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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: David B Zhen
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR