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Pembrolizumab + Decitabine + Pralatrexate for T-Cell Lymphoma
Study Summary
This trial is testing different combinations of drugs to find the best dose of each to treat cancer, while also looking at how well the drugs work and what side effects they have.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- I have been treated with PD-1 inhibitors before.I have not taken immunosuppressive drugs in the last week, except for low-dose steroids.I have a history of active tuberculosis.I have had a stem cell transplant from a donor.I am fully active or restricted in physically strenuous activity but can do light work.My organ functions are within the required range for the study.I have or had lung inflammation not caused by infection that needed steroids.I am 18 years old or older.I have an active Hepatitis B or C infection.My side effects from cancer treatment have not improved to a mild level.I have not received a live vaccine within the last 30 days.I have another cancer besides skin or early cervical cancer that is getting worse or needs treatment.I have stable brain metastases and haven't used steroids in the last 7 days.My lymphoma is confirmed to be a specific type (PTCL or CTCL) and has come back or didn’t respond to treatment.My cancer has returned or didn't respond to treatment, but I meet all other study requirements.I agree to use birth control during and up to 120 days after the study.I am a man who can father children and agree to use birth control during and for 4 months after the study.I am currently being treated for an infection.I am not allergic to pralatrexate, decitabine, pembrolizumab, or their ingredients.I have been diagnosed with HIV.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I agree to provide a new or recent biopsy sample for the study.I may have had multiple treatments and possibly relapsed after a stem cell transplant.
- Group 1: Arm A: Pembrolizumab plus Pralatrexate
- Group 2: Arm B: Pembrolizumab plus Pralatrexate plus Decitabine
- Group 3: Arm C: Pembrolizumab plus Decitabine
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
How many participants are participating in this investigation?
"To initiate the clinical trial, 37 individuals fitting a predetermined set of criteria must enroll. Both Allegheny Health Network in Pittsburgh and University of Virginia located in Charlottesville are participating sites."
Are there any existing investigations that involve Pembrolizumab?
"1062 clinical trials are currently being conducted on Pembrolizumab, 137 of which are in the third stage. Houston is a major hub for this research with 37248 total locations researching this drug."
Are participants of this experiment restricted to any age group?
"The parameters for enrollment in this trial stipulate that participants must be at least 18 years old and not exceed the age of 90."
What health conditions is Pembrolizumab primarily administered for?
"Pembrolizumab is the primary treatment for unresectable melanoma, but it can also be utilized to address microsatellite instability high, potential relapse risk, and other ailments."
Am I eligible to join the experiment?
"Participation in this medical trial is open to those between the ages of 18 and 90 who have been diagnosed with ptcl. As of now, 37 individuals are needed for inclusion."
What is the goal of this medical experiment?
"Merck Sharp and Dohme LLC, the sponsor of this clinical trial, have stated that Maximum Tolerated Dosage (MTD) will be used to measure the primary outcome over a period of 1-2 years. The secondary outcomes being studied are pharmacodynamic markers, anti-tumor activity, and pharmacokinetic profiles for pembrolizumab in conjunction with pralatrexate (Arm A), decitabine (Arm C), or as part of a combination therapy within cycle one only."
Are there currently any openings for participants in this scientific experiment?
"Affirmative. As per clinicaltrials.gov, this research endeavor is currently recruiting patients - it was originally announced on February 2nd 2022 and the most recent update occured on July 18th 2022."
Is Pembrolizumab well-tolerated and without risk for patients?
"Preliminary evidence indicates Pembrolizumab is safe, which has been reflected with a rating of 1 on our safety scale. This score was assigned due to the drug's Phase 1 status and limited supportive data concerning its efficacy."
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