A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE

NCT03989323 | Recruiting

• 1 other identifier: 69HCL18_0816
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 5

Brief Summary

The number of patients affected by cancer and treated with immunotherapy is continuously increasing. With the advent of these new therapies, the investigators observe the emergence of new and unexpected toxicities. The care of patients treated with these molecules require the development of multidisciplinary skills and the introduction of a professional network capable of taking care of immunotherapy related toxicity (irAE) that can affect different organs and for which immediate and effective interventions are necessary for patient survival. IMMUCARE-BASE will comprehensively enable the collection, of clinical and biological data of patients treated with anticancer immunotherapy. The creation of this database is essential to identify clinico-biological factors predisposing to toxicity, and to define the best strategies to prevent the early onset of irAE and/or to treat them. Ultimately, the objective of this database is to collect enough data to be able to personalise in the future the immunotherapy treatment according to the benefits and to anticipate risks for each patient. The objective of the biological collection is to perform ancillary studies for understanding mechanism leading to toxicity and for the development of research programs in the field of immunotherapy.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Estimation of the incidence of immunotherapy-related toxicities (all grades, of all organs, in real life) in patients treated for the first time with anticancer immunotherapy and enrolled in the "IMMUCARE-BASE" clinical database

  Patients can be treated with immunotherapy alone, or in association with other immunotherapies, or association with chemotherapies, targeted therapies or radiotherapy. It will include all types of cancers that can be treated with immunotherapy, also including patients that are in clinical trials.

  10 years

Study Arms (1)

Patients treated with immunotherapy

Patients receiving for the first time an immunotherapy treatment for their cancer (Checkpoints inhibitors, such as PD-1 or PD-L1 or CTLA4…). Patients will be enrolled before starting the immunotherapy treatment and will be followed up for 5 years or until the permanent discontinuation of the immunotherapy treatment to describe the arm.

Other: Estimation of the incidence of the irAE

Interventions

Estimation of the incidence of the irAE OTHER

Assessment of the incidence of the irAE in patients treated with immunotherapy at the Hospices Civils de Lyon (irAE of all grades and from all organs) and creation of a biological collection of blood, plasma, serum and PBMCs from patients before treatment, under treatment and at the onset of irAEs.

Patients treated with immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with cancer and starting anticancer immunotherapy (-immune checkpoint inhibitors: anti-PD-1, anti-PD-L1, anti-CTLA4, anti-Lag-3, anti-Tim-3, anti-TIGIT or other new emerging immune checkpoint inhibitors).

You may qualify if:

• Age \> 18
• Patient starting anticancer immunotherapy treatment(immune checkpoint inhibitors like anti-PD-1, anti-PD-L1, anti-CTLA4, anti-Lag-3, anti-Tim-3, anti-TIGIT or other new anticancer immunotherapy) in monotherapy or associatied with other anticancer molecules.
• Patient who had already received immunotherapy can be eligible to IMMUCARE-BASE provided that the last immunotherapy treatment had been administered \> 6 months ago.
• Patient who received written information about IMMUCARE-BASE.
• Patient receiving immunotherapy as a part of a clinical trial can be eligible to IMMUCARE-BASE according to the indications given by the promoter of this trial.
• Patient in a clinical trial which includes a combination of therapy with one of the drugs administered in a blind manner vs placebo, can be eligible to IMMUCARE-BASE provided that (i) the treatment administered in a blind manner is not the immunotherapy and (ii) the clinical trial allows concomitant participation of a patient in another non-interventional study.
• A Patient that has been already included in IMMUCARE-BASE and who terminates the study because of a change of treatment, can be included again in IMMUCARE-BASE if he/she agrees and provided that (i) is the new treatment includes immunotherapy (alone or in association with other anticancer molecules) and (iii) the new immunotherapy treatment is administered after 6 months from the last administration of the previous immunotherapy.
• Signature of the informed consent.

You may not qualify if:

• Patient who had received immunotherapy within 6 months before entering in IMMUCARE-BASE
• Minor patient
• Pregnant women
• Patient under juridical protection
• Patient refusal to participate.
• Weight ≤ 50kg
• Patient participating in clinical trials where blood samples are taken for ancillary studies.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (5)

Hôpital L. Pradel

Bron, France

NOT YET RECRUITING

Hôpital Pierre Wertheimer

Bron, France

NOT YET RECRUITING

Hôpital de la Croix Rousse

Lyon, France

NOT YET RECRUITING

Hôpital E Herriot

Lyon, France

NOT YET RECRUITING

Centre Hospitalier LYON SUD

Pierre-Bénite, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples (36 mL) will be collected at the time of the first and second immunotherapy administrations, during routine care. In the case of grade 3 or 4 toxicities, blood samples will be collected as well at the time of irAE onset.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jonathan LOPEZ, MD

  Hospices Civils de Lyon

  STUDY DIRECTOR

Central Study Contacts

Jonathan LOPEZ, MD

CONTACT

+33 4 78 86 16 07; jonathan.lopez@chu-lyon.fr

Sara CALATTINI, PhD

CONTACT

+33 4.78.86.37.79; sara.calattini@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 18, 2019
• Study Start: July 15, 2019
• Primary Completion (Estimated): July 15, 2029
• Study Completion (Estimated): July 15, 2029
• Last Updated: July 27, 2021

Record last verified: 2021-06

Locations

FR (5)