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New treatment option for Gastric Cancer
Official title Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas
ClinicalTrials.gov ID: NCT06346197
What this study is testing
What is Balstilimab?
Balstilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- CIME is a multicenter, randomised, comparative, open-label phase III study aiming to compare the survival of patients suffering from MSI-H/dMMR locally advanced or metastatic oeasogastric adenocarcinoma treated by a bi-immunotherapy (experimental arm) versus standard current treatment (FOLFOX/XELOX + nivolumab : standard arm).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female patient ≥18 years of age at time of informed consent form signature.
- Patient with MSI-H/dMMR, HER2 negativeadvanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express...
- Patient to be treated with a first line therapy for locally advanced/metastatic disease.
- No prior treatment with chemotherapy for locally advanced/metastatic disease. o Note - adjuvant or neoadjuvant chemotherapy is allowed providing that...
- Measurable disease (outside any previous irradiated field within the past 6 months) defined as at least one unidimensional lesion that can be...
You likely can't join if
- Oesogastric cancer eligible to treatment with curative intent
- Patients previously treated by anti-PD-1, anti-PD-L1, or anti-CTLA-4 or any other immunotherapy
- Patients with surgery or radiotherapy within less than 4 weeks before C1D1
- Patients with persistent AE Grade \>1 related to previous anti-cancer treatment, except alopecia (all grades), laboratory value according to criteria...
- Patients with: hypokalemia, hypomagnesemia, hypocalcemia less than normal
- Patients with known prolongation QT/QTc interval i.e. QT/QTc interval longer than 450 msec for men and longer than 470 msec for women according to...
See the full eligibility criteria
Who can join
- Male or female patient ≥18 years of age at time of informed consent form signature.
- Patient with MSI-H/dMMR, HER2 negativeadvanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5. Note :The claudin...
- Patient to be treated with a first line therapy for locally advanced/metastatic disease.
- No prior treatment with chemotherapy for locally advanced/metastatic disease. o Note - adjuvant or neoadjuvant chemotherapy is allowed providing that 6 months have relapsed between completion of adjuvant chemotherapy...
- Measurable disease (outside any previous irradiated field within the past 6 months) defined as at least one unidimensional lesion that can be accurately measured as ≥ 10 mm with CT scan according to RECIST V1.1...
- Note: Lesions intended to be biopsied should not be defined as target lesions.
- Note: previously irradiated lesions can be selected as target lesion only if recurrence/PD is documented after RT.
- Patient with PS ECOG 0 or 1 (Appendix 02).
- Adequate hematologic and end-organ function, defined by the following laboratory test results: Absolute neutrophil count ≥ 1.5 109/L (without growth factor support within 14 d) Platelets ≥ 100 109/L (without transfusion...
- Availability of a representative formalin-fixed paraffin-embedded (FFPE) sample of the primary or metastatic tumor tissue (resection or biopsy) with an associated pathology report must be available. This tumor sample...
- Tumor lesion visible by medical imaging and accessible to repeatable percutaneous or endoscopic sampling that permits core needle biopsy without unacceptable risk of a significant procedural complications, and suitable...
- Note 1: Fine needle aspirates, bone biopsies do not satisfy the requirement for tumor tissue.
- Note 2: Tumor lesions used for biopsy should not be lesions used as RECIST 1.1 target lesions unless there are no other lesions suitable for biopsy. If a RECIST target lesion is used for biopsy, the lesion must be ≥ 2...
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at the Screening Visit (within 72 hours of first dose of study drugs) and must agree to use highly effective contraceptive measures...
- 9 months after the end of the treatment with oxaliplatin
- 6 months after the end of the treatment with fluorouracil
- 5 months after the end of the treatment with nivolumab or botensilimab or Balstilimab
- 6 months for capecitabine
- Highly effective contraception is defined in Appendix 03. Note Non-childbearing potential is defined as:
- ≥ 50 years of age and has not had menses for greater than 1 year.
- Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation.
- Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation.
- Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 6 months after the end of the...
- Patient should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed and should be able and willing to comply with study visits and procedures as per...
- Patients must be covered by a medical insurance.
What rules you out
- Oesogastric cancer eligible to treatment with curative intent
- Patients previously treated by anti-PD-1, anti-PD-L1, or anti-CTLA-4 or any other immunotherapy
- Patients with surgery or radiotherapy within less than 4 weeks before C1D1
- Patients with persistent AE Grade \>1 related to previous anti-cancer treatment, except alopecia (all grades), laboratory value according to criteria I7.
- Patients with: hypokalemia, hypomagnesemia, hypocalcemia less than normal
- Patients with known prolongation QT/QTc interval i.e. QT/QTc interval longer than 450 msec for men and longer than 470 msec for women according to the inclusion ECG.
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. Note: Asymptomatic patients with treated CNS lesions are eligible, provided that all of the following criteria are met:
- Measurable disease, per RECIST v1.1, must be present outside the CNS.
- The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.
- Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).
- There is no evidence of interim progression between completion of CNS-directed therapy and initiation of study treatment.
- The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, neurosurgical resection...
- The patient has no ongoing requirement for corticosteroids as therapy for CNS disease. Anticonvulsant therapy at a stable dose is permitted. A minimal wash-out period of 10days for corticosteroids is required.
- Patients with other malignancy unless this malignancy is not expected to interfere with the evaluation of study endpoints (basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, localized...
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- of ILD or non-infectious pneumonitis requiring glucocorticoids.
- History of allogeneic organ transplant.
- Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Patient with peripheral sensory neuropathy with functional impairment.
- Patients with clinically significant active heart disease or myocardial infarction within 6 months, history of uncontrolled or symptomatic cardiac disease.
- Patient with recent (within 7d before C1D1) or concomitant treatment with brivudine.
- Patient with complete absence of dihydropyrimidine dehydrogenase (DPD) activity (blood uracil level ≥ 150 ng/mL) or partial deficit in DPD (i.e. blood uracil level between ≥ 16 ng/ml and \< 150 ng/mL)
- Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study...
- Patient with Live vaccines injection within 4 weeks before C1D1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza...
- Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).
- History or current evidence of any condition, co-morbidity, therapy, any active infections, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full...
- Patients with documented:
- Active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) unless their HBV is stably controlled on nucleoside analogs (eg entecavir or tenofovir) which...
- Active hepatitis C. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA, or
- HIV infection
- Prior organ or bone marrow transplant.
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Brest, France
- Clermont-Ferrand, France
- Lyon, France
- Marseille, France
- Paris, France
- Poitiers, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brest, France; Clermont-Ferrand, France; Lyon, France; Marseille, France; Paris, France; Poitiers, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.