Resectable solid tumors with mismatich repair deficient (excluding colorectal cancer)
Conditions
Interventions
Dostarlimab (500 mg/body) administered over 9 cycles, with each cycle lasting 3 weeks
Sponsors
Oki Eiji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histopathologically diagnosed malignancy (excluding colorectal cancer). 2.Mismatch repair deficiency (dMMR/MSI-H) is found in tissue or blood specimens. 3.Age 18 years or older at the time of enrollment. 4.Curative local treatment using an endoscope, cystoscope, or any other method is not expected. 5.Locally advanced solid tumors that are curable by surgical resection, radiotherapy, or Chemoradiotherapy. 6.Eligible clinical stages are those indicated for surgical resection, definitive radiotherapy, or definitive chemoradiotherapy according to the TNM Classification 8th Edition for each cancer type. While the following stages serve as a general guide for each cancer type, there are no strict stage restrictions as long as the above criteria are met. 7.Written consent to participate in the study has been obtained from the patient. 8.Patients with an ECOG Performance Status (PS) of 0 or 1 at enrollment. 9.For women of childbearing potential (including patients not menstruating due to medical reasons such as chemical menopause), it is required that patients, from the time consent is obtained, agree to dual contraception for at least 5 months after the last dose of dostarlimab and to refrain from egg donation (including the harvest of eggs for personal use). Patients also agreed not to breastfeed for at least 5 months after the last dose of dostarlimab, starting from the time consent was obtained. 10.For male patients, those who have consented to dual contraception and sperm donation restrictions from the time of consent acquisition until at least 7 months after the final administration of Dostarlimab. 11.Patients with adequate organ function at the time of enrollment,however.
Exclusion criteria
Exclusion criteria: 1.Patients with distant metastatic disease 2.Clinical diagnosis of carcinoma in situ or intramucosal carcinoma. 3.Patients diagnosed with active multiple cancer (concurrent multiple cancer and multiple cancer with a disease-free interval of 2 years or less from the time of enrollment). 4.Patients with a history of inflammatory bowel disease. 5.Patients with a history of pulmonary inflammation or interstitial lung disease. 6.Patients with concomitant autoimmune disease or a history of chronic or recurrent autoimmune disease. 7.Systemic therapy with corticosteroids or immunosuppressive agents is required. Substitution therapy (corticosteroid replacement at physiologic doses for adrenal or pituitary insufficiency) does not constitute systemic therapy. 8.Patients with an active infection requiring systemic steroid therapy within 1 week prior to the enrollment. 9.Patients with scirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice. 10.Patients with any of the following events with previous immunotherapy: Grade 3 or higher immune-related adverse events (irAEs), severe immune-related neurological events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barre syndrome, or myelitis transverse), exfoliative dermatitis of any grade (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), or myocarditis of any grade. 11. Patients with a history or findings of cardiovascular given risk factors within 6 months prior to registration. 12.Patients with loss of control of diabetes or other conditions that may interfere with toxicity assessment. 13.Patients with positive HIV-1 and HIV-2 antibody tests, HTLV-1 antibody test, HBs antigen test, or HCV antibody test. In addition, patients with a negative HBs antigen test but a positive HBs antibody test or HBc antibody test and an HBV-DNA titer above the detection sensitivity. Furthermore, if the HCV antibody test is positive but the HCV-RNA is negative, enrollment is acceptable. 14.Pregnant, lactating, or possibly pregnant patients. 15.Patients suffering from a serious or unstable psychiatric or other medical condition that may interfere with the subject's safety, obtaining consent, or compliance with study procedures. 16.Patients previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4, or other antibodies or drug therapies for T-cell control. 17.Patients who received live or attenuated vaccination within 28 days prior to enrollment in this study. 18.Patients who are unwilling or unable to comply with the procedures specified in the study protocol. 19.Patients who are judged by the investigator to be unsuitable for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-months cCR rate | — |
Secondary
| Measure | Time frame |
|---|---|
| cCR rate 24-month cCR rate Dostarlimab monotherapy completion rate Event-free survival Progression-free survival Disease-free survival Overall survival Distant metastasis-free survival Local recurrence-free survival Recurrence lesion Local regrowth rate Time to local regrowth Rate of adverse events as determined by CTCAE ver. 5.0 | — |
Contacts
Public ContactHiroshi Miyamoto
FIVERINGS CO.,LTD.
Outcome results
None listed