Collecting Duct Carcinoma
Conditions
Keywords
Immune Checkpoint Inhibitors, Axitinib
Brief summary
This is a phase II trial to evaluate the efficacy and safety of immune checkpoint inhibitors in combination with axitinib for previously treated advanced collecting duct carcinoma.
Detailed description
Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 8 patients in stage 1 and 22 patients in stage 2. Stage 2 will enroll if 1 or more patients exhibit a response at week 9 or later in stage 1 in the study. All enrolled patients will be treated with immune checkpoint inhibitors in combination with axitinib until disease progression. Efficacy will be assessed by tumor measurements using CT and MRI (when indicated) scans and physical exam at baseline, and scans and physical exam of all disease-involved areas every 9 weeks until progression. Safety will be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All patients will have a follow-up visit 90 days following last study drug treatment.
Interventions
Toripalimab 240mg or Tirelizumab 200mg or pembrolizumab 200mg intravenously every 3 weeks
axitinib 5mg orally twice daily
Sponsors
Study design
Eligibility
Inclusion criteria
1. Fully understand and be willing to provide written informed consent. 2. Male or female with age ≥ 18 years and \<80 years. 3. Have received prior systemic therapy after previous metastasis for collecting duct carcinoma, histologically confirmed diagnosis of unresectable, recurrent or metastatic collecting duct carcinoma. 4. Having at least one measurable disease per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if re-progression has been demonstrated. 5. ECOG PS 0 or 1. 6. Adequate function of vital organs: 6.1 Bone marrow function (without blood or blood products transfusion, without hematopoietic stimulating factor or other medication to improve blood cell count within 2 days prior to first dose of study drug): Absolute neutrophil count (ANC) ≥ 1.5×109/L. Platelets ≥ 100×109/L. Hemoglobin ≥ 9.0g/dL or ≥ 5.6mmol/L. 6.2 Renal function: Serum creatinine ≤ 1.5×ULN 6.3 Hepatic function:Serum total bilirubin ≤1.5×ULN or total bilirubin levels \>1.5×ULN with direct bilirubin ≤ ULN. AST and ALT ≤2.5 × ULN, ≤5×ULN in those with hepatic metastasis. 6.4 Endocrine function: Normal thyroid stimulating hormone, or abnormal TSH whilst normal FT3 and FT4. 6.5 Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, and activated partial thromboplastin time (aPTT) ≤1.5×ULN, Subjects receiving anticoagulant therapy (e.g., heparin or warfarin) may participate in the study with PT or APTT levels within the scope of the proposed therapy and monitored during study treatment. 6.6 Left ventricular ejection fraction (LVEF) ≥ 50%. 7. Being willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 8. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first treatment dose. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must agree to use a highly effective methods of contraceptive throughout the study and for 180 days after the last dose of study therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR assessed by investigators per RECIST 1.1 | Up to approximately 2 years | The treatment effect of with ICI plus axitinib will be assessed using RECIST 1.1 to determine tumor response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS assessed by investigators per RECIST 1.1 | Up to approximately 2 years | The treatment effect of with ICI plus axitinib will be assessed using RECIST 1.1 to determine tumor response. |
Countries
China