Apatinib With Pembrolizumab in Previously Treated Advanced Malignancies

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor: University of Utah
Study ID: NCT03407976
Phase: PHASE1
Status: Terminated

Conditions

Advanced Malignancies
Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
MSI-H or dMMR Solid Tumors
Urothelial Carcinoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Apatinib — DRUG
Apatinib oral daily at starting dose 1, Dose Level 2 or Dose Level 3 in phase I, and then whichever is the maximum tolerated dosage will be used for all Phase II patients.
Pembrolizumab — DRUG
200 mg Q3 weeks IV

Study Details

This is an open label nonrandomized Phase I/ IIA trial designed to assess the safety, tolerability, and efficacy of apatinib in combination with pembrolizumab. Phase I will assess the safety of combining increasing oral daily doses of apatinib with a fixed dose of IV pembrolizumab every three weeks and will determine the RP2D (Recommended Phase 2 Dose). Phase II will assess the efficacy of the RP2D of apatinib in combination with pembrolizumab and provide additional safety and tolerability data in three disease-specific cohorts