FIGURE 1 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

<p>Study design. Note: As of Protocol Amendment 8, enrollment was closed before reaching the planned number of patients. ^aCohort 1 was initially evaluated. Cohort −1 was evaluated if the Cohort 1 dose proved intolerable. ^bCohort 1 was initially evaluated. Further dose exploration may be evaluated on the basis of emerging pharmacokinetic/pharmacodynamic or safety data. Subsequent increases in the dose of parsaclisib were limited to ≤50% and did not exceed the dose level tested as monotherapy. ^cPatients treated at ≥10 mg switched to a once weekly dosing schedule at cycle 4 day 1 and beyond. ^dBased on the review of safety data from the parsaclisib program, patients receiving 30 mg once daily of parsaclisib had the dose reduced to 20 mg once daily. ^eSelected solid tumor types included endometrial cancer, gastric cancer, HNSCC, melanoma, MSI-CRC or other mismatch repair–deficient tumors, NSCLC, PDAC, RCC, TNBC, or UC. CRC, colorectal cancer; HNSCC, head and neck squamous cell carcinoma; MSI, microsatellite instability; NSCLC, non–small cell lung cancer; PD-(L)1, programmed cell death-(ligand)1; PDAC, pancreatic ductal adenocarcinoma; Q3W, every 3 weeks; QD, once daily; QOD, every other day; RCC, renal cell carcinoma; SCLC, small cell lung cancer; TNBC, triple-negative breast cancer; UC, urothelial carcinoma.</p>

Duke Scholars

Author Niharika Bansal Mettu Medicine, Medical Oncology