Actively Recruiting
Neo-adjuvant Immunotherapy Master Trial for Localized Cancers
Led by UNICANCER · Updated on 2026-02-10
200
Participants Needed
1
Research Sites
458 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neo-adjuvant Immunotherapy Master Trial for Localized Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older with at least 40kg body weight or as specified in sub-protocol
- Signed written informed consent for baseline PORTRAIT profiling
- Localized solid cancer eligible for neoadjuvant therapy with unmet medical needs for survival or quality of life
- At least one measurable tumor lesion according to RECIST v1.1 criteria
- ECOG performance status between 0 and 2
- Ability to undergo blood draws and tumor biopsies
- Adequate organ function based on bilirubin, ALT, neutrophil count, platelets, hemoglobin, albumin, and creatinine clearance
- Women of childbearing potential must have a negative pregnancy test within 7 days before treatment
- Agreement to use two effective contraception methods or abstain from sexual activity during the study and specified period after treatment
- Affiliation with French social security
- Mental and legal ability to consent for procedures and treatment
- Willingness and ability to comply with study protocol and visits
You will not qualify if you...
- Advanced cancer with distant metastasis (except some curable oligometastatic cases)
- Life-threatening allergy to experimental products in the study
- History of severe autoimmune or immune-mediated inflammatory diseases (except stable autoimmune endocrinopathies and some mild autoimmune conditions)
- Use of long-term systemic immunosuppressive medications within 4 weeks before enrollment
- Recent chemotherapy, hormone therapy, radiotherapy, immunotherapy, or targeted therapy within 4 weeks or 5 half-lives before study treatment
- Live attenuated vaccine within 4 weeks before enrollment
- Radiotherapy to target lesion unless progression documented
- Ongoing treatment-related toxicity from prior therapies affecting safety or efficacy
- Tumors near major blood vessels at high risk of bleeding or perforation
- Use of other investigational drugs or participation in another trial within 4 weeks before or during study
- Recent major injuries or surgery with incomplete healing or planned surgery during treatment
- Recent significant bleeding or clotting events within 3 months
- Significant cardiovascular diseases or uncontrolled endocrine disorders
- Other malignancies within 5 years except certain treated local cancers
- Active serious infections requiring antibiotics or antimicrobial therapy
- Gastrointestinal conditions interfering with drug absorption
- Pregnancy or breastfeeding
- Use of Ganoderma Lucidum mushroom or herbal remedies prior or during study
- Psychological, social, behavioral, or medical factors that may interfere with study participation
- Active alcoholism or drug abuse
- Persons deprived of liberty or under guardianship or protective custody
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
Research Team
P
Priyanka DEVI-MARULKAR, PhD, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SCREENING
Number of Arms
1
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