Neo-adjuvant Immunotherapy Master Trial for Localized Cancers
ConditionLocalized Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorUNICANCER
About this trial
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.
Eligibility criteria
Qualifiers
Age≥ 12 years with at least 40kg body weight or otherwise as per specified in sub-protocol.
Prior to the inclusion in the NEOREM master protocol, patients must have signed a written informed consent to baseline PORTRAIT profiling.
When the patient is physically unable to give his/her written consent, a trusted person of his/her choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent.
For patients aged between > 12 and < 18, specific consent from legal tutors should be obtained on top of the minor consent and prior procedures.
Disqualifiers
Cancer patients with advanced stages and/or distant metastasis (unless curable oligometastatic disease). Some sub-protocols could enroll patients with loco-regional (N+) stages amenable to curative intention strategies.
Any life-threatening allergy to one of the experimental products tested in the sub-protocol where the patient is eligible. In case of allergy to contrast media, patient monitoring should be performed with alternate methods (both CT-scan or MRI).
History of life threatening autoimmune/immune mediated inflammatory disease, including but not limited to severe colitis, pneumonitis, Guillain-Barré syndrome, anti-phospholipid syndromes and myocarditis. Patients with a history of auto-immune endocrinopathy (hypo/hyper thyroiditis, type 1 diabetes mellitus, …) and who are stable on hormone replacement therapy are eligible for the study. Patients with a history of vitiligo, alopecia areata, cutaneous psoriasis and grade 1-2 Sjogren syndrome are eligible.
Treatment with systemic long-term immunosuppressive medications unless otherwise specified in the specific therapeutic sub-protocols. Those immunosuppressive drugs must have been stopped at least 4 weeks prior to enrolment. Hormone replacement therapy with physiological doses of hydrocortisone is acceptable.
Trial design
Treatments tested in this trial
- Each therapeutic NEOREM sub-protocol will mention the description of intervention
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov