Pemetrexed + Pembrolizumab for Salivary Gland Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Mayo Clinic
Must not be taking: Immunosuppressants, Corticosteroids
Disqualifiers: Active infection, Autoimmune disease, CNS metastases, others
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This phase II trial studies the effect of pemetrexed and pembrolizumab in treating patients with salivary gland cancer that has come back (recurrent) and/or has spread to other places in the body (metastatic). Chemotherapy drugs, such as pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. 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. The purpose of this study is to evaluate whether pembrolizumab, an immunotherapy drug, in combination with the chemotherapy drug, pemetrexed, has an effect on advanced salivary gland cancer.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have used immunosuppressive medication within 14 days before joining, and certain conditions like active infections or autoimmune diseases requiring treatment might affect eligibility. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug pembrolizumab for salivary gland cancer?
Research shows that pembrolizumab, a drug that helps the immune system fight cancer, has been studied for advanced salivary gland cancer and other types of cancer. It has shown promise in treating salivary gland cancer, especially when the cancer cells have certain markers (PD-L1) that pembrolizumab targets.
12345Is the combination of Pemetrexed and Pembrolizumab generally safe for humans?
Pembrolizumab (also known as Keytruda) has been used in various cancer treatments and can cause side effects affecting different body systems, such as skin issues and immune-related reactions. In some cases, it has led to conditions like glossitis (inflammation of the tongue), which improved with treatment. Safety data from studies on other cancers suggest it is generally safe, but side effects can occur.
12345How is the drug Pemetrexed + Pembrolizumab unique for treating salivary gland cancer?
This drug combination is unique because there are no proven systemic therapies for salivary gland cancer, and Pemetrexed has not been previously used for this condition, while Pembrolizumab has shown promise in treating similar cancers.
13567Eligibility Criteria
Adults with advanced salivary gland cancer that has returned or spread and can't be cured by surgery. They should have a life expectancy of at least 12 weeks, good organ function, no severe illnesses that could interfere with the study, and must agree to use contraception. Prior treatments are allowed but there are restrictions on recent surgeries, therapies, and certain medications.Inclusion Criteria
Willingness to provide mandatory blood specimens for correlative research
Alanine aminotransferase (ALT) and aspartate transaminase (AST) =< 2.5 x ULN (=< 5 x ULN for patients with liver involvement) (obtained =< 8 days prior to registration)
Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 8 days prior to registration)
+22 more
Exclusion Criteria
I have had pneumonitis treated with steroids or currently have it.
I have not received any live vaccines or been part of a drug study in the last 4 weeks.
I have received an organ or tissue transplant from another person.
+22 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive pembrolizumab and pemetrexed intravenously every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity
2 years
Every 21 days
Extension
Participants with stable disease, partial response, or complete response may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity
1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
3 years
Every 3 months
Participant Groups
The trial is testing the combination of pemetrexed (a chemotherapy drug) and pembrolizumab (an immunotherapy antibody) in patients with recurrent or metastatic salivary gland cancer. The goal is to see if this combo can stop cancer cells from growing by killing them directly or boosting the immune system's response.
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, pemetrexed)Experimental Treatment7 Interventions
Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
Mayo ClinicScottsdale, AZ
Mayo ClinicJacksonville, FL
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Evaluation of pembrolizumab monotherapy in patients with previously treated advanced salivary gland carcinoma in the phase 2 KEYNOTE-158 study. [2022]We evaluated pembrolizumab monotherapy in patients with advanced salivary gland carcinoma on the phase 2 KEYNOTE-158 study (NCT02628067).
Pembrolizumab-Induced Immune-Mediated Glossitis. [2022]Pembrolizumab (Keytruda), an anti-PD-1 antibody used in the treatment of several different malignancies has been identified to cause adverse effects pertaining to multiple body systems which include respiratory, gastrointestinal, dermatologic, and endocrine manifestations known as immune-related adverse events (IRAEs). Skin manifestations have been most described in current literature highlighting the most common adverse effects of this agent. However, adverse outcomes involving the oral mucosa have been rarely identified in the PD-1 and PD-L1 inhibitor classes of immunotherapeutic agents. We present a case of a 71-year-old male who was treated with a chemotherapeutic regimen including pembrolizumab for newly diagnosed squamous cell carcinoma of the lung, who later developed ulcerations on his tongue that were consistent with glossitis. Upon determining that this adverse effect may be immune-related, the patient was treated with oral prednisone 40 mg with a 10 mg taper each subsequent week, which resulted in significant improvement in the patient's symptoms following one month of treatment.
Pembrolizumab for the Treatment of Advanced Salivary Gland Carcinoma: Findings of the Phase 1b KEYNOTE-028 Study. [2021]Treatment options for patients with unresectable or metastatic salivary gland carcinoma (SGC) are limited. Safety and efficacy of pembrolizumab for SGC expressing programmed death ligand 1 (PD-L1) were explored.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]New insights into the interaction between the immune system and the tumor microenvironment have led to the development of checkpoint inhibitors that target the PD-1/PD-L1 pathway. Pembrolizumab (MK-3475, lambrolizumab, Keytruda(®)) is a PD-1 inhibitor that has shown clinical activity in a variety of solid tumors and is currently approved for the second-line treatment of PD-L1-positive non-small-cell lung cancer and for unresectable/metastatic melanoma. This article will discuss the results of early-phase trials of pembrolizumab in thoracic malignancies as well as ongoing studies aimed to confirm clinical benefit.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]A phase II trial investigating the therapeutic effect of neoadjuvant programmed cell death 1 (PD-1) inhibitor pembrolizumab (MK-3475, KEYTRUDA®) administered prior to surgery for the treatment of non-small cell lung cancer (NSCLC) has been conducted (NCT03197467). We report the first clinical results of a planned interim safety analysis after 15 patients were enrolled.
Marked responses to pemetrexed chemotherapy for metastatic adenocarcinoma of the parotid gland: Case series. [2020]There are no proven systemic therapies for metastatic adenocarcinoma of the salivary glands. Pemetrexed use in adenocarcinoma of the salivary glands has not been previously described.
A Case of Recurrent Metastatic Parotid Acinic Cell Carcinoma Responsive to Pembrolizumab. [2022]No clear chemotherapy regimen for recurrent or metastatic parotid cancer exists. We describe our experience with pembrolizumab to treat recurrent or metastatic parotid cancer.