CancerITHERNCT02840058
Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1
A study testing Biological samples and Anti PD1/PDL1 treatment in people with Cancer, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer
- What is being tested?
- Biological samples and Anti PD1/PDL1 treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 4 sitesFrance
- Study dates
- 31 Aug 2016to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
France4 sites
University Hospital of Besançon
Besançon, 25000
Institut Paoli Calmette
Marseille
Hôpital Nord Franche-Comté
Montbéliard, 25200
Hôpital Saint-Louis - APHP
Paris
About this study
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.
- Conditions
- Cancer
- Being tested
- Biological samples, Anti PD1/PDL1 treatment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplesOther
blood and tumor tissue samples
Anti PD1/PDL1 treatmentDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Biological samples; Drug: Anti PD1/PDL1 treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-telomerase specific Th1 responses
measured by ELISPOT assay
Measured: up to 12 months after the initiation of anti-PD1/PDL1 therapy
objective response rate
according to RECIST v1.1 criteria
Measured: up to 12 months after the initiation of anti-PD1/PDL1 therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start31 Aug 2016
- Primary completion23 Jul 2024
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840058
- Sponsor's protocol ID
- API/2015/58
- Acronym
- ITHER
- Status last verified
- Mar 2026
- First submitted
- 13 Jul 2016
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Anti-telomerase T CD4 Immune Responses for Predicting the Effectiveness of Immunotherapies Targeting PD1 / PDL1
- ClinicalTrials.gov ID
- NCT02840058
- Acronym / sponsor ID
- ITHER / API/2015/58
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 31 Aug 2016 (actual)
- Primary completion
- 23 Jul 2024 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biological samples | Experimental | Other: Biological samples, Drug: Anti PD1/PDL1 treatmentBlood 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological samplesblood and tumor tissue samples | Other | Biological samples |
| Anti PD1/PDL1 treatment | Drug | Biological samples |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological samples and Anti PD1/PDL1 treatment in people with Cancer, run by Centre Hospitalier Universitaire de Besancon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti-telomerase specific Th1 responses (time frame: up to 12 months after the initiation of anti-PD1/PDL1 therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.