Taking people in United StatesPhase 2/3

Adding Atezolizumab to Chemotherapy for Advanced Neuroendocrine Carcinoma Outside the Lung

Tests adding atezolizumab to chemotherapy in adults with advanced neuroendocrine carcinoma.

Plain-language title generated from the registry record
Registry title: Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung

Key facts

Where: ‘Aiea, ‘Ewa Beach, Ames, Anaconda, Anaheim, Anchorage, Ankeny, Ann Arbor, Auburn, Aurora, Baldwin Park, Baton Rouge, Battle Creek, Bellflower, Bend, Berkeley, Billings, Boone, Bridgeport, Brighton, Brownstown, Buffalo, Burlington, Burnsville, Cameron Park, Canton, Cape Girardeau, Carmichael, Carroll, Cary, Centralia, Chambersburg, Charleston, Charlotte, Chelsea, Chicago, Clackamas, Clinton, Clinton Township, Clive, Coeur d'Alene, Columbus, Concord, Creston, Crown Point, Dallas, Danville, Dearborn, Decatur, DeKalb, Denver, Derby, Des Moines, Detroit, Duluth, Durham, East China Township, Eau Claire, Edina, Effingham, Elk Grove, Ephrata, Fairfield, Farmington Hills, Flint, Fontana, Fort Dodge, Fort Lauderdale, Fort Worth, Fremont, Gastonia, Geneva, Gettysburg, Glastonbury, Glenview, Goldsboro, Grand Rapids, Grayslake, Great Falls, Greenwich, Grosse Pointe Woods, Guilford, Hanover, Harbor City, Hartford, Harvey, Honolulu, Houston, Irvine, Jackson, Jacksonville, Jefferson, Joplin, Kalamazoo, Kalispell, La Crosse, Lake Forest, Lansing, Lawton, Lebanon, Littleton, Livonia, Los Angeles, Macomb, Marshalltown, Marshfield, Mattoon, Metairie, Milwaukee, Minneapolis, Minocqua, Missoula, Modesto, Morgantown, Mount Vernon, Mountain View, Muskegon, Nampa, Nashville, New Haven, New Lenox, New Orleans, New York, Newberg, Niles, Normal, North Haven, Norton Shores, Novi, O'Fallon, Oklahoma City, Ontario, Oregon City, Orland Park, Palo Alto, Panorama City, Parker, Peabody, Phoenix, Pinehurst, Pontiac, Portland, Post Falls, Raleigh, Rapid City, Reed City, Rice Lake, Richardson, Riverside, Rochester, Rock Hill, Rockford, Rocklin, Roseville, Royal Oak, Sacramento, Saint Johnsbury, Saint Joseph, Saint Louis Park, Saint Paul, Salt Lake City, San Diego, San Francisco, San Marcos, Sandpoint, Santa Cruz, Santa Rosa, Seattle, Shakopee, Shelby, Springfield, St Louis, Stamford, Stevens Point, Stony Brook, Sunnyvale, Tampa, Toledo, Torrington, Traverse City, Troy, Trumbull, Urbana, Vallejo, Warren, Warrenville, Waterbury, Waterford, Waukee, West Bloomfield, West Des Moines, Westerly, Weston, Woodland, Woodland Hills, Wyandotte, Wyoming, York, Yorkville, and Ypsilanti, United StatesSee the 266 sites
Phase: Phase 2/3

Where in United States

Hawaii Cancer Care - Westridge‘Aiea, United StatesTaking people
Pali Momi Medical Center‘Aiea, United StatesNo longer taking part
The Queen's Medical Center - West Oahu‘Ewa Beach, United StatesTaking people
Mary Greeley Medical CenterAmes, United StatesTaking people
McFarland Clinic - AmesAmes, United StatesTaking people
Community Hospital of AnacondaAnaconda, United StatesTaking people
Kaiser Permanente-AnaheimAnaheim, United StatesTaking people
Alaska Women's Cancer CareAnchorage, United StatesNo longer taking part
UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, United StatesTaking people
Trinity Health Saint Joseph Mercy Hospital Ann ArborAnn Arbor, United StatesTaking people
University of Michigan Rogel Cancer CenterAnn Arbor, United StatesTaking people
Sutter Auburn Faith HospitalAuburn, United StatesTaking people
Sutter Cancer Centers Radiation Oncology Services-AuburnAuburn, United StatesTaking people
Rush-Copley Medical CenterAurora, United StatesNo longer taking part
Kaiser Permanente-Baldwin ParkBaldwin Park, United StatesTaking people
LSU Health Baton Rouge-North ClinicBaton Rouge, United StatesTaking people
Our Lady of the Lake Physician GroupBaton Rouge, United StatesTaking people
Bronson Battle CreekBattle Creek, United StatesTaking people
Kaiser Permanente-BellflowerBellflower, United StatesTaking people
Saint Charles Health SystemBend, United StatesTaking people
Alta Bates Summit Medical Center-Herrick CampusBerkeley, United StatesTaking people
Billings Clinic Cancer CenterBillings, United StatesTaking people
Saint Vincent Frontier Cancer CenterBillings, United StatesTaking people
McFarland Clinic - BooneBoone, United StatesNo longer taking part
United Hospital CenterBridgeport, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - BrightonBrighton, United StatesTaking people
Trinity Health Medical Center - BrightonBrighton, United StatesTaking people
Henry Ford Cancer Institute-DownriverBrownstown, United StatesTaking people
Roswell Park Cancer InstituteBuffalo, United StatesNo longer taking part
Lahey ClinicBurlington, United StatesTaking people
Minnesota Oncology - BurnsvilleBurnsville, United StatesTaking people
Sutter Cancer Centers Radiation Oncology Services-Cameron ParkCameron Park, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - CantonCanton, United StatesTaking people
Trinity Health Medical Center - CantonCanton, United StatesTaking people
Saint Francis Medical CenterCape Girardeau, United StatesTaking people
Mercy Cancer Center - CarmichaelCarmichael, United StatesTaking people
Mercy San Juan Medical CenterCarmichael, United StatesTaking people
Saint Anthony Regional HospitalCarroll, United StatesTaking people
Duke Cancer Center CaryCary, United StatesNo longer taking part
Centralia Oncology ClinicCentralia, United StatesTaking people
WellSpan Medical Oncology and HematologyChambersburg, United StatesTaking people
Medical University of South CarolinaCharleston, United StatesNo longer taking part
Atrium Health Pineville/LCI-PinevilleCharlotte, United StatesTaking people
Atrium Health University City/LCI-UniversityCharlotte, United StatesTaking people
Carolinas Medical Center/Levine Cancer InstituteCharlotte, United StatesTaking people
Levine Cancer Institute-BallantyneCharlotte, United StatesTaking people
Levine Cancer Institute-SouthParkCharlotte, United StatesTaking people
Chelsea HospitalChelsea, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalChelsea, United StatesTaking people
Northwestern UniversityChicago, United StatesTaking people
University of Chicago Comprehensive Cancer CenterChicago, United StatesTaking people
Providence Cancer Institute Clackamas ClinicClackamas, United StatesNo longer taking part
Southeastern Medical Oncology Center-ClintonClinton, United StatesTaking people
Henry Ford Macomb Hospital-Clinton TownshipClinton Township, 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 StatesTaking people
Ohio State University Comprehensive Cancer CenterColumbus, United StatesTaking people
Atrium Health Cabarrus/LCI-ConcordConcord, United StatesTaking people
Greater Regional Medical CenterCreston, United StatesNo longer taking part
UChicago Medicine Northwest IndianaCrown Point, 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
Corewell Health Dearborn HospitalDearborn, United StatesTaking people
Henry Ford Medical Center-FairlaneDearborn, 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
AdventHealth PorterDenver, United StatesTaking people
Smilow Cancer Hospital-Derby Care CenterDerby, United StatesTaking people
Broadlawns Medical CenterDes Moines, 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
Henry Ford Health Saint John HospitalDetroit, United StatesTaking people
Henry Ford HospitalDetroit, United StatesTaking people
Wayne State University/Karmanos Cancer InstituteDetroit, United StatesNo longer taking part
Saint Luke's Hospital of DuluthDuluth, United StatesNo longer taking part
Duke University Medical CenterDurham, United StatesTaking people
Henry Ford River District HospitalEast China Township, United StatesTaking people
Marshfield Medical Center-EC Cancer CenterEau Claire, United StatesTaking people
Fairview Southdale HospitalEdina, United StatesTaking people
Minnesota Oncology - EdinaEdina, United StatesTaking people
Carle Physician Group-EffinghamEffingham, United StatesTaking people
Crossroads Cancer CenterEffingham, United StatesTaking people
Mercy Cancer Center - Elk GroveElk Grove, United StatesTaking people
Ephrata Cancer CenterEphrata, United StatesTaking people
Smilow Cancer Hospital Care Center-FairfieldFairfield, United StatesTaking people
Corewell Health Farmington Hills HospitalFarmington Hills, United StatesTaking people
Weisberg Cancer Treatment CenterFarmington Hills, United StatesNo longer taking part
Cancer Hematology Centers - FlintFlint, United StatesTaking people
Genesys Hurley Cancer InstituteFlint, United StatesTaking people
Hurley Medical CenterFlint, United StatesTaking people
