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Spots Global Cancer Trial Database for A Study of Intravenous (IV) Cergutuzumab Amunaleukin and Atezolizumab in Combination in Participants With Locally Advanced and/or Metastatic Solid Tumors

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Trial Identification

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

Official Title: A Phase 1b, Open-Label, Multi-Center, Dose Escalation Study of the Safety, Pharmacokinetics, and Therapeutic Activity of Cergutuzumab Amunaleukin, an Immunocytokine, Which Consists of a Variant of Interleukin 2 (IL 2v), That Targets Carcinoembryonic Antigen (CEA), and Atezolizumab, an Antibody That Targets Programmed Death-Ligand 1 (PD-L1), Administered Intravenously, in Patients With Locally Advanced and/or Metastatic Solid Tumors

Study ID: NCT02350673

Conditions

Solid Tumors

Study Description

Brief 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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Yale Cancer Center; Medical Oncology, New Haven, Connecticut, United States

Columbia Univ Med Ctr, New York, New York, United States

Memorial Sloan Kettering Cancer Center, New York, New York, United States

SCRI-Tennessee Oncology, Nashville, Tennessee, United States

University Health Network; Princess Margaret Hospital; Medical Oncology Dept, Toronto, Ontario, Canada

Herlev Hospital; Onkologisk afdeling, Herlev, , Denmark

Rigshospitalet; Onkologisk Klinik, København Ø, , Denmark

Antoni van Leeuwenhoek Ziekenhuis, Amsterdam, , Netherlands

Erasmus MC, Rotterdam, , Netherlands

Clinica Universitaria de Navarra; Servicio de oncología, Pamplona, Navarra, Spain

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain

START Madrid. Centro Integral Oncologico Clara Campal; CIOCC, Madrid, , Spain

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain

CHUV; Departement d'Oncologie, Lausanne, , Switzerland

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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