NCT01676753

Phase 1b Trial of Dinaciclib With Pembrolizumab for Advanced Breast Cancer

A Phase 1b Trial of the Cyclin-dependent Kinase Inhibitor Dinaciclib in Combination With Pembrolizumab in Patients With Advanced Breast Cancer and Assessment of MYC Oncogene Overexpression

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Jo Chien · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to determine the safety and tolerability (maximum tolerated dose (MTD)) of weekly dinaciclib in combination with pembrolizumab in patients with advanced breast cancer. Once this is defined, dose expansion will be performed at this MTD in patients with metastatic or locally advanced and unresectable triple negative breast cancer, to evaluate the efficacy of combined dinaciclib and pembrolizumab.

Detailed description

PRIMARY OBJECTIVE: I. Define the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of dinaciclib SECONDARY OBJECTIVE: I. Evaluation of the preliminary efficacy of this combination using RECIST 1.1 and irRECIST. EXPLORATORY OBJECTIVE: I. Characterizing and correlating PDL-1 and MYC overexpression with clinical response. OUTLINE: This is an open-label phase Ib trial of weekly dinaciclib in combination pembrolizumab in participants with advanced triple negative breast cancer. Participants will undergo a single needle biopsy of a site of active disease prior to initiating treatment of Pembrolizumab and dinaciclib in 21 day cycles. The dose of dinaciclib will be escalated following a toxicity probability interval (TPI) design where dose-limiting toxicities (DLT) observed during the first cycle will be used to determine whether additional participants should be enrolled at the same, higher, or lower dose level. Treatment will continue until disease progression, intolerable toxicity, or participant withdraws consent. In the event of a complete response (CR), participants may elect to hold dinaciclib treatment and continue with pembrolizumab alone. At the time of radiographic disease progression, dinaciclib can be resumed at the same dose as at the time of discontinuation. Participants will be followed for 30 days after the last dose of treatment.

Conditions

• Advanced or Metastatic Breast Cancer
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Dinaciclib	Given IV
DRUG	Pembrolizumab	Given IV

Timeline

• Start date: 2016-12-28
• Primary completion: 2020-06-30
• Completion: 2022-02-28
• First posted: 2012-08-31
• Last updated: 2022-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study