Nivolumab for Recurrent/Metastatic Carcinosarcoma

Inclusion Criteria:

1. Histologically confirmed recurrent/metastatic carcinosarcoma
2. ECOG performance status of 0 to 1
3. ≥ 19 years of age
4. At least 1 prior chemotherapy
5. Patients who have at least 1 measurable disease per the RECIST Guideline Ver. 1.1 as confirmed by imaging within 28 days before randomization

6. Subjects who meet the following criteria:

   • Absolute neutrophil count (ANC) ≥ 1500 /µ
   • Platelet count ≥ 75,000/ µL
   • Serum creatinine < 1.5 x upper limit of normal (ULN)
   • AST (SGOT) and ALT (SGPT) < 3 x upper limit of normal (ULN) (If there is Liver Metastasis < 5 x upper limit of normal (ULN))
   • Total bilirubin < 1.5 x upper limit of normal (ULN)

Exclusion Criteria:

1. More than 4 prior cytotoxic agents
2. Prior treatment with systemic PD-L1-directed therapy
3. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to entering the study, or who has not recovered from the adverse events due to previous agents administered more than 2 weeks prior to study day
4. Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
5. Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 3 years)
6. History of active non-infectious pneumonitis requiring treatment with steroids, or history or current signs of chronic interstitial lung disease
7. Known active infection