Trials / Completed
CompletedNCT02909452
Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
A Phase 1, Randomized, Open-Label, Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors (SNDX-275-0141, MK3475-460/KEYNOTE-460)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Syndax Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of this study are to explore different dosing levels and schedules of entinostat in combination with pembrolizumab in patients with advanced solid tumors, in terms of safety, tolerability, pharmacokinetics (PK), impact on immune correlatives, and efficacy
Detailed description
This is a Phase 1, open-label, single center, randomized study to assess the safety and tolerability of 3 different dose regimens of entinostat in combination with pembrolizumab in patients with advanced solid tumors who previously completed Study SNDX-275-0140 (NCT02897778). Up to 30 patients will be randomized in a 1:1:1 fashion to one of three arms. In the event that greater than or equal to 2 out of the first 6 patients randomized experience a dose-limiting toxicity, the next patient randomized to that Arm will receive treatment at a reduced starting dose as outlined in the protocol.
Conditions
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms by Histologic Type
- Bronchial Neoplasms
- Lung Neoplasms
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Lung Diseases
- Breast Diseases
- Renal Neoplasm
- Solid Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Entinostat | HDAC (histone deacetylase) inhibitor |
| DRUG | Pembrolizumab | A selective humanized monoclonal antibody (mAb) |
Timeline
- Start date
- 2016-09-20
- Primary completion
- 2019-07-17
- Completion
- 2021-02-09
- First posted
- 2016-09-21
- Last updated
- 2022-01-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02909452. Inclusion in this directory is not an endorsement.