---
title: Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1
nct_id: NCT02840058
overall_status: COMPLETED
phase: NA
sponsor: Centre Hospitalier Universitaire de Besancon
study_type: INTERVENTIONAL
primary_condition: Cancer
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02840058.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02840058"
ct_last_update_post_date: 2026-03-06
last_seen_at: "2026-05-12T06:44:02.413Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1

**NCT ID:** [NCT02840058](https://clinicaltrials.gov/study/NCT02840058)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 295
- **Lead Sponsor:** Centre Hospitalier Universitaire de Besancon
- **Conditions:** Cancer
- **Start Date:** 2016-08-31
- **Completion Date:** 2025-07-15
- **CT.gov Last Update:** 2026-03-06

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Biological samples** (EXPERIMENTAL) — 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.

## Interventions

- **Biological samples** (OTHER) — blood and tumor tissue samples
- **Anti PD1/PDL1 treatment** (DRUG)

## Primary Outcomes

- **anti-telomerase specific Th1 responses** _(time frame: up to 12 months after the initiation of anti-PD1/PDL1 therapy)_ — measured by ELISPOT assay
- **objective response rate** _(time frame: up to 12 months after the initiation of anti-PD1/PDL1 therapy)_ — according to RECIST v1.1 criteria

## Locations (4)

- University Hospital of Besançon, Besançon, France
- Institut Paoli Calmette, Marseille, France
- Hôpital Nord Franche-Comté, Montbéliard, France
- Hôpital Saint-Louis - APHP, Paris, France

## Recent Field Changes (last 30 days)

- `locations.hôpital saint-louis - aphp|paris||france` — added _(2026-05-12)_
- `locations.hôpital nord franche-comté|montbéliard||france` — added _(2026-05-12)_
- `locations.institut paoli calmette|marseille||france` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university hospital of besançon|besançon||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02840058.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02840058*  
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