An Open-Labeled, Phase I Study to Evaluate the Safety and Tolerability of Apatinib With Nivolumab in Patients With Unresectable or Metastatic Cancer
This is an open-labeled, single-center, Phase I study to evaluate the safety, tolerability, and efficacy of apatinib with nivolumab treatment in participants with unresectable or metastatic cancer. Total study duration will be approximately 50 months: 12 months of recruitment plus 6 months of treatment and subsequent survival follow up.
• Documented primary diagnosis of histologic- or cytologic-confirmed solid tumor cancer inclusive of gastric adenocarcinoma, renal cell carcinoma, melanoma, non-small cell lung cancer (NSCLC), breast cancer, angiosarcoma, leiomyosarcoma, synovial sarcoma, and alveolar soft part sarcoma or other solid tumor for which anti-Vascular endothelial growth factor receptor (VEGFR)2 targeted therapy could be applicable.
• Locally advanced unresectable or metastatic disease.
• Nivolumab treatment naive and able to begin nivolumab treatment concurrently with initiation of apatinib or have received at least 3 doses of nivolumab treatment and are continuing nivolumab therapy.
• 1 or more measurable lesions per RECIST v1.1.
• Participants who have adequate bone-marrow, renal and liver function including:
‣ Hematologic: absolute neutrophil count ≥ 1,500/ cubic millimetre (mm\^3), platelets≥ 100,000/mm\^3, hemoglobin ≥ 9.0 grams (g)/ per decilitre (dL) (blood transfusion to meet the inclusion criteria within 2 weeks is not allowed).
⁃ Renal: serum creatinine \< 1.5× upper limit of normal (ULN); urinary protein should be\< 2+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥ 2+, then a 24-hour urine or urine protein/creatinine ratio must be collected and must demonstrate \<2 g of protein in 24 hours to allow participation in the study.
⁃ Hepatic: serum bilirubin \< 1.5× ULN, aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0× ULN(≤ 4.0× ULN, if with liver metastases).
⁃ Blood coagulation tests: Partial thromboplastin time (PTT) and international normalized ratio (INR) ≤ 1.5× ULN and ≤ 1.5×ULN, respectively.
• Eastern Cooperative Oncology Group (ECOG) performance status are evaluated to be ≤ 1 (Participants with ECOG performance status of 2 may be enrolled only with advance review and written approval by the medical monitor).
• Expected survival of ≥ 12 weeks, in the judgement of the investigator.
• Ability to swallow the study drug tablets.