SYSTEMATIC SYMPTOM ASSESSMENT IN CANCER PATIENTS TREATED WITH IMMUNE CHECKPOINT INHIBITORS (IRMA)

University Of Perugia

Status: Not yet enrolling

Conditions: Melanoma; Lung Cancer

Treatments: Other: Systematic symptom assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04929353

IRMA

Details and patient eligibility

About

Immune-related adverse events (irAEs) can be different in their onset, kinetics and presentation but unlike chemotherapy are seldom predictable. Toxicity can affect nearly any organ system and multiple presentations of rare but severe irAEs have been reported, highlighting the relevance of vigilant monitoring.

Although early detection and timely management of high grade or special interest irAEs (such as cardiac and neurological) is obvious, it is unclear whether early identification of less serious events can lead to clinical benefit. Furthermore, it is of the utmost importance to develop new tools which can increase identification of side effects. The current study investigates systematic symptom assessment through an electronic patient reported outcome tool and aims to define whether this can reduce the rate of serious irAEs.

Full description

Systematic collection of symptom information during immunotherapy treatment will be compared to usual care in locally advanced or metastatic lung cancer (NSCLC or SCLC) and surgically resected or advanced melanoma. Electronic survey will be administered every other day to report 14 common symptoms selected from the NCI-PRO-CTCAE TM library developed by the NATIONAL CANCER INSTITUTE (NATIONAL INSTITUTES OF HEALTH, Bethesda, Maryland) Italian version (NCI-PRO-CTCAETM ITEMS-ITALIAN-Item Library Version 1.0).

Enrollment: 280 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old at time of signing Informed Consent Form

• Histologically documented diagnosis of locally advanced or metastatic lung cancer (NSCLC or SCLC), surgically resected or advanced melanoma

• Patients eligible for immunotherapy in any line of treatment, either alone or in combination with other immunotherapy drugs or with chemotherapy

• Signed Informed Consent Form

• Life expectancy ≥3 months

• ECOG Performance Status of ≤2

• Adequate hematologic and end-organ function, defined by laboratory test result by investigator's judgment

• Viral hepatitis screening:

  1. Negative hepatitis B surface antigen (HBsAg) test
  2. For patients with positive total HBcAb test, hepatitis B virus (HBV) DNA test is required
  3. For patients with positive HCV antibody test, hepatitis C virus (HCV) RNA test is required

Exclusion criteria

• Patients receiving immunotherapy at time of enrollment
• > 1 grade adverse events from previous treatments
• Any uncontrolled symptom
• Clinically unstable brain metastases (i.e., symptomatic, not treated with RT and rapidly evolving)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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280 participants in 2 patient groups

ARM A

Other group

Description:

Self-Reporting by electronic survey consisting of 14 items selected by the NCI-PRO-CTCAE TM ITEMS-ITALIAN (Item Library Version 1.0)

Treatment:

Other: Systematic symptom assessment

Arm B

Other group

Description:

Standard symptom reporting following the conventional modalities of clinical oncology practice

Treatment:

Other: Systematic symptom assessment