NCT06321640: POSITive

Study for the Multidimensional Analyses of Resistance and Toxicity to Immune- and Targeted-therapies.

Status unknown Last updated 20 March 2024

What this trial tests

trial testing Cohort A: primarily operable disease, candidate to adjuvant in Breast Cancer in 265 participants. Status unknown.

Timeline

8 July 2022

Primary endpoint
31 December 2024

31 December 2025

Quick facts

Lead sponsor	European Institute of Oncology
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	265
Start date	8 July 2022
Primary completion	31 December 2024
Estimated completion	31 December 2025
Sites	1 location across Italy

Drugs / interventions tested

• Cohort A: primarily operable disease, candidate to adjuvant
• Cohort B: locally advanced disease
• Cohort C: metastatic disease
• Cohort D: Progressive disease
• Cohort E: Hematological neoplasms
• Cohort F: Toxicity

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Lung Cancer — all drugs for Lung Cancer →
• Melanoma — all drugs for Melanoma →
• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

European Institute of Oncology

Who can join

18 and older, any sex, with Breast Cancer or Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Novel treatment modalities like targeted therapies and Immune checkpoint inhibitors have revolutionised the therapeutic landscape in oncology and hematology, significantly improving outcomes even in clinical contexts in which little improvement had been observed for decades such as metastatic melanoma, lung cancer, and lymphoproliferative neoplasms such as chronic lymphoid leukemia or Hodgkin lymphoma. However, major issues remain unsolved, given the frequent occurrence of primary or secondary resistance and the still incomplete understanding of the physiopathology of adverse events, which represent a major cause of morbidity and treatment interruption and often remain difficult to treat and diagnose. In this complex landscape, identifying the best treatment option for each patient remains challenging. For both targeted therapies and Immune checkpoint inhibitors, several biomarkers have been reported, but their implementation in clinical practice is still uncommon, and most of the decision-making process remains based on purely clinical considerations or constraints dictated by the regulatory bodies. Obstacles to biomarker-driven decision making are manifold and include insufficient understanding of the underlying biology, lack of strong evidence on their predictive power and limited tumor sampling, which may be circumvented by non-invasive techniques such as liquid biopsies.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Insights into the Relationship Between the Gut Microbiome and Immune Checkpoint Inhibitors in Solid Tumors.
   Ciernikova S, Sevcikova A, Novisedlakova M, Mego M. · · 2024 · cited 9× · PMID 39766170 · DOI 10.3390/cancers16244271
2. Immune biomarkers for head and neck cancer.
   Sobhani N, D'Angelo A, Kugeratski FG, Nguyen T, et al · · 2025 · cited 1× · PMID 41410866 · DOI 10.1007/s00262-025-04233-7
3. Immune checkpoint blockade in cancer: current insights and future horizons.
   Saman H, Makni-Maalej K, El-Ella DMA, Al-Tamimi MY, et al · · 2026 · PMID 41483376 · DOI 10.1007/s12672-025-04361-7