Skip to main content
Clinical Trials/JPRN-jRCTs031180013
JPRN-jRCTs031180013
Active, not recruiting
Phase 2

Phase II study Nivolumab in previously treated non-small-cell lung cancer subjects to evaluate the peripheral blood mononuclear cell immunological biomarker - IMMUNITY-ONE(NEJ029B)

Kagamu Hiroshi0 sites60 target enrollmentStarted: August 7, 2018Last updated:

Overview

Phase
Phase 2
Status
Active, not recruiting
Sponsor
Kagamu Hiroshi
Enrollment
60

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 20age old to ot applicable (—)
Sex
All

Inclusion Criteria

  • 1\.Advanced non\-small\-cell lung cancer
  • 2\.History of one regimen or more cytotoxic chemotherapy
  • 3\.Twenty years and over
  • 4\.Expect survival for more than 3 months
  • 5\.ECOG PS 0\-1
  • 6\.Having measurable leasions
  • 7\.Main organs function is maintained
  • 8\.With consent of the person or the substitute

Exclusion Criteria

  • 1\.Having history of immuno\-checkpoint\-inhibitor
  • 2\.Having history of autoimune disease
  • 3\.Having active or symptomatic interstitial lung disease
  • 4\.With infections requiring systemic treatment
  • 5\.Having symptomatic brain metastasis
  • 6\.Having poorly controlled diabetes
  • 7\.Having active liver disease
  • 8\.Having history of severe hypersensitivity
  • 9\.Patient judged inappropriate by the attending physician

Investigators

Sponsor
Kagamu Hiroshi

Similar Trials

Completed
Not Applicable
Phase II study Nivolumab in previously treated non-small-cell lung cancer subjects to evaluate the peripheral blood mononuclear cell immunological biomarkernon-small-cell lung cancer
JPRN-UMIN000028468orst East Japan Study Group(NEJSG)60
Completed
Phase 2
A single arm phase II study of Nivolumab in patients with progressive malignant pleural mesothelioma: interim biopsy analysis to determine efficacy. Acronym: NivoMes Studypleural mesothelioma10027412
NL-OMON41970Antoni van Leeuwenhoek Ziekenhuis33
Active, not recruiting
Not Applicable
ivolumab in patients with progressive malignant pleural mesothelioma: NivoMesA single arm phase II study of Nivolumab in patients with progressive malignant pleural mesothelioma: interim biopsy analysis to determine efficacy. Acronym: NivoMes StudyMedDRA version: 17.1Level: LLTClassification code 10027408Term: Mesothelioma malignant advancedSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2014-003935-20-NLStichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Active, not recruiting
Phase 1
Phase II Study of Nivolumab (Group 1) and Nivolumab plus Relatlimab (Group 2) in Patients with Locally Advanced/ Metastatic Squamous Cell Carcinoma of the Ski
CTIS2024-513637-20-00Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH61
Recruiting
Phase 2
Phase II Study of Nivolumab (Group 1) and Nivolumab plus Relatlimab (Group 2) in Patients with Locally Advanced/ Metastatic Squamous Cell Carcinoma of the Skin
2024-513637-20-00Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH61