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Monoclonal Antibodies

Atezolizumab + Chemotherapy for Neuroendocrine Carcinoma

Phase 2 & 3
Recruiting
Led By David B Zhen
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have radiologically evaluable disease, measurable or non-measurable, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. All measurable and non-measurable lesions must be assessed by CT scan with IV contrast within 28 days prior to registration. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form
Participants must be >= 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years from study enrollment
Awards & highlights

Study Summary

This trial is comparing the effect of immunotherapy with atezolizumab in combination with standard chemotherapy versus standard therapy alone for the treatment of poorly differentiated extrapulmonary small cell neuroendocrine cancer.

Who is the study for?
This trial is for adults with advanced or metastatic extrapulmonary neuroendocrine carcinoma that's not eligible for surgery. They must have a good performance status, no prior treatments for advanced NEC (except possibly one cycle of specific chemo), and meet certain lab test criteria. People with symptomatic brain metastases, active cancers elsewhere, severe allergies to trial drugs, or certain medical conditions can't join.Check my eligibility
What is being tested?
The study compares standard chemotherapy (cisplatin/carboplatin and etoposide) alone versus adding the immunotherapy drug Atezolizumab to it in treating poorly differentiated neuroendocrine cancer outside the lung. It also looks at whether continuing Atezolizumab after initial treatment is beneficial.See study design
What are the potential side effects?
Atezolizumab may cause immune-related reactions affecting organs, infusion reactions similar to allergic responses, fatigue, and increased risk of infections. Chemotherapy can lead to nausea, hair loss, blood cell count changes increasing infection risk or bleeding tendency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be seen and measured on scans according to specific criteria.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My cancer is a type of neuroendocrine carcinoma that cannot be surgically removed or cured with current treatments.
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I will stop taking denosumab and switch to a bisphosphonate for the study.
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I have brain lesions and haven't received any treatment for them.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years from study enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years from study enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival
Secondary outcome measures
Clinical benefit rate (confirmed CR or PR of any amount of time or stable disease for 6 months or longer)
Duration of response
Objective response rate (confirmed complete response [CR] or partial response [PR])
+1 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (atezolizumab, platinum drug, etoposide, observation)Experimental Treatment8 Interventions
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. Patients also undergo CT scan and/or MRI throughout the trial and blood sample collection on study.
Group II: Arm I (atezolizumab, platinum drug, etoposide)Experimental Treatment7 Interventions
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. 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. Patients also undergo CT scan and/or MRI throughout the trial and blood sample collection on study.
Group III: Arm III (platinum drug, etoposide, observation)Active Control7 Interventions
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 also undergo CT scan and/or MRI throughout the trial and blood sample collection on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Computed Tomography
2017
Completed Phase 2
~2720
Etoposide
2010
Completed Phase 3
~2440
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Biospecimen Collection
2004
Completed Phase 2
~1730
Carboplatin
2014
Completed Phase 3
~6670
Atezolizumab
2017
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,664 Previous Clinical Trials
40,925,817 Total Patients Enrolled
David B ZhenPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05058651 — Phase 2 & 3
Neuroendocrine Carcinoma Research Study Groups: Arm I (atezolizumab, platinum drug, etoposide), Arm III (platinum drug, etoposide, observation), Arm II (atezolizumab, platinum drug, etoposide, observation)
Neuroendocrine Carcinoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05058651 — Phase 2 & 3
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05058651 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study taking place in multiple states?

"100 patients are being enrolled at this time from locations such as Kaiser Permanente-Ontario, Fred Hutchinson Cancer Research Center, and Kaiser Permanente-San Marcos. There are also 100 other enrolling sites."

Answered by AI

What other cancer drugs have been tested with Cisplatin in the past?

"Currently, there are 1655 ongoing trials concerning Cisplatin. Of these, 489 have reached Phase 3 status. Most of the research is based in Shanghai; however, there are 86449 total locations conducting studies related to Cisplatin."

Answered by AI

To what extent has Cisplatin been shown to be an effective treatment?

"Cisplatin is a medication that oncologists tend to recommend for advanced head and neck cancer. That being said, it can also be used as a last resort for sarcoma and other conditions where standard therapies have failed."

Answered by AI

Are there any open spots available for this research project?

"Yes, this is an ongoing study that originally posted on December 2nd, 2021 and is currently looking for eligible candidates. The listing was last updated on November 4th, 2022."

Answered by AI

How many people are being asked to participate in this clinical trial?

"The information available on clinicaltrials.gov supports that this study is still searching for eligible participants. The trial was posted on December 2nd, 2021 and updated November 4th, 2022. There are 100 sites enrolling a total of 189 patients in the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung
2022. "Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05058651.
~126 spots leftby Oct 2028
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