisplatin-based combination chemotherapy (e.g. cisplatin and gemcitabine [GC] with or without PD-1/L1 inhibitors) dose dense or accelerated methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) or enfortumab vedotin with PD-1/L1 inhibitor; Participants must not have had anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody, any other antibody or drug targeting T-cell co-stimulation, enfortumab vedotin, or any other drug targeting nectin-4 other than for neoadjuvant treatment for MIBC; NOTE: Prior intravesical immunotherapy or chemotherapy for non-muscle invasive disease is allowed; Participants must not have had prior pelvic radiotherapy; Participants must not have received a live attenuated vaccination within 28 days prior to registration; Participants with conditions requiring immunosuppressive doses of steroids (> 10 mg/day of prednisone or equivalent) or other immunosuppressive medications must not be taking steroids at time of trial registration; Participants must be ≥ 18 years old at the time of registration; Participants must have Zubrod performance status of 0-2; Participants must have a complete medical history and physical exam within 28 days prior to registration; Leukocytes ≥ 3 x 10\^3/uL (within 28 days prior to registration); Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to registration); Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration); Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration); Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to registration); Participants must have a creatinine ≤ the institutional (I)ULN OR measured OR calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration; Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better; Participants with a history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration; For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated; Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured (defined as undetectable HCV viral load); 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 (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). 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; Participants must be offered the opportunity to participate in specimen banking; Participants who can complete the PRO-CTCAE questionnaire in English or Spanish will be offered the opportunity to participate in the optional patient-reported outcome study; 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; For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and central institutional review board (CIRB) regulations.
ClinicalTrials.gov NCT07061964