Rare cancers with MSI-low or pMMR
Conditions
Sponsors
Kan Yonemori, National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients diagnosed with rare cancers or rare histological subtype of a common cancer 2)Patients who have a cancer type that nivolumab is not approved for. 3)Diagnosed as pMMR or MSI-low or MSS 4)Patient has a metastatic, non-resectable, or reccurent lesion 5)Patients have no further standard treatment. 6)No symptomatic brain metastasis, carcinomatous meningitis, vertebral metastasis requiring radiotherapy or surgery 7)No cardiac effusion, pleural effusion and ascites requiring any treatment 8)Aged 16 or above at the time of registration 9)Performance Status 0 or 1 10)One or more measurable lesions confirmed by contrast enhanced CT 11)No prior treatment of immune checkpoint inhibitors 12)Not receiving prednisolone or any immunosuppressive agents within 14 days before registration 13)Not received anti-cancer therapy within 28 days before registration 14)Not undergone surgery under general anesthesia within 28 days before registration 15)Not received radiotherapy within 28 days before registration 16)Not received radioactive pharmaceuticals within 56 days before registration 17)Patients received laboratory tests within 14 days before registration and have adequate organ function 18)Patients who achieved an SpO2 of 92% or more under room air conditions within 14 days before registration 19)Given consent to contraception 20)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Active double cancer; synchronous or metachronous within 5years. Patients with carcinoma in situ are eligible 2) Infections requiring systemic therapy 3) Active gastrointestinal ulcer 4) Interstitial pneumonia and/or pulmonary fibrosis diagnosed by chest CT imaging or clinical examinations 5) History of hypersensitivity reaction to antibody agents 6) Active autoimmune disease 7) HIV antibody positive, HBV-DNA positive, etc. 8) Pregnant or breast-feeding women, or women suspected of being pregnant 9) Mental disease interfering taking part in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (central review) | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (investigator assessed), disease control rate, progression-free survival, overall survival, safety | — |
Countries
Japan
Contacts
Public ContactNatsuko Okita
National Cancer Center Hospital
Outcome results
None listed