Autoantibodies in Treatment with Immune Checkpoint Inhibitors (AUTENTIC)

NCT03868046 | Completed

• 1 other identifier: PI2018106 (EPA-SP)
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the effectiveness of a battery of autoantibodies to predict the occurrence of immune-related adverse events (irAEs) in patients with cancer who will be treated with immune checkpoint inhibitors (ICIs) per standard protocol.

Conditions

Cancer; Metastatic Cancer; Solid Organ Cancer

Keywords

Immune-related Adverse Events; Immune Checkpoint Inhibitors; Biomarkers; Autoantibodies

Outcome Measures

Primary Outcomes (1)

• Incidence of irAEs.

  An irAE was defined as any symptom, sign, syndrome or disease attributable to an immune activation mechanism during an ongoing treatment with an ICI or a combination of ICIs, provided that an infectious cause and/or tumor progression have been ruled out.

  At 48 weeks from the initiation of ICIs.

Secondary Outcomes (4)

• irAE-free survival.

  At 24 weeks and at 48 weeks from the initiation of ICIs.

• Progression-free survival.

  At 24 weeks and at 48 weeks from the initiation of ICIs.

• Overall survival.

  At 24 weeks and at 48 weeks from the initiation of ICIs.

• Incidence of development of autoantibodies.

  At 24 weeks and at 48 weeks from the initiation of ICIs.

Study Arms (1)

Patients treated with ICIs.

All enrolled patients must have been diagnosed with a cancer potentially treatable with ipilimumab, nivolumab, pembrolizumab, atezolizumab or avelumab, alone or in combination, per standard protocol.

Drug: Treatment with immune checkpoint inhibitors.; Diagnostic Test: Blood tests.

Interventions

Treatment with immune checkpoint inhibitors. DRUG

Treatment with approved immune checkpoint inhibitors, namely ipilimumab, nivolumab, pembrolizumab, atezolizumab and avelumab, alone or in combination, administered per standard protocol.

Patients treated with ICIs.

Blood tests. DIAGNOSTIC_TEST

Patients will undergo ordinary blood tests obtained at specific moments predefined per protocol and extraordinary blood tests at the time of the detection of an eventual irAE.

Patients treated with ICIs.

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with cancer amenable to treatment with ICIs will be considered eligible. Potential candidates will be identified and consecutively included in the oncology outpatient clinics of five university hospitals in Spain.

You may qualify if:

• Initiation of treatment with a single ICI or a combination of ICIs.
• Acceptation of an informed consent.

You may not qualify if:

• Life expectancy lower than 3 months from the initiation of treatment with ICIs.
• Proven hypersensitivity or previous allergic anaphylactic reaction induced by a specific ICI.
• Active autoimmune disease with severe involvement.
• Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3.
• Ongoing immunosuppressive therapy: prednisone at doses \>10 mg/day or equivalent (\>1.5 mg/day of dexamethasone), and/or any dose of azathioprine, methotrexate, mycophenolate, cyclophosphamide, leflunomide, rituximab, anti-tumor necrosis factor drugs (infliximab, etanercept, adalimumab, golimumab), belimumab and abatacept.

Sponsors & Collaborators

• Hospital Universitario Araba: lead
• Hospital de Basurto: collaborator
• Hospital Donostia: collaborator
• Complejo Hospitalario de Navarra: collaborator
• Hospital Galdakao-Usansolo: collaborator

Study Sites (1)

Hospital Universitario Araba

Vitoria-Gasteiz, Álava, 01009, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and white cells (buffy coat).

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Interventions

Therapeutics; Immune Checkpoint Inhibitors; Hematologic Tests

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Iñigo Les Bujanda, MD PhD

  Hospital Universitario Araba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 8, 2019
• Study Start: August 25, 2019
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)