Genesee Hematology Oncology PCFlint, United StatesNo longer taking part
Kaiser Permanente-FontanaFontana, United StatesTaking people
McFarland Clinic - Trinity Cancer CenterFort Dodge, United StatesTaking people
Holy Cross HospitalFort Lauderdale, United StatesTaking people
UT Southwestern/Simmons Cancer Center-Fort WorthFort Worth, United StatesTaking people
Palo Alto Medical Foundation-FremontFremont, United StatesTaking people
Levine Cancer Institute-GastonGastonia, United StatesTaking people
Northwestern Medicine Cancer Center DelnorGeneva, United StatesTaking people
Adams Cancer CenterGettysburg, United StatesTaking people
Smilow Cancer Hospital Care Center at GlastonburyGlastonbury, United StatesNo longer taking part
Northwestern Medicine Glenview Outpatient CenterGlenview, United StatesTaking people
Southeastern Medical Oncology Center-GoldsboroGoldsboro, United StatesTaking people
Corewell Health Grand Rapids Hospitals - Butterworth HospitalGrand Rapids, United StatesTaking people
Trinity Health Grand Rapids HospitalGrand Rapids, United StatesTaking people
Northwestern Medicine Grayslake Outpatient CenterGrayslake, United StatesTaking people
Benefis Sletten Cancer InstituteGreat Falls, United StatesTaking people
Smilow Cancer Hospital Care Center at GreenwichGreenwich, United StatesTaking people
Henry Ford Saint John Hospital - AcademicGrosse Pointe Woods, United StatesTaking people
Henry Ford Saint John Hospital - BreastGrosse Pointe Woods, United StatesTaking people
Henry Ford Saint John Hospital - Van ElslanderGrosse Pointe Woods, United StatesTaking people
Smilow Cancer Hospital Care Center - GuilfordGuilford, United StatesTaking people
WellSpan Medical Oncology and HematologyHanover, United StatesTaking people
Kaiser Permanente South BayHarbor City, United StatesTaking people
Smilow Cancer Hospital Care Center at Saint FrancisHartford, United StatesNo longer taking part
Ingalls Memorial HospitalHarvey, United StatesTaking people
Hawaii Cancer Care Inc - Waterfront PlazaHonolulu, United StatesTaking people
Queen's Cancer Cenrer - POB IHonolulu, United StatesTaking people
Queen's Cancer Center - KuakiniHonolulu, United StatesTaking people
Queen's Medical CenterHonolulu, United StatesTaking people
Straub Clinic and HospitalHonolulu, United StatesTaking people
University of Hawaii Cancer CenterHonolulu, United StatesTaking people
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterHouston, United StatesTaking people
Ben Taub General HospitalHouston, United StatesTaking people
Kaiser Permanente-IrvineIrvine, United StatesTaking people
Allegiance HealthJackson, United StatesTaking people
Mayo Clinic in FloridaJacksonville, United StatesTaking people
Southeastern Medical Oncology Center-JacksonvilleJacksonville, United StatesTaking people
McFarland Clinic - JeffersonJefferson, United StatesNo longer taking part
Mercy Hospital JoplinJoplin, United StatesTaking people
Bronson Methodist HospitalKalamazoo, United StatesTaking people
West Michigan Cancer CenterKalamazoo, United StatesTaking people
Logan Health Medical CenterKalispell, United StatesTaking people
Gundersen Lutheran Medical CenterLa Crosse, United StatesTaking people
Northwestern Medicine Lake Forest HospitalLake Forest, United StatesTaking people
Karmanos Cancer Institute at McLaren Greater LansingLansing, United StatesNo longer taking part
Cancer Centers of Southwest Oklahoma ResearchLawton, United StatesTaking people
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United StatesTaking people
Sechler Family Cancer CenterLebanon, United StatesTaking people
AdventHealth LittletonLittleton, United StatesTaking people
Trinity Health Saint Mary Mercy Livonia HospitalLivonia, United StatesTaking people
Kaiser Permanente Los Angeles Medical CenterLos Angeles, United StatesTaking people
Kaiser Permanente West Los AngelesLos Angeles, United StatesTaking people
Henry Ford Saint John Hospital - Macomb MedicalMacomb, United StatesTaking people
Henry Ford Warren Hospital - Breast MacombMacomb, United StatesTaking people
McFarland Clinic - MarshalltownMarshalltown, United StatesTaking people
Marshfield Medical Center-MarshfieldMarshfield, United StatesTaking people
Carle Physician Group-Mattoon/CharlestonMattoon, United StatesTaking people
East Jefferson General HospitalMetairie, United StatesTaking people
LSU Healthcare Network / Metairie Multi-Specialty ClinicMetairie, United StatesTaking people
Medical College of WisconsinMilwaukee, United StatesTaking people
Abbott-Northwestern HospitalMinneapolis, United StatesTaking people
Hennepin County Medical CenterMinneapolis, United StatesTaking people
Marshfield Medical Center - MinocquaMinocqua, United StatesTaking people
Community Medical CenterMissoula, United StatesTaking people
Memorial Medical CenterModesto, United StatesTaking people
West Virginia University HealthcareMorgantown, United StatesTaking people
SSM Health Good SamaritanMount Vernon, United StatesTaking people
Palo Alto Medical Foundation-Camino DivisionMountain View, United StatesTaking people
Trinity Health Muskegon HospitalMuskegon, United StatesTaking people
Saint Alphonsus Cancer Care Center-NampaNampa, United StatesTaking people
Vanderbilt University/Ingram Cancer CenterNashville, United StatesTaking people
Yale UniversityNew Haven, United StatesTaking people
UC Comprehensive Cancer Center at Silver CrossNew Lenox, United StatesTaking people
University Medical Center New OrleansNew Orleans, United StatesTaking people
Mount Sinai HospitalNew York, United StatesNo longer taking part
Providence Newberg Medical CenterNewberg, United StatesTaking people
Corewell Health Lakeland Hospitals - Niles HospitalNiles, United StatesTaking people
Carle BroMenn Medical CenterNormal, United StatesTaking people
Carle Cancer Institute NormalNormal, United StatesTaking people
Yale-New Haven Hospital North Haven Medical CenterNorth Haven, United StatesTaking people
Cancer and Hematology Centers of Western Michigan - Norton ShoresNorton Shores, United StatesNo longer taking part
Henry Ford Medical Center-ColumbusNovi, United StatesTaking people
Cancer Care Center of O'FallonO'Fallon, United StatesTaking people
Mercy Hospital Oklahoma CityOklahoma City, United StatesTaking people
University of Oklahoma Health Sciences CenterOklahoma City, United StatesTaking people
Kaiser Permanente-OntarioOntario, United StatesTaking people
Providence Willamette Falls Medical CenterOregon City, United StatesTaking people
Northwestern Medicine Orland ParkOrland Park, United StatesTaking people
University of Chicago Medicine-Orland ParkOrland Park, United StatesTaking people
Palo Alto Medical Foundation Health CarePalo Alto, United StatesTaking people
Kaiser Permanente - Panorama CityPanorama City, United StatesTaking people
AdventHealth ParkerParker, United StatesTaking people
Lahey Clinic PeabodyPeabody, United StatesTaking people
Cancer Center at Saint Joseph'sPhoenix, United StatesTaking people
Mayo Clinic Hospital in ArizonaPhoenix, United StatesTaking people
FirstHealth of the Carolinas-Moore Regional HospitalPinehurst, United StatesTaking people
Trinity Health Saint Joseph Mercy Oakland HospitalPontiac, United StatesTaking people
Providence Portland Medical CenterPortland, United StatesTaking people
Providence Saint Vincent Medical CenterPortland, United StatesTaking people
Kootenai Clinic Cancer Services - Post FallsPost Falls, United StatesTaking people
Duke Cancer Center RaleighRaleigh, United StatesTaking people
Rapid City Regional HospitalRapid City, United StatesTaking people
Corewell Health Reed City HospitalReed City, United StatesTaking people
Marshfield Medical Center-Rice LakeRice Lake, United StatesTaking people
UT Southwestern Clinical Center at Richardson/PlanoRichardson, United StatesTaking people
Kaiser Permanente-RiversideRiverside, United StatesTaking people
Mayo Clinic in RochesterRochester, United StatesTaking people
Levine Cancer Institute-Rock HillRock Hill, United StatesTaking people
UW Health Carbone Cancer Center RockfordRockford, United StatesTaking people
Mercy Cancer Center - RocklinRocklin, United StatesTaking people
Sutter Cancer Centers Radiation Oncology Services-RosevilleRoseville, United StatesTaking people
Sutter Roseville Medical CenterRoseville, United StatesTaking people
Corewell Health William Beaumont University HospitalRoyal Oak, United StatesTaking people
Mercy Cancer Center - SacramentoSacramento, United StatesTaking people
Sutter Medical Center SacramentoSacramento, United StatesTaking people
Dartmouth Cancer Center - NorthSaint Johnsbury, United StatesTaking people
Corewell Health Lakeland Hospitals - Marie Yeager Cancer CenterSaint Joseph, United StatesTaking people
Corewell Health Lakeland Hospitals - Saint Joseph HospitalSaint Joseph, United StatesTaking people
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United StatesTaking people
Regions HospitalSaint Paul, United StatesTaking people
United HospitalSaint Paul, United StatesTaking people
Huntsman Cancer Institute/University of UtahSalt Lake City, United StatesTaking people
Kaiser Permanente-San Diego ZionSan Diego, United StatesTaking people
California Pacific Medical Center-Pacific CampusSan Francisco, United StatesTaking people
Kaiser Permanente-San MarcosSan Marcos, United StatesTaking people
Kootenai Clinic Cancer Services - SandpointSandpoint, United StatesTaking people
Palo Alto Medical Foundation-Santa CruzSanta Cruz, United StatesTaking people
Sutter Pacific Medical FoundationSanta Rosa, United StatesTaking people
Fred Hutchinson Cancer CenterSeattle, United StatesTaking people
University of Washington Medical Center - MontlakeSeattle, United StatesTaking people
Saint Francis Regional Medical CenterShakopee, United StatesTaking people
Atrium Health Cleveland/LCI-ClevelandShelby, United StatesTaking people
CoxHealth South HospitalSpringfield, United StatesTaking people
Mercy Hospital SpringfieldSpringfield, United StatesTaking people
Southern Illinois University School of MedicineSpringfield, United StatesTaking people
Springfield ClinicSpringfield, United StatesTaking people
Springfield Memorial HospitalSpringfield, United StatesTaking people
Mercy Hospital SouthSt Louis, United StatesTaking people
Smilow Cancer Hospital Care Center at Long RidgeStamford, United StatesTaking people
Marshfield Medical Center-River Region at Stevens PointStevens Point, United StatesTaking people
Stony Brook University Medical CenterStony Brook, United StatesNo longer taking part
Palo Alto Medical Foundation-SunnyvaleSunnyvale, United StatesTaking people
Moffitt Cancer CenterTampa, United StatesTaking people
Toledo Clinic Cancer Centers-ToledoToledo, United StatesNo longer taking part
Smilow Cancer Hospital-Torrington Care CenterTorrington, United StatesTaking people
Munson Medical CenterTraverse City, United StatesTaking people
Corewell Health Beaumont Troy HospitalTroy, United StatesTaking people
Smilow Cancer Hospital Care Center-TrumbullTrumbull, United StatesTaking people
Carle Cancer CenterUrbana, United StatesTaking people
Sutter Solano Medical Center/Cancer CenterVallejo, United StatesTaking people
Henry Ford Health Warren HospitalWarren, United StatesTaking people
Henry Ford Madison Heights Hospital - BreastWarren, United StatesTaking people
Henry Ford Warren Hospital - GLCMSWarren, United StatesTaking people
Northwestern Medicine Cancer Center WarrenvilleWarrenville, 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
Henry Ford West Bloomfield HospitalWest Bloomfield, United StatesTaking people
Mercy Medical Center-West LakesWest Des Moines, United StatesTaking people
Smilow Cancer Hospital Care Center - WesterlyWesterly, United StatesTaking people
Marshfield Medical Center - WestonWeston, United StatesTaking people
Woodland Memorial HospitalWoodland, United StatesTaking people
Kaiser Permanente-Woodland HillsWoodland Hills, United StatesTaking people
Henry Ford Wyandotte HospitalWyandotte, United StatesTaking people
University of Michigan Health - WestWyoming, United StatesTaking people
WellSpan Health-York Cancer CenterYork, United StatesTaking people
Cancer Care Associates of YorkYork, United StatesNo longer taking part
Rush-Copley Healthcare CenterYorkville, United StatesNo longer taking part
Huron Gastroenterology PCYpsilanti, United StatesTaking people
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilanti, 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?

Print a page for my doctor

Trial details

Who runs it: National Cancer Institute (NCI)
Trial code: NCT05058651
Record updated: 6 November 2026
Original description: This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone.Read full original descriptionShow less
Randomized Phase II/III Trial of First Line Platinum/Etoposide With or Without Atezolizumab (NSC#783608) in Patients With Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)
This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone.
Inclusion: Participants must have histologically-confirmed (local site pathological confirmation sufficient) extrapulmonary poorly differentiated, neuroendocrine carcinoma (NEC); Participants must have disease that is unresectable or metastatic and not eligible for definitive therapy as deemed per the treating investigator; Participants must have radiologically evaluable disease, measurable or non-measurable, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. All measurable and nonmeasurable lesions must be assessed by CT scan with IV contrast of the chest/abdomen/and pelvis (or CT chest without contrast and MRI abdomen/pelvis with gadolinium contrast, if contraindication to CT iodinated contrast) within 28 days prior to registration. While may be used for routine clinical evaluation, PET scans and bone scans alone are not acceptable for disease assessment while participating in this study. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form; Participants must have brain MRI (or CT head with contrast if there is contraindication to MRI brain) if clinically indicated within 28 days prior to registration. Note: Brain imaging is not required in participants without known and/or clinical concern for brain metastases. Participants with asymptomatic central nervous system (CNS) metastases are eligible if one or more of the following apply:; Participants who have received treatment for brain metastases must have:; No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration; Discontinued all corticosteroids at least 14 days prior to registration; Participants with treatment-naive brain lesions must have:; No lesion measuring > 2.0 cm in size in any axis; MRI brain or CT head with contrast (if there is contraindication to MRI brain) demonstrating no evidence for mass effect, edema, or other impending neurological compromise within 28 days prior to registration; No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration; No need for > 2 mg of dexamethasone (or equivalent of > 10 mg prednisone) per day at time of registration; Participants must not have symptomatic central nervous system (CNS) metastases; Participants must not have known or suspected leptomeningeal disease; Participants with prior history of non-metastatic (localized/locally advanced disease) extrapulmonary poorly differentiated NEC may have had prior platinum-based therapy +/- radiation +/- surgery provided that all therapy was completed >= 6 months prior to registration; Participants must discontinue denosumab prior to study registration and plan to replace with a bisphosphonate while on the study; Participants must not have had prior treatment for advanced or metastatic NEC EXCEPT one cycle of platinum (carboplatin/cisplatin) + etoposide is allowed prior to registration. Other chemotherapy regimens are not allowed. For participants with prostate or urothelial NEC, prior chemotherapy for the non-NEC component (e.g. adenocarcinoma or urothelial) is allowed as long as such therapy was completed >= 24 weeks prior to registration and participants have recovered from all prior toxicities to =< grade 1; Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, antiPD-L2, CD137 agonists, anti-CTLA-4 agent, or any other immune checkpoint inhibitors for any neuroendocrine neoplasm. Immune checkpoint inhibitors given for other cancer indications are allowed provided last therapy was given at least 12 months prior to study registration; Participants must not have received treatment with systemic immunostimulatory agents including, but not limited to, interferon and interleukin2 [IL-2] within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to registration; Participants must not have had history of known severe allergy, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies, including to Chinese hamster ovary cell products or to any component of the atezolizumab formulation, cisplatin, carboplatin, or etoposide; Participants must not be on active systemic therapy for another cancer with the exception of hormonal therapy including androgen deprivation therapy (e.g., gonadotropin-releasing hormone [GnRH] agonists or antagonists), which can be continued while participants are receiving protocol therapy. Use of enzalutamide or apalutamide is permitted after completion of chemotherapy and must be held during chemotherapy for participants receiving prior to enrollment. Use of darolutamide is permitted during chemotherapy. Glucocorticoid-containing regimens, including abiraterone, are not permitted; Participants must be >= 18 years of age; Participants must have a Zubrod performance status of =< 2 within 28 days prior to registration; Participants must have a complete medical history and physical exam within 28 days prior to registration; Absolute neutrophil count (ANC) >= 1.5 x 10\^9 /L (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests); Hemoglobin >= 9.0 g/dl (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests); Platelet count >= 100 x 10\^9/L (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests); Serum total bilirubin =< 1.5 x ULN (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests); Adequate renal function as defined by any 1 of the following: 1) Measured creatinine clearance (CL) > 50 mL/min OR 2) Calculated creatinine CL > 50 mL/min by the Cockcroft-Gault formula OR by 24-hour urine collection for determination of creatinine clearance (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests); Participants must not have uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN) within 14 days prior to registration. Participants who have asymptomatic hypercalcemia are eligible provided that medical therapy to treat the hypercalcemia is planned; Participants must not have a diagnosis of immunodeficiency nor be receiving systemic steroid therapy (equivalent of > 20 mg of hydrocortisone per day) or any other form of immunosuppressive therapy within 14 days prior to registration; Participants must not have active or history of autoimmune disease or immune deficiency, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis with the following exceptions:; Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study; Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study; Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:; Rash must cover < 10% of body surface area; Disease is well controlled at baseline and requires only low-potency topical corticosteroids; No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months; Participants must not have history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. NOTE: History of radiation pneumonitis in the radiation field (fibrosis) is permitted; Participants must not have significant cardiovascular disease, such as New York Heart Association class II or greater cardiac disease, myocardial infarction within 3 months prior to registration, unstable arrythmias, or unstable angina; Participants must not have had a major surgical procedure other than for diagnosis within 28 days prior to registration. Participant must not plan to receive a major surgical procedure during the course of protocol treatment. NOTE: Patient port placement is not considered a major surgery; Participants must not have severe infections (i.e., Common Terminology Criteria for Adverse Events [CTCAE] grade >= 2) at time of registration, including but not limited to hospitalization for complications for infection, bacteremia, or severe pneumonia; Participants must not have known active tuberculosis; Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load, with testing performed as clinically indicated; Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load, with testing performed as clinically indicated; Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load within 6 months of registration; Participants must not have prior allogeneic bone marrow transplantation or solid organ transplant; Participants must not have received administration of a live, attenuated vaccine (e.g., FluMist [registered trademark]) within 28 days prior to initiation of study treatment, during treatment with atezolizumab, and not plan to receive for 5 months after the last dose of atezolizumab; Participants must not be pregnant due to the possibility of harm to the fetus. 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) during the treatment period and for 5 months after the final dose of atezolizumab. 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. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking 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.
ClinicalTrials.gov NCT05058651