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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT04431635
Phase
PHASE1
Status
Terminated

Conditions

  • Indolent Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Copanlisib — DRUG
    Copanlisib IV: day 1, 8, 15 every 28 days
  • Nivolumab — DRUG
    Nivolumab IV: Cycle 1 days 1 and 15; then day 1 only
  • Rituximab — DRUG
    Rituximab IV: Cycle 1 days 1, 8, 15, 22; then day 1 (C2-6); then Q2 cycles (8-12)

Study Details

Patients with relapsed or refractory follicular or marginal zone lymphoma who have received at least one prior line of therapy will receive * Copanlisib IV: day 1, 8, 15 every 28 days * Nivolumab IV: Cycle 1 days 1 and 15; then day 1 only * Rituximab IV: Cycle 1 days 1, 8, 15, 22; then day 1 (C2-6); then Q2 cycles (8-12)

Key Dates

Start date
Jun 15, 2020
Status verified
Sep 2024
Primary completion
Nov 14, 2023
Completion
Nov 14, 2023

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Copanlisib, Nivolumab & Rituximab
    Copanlisib IV: day 1, 8, 15 every 28 days Nivolumab IV: Cycle 1 days 1 and 15; then day 1 only Rituximab IV: Cycle 1 days 1, 8, 15, 22; then day 1 (C2-6); then Q2 cycles (8-12)

Primary Outcome Measure

MTD (Maximum Tolerated Dose) of copanlisib given in combination with nivolumab and rituximab [ Time Frame: 28 days ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Illinois Cancer CenterChicagoIllinois60612-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
University of Michigan Health SystemAnn ArborMichigan48109-
University of Nebraska Medical CenterOmahaNebraska68198-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-

Find similar trials in Chicago, IL

By research site
University of Illinois Cancer Center· Chicago, ILUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MIUniversity of Michigan Health System· Ann Arbor, MIUniversity of Nebraska Medical Center· Omaha, NERutgers Cancer Institute of New Jersey· New Brunswick, NJ

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