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Checkpoint Inhibitor
Talabostat + Pembrolizumab for Cancer
Phase 2
Waitlist Available
Led By Filip Janku
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x institutional ULN (patients with hepatic metastases must have AST/ALT =< 5 x ULN)
Efficacy stage cohort B: patients with advanced cancers which have relapsed or progressed with PD1/PDL1 antibodies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights
Study Summary
This trial studies talabostat and pembrolizumab as a treatment for advanced solid cancers. Talabostat may stop cancer cell growth by blocking enzymes needed for cell growth. Pembrolizumab is an immunotherapy that may help the body's immune system attack the cancer. Giving talabostat and pembrolizumab may help control the disease.
Who is the study for?
Adults with advanced solid cancers that haven't been treated with PD1/PDL1 antibodies or have relapsed after such treatment. They must have a life expectancy over 3 months, be able to perform daily activities (ECOG 0-2), and not be pregnant or breastfeeding. Participants need normal organ function tests, no active brain metastases, and can't be on certain medications like gliptins.Check my eligibility
What is being tested?
The trial is testing the combination of Talabostat Mesylate, an enzyme inhibitor that may stop tumor growth, and Pembrolizumab, an immunotherapy drug designed to boost the immune system's attack on cancer cells. The goal is to see if this combo is effective for treating advanced solid tumors.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation which could affect various organs, infusion-related reactions from the drugs being administered into the bloodstream, fatigue, digestive issues like nausea or diarrhea, potential blood disorders such as anemia or clotting problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver enzymes are within the acceptable range.
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My advanced cancer has worsened after treatment with PD1/PDL1 inhibitors.
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My kidney function, measured by creatinine levels, is within the normal range.
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I am under 18 and weigh more than 40 kg.
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I am able to get out of my bed or chair and move around.
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I have advanced cancer and haven't been treated with PD1/PDL1 antibodies.
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My hemoglobin is at least 8 g/dL and I haven't had a blood transfusion in the last week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity
Response rate
Side 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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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: Treatment (talabostat, pembrolizumab)Experimental Treatment2 Interventions
Patients receive talabostat PO BID on days 1-14 and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,356 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,493 Total Patients Enrolled
Filip JankuPrincipal InvestigatorM.D. Anderson Cancer Center
7 Previous Clinical Trials
280 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver enzymes are within the acceptable range.My advanced cancer has worsened after treatment with PD1/PDL1 inhibitors.My advanced cancer is resistant or intolerant to standard treatments, except PD1 or PD-L1 inhibitors.I have HIV or hepatitis B/C, but my viral load is undetectable.My kidney function, measured by creatinine levels, is within the normal range.My brain cancer has not spread, or if it has, it's under control without steroids.You have taken a new and untested cancer medication within the 14 days before starting this study.I have advanced cancer and may or may not have been treated with PD1/PDL1 antibodies. If treated, my cancer has returned.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I am able to get out of my bed or chair and move around.I am not pregnant, use effective birth control, or am not of childbearing potential.I agree to use barrier contraception and my partner will use additional birth control during and after the study.I am under 18 and weigh more than 40 kg.The doctor thinks you will live for at least 3 more months.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have a stomach or intestine problem that affects how I absorb medicine.I do not have serious heart problems or uncontrolled high blood pressure.My doctor believes I have more than 3 months to live and I can care for myself.I haven't had radiation or cancer drugs within the last 14 days or 5 half-lives.I have advanced cancer and haven't been treated with PD1/PDL1 antibodies.My cancer can be measured by specific medical scans.I have another cancer, but it's either non-melanoma skin cancer, carcinoma in situ, or not requiring treatment.My hemoglobin is at least 8 g/dL and I haven't had a blood transfusion in the last week.I am currently taking gliptin medication.Side effects from my previous cancer treatment are mild, except for possible nerve pain or hair loss.You have a medical condition that increases your risk of experiencing harmful side effects, as determined by the investigator.I cannot swallow pills.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (talabostat, 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.
Are volunteers still needed for this research project?
"That is correct, the information available on clinicaltrials.gov does show that this study is still looking for research subjects. This trial was originally announced on March 19th 2020 and updated September 7th 2020. They are currently enrolling 15 individuals at a single location."
Answered by AI
What other immunotherapy drugs have been trialed with Pembrolizumab?
"Pembrolizumab is being investigated in 1000 different clinical trials, 122 of which are Phase 3. There are many studies for Pembrolizumab located in Houston, Texas, but there are 36030 locations running trials for Pembrolizumab globally."
Answered by AI
How many individuals are signing up to participate in this experiment?
"That is correct, the online clinicaltrials.gov registry currently shows that this study is open and recruiting patients. The listing indicates that the trial was first posted on March 19th, 2020 and updated September 7th, 2020. Currently, they are looking for 15 more participants across 1 location."
Answered by AI
Is Pembrolizumab known to have negative side effects for patients?
"While there is some data supporting its safety, pembrolizumab did not yet receive a score of 3 because there is no efficacy data from clinical trials."
Answered by AI
What are the benefits of Pembrolizumab?
"Oftentimes, Pembrolizumab is used to fight malignant neoplasms. However, this treatment has also been found effective in cases of unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
Answered by AI
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