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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with adverse events
Secondary outcome measures
MRD negativity rate
duration of response (DOR)
nodal response rate
+3 more

Side effects data

From 2023 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%
Arthralgia
67%
Myalgia
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%
Anxiety
33%
Arthritis
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%
0%
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)

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 2
~260
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,013 Previous Clinical Trials
734,090 Total Patients Enrolled
Michael Thirman, MDPrincipal InvestigatorUniversity of Chicago

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03283137 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: TGR-1202 and pembrolizumab
Non-Hodgkin's Lymphoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03283137 — Phase 1
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03283137 — Phase 1
~7 spots leftby Dec 2027
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