Pembrolizumab + TGR-1202 for Non-Hodgkin's Lymphoma

Palo Alto (17 mi)

Overseen byMichael Thirman, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This study will be a standard 3+3 design with a lead in of TGR-1202 at dose of 600mg (dose level 1) or 800mg daily (dose level 2) for 6 weeks, i.e. 2 cycles, followed by pembrolizumab at 200mg every 3 weeks for 8 cycles along with TGR-1202 for patients with relapsed/refractory B-cell NHL or CLL. If the dose of 600mg daily of TGR-1202 (dose level 1) is tolerated in the first cohort the dose will be increased to 800mg qd which is the only and final dose escalation. If TGR-1202 is not tolerated at 600mg daily the dose will be decreased to 400mg daily. The lead in of TGR-1202 was chosen to ensure clinical benefit and to minimize the occurrence of early overlapping toxicity with pembrolizumab as most toxicities were observed early on in the treatment with idelalisib, a related PI3K-inhibitor, and rituximab.

Eligibility Criteria

Adults over 18 with relapsed/refractory B-cell NHL or CLL who've had at least one prior standard therapy can join. They must have measurable disease, be able to consent, and have good organ function and performance status. Women of childbearing potential must use birth control, as should men.

Inclusion Criteria

I am 18 years old or older.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have a history of active tuberculosis.

I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.

I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

I have had or currently have lung inflammation treated with steroids.

I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

I have been diagnosed with HIV.

I haven't had cancer treatment in the last 4 weeks or have recovered from its side effects.

I am currently being treated for an infection.

Treatment Details

The trial tests TGR-1202 in two doses (600mg or 800mg daily) for six weeks followed by pembrolizumab every three weeks for eight cycles. The study uses a '3+3 design' to find the safest dose that shows benefits while minimizing early toxicities.

1Treatment groups

Experimental Treatment

Group I: TGR-1202 and pembrolizumabExperimental Treatment2 Interventions

All patients will receive TGR-1202 and pembrolizumab. Patients will start receiving TGR-1202 daily for 6 weeks (2 cycles). Pembrolizumab will be given every 3 weeks for 8 cycles. If the daily dose of TGR-1202 (dose level 1) is tolerated in the first cohort the dose will be increased which is the only and final dose escalation. If TGR-1202 is not tolerated the dose will be decreased.

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

🇺🇸 Approved in United States as KEYTRUDA for: