MC200708 Pemetrexed and Pembrolizumab for the Treatment of Recurrent and/or Metastatic Salivary Gland Cancer

Running, not enrolling · Phase 2

Conditions studied: Metastatic Salivary Gland Carcinoma, Recurrent Salivary Gland Carcinoma, Stage IV Major Salivary Gland Cancer AJCC v8, Adenoid Cystic Carcinoma

In brief

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.

Key facts

Study ID

NCT04895735

Run by

Mayo Clinic

People needed

45

Starts

2021-07-23

Expected to finish

2028-02-28

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• REGISTRATION - INCLUSION CRITERIA
• Age >= 18 years
• Histologically confirmed diagnosis of recurrent or metastatic salivary gland cancer not amenable to curative-intent therapy
• COHORT A1: Rochester Minnesota only: Diagnosis of adenoid cystic carcinoma (ACC)
• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria
• NOTE: Tumor lesions in a previously irradiated area are considered measurable disease if progression has been demonstrated in such lesions. Disease that is measurable by physical examination only is not eligible
• Prior treatment:
• Prior treatment with checkpoint inhibitor(s) allowed
• Any number of lines of prior therapy in the recurrent/metastatic setting is permitted at the investigator's discretion
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• NOTE: PS must be assessed again within 7 days prior to first dose of study drug
• Hemoglobin >= 9.0 g/dL (obtained =< 8 days prior to registration)
• NOTE: Must be met without growth factor support and no transfusions <14 days prior to testing
• Absolute neutrophil count (ANC) >= 1500/mm\^3 (obtained =< 8 days prior to registration)
• Platelet count >= 100,000/mm\^3 (obtained =< 8 days prior to registration)
• Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 8 days prior to registration)
• 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)
• Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained =< 8 days prior to registration)
• Creatinine =< 1.5 x ULN OR calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula (obtained =< 8 days prior to registration)
• Negative pregnancy test done =< 7 days prior to registration, for persons of childbearing potential only
• Note: If testing done for eligibility is > 72 hours prior to first dose, then pregnancy testing must be repeated and result must be negative for patient to receive treatment
• Persons able to become pregnant OR able to father a child must be willing to use an adequate method of contraception while on treatment and for 180 days after last treatment
• Life expectancy >= 12 weeks
• Provide written informed consent
• Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

You may not qualify if…

• REGISTRATION - EXCLUSION CRITERIA
• Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception
• Persons expecting to conceive or father children during study treatment or within 180 days (6 months) after the last treatment
• Any of the following prior therapies:
• Surgery < 3 weeks prior to registration
• Systemic anti-cancer therapy < 3weeks prior to registration
• Radiotherapy < 2 weeks prior to registration OR Palliative radiation < 1 week prior to registration
• NOTES: Must have recovered from all radiation related adverse effects (=< grade 1) Must not currently require corticosteroids Must not have had radiation pneumonitis
• Live vaccine < 4 weeks prior to registration
• NOTES: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed
• Received an investigational agent or used an investigational device or participated in a study of an investigational agent < 4 weeks prior to registration
• Known active human immunodeficiency virus (HIV) infection (defined as patients who are not on anti-retroviral treatment and have detectable viral load and CD4+ < 500/ml)
• NOTE: HIV-positive patients who are well controlled on anti-retroviral therapy are allowed to enroll
• Active autoimmune disease requiring systemic treatment < 2 years prior to registration, documented history of severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents with use of disease modifying agents, corticosteroids or immunosuppressive drugs
• NOTE: Exceptions are allowed for:
• Vitiligo
• Resolved childhood asthma/atopy
• Intermittent use of bronchodilators or inhaled steroids
• Daily steroids at dose of =< 10 mg of prednisone (or equivalent)
• Local steroid injections
• Stable hypothyroidism on replacement therapy
• Stable diabetes mellitus on therapy (with or without insulin)

Where it is running

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.