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Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1 (ITHER)

C

Centre Hospitalier Universitaire de Besancon

Status

Unknown

Conditions

Cancer

Treatments

Drug: Anti PD1/PDL1 treatment
Other: Biological samples

Study type

Interventional

Funder types

Other

Identifiers

NCT02840058
API/2015/58

Details and patient eligibility

About

Recent scientific advances have shown the important role of immune system against cancer. Today, many immunological biotherapy like anti-PD1/PDL-1 are available in cancer treatment and generate durable clinical responses in some patients. The development of tools for monitoring anti-tumor immune responses dynamically is a major challenge to predict the effectiveness of immunotherapies anti-PD-1 and anti-PDL-1.

Thus, the objective of our study is to analyse the interest of the monitoring of anti-telomerase T helper 1 (TH1) responses in predicting the efficacy of immunotherapy, using an immunoassay developed by our group.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient with metastatic or locally advanced cancer candidate to anti-PD1/PDL1 immunotherapy
  • Performance status 0, 1 or 2 on the ECOG scale
  • Written informed consent

Exclusion criteria

  • Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
  • Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
  • Active autoimmune diseases, HIV, hepatitis C or B virus
  • Patients with any medical or psychiatric condition or disease,
  • Patients under guardianship, curatorship or under the protection of justice.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

Biological samples
Experimental group
Description:
Blood samples will be realized specifically to the study at inclusion (baseline before starting anti PD1/PDL1 treatment), and then 1 month, 3 months and 12 months after initiation of anti-PD1/PDL1 treatment. Peripheral blood mononuclear cells (PBMC) and plasma will be collected. Available tumor tissues will be collected.
Treatment:
Other: Biological samples
Drug: Anti PD1/PDL1 treatment

Trial contacts and locations

1

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Central trial contact

Laura MANSI, Dr; Christophe BORG, Pr

Data sourced from clinicaltrials.gov

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