NCT02880046

Brief Summary

Purposes of this study are :

  • Characterization of polyfunctionality of anti-tumor T lymphocytes using in vitro inhibition of PD-1/PDL-1 pathway
  • Study and comparison of polyfunctionality of anti-tumor T lymphocytes in cohorts of patients with melanoma, lung cancer and renal carcinoma. This cancers are chosen because of use of anti-PD-1 or anti-PDL-1 antibodies
  • Comparison of this technique with IFN-γ Elispot assay for detection and quantification of anti-tumor T lymphocytes after in vitro blockade of PD-1/PDL-1 pathway.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

August 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

August 23, 2016

Last Update Submit

August 25, 2016

Conditions

Cancer

Keywords

immune responseT lymphocytePD-1/PDL-1 pathway

Outcome Measures

Primary Outcomes (1)

  • Polyfunctionality of universal cancer peptides (UCP) and/or survivin-specific responses of T lymphocytes in presence of anti-PDL-1 antibody or isotype control, evaluated with flow cytometry

    Inclusion

Secondary Outcomes (3)

  • Polyfunctionality of UCP and/or survivin-specific responses of T lymphocytes in each cohort

    Inclusion

  • Amplitude of UCP and/or survivin-specific responses of T lymphocytes in presence of anti-PDL-1 antibody or isotype control

    Inclusion

  • Amplitude of UCP and/or survivin-specific responses of T lymphocytes evaluated with flow cytometry or IFN-γ Elispot assay

    Inclusion

Study Arms (3)

Melanoma (LyteloMel)

Lung cancer (TeloCap)

Renal carcinoma (EMIR)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Frozen samples from patients affected by melanoma (LyteloMel), lung cancer (TeloCap) or renal carcinoma (EMIR) from cohorts of medical oncology department of CHRU Besançon (France).

You may qualify if:

  • Patients affected by melanoma (LyteloMel), lung cancer (TeloCap) or renal carcinoma (EMIR) from cohorts of medical oncology department of CHRU Besançon (France)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Frozen PBMC

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Marcelo DE CARVALHO BITTENCOURT, Pr

    Laboratoire d'immunologie - CHRU Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcelo DE CARVALHO BITTENCOURT, Pr

CONTACT

m.decarvalho@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 26, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

August 26, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share