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Monoclonal Antibodies

Atezolizumab + Standard Chemotherapy for Neuroendocrine Carcinoma

Cancer Center at Saint Joseph's, Phoenix, AZ

Targeting 4 different conditionsCisplatin +7 morePhase 2 & 3RecruitingLed by David B ZhenResearch 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 have histologically-confirmed (local site pathological confirmation sufficient) extrapulmonary poorly differentiated, neuroendocrine carcinoma (NEC) that is unresectable or metastatic and not eligible for definitive therapy as deemed per the treating investigator

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 5 years from study enrollment

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Neuroendocrine Carcinoma
Extrapulmonary Neuroendocrine Carcinoma

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

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You must have a disease that can be seen on a CT scan with IV contrast, and the scan must have been done within the last 28 days before joining the study. All the spots of the disease must be checked and recorded.

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You have a confirmed diagnosis of a specific type of advanced cancer that cannot be removed by surgery or treated with definitive therapy.

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You had a certain type of cancer that was treated with specific therapies at least 6 months ago.

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You need to have certain blood and liver tests done to make sure you are healthy enough to participate in the study.

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You need to have a brain scan if your doctor thinks it's necessary, but you don't need it if there are no signs of brain tumors and you're feeling fine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years from study enrollment

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] and 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

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Cerebral infarction

Ischaemic stroke

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Etoposide

2010

Completed Phase 3

~2440

Magnetic Resonance Imaging

2017

Completed Phase 3

~1250

Cisplatin

2013

Completed Phase 3

~1940

Computed Tomography

2017

Completed Phase 2

~2890

Biospecimen Collection

2004

Completed Phase 1

~1540

Carboplatin

2014

Completed Phase 3

~6670

Atezolizumab

2016

Completed Phase 3

~6040

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,489 Previous Clinical Trials

41,266,486 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 II (atezolizumab, platinum drug, etoposide, observation), Arm III (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.

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