Talabostat + Pembrolizumab for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the combination of talabostat and pembrolizumab for advanced solid cancers that have spread. Talabostat may block certain enzymes to stop tumor growth, while pembrolizumab, an immunotherapy, could help the immune system attack cancer cells. The trial aims to determine if this combination can control the disease. It seeks participants whose solid cancers haven't responded to other treatments, who can't tolerate those treatments, and who haven't been effectively treated with certain antibodies before. Participants should currently have measurable cancer that has spread. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking gliptins. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of talabostat and pembrolizumab is generally safe for people with advanced solid cancers. Studies found that most patients tolerated the treatment well. Specifically, nine out of 19 patients experienced stable disease, meaning their cancer did not worsen during the study. No severe or unexpected side effects were reported, suggesting the treatment is manageable for most patients. These findings indicate that the treatment is safe, but discussing any concerns with a doctor remains important.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of Talabostat Mesylate and Pembrolizumab because it offers a novel approach to cancer treatment. Pembrolizumab, an established immunotherapy, works by blocking a protein called PD-1 to help the immune system attack cancer cells more effectively. Talabostat Mesylate adds a unique twist by inhibiting enzymes known as dipeptidyl peptidases, which can further enhance immune responses against cancer. This dual mechanism potentially boosts the effectiveness of the immune system beyond what current treatments offer, providing new hope for patients.
What evidence suggests that talabostat and pembrolizumab could be effective for advanced solid cancers?
Research has shown that the combination of talabostat and pembrolizumab, which participants in this trial will receive, holds promise for treating advanced solid cancers. In one study, this treatment helped nine out of 19 patients maintain stable disease. Talabostat blocks enzymes that aid tumor growth, potentially halting their progress. Pembrolizumab, an immunotherapy, helps the immune system attack cancer cells. Together, these drugs aim to control the disease by preventing tumors from growing and spreading.12346
Who Is on the Research Team?
Aung Naing, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive talabostat orally twice daily on days 1-14 and pembrolizumab intravenously on day 1. Cycles repeat every 21 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- Talabostat Mesylate
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator