NCT03636503

Rituximab + Immunotherapy in Follicular Lymphoma

A Multi-Cohort Phase 1b Clinical Trial of Rituximab in Combination With Immunotherapy in Untreated and Previously Treated Follicular Lymphoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying several new investigational drug combinations as a possible treatment for follicular lymphoma. The drugs involved are: * Rituximab * Utomilumab * Avelumab * PF-04518600

Detailed description

This research study is a Phase 1 clinical trial. Phase 1 clinical trials test the safety of an investigational intervention and also try to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied. Utomilumab and avelumab are drugs which may stimulate the immune system against tumor cells. Because they activate the immune system, they are sometimes called immunotherapy drugs. The FDA (the U.S. Food and Drug Administration) has not approved utomilumab or avelumab for treatment of this cancer. Rituximab is approved by the FDA (the U.S. Food and Drug Administration) as a treatment option for this disease. The purpose of this research is to learn about the effects of combining the immunotherapy drugs utomilumab and avelumab with rituximab in follicular lymphoma. The investigators hope to learn how safe the combinations of treatments are for participants with follicular lymphoma.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatment
DRUG	Utomilumab	Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
DRUG	Avelumab	Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
DRUG	PF04518600	In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40

Timeline

• Start date: 2018-10-30
• Primary completion: 2021-07-23
• Completion: 2023-07-30
• First posted: 2018-08-17
• Last updated: 2025-02-06
• Results posted: 2025-02-06

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study