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PD-1 Inhibitor

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

Phase 1

Waitlist Available

Led By Michael Thirman, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be greater than or equal to 18 years of age on day of signing informed consent

Have a performance status of 0-1 on the ECOG Performance Scale

Must not have

Has a known history of active TB (Bacillus Tuberculosis)

Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or has not recovered (i.e., less than or equal to Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new drug combo for people with B-cell NHL or CLL. The new drug, TGR-1202, will be given at different doses to see what is safe and works best. Pembrolizumab will also be given along with TGR-1202.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions, fatigue, liver enzyme elevation, blood count changes and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of active tuberculosis.

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

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

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

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

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I have been diagnosed with HIV.

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

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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with adverse events

Secondary study objectives

MRD negativity rate

duration of response (DOR)

nodal response rate

+3 more

Side effects data

From 2022 Phase 1 trial • 45 Patients • NCT02268851

100%

Back pain

100%

Hyperglycemia

100%

Aspartate aminotransferase increased

100%

Fatigue

100%

Hyperhidrosis

100%

Lymphocyte count increased

100%

Upper respiratory infection

67%

Myalgia

67%

Arthralgia

67%

Hypophosphatemia

67%

Edema limbs

67%

Anemia

67%

Localized edema

67%

Nasal congestion

67%

Pain in extremity

67%

Alkaline phosphatase increased

67%

Dehydration

67%

Diarrhea

67%

Dizziness

67%

Insomnia

67%

Platelet count decreased

67%

White blood cell decreased

67%

Headache

67%

Leukocytosis

33%

Arthritis

33%

Anxiety

33%

Disease Progression

33%

Supraventricular Tachycardia

33%

Alanine aminotransferase increased

33%

Alopecia

33%

Blood bilirubin increased

33%

Colitis

33%

Constipation

33%

Cough

33%

Dyspepsia

33%

Epistaxis

33%

Nausea

33%

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

33%

Neutrophil count decreased

33%

Non-cardiac chest pain

33%

Skin infection

33%

Stomach pain

33%

Vomiting

33%

Reproductive system and breast disorders - Other, specify

33%

Fever

33%

Hypoalbuminemia

33%

Hyponatremia

33%

Skin/subcutaneous tissue disorders

33%

Thromboembolic event

33%

Hearing impaired

33%

Hematoma

33%

Hypomagnesemia

33%

Nervous system disorders - Other, specify

33%

Bruising

33%

Creatinine increased

33%

Sepsis

33%

Abdominal pain

33%

Blurred vision

33%

Urinary tract infection

33%

Hypocalcemia

33%

Mucositis oral

100%

80%

60%

40%

20%

Study treatment Arm

CLL: Phase I Cohort 1

MCL: Phase I Cohort 1

CLL: Phase I Cohort 2

MCL: Phase I Cohort 2

CLL: Phase I/IICohort 3 (RPD2)

MCL: Phase I/II Cohort 3 (RPD2)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TGR-1202

2015

Completed Phase 1

~270

Pembrolizumab

2017

Completed Phase 3

~3150