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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

NCT04431635 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-09-27

No results posted yet for this study

Summary

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)

Conditions

  • Indolent Lymphoma

Interventions

DRUG

Copanlisib

Copanlisib IV: day 1, 8, 15 every 28 days

DRUG

Nivolumab

Nivolumab IV: Cycle 1 days 1 and 15; then day 1 only

DRUG

Rituximab

Rituximab IV: Cycle 1 days 1, 8, 15, 22; then day 1 (C2-6); then Q2 cycles (8-12)

Sponsors & Collaborators

Principal Investigators

  • Yasmin H Karimi, MD · The University of Michigan Rogel Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-15
Primary Completion
2023-11-14
Completion
2023-11-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04431635 on ClinicalTrials.gov