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Spots Global Cancer Trial Database for Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung

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Trial Identification

Brief Title: Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung

Official Title: 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)

Study ID: NCT05058651

Study Description

Brief Summary: 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.

Detailed Description: PRIMARY OBJECTIVES: I. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus induction platinum/etoposide alone (Arm 3). II. Compare the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2) versus induction platinum/etoposide alone (Arm 3). III. Compare the combination of induction platinum/etoposide and atezolizumab followed by maintenance atezolizumab (Arm 1) versus the combination of induction platinum/etoposide and atezolizumab followed by observation (Arm 2). SECONDARY OBJECTIVES: I. To compare overall survival (OS), measured from start of observation/maintenance, across arms. II. To compare progression free survival (PFS) (measured from randomization and measured from start of observation/maintenance) across arms. III. To compare objective response rate (ORR = confirmed and unconfirmed partial response \[PR\] + confirmed and unconfirmed complete response \[CR\]) across arms among patients with measurable disease at randomization. IV. To compare clinical benefit rate (CBR = confirmed and unconfirmed PR + confirmed and unconfirmed CR + stable disease \[SD\]) across arms among patients with measurable disease at randomization. V. To compare duration of response (DOR) across arms. VI. To evaluate the safety and tolerability of each arm. ADDITIONAL OBJECTIVE: I. To bank tumor and blood samples for future biomarker correlative studies. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: During induction phase, patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. During maintenance phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. ARM II: During induction phase, patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle, and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year. ARM III: During induction phase, patients receive carboplatin IV over 30 minutes or cisplatin IV over 60 minutes on day 1 of each cycle and etoposide IV on days 1-3 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo observation for 1 year. Patients in all arms also undergo compute tomography (CT) scan and/or magnetic resonance imaging (MRI) throughout the trial and blood sample collection on study. After completion of study treatment, patients are followed up for 5 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Cancer Center at Saint Joseph's, Phoenix, Arizona, United States

Kaiser Permanente-Anaheim, Anaheim, California, United States

Sutter Auburn Faith Hospital, Auburn, California, United States

Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California, United States

Kaiser Permanente-Baldwin Park, Baldwin Park, California, United States

Kaiser Permanente-Bellflower, Bellflower, California, United States

Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, United States

Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, United States

Mercy Cancer Center - Carmichael, Carmichael, California, United States

Mercy San Juan Medical Center, Carmichael, California, United States

Mercy Cancer Center - Elk Grove, Elk Grove, California, United States

Kaiser Permanente-Fontana, Fontana, California, United States

Palo Alto Medical Foundation-Fremont, Fremont, California, United States

Kaiser Permanente - Harbor City, Harbor City, California, United States

Kaiser Permanente-Irvine, Irvine, California, United States

Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States

Kaiser Permanente West Los Angeles, Los Angeles, California, United States

Memorial Medical Center, Modesto, California, United States

Palo Alto Medical Foundation-Camino Division, Mountain View, California, United States

Kaiser Permanente-Ontario, Ontario, California, United States

Palo Alto Medical Foundation Health Care, Palo Alto, California, United States

Kaiser Permanente - Panorama City, Panorama City, California, United States

Kaiser Permanente-Riverside, Riverside, California, United States

Mercy Cancer Center - Rocklin, Rocklin, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, United States

Sutter Roseville Medical Center, Roseville, California, United States

Mercy Cancer Center - Sacramento, Sacramento, California, United States

Sutter Medical Center Sacramento, Sacramento, California, United States

Kaiser Permanente-San Diego Zion, San Diego, California, United States

California Pacific Medical Center-Pacific Campus, San Francisco, California, United States

Kaiser Permanente-San Marcos, San Marcos, California, United States

Palo Alto Medical Foundation-Santa Cruz, Santa Cruz, California, United States

Palo Alto Medical Foundation-Sunnyvale, Sunnyvale, California, United States

Sutter Solano Medical Center/Cancer Center, Vallejo, California, United States

Kaiser Permanente-Woodland Hills, Woodland Hills, California, United States

Woodland Memorial Hospital, Woodland, California, United States

Parker Adventist Hospital, Parker, Colorado, United States

Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut, United States

Smilow Cancer Hospital Care Center-Fairfield, Fairfield, Connecticut, United States

Smilow Cancer Hospital Care Center at Glastonbury, Glastonbury, Connecticut, United States

Smilow Cancer Hospital Care Center at Greenwich, Greenwich, Connecticut, United States

Smilow Cancer Hospital Care Center - Guilford, Guilford, Connecticut, United States

Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States

Yale University, New Haven, Connecticut, United States

Yale-New Haven Hospital North Haven Medical Center, North Haven, Connecticut, United States

Smilow Cancer Hospital Care Center at Long Ridge, Stamford, Connecticut, United States

Smilow Cancer Hospital-Torrington Care Center, Torrington, Connecticut, United States

Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, United States

Smilow Cancer Hospital-Waterbury Care Center, Waterbury, Connecticut, United States

Smilow Cancer Hospital Care Center - Waterford, Waterford, Connecticut, United States

Holy Cross Hospital, Fort Lauderdale, Florida, United States

Moffitt Cancer Center, Tampa, Florida, United States

Hawaii Cancer Care - Westridge, 'Aiea, Hawaii, United States

Pali Momi Medical Center, 'Aiea, Hawaii, United States

Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, United States

Queen's Cancer Cenrer - POB I, Honolulu, Hawaii, United States

Queen's Medical Center, Honolulu, Hawaii, United States

Straub Clinic and Hospital, Honolulu, Hawaii, United States

Queen's Cancer Center - Kuakini, Honolulu, Hawaii, United States

Centralia Oncology Clinic, Centralia, Illinois, United States

Northwestern University, Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Carle at The Riverfront, Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States

Decatur Memorial Hospital, Decatur, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee, DeKalb, Illinois, United States

Carle Physician Group-Effingham, Effingham, Illinois, United States

Crossroads Cancer Center, Effingham, Illinois, United States

Northwestern Medicine Cancer Center Delnor, Geneva, Illinois, United States

Northwestern Medicine Glenview Outpatient Center, Glenview, Illinois, United States

Northwestern Medicine Grayslake Outpatient Center, Grayslake, Illinois, United States

Ingalls Memorial Hospital, Harvey, Illinois, United States

Northwestern Medicine Lake Forest Hospital, Lake Forest, Illinois, United States

Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross, New Lenox, Illinois, United States

Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States

Northwestern Medicine Orland Park, Orland Park, Illinois, United States

University of Chicago Medicine-Orland Park, Orland Park, Illinois, United States

Southern Illinois University School of Medicine, Springfield, Illinois, United States

Springfield Clinic, Springfield, Illinois, United States

Memorial Medical Center, Springfield, Illinois, United States

Carle Cancer Center, Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States

Mary Greeley Medical Center, Ames, Iowa, United States

McFarland Clinic - Ames, Ames, Iowa, United States

Mission Cancer and Blood - Ankeny, Ankeny, Iowa, United States

McFarland Clinic - Boone, Boone, Iowa, United States

Mercy Cancer Center-West Lakes, Clive, Iowa, United States

Mission Cancer and Blood - West Des Moines, Clive, Iowa, United States

Greater Regional Medical Center, Creston, Iowa, United States

Mission Cancer and Blood - Des Moines, Des Moines, Iowa, United States

Mercy Medical Center - Des Moines, Des Moines, Iowa, United States

Mission Cancer and Blood - Laurel, Des Moines, Iowa, United States

McFarland Clinic - Trinity Cancer Center, Fort Dodge, Iowa, United States

McFarland Clinic - Jefferson, Jefferson, Iowa, United States

McFarland Clinic - Marshalltown, Marshalltown, Iowa, United States

Mercy Medical Center-West Lakes, West Des Moines, Iowa, United States

LSU Health Baton Rouge-North Clinic, Baton Rouge, Louisiana, United States

Our Lady of the Lake Physician Group, Baton Rouge, Louisiana, United States

University Medical Center New Orleans, New Orleans, Louisiana, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor, Ann Arbor, Michigan, United States

University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton, Brighton, Michigan, United States

Trinity Health Medical Center - Brighton, Brighton, Michigan, United States

Henry Ford Cancer Institute-Downriver, Brownstown, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton, Canton, Michigan, United States

