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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 belowSelect...
I am 18 years old or older.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
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 3
~810
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,002 Previous Clinical Trials
817,830 Total Patients Enrolled
Michael Thirman, MDPrincipal InvestigatorUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain or nervous system cancer is stable, and I haven't used steroids in the last 7 days.My organ functions are within the required range for treatment.I agree to provide tissue samples for testing during and after treatment.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 another cancer besides skin or in situ cervical cancer that is getting worse or needs treatment.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have been treated with a PI3K-inhibitor before.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 agree to use birth control during and for 4 months after the study treatment.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have been diagnosed with HIV.I am using two birth control methods or am not having sex to join this study.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I have not received a live vaccine in the last 30 days.I have received at least one standard treatment before.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.
Research Study Groups:
This trial has the following groups:- Group 1: TGR-1202 and pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the capacity of participants for this experiment?
"This clinical trial is no longer actively seeking participants. Initially posted on January 23rd 2018, with the most recent edit occurring May 19th 2022; if you are still looking for a suitable study there are 1874 trials recruiting patients with chronic lymphocytic leukemia and 972 studies enrolling people to receive TGR-1202."
Answered by AI
Has TGR-1202 been subjected to any other research projects?
"Initial research into TGR-1202 began at the City of Hope in 2010, with a total of 260 clinical trials being completed since then. Presently there are 972 active investigations taking place, mainly within Chicago's hospitals and laboratories."
Answered by AI
Has the FDA given their stamp of approval to TGR-1202?
"Our analysts have assigned TGR-1202 a safety score of 1 due to the limited clinical evidence in Phase 1 trials regarding both effectiveness and safety."
Answered by AI
What are the common applications of TGR-1202?
"TGR-1202 has been shown to be an effective treatment for unresectable melanoma, microsatellite instability high metastases, and lymphomas."
Answered by AI
Are there still vacancies available in this clinical trial?
"Based on the information available, this trial is not progressing with recruitment at present. Initially posted in January 2018 and last edited in May 2022, there are currently 2846 other trials actively enrolling candidates into study programs."
Answered by AI
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