Testing the Combination of ZEN003694 and Nivolumab With or Without Ipilimumab in Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Malignant Solid Neoplasm
- Recurrent Malignant Solid Neoplasm
- Recurrent Platinum-Resistant Ovarian Carcinoma
- Refractory Ovarian Carcinoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To evaluate the safety/tolerability and recommended phase 2 dose (RP2D) of the BET inhibitor (BETi) BET Bromodomain Inhibitor ZEN-3694 (ZEN003694) when combined with nivolumab with or without low dose ipilimumab in solid tumors SECONDARY OBJECTIVES: I. The efficacy of the tripl...
PRIMARY OBJECTIVE: I. To evaluate the safety/tolerability and recommended phase 2 dose (RP2D) of the BET inhibitor (BETi) BET Bromodomain Inhibitor ZEN-3694 (ZEN003694) when combined with nivolumab with or without low dose ipilimumab in solid tumors SECONDARY OBJECTIVES: I. The efficacy of the triplet regimen will be evaluated in a cohort of patients with recurrent platinum-resistant BRCA wild type (wt) epithelial ovarian cancer. Ia. To observe and record anti-tumor activity. II. The impact of BET inhibition on the tumor immune microenvironment (TIME) will be characterized. III. Predictors of response and resistance to therapy will be explored. OUTLINE: This is a dose-escalation study of ZEN003694. DOSE ESCALATION (DOUBLET TREATMENT): Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 and ZEN003694 orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. DOES ESCALATION AND DOSE EXPANSION (TRIPLET TREATMENT): Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes on day 1, and ZEN003694 PO QD on days 1-21. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 5, patients receive nivolumab IV over 30 minutes on day 1 and ZEN003694 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days, then every 3 months for 1 year.
Tracking Information
- NCT #
- NCT04840589
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Haider S Mahdi University of Pittsburgh Cancer Institute LAO