Elderly Cancer PatIents, Safety and qualiTy of Life Under immunOtheraPies (EPITOP-01)

Institut Paoli-Calmettes

Status and phase: Terminated; Phase 4

Conditions: Advanced or Metastatic NSCLC; Advanced or Metastatic Melanoma

Treatments: Drug: immune-checkpoint inhibitors therapies

Study type: Interventional

Funder types: Other

Identifiers

NCT03673332

EPITOP-01-IPC 2017-049

2018-002092-18 (EudraCT Number)

Details and patient eligibility

About

The co-primary objectives will be to assess the safety and quality of life under treatment.

Full description

The co-primary objectives will be to assess the safety and quality of life under treatment. Secondary objectives will be evaluations of geriatric data modifications under treatment, efficacy (progression-free survival and overall survival), correlation between toxicity and efficacy, and comparison of the safety profiles between various immunotherapy regimens.

Another secondary objective will be the comparison between patients and clinicians symptom reporting. The investigators will also perform a pharmacokinetics analysis on PD1-monoclonal antibodies to improve the understanding of PD-1 inhibitors pharmacokinetics for the elderly population.

Finally, toxicity and efficacy will be compared to immunological parameters such as the description of tumor infiltrating lymphocytes, markers of immunosenescence and inflammation.

Enrollment: 40 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients eligible to start a treatment including immune checkpoint inhibitors (Nivolumab, Ipilimumab, Pembrolizumab, and so on…)
• Diagnosis of advanced or metastatic melanoma or NSCLC (All treatment lines will be allowed)
• Age ≥ 70 years
• Having personally signed and dated informed consent
• Patient affiliated to the ''National security'' regimen or beneficiary of this regimen

Exclusion criteria

• Immune checkpoint inhibitor therapy initiated before study enrolment
• Concomitant participation in other investigational clinical trials involving an immune checkpoint inhibitor
• Immune checkpoint inhibitor treatment in a context of other solid tumours
• Immune checkpoint inhibitor treatment in a context of haematological malignancies
• Being unable or unwilling to comply with the requirements of the protocol, as assessed by the investigator
• Patient in urgency situation, adult under legal protection, or unable to give his consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

treatment including immune checkpoint inhibitors

Experimental group

Description:

All patients included in this study will receive approved immune-checkpoint inhibitors therapies, such as CTLA-4, PD-1, and PD-L1 inhibitors.

Treatment:

Drug: immune-checkpoint inhibitors therapies