Talabostat + Pembrolizumab for Cancer

Overseen By Filip Janku, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Gliptins, Steroids

Disqualifiers: CNS metastases, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

31 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects of talabostat and pembrolizumab and to see how well they work for the treatment of solid cancers that have spread to other places in the body (advanced). Talabostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving talabostat and pembrolizumab may help control the disease.

Research Team

Aung Naing, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

My liver enzymes are within the acceptable range.

Absolute neutrophil count (ANC) >= 1.0 x 10^9/L

My advanced cancer has worsened after treatment with PD1/PDL1 inhibitors.

Exclusion Criteria

I have HIV or hepatitis B/C, but my viral load is undetectable.

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.

Treatment Details

Interventions

• Pembrolizumab
• Talabostat Mesylate

Trial Overview 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.

Participant Groups

Group I: Treatment (talabostat, pembrolizumab) Experimental Treatment 2 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.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as KEYTRUDA for:

• 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

Approved in European Union as KEYTRUDA for:

• 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

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+