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NCT05058651 · ClinicalTrials.gov registry record · Phase 2
Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
A Phase 2 study of Advanced Extrapulmonary Neuroendocrine Carcinoma and Metastatic Extrapulmonary Neuroendocrine Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 189
- Enrollment target
- 20
- Study locations
NCT05058651 is a Phase 2 study of Advanced Extrapulmonary Neuroendocrine Carcinoma and Metastatic Extrapulmonary Neuroendocrine Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 189 participants. The trial reports 20 study locations across 3 states.
The verdict
NCT05058651, a Phase 2 study of Advanced Extrapulmonary Neuroendocrine Carcinoma and Metastatic Extrapulmonary Neuroendocrine Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 189 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- BIOLOGICAL Atezolizumab
- DRUG Cisplatin
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Mercy Cancer Center - Elk Grove - Elk Grove
- Kaiser Permanente-Fontana - Fontana
- Palo Alto Medical Foundation-Fremont - Fremont
- Kaiser Permanente South Bay - Harbor City
- Kaiser Permanente-Irvine - Irvine
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Kaiser Permanente West Los Angeles - Los Angeles
- Memorial Medical Center - Modesto
Arizona
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
Alaska
- Alaska Women's Cancer Care - Anchorage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2022-06-28 |
| Est. Completion | 2028-10-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05058651
The ClinicalTrials.gov registry entry for NCT05058651 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 189 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Advanced Extrapulmonary Neuroendocrine Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT05058651 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Alaska.
Frequently Asked Questions
What is clinical trial NCT05058651 about?
NCT05058651 is a clinical study titled "Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung". 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)...
What is the current status of trial NCT05058651?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 189 participants. The study started on 2022-06-28. Estimated completion is 2028-10-01.
What conditions does trial NCT05058651 study?
This clinical trial studies the following conditions: Advanced Extrapulmonary Neuroendocrine Carcinoma, Metastatic Extrapulmonary Neuroendocrine Carcinoma, Recurrent Extrapulmonary Neuroendocrine Carcinoma, Unresectable Extrapulmonary Neuroendocrine Carcinoma.
What interventions are being tested in trial NCT05058651?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Atezolizumab (BIOLOGICAL), Cisplatin (DRUG).
Who is sponsoring clinical trial NCT05058651?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05058651 being conducted?
This trial has 20 study locations across Alaska, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Advanced Extrapulmonary Neuroendocrine Carcinoma
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Metastatic Extrapulmonary Neuroendocrine Carcinoma
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Alaska
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