Continuation Study of Entinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Lung Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Pulmonary |
| Therapuetic Areas: | Oncology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/27/2018 |
| Start Date: | September 20, 2016 |
| End Date: | February 2019 |
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)
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
entinostat in combination with pembrolizumab in patients with advanced solid tumors, in terms
of safety, tolerability, pharmacokinetics (PK), impact on immune correlatives, and efficacy
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.
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.
Inclusion Criteria:
1. Completed Study SNDX-275-0140 (NCT02897778)
2. Any AE or toxicity experienced in Study SNDX-275-0140 (NCT02897778) is resolved to
less than or equal to Grade 1
3. Continues to meet inclusion criteria for Study SNDX-275-0140 (NCT02897778) at the time
of entry into this study
Exclusion Criteria:
1. Completed Study SNDX-275-0140 (NCT02897778) more than 30 days prior to Cycle 1 Day 1
of this study
2. Continues to meet exclusion criteria for Study SNDX-275-0140 (NCT02897778) at the time
of entry into this study
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