NCT05058651|RecruitingPhase 2FDA Drug

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

Randomized Phase II/III Trial of First Line Platinum/Etoposide With or Without Atezolizumab (NSC#783608) in Patients With Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Carcinomas (NEC)

National Cancer Institute (NCI)ClinicalTrials.gov

Compare

3 other identifiers

NCI-2021-09851S2012U10CA180888

Study Type

interventional

Target

189

Locations

1 country

Sites

249

Timeline

RegisteredSep 2021

StartedJun 2022

CompletionOct 2028

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

189

participants targeted

Target at P75+ for phase_2

Timeline

28mo left

Started Jun 2022

Longer than P75 for phase_2

Geographic Reach

1 country

249 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.3 years study duration

Study Progress63%

Jun 2022Oct 2028

First Submitted

Initial submission to the registry

September 25, 2021

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed

9 months until next milestone

Study Start

First participant enrolled

June 28, 2022

Completed

6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

June 12, 2026

Status Verified

April 1, 2026

Enrollment Period

6.3 years

First QC Date

September 25, 2021

Last Update Submit

June 11, 2026

Conditions

Recurrent Extrapulmonary Neuroendocrine Carcinoma Unresectable Extrapulmonary Neuroendocrine Carcinoma Advanced Extrapulmonary Neuroendocrine Carcinoma Metastatic Extrapulmonary Neuroendocrine Carcinoma

Outcome Measures

Primary Outcomes (1)

Overall survival
Log-rank tests stratified by the randomization stratification factors will be used for null hypothesis (efficacy) tests. Cox regression models stratified by the randomization stratification factors will be used for alternative hypothesis (futility) tests.
From date of registration or from date of start of observation/maintenance therapy to date of death due to any cause, assessed up to 5 years

Secondary Outcomes (4)

Progression-free survival
From date of registration or start of observation/maintenance therapy to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 5 years
Duration of response
Time from date of initial response to date of progression or death, assessed up to 5 years
Objective response rate (confirmed complete response [CR] or partial response [PR])
Up to 5 years from study enrollment
Clinical benefit rate (confirmed CR or PR of any amount of time or stable disease for 6 months or longer)
Up to 5 years from study enrollment

Study Arms (3)

Arm I (atezolizumab, platinum drug, etoposide)

EXPERIMENTAL

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.

Biological: AtezolizumabProcedure: Biospecimen CollectionDrug: CarboplatinDrug: CisplatinProcedure: Computed TomographyDrug: EtoposideProcedure: Magnetic Resonance Imaging

Arm II (atezolizumab, platinum drug, etoposide, observation)

EXPERIMENTAL

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.

Biological: AtezolizumabProcedure: Biospecimen CollectionDrug: CarboplatinDrug: CisplatinProcedure: Computed TomographyDrug: EtoposideProcedure: Magnetic Resonance ImagingOther: Patient Observation

Arm III (platinum drug, etoposide, observation)

ACTIVE COMPARATOR

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.

Procedure: Biospecimen CollectionDrug: CarboplatinDrug: CisplatinProcedure: Computed TomographyDrug: EtoposideProcedure: Magnetic Resonance ImagingOther: Patient Observation

Interventions

AtezolizumabBIOLOGICAL

Given IV

Also known as: MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG 7446, RG-7446, RG7446, RO 5541267, RO-5541267, RO5541267, Tecentriq

Arm I (atezolizumab, platinum drug, etoposide)Arm II (atezolizumab, platinum drug, etoposide, observation)

Biospecimen CollectionPROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection