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RECRUITING
NCT05058651
PHASE2/PHASE3

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

189

Start Date

2022-06-28

Completion Date

2028-10-01

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

Atezolizumab

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

PROCEDURE

Computed Tomography

Undergo CT scan

DRUG

Etoposide

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

OTHER

Patient Observation

Undergo observation

Locations (265)

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Mayo Clinic Hospital in Arizona

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 South Bay

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

Sutter Pacific Medical Foundation

Santa Rosa, California, United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

AdventHealth Porter

Denver, Colorado, United States

AdventHealth Littleton

Littleton, Colorado, United States

AdventHealth Parker

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

Mayo Clinic in Florida

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, 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

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, United States

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, United States

Pali Momi Medical Center

‘Aiea, Hawaii, United States

The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Rush-Copley Medical Center

Aurora, Illinois, 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

SSM Health Good Samaritan

Mount Vernon, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

Carle BroMenn Medical Center

Normal, Illinois, United States

Carle Cancer Institute Normal

Normal, 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

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

And 165 more locations on ClinicalTrials.gov