Immunotherapy for Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the trial, except for certain hormone replacement therapies.
What data supports the effectiveness of the drug Obinutuzumab for treating lymphoma?
Obinutuzumab has shown effectiveness in treating follicular lymphoma, especially in patients who did not respond to or relapsed after rituximab treatment. In a large study, it significantly prolonged the time patients lived without the disease getting worse compared to another treatment, and it also improved overall survival for these patients.12345
Is immunotherapy for lymphoma generally safe for humans?
Obinutuzumab, used in various lymphoma treatments, generally has a manageable safety profile. Common side effects include mild to moderate infusion-related reactions (like fever or chills during the drug infusion) and neutropenia (a drop in white blood cells that can increase infection risk). Serious side effects are less common, and the safety profile is consistent with current risk management strategies.16789
What makes the drug combination of Obinutuzumab, Pembrolizumab, and Rituximab unique for treating lymphoma?
This drug combination is unique because it includes Obinutuzumab, a novel anti-CD20 monoclonal antibody, which has shown effectiveness in patients who do not respond to or relapse after Rituximab treatment. Obinutuzumab is engineered to improve the immune system's ability to target and destroy cancer cells, offering a new option for those with limited responses to existing therapies.12101112
What is the purpose of this trial?
This phase II trial studies how well pembrolizumab with rituximab or obinutuzumab work in treating patients with follicular lymphoma or diffuse large B cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Rituximab and obinutuzumab are monoclonal antibodies. They bind to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving pembrolizumab with rituximab or obinutuzumab may help kill more cancer cells in patients with follicular lymphoma or diffuse large B cell lymphoma.
Research Team
Stephen Smith
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Eligibility Criteria
This trial is for adults with relapsed or refractory follicular lymphoma or diffuse large B cell lymphoma. They must have tried certain treatments like CD20 antibody therapy, not be eligible for high-dose chemotherapy and stem cell transplant, and lack better treatment options. Participants need a minimum hemoglobin level, measurable disease, good performance status (able to carry out daily activities), adequate organ function, and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction
Patients receive pembrolizumab and either rituximab or obinutuzumab. Treatment repeats every 3 weeks for 4 cycles.
Extended Therapy
Patients with at least a partial response receive pembrolizumab every 3 weeks for up to 2 years. Obinutuzumab may be given on specific cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Obinutuzumab
- Pembrolizumab
- Rituximab
Obinutuzumab is already approved in United States, European Union for the following indications:
- Chronic Lymphocytic Leukemia (CLL)
- Follicular Lymphoma
- Chronic Lymphocytic Leukemia (CLL)
- Follicular Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University