Trinity Health Medical Center - Canton, Canton, Michigan, United States

Saint Joseph Mercy Chelsea, Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital, Chelsea, Michigan, United States

Henry Ford Macomb Hospital-Clinton Township, Clinton Township, Michigan, United States

Beaumont Hospital - Dearborn, Dearborn, Michigan, United States

Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

Henry Ford Hospital, Detroit, Michigan, United States

Ascension Saint John Hospital, Detroit, Michigan, United States

Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States

Beaumont Hospital - Farmington Hills, Farmington Hills, Michigan, United States

Genesee Cancer and Blood Disease Treatment Center, Flint, Michigan, United States

Genesee Hematology Oncology PC, Flint, Michigan, United States

Genesys Hurley Cancer Institute, Flint, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital, Livonia, Michigan, United States

William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, United States

William Beaumont Hospital - Troy, Troy, Michigan, United States

Saint John Macomb-Oakland Hospital, Warren, Michigan, United States

Huron Gastroenterology PC, Ypsilanti, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus, Ypsilanti, Michigan, United States

Minnesota Oncology - Burnsville, Burnsville, Minnesota, United States

Saint Luke's Hospital of Duluth, Duluth, Minnesota, United States

Fairview Southdale Hospital, Edina, Minnesota, United States

Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States

Regions Hospital, Saint Paul, Minnesota, United States

Saint Francis Medical Center, Cape Girardeau, Missouri, United States

Mercy Hospital Joplin, Joplin, Missouri, United States

CoxHealth South Hospital, Springfield, Missouri, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center, Lebanon, New Hampshire, United States

Roswell Park Cancer Institute, Buffalo, New York, United States

Mount Sinai Hospital, New York, New York, United States

Stony Brook University Medical Center, Stony Brook, New York, United States

Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States

Levine Cancer Institute-SouthPark, Charlotte, North Carolina, United States

Atrium Health University City/LCI-University, Charlotte, North Carolina, United States

Levine Cancer Institute-Ballantyne, Charlotte, North Carolina, United States

Southeastern Medical Oncology Center-Clinton, Clinton, North Carolina, United States

Atrium Health Cabarrus/LCI-Concord, Concord, North Carolina, United States

Levine Cancer Institute-Gaston, Gastonia, North Carolina, United States

Southeastern Medical Oncology Center-Goldsboro, Goldsboro, North Carolina, United States

Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina, United States

FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst, North Carolina, United States

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Toledo Clinic Cancer Centers-Toledo, Toledo, Ohio, United States

Cancer Centers of Southwest Oklahoma Research, Lawton, Oklahoma, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Providence Cancer Institute Clackamas Clinic, Clackamas, Oregon, United States

Providence Newberg Medical Center, Newberg, Oregon, United States

Providence Willamette Falls Medical Center, Oregon City, Oregon, United States

Providence Portland Medical Center, Portland, Oregon, United States

Providence Saint Vincent Medical Center, Portland, Oregon, United States

Smilow Cancer Hospital Care Center - Westerly, Westerly, Rhode Island, United States

Medical University of South Carolina, Charleston, South Carolina, United States

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States

UT Southwestern Simmons Cancer Center - RedBird, Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Fort Worth, Fort Worth, Texas, United States

UT Southwestern Clinical Center at Richardson/Plano, Richardson, Texas, United States

Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States

Dartmouth Cancer Center - North, Saint Johnsbury, Vermont, United States

FHCC South Lake Union, Seattle, Washington, United States

Fred Hutchinson Cancer Center, Seattle, Washington, United States

University of Washington Medical Center - Montlake, Seattle, Washington, United States

West Virginia University Healthcare, Morgantown, West Virginia, United States

Marshfield Medical Center-EC Cancer Center, Eau Claire, Wisconsin, United States

Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States

Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States

Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States

Marshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, United States

Marshfield Medical Center-River Region at Stevens Point, Stevens Point, Wisconsin, United States

Marshfield Medical Center - Weston, Weston, Wisconsin, United States

Contact Details

Name: David B Zhen

Affiliation: SWOG Cancer Research Network

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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