ivolumab monotherapy in Rare tumor patients with mismatch repair deficiency biomarker: A phase II trial
- Conditions
- Rare cancers with MSI-high or dMMR
- Registration Number
- JPRN-jRCT2091220344
- Lead Sponsor
- Kan Yonemori, National Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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 dMMR or MSI-high
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
1) Active double cancer
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method Objective response rate (investigator assessed), disease control rate, progression-free survival, overall survival, safety