NCT03884998

Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma

Active, enrolled Phase 1 Last updated 30 December 2025

What this trial tests

Phase 1 trial testing Copanlisib in Chronic Lymphocytic Leukemia in 27 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

26 February 2019

Primary endpoint
4 November 2026

4 November 2026

Quick facts

Lead sponsor	City of Hope Medical Center
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	26 February 2019
Primary completion	4 November 2026
Estimated completion	4 November 2026
Sites	3 locations across United States

Drugs / interventions tested

• Copanlisib (COPANLISIB) — full drug profile →
• Nivolumab (nivolumab) — full drug profile →

Conditions studied

• Chronic Lymphocytic Leukemia — all drugs for Chronic Lymphocytic Leukemia →
• Diffuse Large B-Cell Lymphoma — all drugs for Diffuse Large B-Cell Lymphoma →
• Follicular Lymphoma — all drugs for Follicular Lymphoma →
• Indolent Non-Hodgkin Lymphoma — all drugs for Indolent Non-Hodgkin Lymphoma →

Sponsor

City of Hope Medical Center

Who can join

18 and older, any sex, with Chronic Lymphocytic Leukemia or Diffuse Large B-Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the best dose and how well copanlisib when given together with nivolumab works in treating patients with Richter's transformation or transformed indolent non-Hodgkin lymphoma. Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving copanlisib and nivolumab may work better in treating patients with Richter's transformation or transformed non-Hodgkin lymphoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PI3K/AKT/mTOR signaling transduction pathway and targeted therapies in cancer.
   Glaviano A, Foo ASC, Lam HY, Yap KCH, et al · · 2023 · cited 1279× · PMID 37596643 · DOI 10.1186/s12943-023-01827-6
2. Role of PI3K/AKT pathway in cancer: the framework of malignant behavior.
   Jiang N, Dai Q, Su X, Fu J, et al · · 2020 · cited 419× · PMID 32333246 · DOI 10.1007/s11033-020-05435-1
3. Tumor-Associated Macrophages Regulate PD-1/PD-L1 Immunosuppression.
   Pu Y, Ji Q. · · 2022 · cited 212× · PMID 35592338 · DOI 10.3389/fimmu.2022.874589
4. Immune Response Dysfunction in Chronic Lymphocytic Leukemia: Dissecting Molecular Mechanisms and Microenvironmental Conditions.
   Arruga F, Gyau BB, Iannello A, Vitale N, et al · · 2020 · cited 118× · PMID 32155826 · DOI 10.3390/ijms21051825
5. Defects in Macrophage Reprogramming in Cancer Therapy: The Negative Impact of PD-L1/PD-1.
   Cai H, Zhang Y, Wang J, Gu J. · · 2021 · cited 100× · PMID 34248982 · DOI 10.3389/fimmu.2021.690869
6. Clinical characteristics and outcomes of Richter transformation: experience of 204 patients from a single center.
   Wang Y, Tschautscher MA, Rabe KG, Call TG, et al · · 2020 · cited 96× · PMID 31197071 · DOI 10.3324/haematol.2019.224121
7. PI3K activation allows immune evasion by promoting an inhibitory myeloid tumor microenvironment.
   Collins NB, Al Abosy R, Miller BC, Bi K, et al · · 2022 · cited 65× · PMID 35264433 · DOI 10.1136/jitc-2021-003402
8. Biology and Treatment of Richter Transformation.
   Condoluci A, Rossi D. · · 2022 · cited 39× · PMID 35392219 · DOI 10.3389/fonc.2022.829983