Phase IB Dose De-escalation Study of the PI3k Alpha/Delta Inhibitor, Copanlisib Given in Combination With the Immunotherapeutic Agents, Nivolumab and Rituximab in Patients With Relapsed/Refractory Indolent Lymphoma.Big Ten Cancer Research Consortium BTCRC-LYM17-145
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: I
Principal Investigator: Bociek, R Gregory
Contact Information:
Susan Blumel, RN
402-559-9183
sblumel@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04431635?term=NCT04431635&rank=1
Summary
Primary Objective: 1. To estimate the MTD of copanlisib given in combination with nivolumab and rituximab. 2. To evaluate the efficacy, as described by the CR rate, of the combination of copanlisib, nivolumab, and rituximab given at the MTD. Secondary Objectives: 1. To evaluate the safety and tolerability of the combination of copanlisib given in combination with nivolumab and rituximab in patients with relapsed/refractory follicular/marginal zone lymphoma. 2. To estimate ORR of patients treated with the combination. 3. To estimate average duration of response of patients treated with the combination. 4. To estimate PFS of patients treated with the combination. 5. To estimate the average TTNT of patients treated with the combination. Exploratory Objectives: 1. To measure the association between PD-L1 expression on malignant and surrounding stromal cells in the primary tumor and response to treatment. 2. Evaluate the T cell repertoire in the malignant stroma and evaluate changes in this population in response to treatment. 3. To measure the association between changes in the plasma levels of soluble PD-1 and response to treatment. 4. Evaluate response in relation to pre-treatment interferon-gamma gene signature score.