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NCT02350673 · ClinicalTrials.gov registry record · Phase 1

A Study of Intravenous (IV) Cergutuzumab Amunaleukin and Atezolizumab in Combination in Participants With Locally Advanced and/or Metastatic Solid Tumors

A Phase 1 study of Solid Tumors, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
70
Enrollment target
14
Study locations

NCT02350673 is a Phase 1 study of Solid Tumors that has completed, run by Hoffmann-La Roche. The registered enrollment target is 70 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (75% lower). The trial reports 14 study locations across 6 states.

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The verdict

NCT02350673, a Phase 1 study of Solid Tumors, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
70 participants
Enrollment target
14
Study locations

Study Summary

This is an open-label, multi-center, Phase Ib clinical study of cergutuzumab amunaleukin, in combination with atezolizumab, to investigate the safety, pharmacokinetics, and therapeutic activity in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA)-positive solid tumors, whose disease has progressed on or who are intolerant to the standard of care therapy. Enrolled participants who continue treatment will be treated until loss of clinical benefit, unacceptable toxicities, or withdrawal of consent. The study will include 2 parts: a dose-escalation Part I and a dose expansion Part II. The anticipated treatment period is 24 months for both cergutuzumab amunaleukin and atezolizumab and may be modified if emerging data suggest a benefit.

Conditions Studied

Solid Tumors

Interventions

  • DRUG Atezolizumab
  • DRUG Cergutuzumab Amunaleukin

Study Locations (14)

Other

  • Herlev Hospital; Onkologisk afdeling - Herlev
  • Rigshospitalet; Onkologisk Klinik - København Ø
  • Antoni van Leeuwenhoek Ziekenhuis - Amsterdam
  • Erasmus MC - Rotterdam
  • Hospital Univ Vall d'Hebron; Servicio de Oncologia - Barcelona
  • START Madrid. Centro Integral Oncologico Clara Campal; CIOCC - Madrid
  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia - Valencia
  • CHUV; Departement d'Oncologie - Lausanne

New York

  • Columbia Univ Med Ctr - New York
  • Memorial Sloan Kettering Cancer Center - New York

Connecticut

  • Yale Cancer Center; Medical Oncology - New Haven

Tennessee

  • SCRI-Tennessee Oncology - Nashville

Ontario

  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept - Toronto

Navarre

  • Clinica Universitaria de Navarra; Servicio de oncología - Pamplona

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2015-06-29
Est. Completion 2019-12-16
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT02350673

The ClinicalTrials.gov registry entry for NCT02350673 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (75% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which Atezolizumab is the first listed.

NCT02350673 reports 14 study locations spanning 6 distinct geographic areas - top geographies include Other, New York, Connecticut.

Frequently Asked Questions

What is clinical trial NCT02350673 about?

NCT02350673 is a clinical study titled "A Study of Intravenous (IV) Cergutuzumab Amunaleukin and Atezolizumab in Combination in Participants With Locally Advanced and/or Metastatic Solid Tumors". This is an open-label, multi-center, Phase Ib clinical study of cergutuzumab amunaleukin, in combination with atezolizumab, to investigate the safety, pharmacokinetics, and therapeutic activity in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA)-positive solid tumo...

What is the current status of trial NCT02350673?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2015-06-29. Estimated completion is 2019-12-16.

What conditions does trial NCT02350673 study?

This clinical trial studies the following conditions: Solid Tumors.

What interventions are being tested in trial NCT02350673?

The interventions under investigation include: Atezolizumab (DRUG), Cergutuzumab Amunaleukin (DRUG).

Who is sponsoring clinical trial NCT02350673?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02350673 being conducted?

This trial has 14 study locations across Connecticut, New York, Tennessee, Ontario, Navarre. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.