NCT07262489

Neo-adjuvant Immunotherapy Master Trial for Localized Cancers

Neo-adjuvant Adaptive Master Trial for Localized Cancers With Rapid Evaluation of Molecular & Immune Status for Stratified Immunotherapies in Oncology

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Most cancer treatments are developed without knowing whether the drug's targets are actually present in a patient's tumor or whether the patient is likely to benefit from the treatment. In addition, the immune environment surrounding the tumor changes significantly during the course of the disease, and the body's immune response to cancer tends to become less effective in later stages. Currently, standard blood tests provide only basic information about a patient's immune, inflammatory, and metabolic systems. These tests do not offer a comprehensive picture of how each person's immune system is functioning. Similarly, traditional tests on tumor samples-which require frozen or preserved tissue and take a long time to process-are not fast enough to guide treatment decisions during clinical trials. NEOREM is a "Master Protocol" which includes multiple therapeutic sub-protocols testing new immunotherapy strategies. (Immunotherapy is a type of cancer treatment that helps the immune system fight cancer.) Neoadjuvant immunotherapies are treatments given before surgery. Their goals are to shrink the tumor to make it easier to remove, strengthen the immune system's ability to fight cancer, increase the chances of long-term recovery, and reduce the risk of the cancer returning. This master protocol focuses on cancers that are still localized (have not spread) and aims to personalize treatments based on each patient's individual immuno-biological profile. As a part of this master protocol, a rapid analysis called PORTRAIT-which stands for "Profile in Onco-Immunology for a Rapid Treatment Research Adapted to Immunity and Tumor"-will be performed using fresh blood and tumor samples from each patient. This profiling uses highly sensitive and specific techniques to accurately detect biological markers that can predict how well someone will respond to immunotherapy before surgery. NEOREM's overall goal is to test new treatment strategies and new methods of selecting patients (using the PORTRAIT immune profiling) to improve the effectiveness of current standard treatments for certain types of cancer while also reducing their side effects.

Detailed description

Most cancer treatments are developed without knowing whether the drug targets are present in the tumors of patients enrolled in clinical trials or whether the patients have the tumor biology needed to benefit from such treatments. Tumor biology evolves as cancer progresses, resulting in weaker immune responses in advanced stages. Traditional tumor analyses rely on formalin-fixed, paraffin-embedded (FFPE) or frozen materials for techniques such as immunohistochemistry (IHC) or DNA/RNA sequencing, which require long turnaround times. Routine blood tests provide only basic information about a patient's immune, inflammatory, and metabolic status, without offering detailed insight into the immune system. Research shows that analyzing fresh tumor and blood samples better predicts immunotherapy responses, supports patient monitoring, and helps identify biological subgroups that may benefit from new treatments. The PORTRAIT method (Profile in Onco-Immunology for a Rapid Treatment Research Adapted to Immunity and Tumor) reduces turnaround time for biological analyses within NEOREM. It allows patients and oncologists to access relevant tumor and blood information at the molecular and cellular levels, identify appropriate treatment options, and assess treatment effects on the disease. PORTRAIT uses multicolor flow cytometry on fresh mononuclear cells from patient blood and tumor biopsies to screen for specific biomarkers. Plasma and tumor secretome are analyzed for cytokines, chemokines, and soluble factors to provide a comprehensive immune and tumor profile. This approach helps determine which patients are eligible for specific treatments within the sub-protocols. NEOREM is part of the REMISSION program, which includes a Master Protocol linked to therapeutic sub-protocols. The Master Protocol provides a unified framework to test multiple study drugs efficiently, streamline operations, optimize resources, and accelerate patient access to treatments. Its flexible design allows sub-protocols to be added or closed quickly without affecting ongoing studies, while adaptive analytics integrate evidence across studies to maximize knowledge and leverage historical data. Standardized processes, centralized data infrastructure, and consistent recruitment centers further improve safety, data quality, and operational efficiency. The goal of the NEOREM protocol is to improve cancer care by accelerating the development of neoadjuvant immunotherapy strategies. These therapies leverage pre-existing tumor-infiltrating lymphocytes (TILs) and draining lymph nodes before surgery to strengthen the antitumor immune response. Neoadjuvant therapy may downstage localized tumors, simplify surgery, achieve complete responses, sometimes eliminate the need for major procedures, improve quality of life, and reduce the risk of recurrence. PORTRAIT immunoprofiling from fresh blood and tumor samples provides a rapid and detailed description of each patient's immune profile. This enables a deeper understanding of disease biology and allows patients to be quickly stratified into the most appropriate therapeutic sub-protocol, supporting truly personalized cancer treatment.

Conditions

• Localized Cancer

Interventions

Type	Name	Description
DRUG	Each therapeutic NEOREM sub-protocol will mention the description of intervention	Each therapeutic NEOREM sub-protocol will mention the description of intervention

Timeline

• Start date: 2026-01-21
• Primary completion: 2029-11-01
• Completion: 2034-11-01
• First posted: 2025-12-03
• Last updated: 2026-02-10

Locations

1 site across 1 country: France