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

Recruiting in Palo Alto (17 mi)

+2 other locations

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.

Research Team

Michael Thirman, MD

Principal Investigator

University of Chicago

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

My organ functions are within the required range for treatment.

Female subject of childbearing potential should have a negative urine or serum pregnancy prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

I agree to provide tissue samples for testing during and after treatment.

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Exclusion Criteria

My brain or nervous system cancer is stable, and I haven't used steroids in the last 7 days.

I have a history of active tuberculosis.

Hypersensitivity to pembrolizumab or any of its excipients

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Treatment Details

Interventions

Pembrolizumab (PD-1 Inhibitor)
TGR-1202 (PI3K Inhibitor)

Trial OverviewThe 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.

Participant Groups

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: