Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 50
Summary
- Conditions
- Ann Arbor Stage III Lymphoma
- Ann Arbor Stage IV Lymphoma
- Metastatic Malignant Solid Neoplasm
- Recurrent Malignant Solid Neoplasm
- Unresectable Malignant Solid Neoplasm
- 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 OBJECTIVES: I. To establish the safety, tolerability, and the recommended phase 2 dose (RP2D) of copanlisib and nivolumab combination in patients with advanced solid tumors and lymphomas. II. To evaluate the safety and tolerability of copanlisib combined with nivolumab and ipilimumab in pati...
PRIMARY OBJECTIVES: I. To establish the safety, tolerability, and the recommended phase 2 dose (RP2D) of copanlisib and nivolumab combination in patients with advanced solid tumors and lymphomas. II. To evaluate the safety and tolerability of copanlisib combined with nivolumab and ipilimumab in patients with advanced solid tumors and lymphomas. EXPLORATORY OBJECTIVES: I. Evaluate the effect of the doublet and triplet combinations on markers of anti-tumor immunity in circulating immune cells and pre- and post-treatment tumor biopsies. II. Evaluate the effect of the combination on biomarkers of AKT inhibition, deoxyribonucleic acid (DNA) damage (gammaH2AX, pNbs1, Rad51), apoptosis, and epithelial-mesenchymal transition in CTCs and pre- and post- treatment tumor biopsies. III. Assess preliminary antitumor activity of the combination. OUTLINE: This is a dose-escalation study. DOUBLET TREATMENT PLAN: Patients receive copanlisib intravenously (IV) over 1 hour on days 1, 8, and 15 and nivolumab IV over 30 minutes on day 1 or on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. TRIPLET TREATMENT PLAN: Patients receive copanlisib IV over 1 hour on days 1, 8, and 15, nivolumab IV over 30 minutes on day 1 or on days 1 and 15. Beginning cycle 2, patients also receive ipilimumab IV over 90 minutes on day 1 for a total of 4 doses. 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.
Tracking Information
- NCT #
- NCT03502733
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Geraldine O'Sullivan Coyne National Cancer Institute LAO
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