Clinical Trial Search

Primary: Single Rising Dose Part - Number of Subjects With Ocular Dose Limiting Events (DLEs) From Drug Administration Until Day 8 (7 Days After Treatment) — 0; 0; 0 Participants

Primary: Number of Participants With Grades 1-5 Solicited (Expected) and/or Unsolicited (Unexpected) Adverse Events (AE's): Initial Phase — 0; 0; 1; 0 Participants

Primary: Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16 — 8.1; 36.1; 44.4; 56.8 percentage of participants…

Primary: Geometric Mean Titers (GMTs) of Pneumococcal Serotypes Using Serotype-Specific MOPA — 128; 127; 158; 254 Titer

Primary: Daily Stool Record (DSR( — -2.3; 0 days

Primary: Incidence of Treatment-emergent Adverse Events (TEAEs) — 1; 2; 0; 2 Participants

Primary: Number of Participants With 2-year Event-Free Survival (EFS) — 28; 11 Participants

Primary: Assess the Objective Response Rate (ORR) to Axitinib and Avelumab Combination According to RECIST 1.1 Criteria. — 18 percentage of participants

Primary: Relative Change of ≥ 5% in Breast Density at 6 Months — 13; 8; 4 Participants — p=0.026

Primary: Peak Aspartate Aminotransferase Within First 72h Post Transplant — 1262.9; 1451.2 U/L

Primary: Number of Participants With Treatment-related Serious Adverse Events — 0; 0; 0 Participants

Primary: Percent of Participants With Disease-Free Survival (DFS) at 3 Years — 69.5 Percent

Primary: Proportion of Patients Alive and Without Radiological or Clinical Progression at 4 Months — 54.8 percentage of participants

Primary: Adverse Events — 2; 1; 2; 6 participants

Primary: Confirmed Objective Response Rate (ORR) by Independent Central Review (ICR) — 33; 0 Participants