Trials / Terminated
TerminatedNCT03407976
Apatinib With Pembrolizumab in Previously Treated Advanced Malignancies
A Phase I/II Open Label Study of the Safety and Efficacy of Apatinib Administered to Patients With Advanced Malignancies to Improve Sensitivity to Pembrolizumab in the Second- or Later-line Setting (APPEASE)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- University of Utah · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Conditions
- Advanced Malignancies
- Urothelial Carcinoma
- MSI-H or dMMR Solid Tumors
- Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apatinib | 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. |
| DRUG | Pembrolizumab | 200 mg Q3 weeks IV |
Timeline
- Start date
- 2018-06-19
- Primary completion
- 2019-08-19
- Completion
- 2020-07-02
- First posted
- 2018-01-23
- Last updated
- 2020-07-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03407976. Inclusion in this directory is not an endorsement.