Immunotherapy for Lymphoma

Recruiting in Palo Alto (17 mi)

Smith | Division of Hematology & Oncology

Overseen byStephen Smith

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Washington

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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.

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

My DLBCL has returned or I can't have high-dose chemo and stem cell transplant.

Serum total bilirubin =< 1.5 X ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 X ULN (within 28 days of cycle 1 day 1)

Be willing and able to provide written informed consent/assent for the trial

+15 more

Exclusion Criteria

Hypersensitivity to pembrolizumab or any of its excipients

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment

I have or had lung inflammation not caused by an infection.

+16 more

Participant Groups

The study tests pembrolizumab combined with either rituximab or obinutuzumab in patients whose lymphoma has returned after treatment or hasn't responded to previous therapies. Pembrolizumab is an immunotherapy drug that may help the immune system attack cancer cells; rituximab and obinutuzumab are antibodies targeting specific proteins on cancer cells.

2Treatment groups

Experimental Treatment

Group I: Arm II (pembrolizumab, obinutuzumab)Experimental Treatment3 Interventions

INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better, who are experiencing clinical benefit in the judgment of the investigator, may receive obinutuzumab IV on day 1 of cycles 5, 9, 13, 17, 21, and 25.

Group II: Arm I (pembrolizumab, rituximab)Experimental Treatment3 Interventions

INDUCTION: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab IV on days 1, 8, and 15 of cycle 1, and on day 1 of cycle 2. EXTENDED THERAPY: Patients with at least a partial response receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years (35 cycles) in the absence of disease progression or unacceptable toxicity.

Obinutuzumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Gazyva for: