MD Anderson starts Phase I of evofosfamide plus Yervoy in solid tumors

Threshold Pharmaceuticals Inc. (NASDAQ:THLD) said the University of Texas MD Anderson Cancer Center (Houston, Texas) started a Phase I trial to evaluate evofosfamide plus Yervoy ipilimumab in up to 69 patients with metastatic or locally advanced prostate cancer, metastatic pancreatic cancer, melanoma or HPV-negative squamous cell carcinoma of head and neck (SCCHN).

The open-label, U.S. trial will evaluate escalating doses of 320-480 mg/m² IV evofosfamide given on days 1 and 8 plus Yervoy given on day 8 of the first 2 cycles and Yervoy given alone on day 8 of the last 2 cycles for 4 total 21-day cycles. The primary endpoint will determine the recommended Phase II dose based on immune-related response rate. Secondary endpoints include duration of response, progression-free survival (PFS), overall survival (OS), safety and pharmacokinetics...