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New treatment option for Adenocarcinoma - GEJ
Official title Watch-and-Wait Approach With Dostarlimab in Localized dMMR/MSI-H Gastric Cancer: GERCOR Phase II Study
ClinicalTrials.gov ID: NCT06059495
What this study is testing
What is Dostarlimab?
Dostarlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for adenocarcinoma - gej.
Also referred to as Jemperli.
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
- This phase II study will evaluate dostarlimab with a watch-and-wait approach for patients with localized mismatch repair deficiency (dMMR)/microsatellite instability (MSI) gastric or oeso-gastric junction adenocarcinoma. The goal of the study is to determine whether the surgery could be avoided in patients with localized dMMR/MSI-H gastric/OGJ adenocarcinoma with complete response at endoscopy and biopsies free of tumoral cells after treatment with dostarlimab, with a watch-and-wait approaches.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Capable of giving signed and dated informed consent,
- An ECOG PS of 0-1,
- ≥18 and ≤75 years old, The patient over 75 years of age is eligible only if all the following conditions are met:
- The patient's G8 questionnaire score is above 14 AND
- The patient is eligible for surgery and has no contraindications to repeated UGI endoscopy with biopsies,
You likely can't join if
- Prior concomitant unplanned antitumor therapy (e.g., chemotherapy, molecular targeted therapy, immunotherapy),
- Treatment with any investigational medicinal product within 28 days prior to study entry,
- Treatment anticoagulant or hemostasis disorder contraindicating - biopsies during endoscopy,
- Major surgical procedure within 28 days (4 weeks) prior to the first dose of study treatment,
- Other serious and uncontrolled non-malignant disease (including active infection) or is considered a poor medical risk due to a serious, uncontrolled...
- Other concomitant or previous malignancy other than the disease under study, except as noted below: i/ adequately treated in-situ carcinoma of the...
See the full eligibility criteria
Who can join
- Capable of giving signed and dated informed consent,
- An ECOG PS of 0-1,
- ≥18 and ≤75 years old, The patient over 75 years of age is eligible only if all the following conditions are met:
- The patient's G8 questionnaire score is above 14 AND
- The patient is eligible for surgery and has no contraindications to repeated UGI endoscopy with biopsies,
- Histologically proven non-metastatic gastric or OGJ adenocarcinoma cT2 to T4, Nx, M0 after computed tomography thorax-abdomen-pelvis (TAP-CT) and echo-endoscopy (EUS) according to the 7th Edition of the International...
- No peritoneal carcinomatosis (optional coelioscopy; recommended in case of doubt/ suspicious on CT/ imaging),
- No prior therapy (chemotherapy, radiotherapy, or immunotherapy) for localized gastric or OGJ adenocarcinoma,
- Tumor status confirmed to be dMMR/MSI-H as follows: \- MMR protein expression status will be evaluated by immunohistochemistry (IHC) with four antibodies (anti-hMLH1, anti-hMSH2, anti-hMSH6, anti-hPMS2) according to the...
- Hematological status: absolute neutrophil count (ANC) ≥1.5 x 109/L; platelets ≥100 x 109/L; hemoglobin ≥9 g/dL,
- Adequate renal function: serum creatinine level ≤150 μM and clearance ≥50 ml/min (Modification of the Diet in Renal Disease [MDRD] or Cockcroft and Gault),
- Adequate liver function: ≤1.5 x upper limit of normal (ULN) of direct bilirubin ≤ ULN for participants with total bilirubin levels \>1.5 x ULN (inclusion possible if known Gilbert syndrome), alkaline phosphatase \<5 x...
- International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) ≤1.5 x ULN, except for the patient on anticoagulant therapy who must have PT-INR-aPTT within therapeutic...
- Radiological tumor assessment at screening performed within 28 days before inclusion according to RECIST version 1.1 by chest, abdomen, and pelvis CT, showing the absence of metastatic or non-surgical disease,
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
- Is a woman of non-childbearing potential as defined: i/ ≥ 45 years of age and has not had menses for \>1 year, ii/ Amenorrheic for \<2 years without a hysterectomy and oophorectomy and have a follicle stimulating...
- Negative pregnancy blood test within 72 hours before the first dose of dostarlimab, AND
- If woman of childbearing potential (WOCBP), female patient must be willing to use a highly effective form of contraception from screening throughout the study treatment and 4 months after the last dose of dostarlimab,
- Male participants are eligible to participate if they agree to the following during the study treatment and for 4 months after the last dose of dostarlimab:
- Refrain from donating sperm,
- Must use contraception/barrier as follows:
- Agree to use a male condom when having sexual intercourse with a WOCBP who is not currently pregnant.
- Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person,
- Providing primary tumor tissue samples (processed as formalin-fixed, paraffin-embedded [FFPE] blocks or freshly frozen) acquired during UGI endoscopy together with images (mandatory), NB: The patient's agreement will be...
- Willingness and capablility to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study,
- Registration in a National Health Care System (PUMa - Protection Universelle Maladie included).
What rules you out
- Prior concomitant unplanned antitumor therapy (e.g., chemotherapy, molecular targeted therapy, immunotherapy),
- Treatment with any investigational medicinal product within 28 days prior to study entry,
- Treatment anticoagulant or hemostasis disorder contraindicating - biopsies during endoscopy,
- Major surgical procedure within 28 days (4 weeks) prior to the first dose of study treatment,
- Other serious and uncontrolled non-malignant disease (including active infection) or is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active infection...
- Other concomitant or previous malignancy other than the disease under study, except as noted below: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/...
- Metastases (M stage disease) whatever the location,
- Pregnancy or breastfeeding,
- Human immunodeficiency virus (HIV),
- Active hepatitis B virus (HBV, defined as having a positive hepatitis B surface antigen [HBsAg] test) or hepatitis C virus (HCV) prior to inclusion, Note: Patients with past HBV infection or resolved HBV infection...
- Patient under a legal protection regime (guardianship, curatorship, judicial safeguard) or administrative decision or incapable of giving his/her consent,
- Impossibility of submitting to the medical follow-up of the study for geographical, social, or psychiatric illness. Non-eligible to immunotherapy:
- Pyloric tumor, NB: tumors of the pylorus will be excluded because of the risk of high occlusion in case of pseudo progression and associated surgery,
- Any history of autoimmune disease including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis...
- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on...
- Any live, attenuated vaccine within 14 days prior to the firs dose of study treatment or such administration is anticipated during the study,
- Prior therapy with any immune-checkpoint inhibitors, including antibodies or drugs targeting CD137, CTLA-4, PD-1, or PD-L1 or other checkpoint pathways,
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation,
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor...
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
- Paris, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France; Paris, 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.