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

NCT04895735 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: MC200708NCI-2021-0416120-010144
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Adenoid Cystic Carcinoma; Metastatic Salivary Gland Carcinoma; Recurrent Salivary Gland Carcinoma; Stage IV Major Salivary Gland Cancer AJCC v8

Outcome Measures

Primary Outcomes (2)

• Confirmed response rate

  Evaluated by Response Evaluation Criteria in Solid Tumors version 1.1.

  Up to 24 weeks

• Clinical benefit rate (CBR)

  CBR will be defined as the rate of patients with stable disease, partial response or complete response as their best response during treatment.

  Up to 24 weeks

Secondary Outcomes (5)

• Overall survival

  From study entry to death from any cause, assessed up to 3 years

• Progression-free survival

  From study entry to the first of either disease progression or death from any cause, assessed up to 3 years

• Incidence of adverse events

  Up to 3 years

• Response rate [adenoid cystic carcinoma (ACC) cohort]

  Up to 3 years

• CBR (non-ACC cohort)

  Up to 3 years

Other Outcomes (3)

• Frequency of MTAP loss

  Up to 3 years

• Degree of PDL1 expression using formalin-fixed tumor samples

  Up to 3 years

• Expression of thymidylate synthase

  Up to 3 years

Study Arms (1)

Treatment (pembrolizumab, pemetrexed)

EXPERIMENTAL

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.

Biological: Pembrolizumab; Drug: Pemetrexed Disodium; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Procedure: Magnetic Resonance Imaging; Procedure: PSMA PET Scan

Interventions

Computed Tomography PROCEDURE

Undergo CT or PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, Computerized axial tomography (procedure), Computerized Tomography (CT) scan, tomography

Treatment (pembrolizumab, pemetrexed)

Positron Emission Tomography PROCEDURE

Undergo PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (pembrolizumab, pemetrexed)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, nuclear magnetic resonance imaging, sMRI, Structural MRI

Treatment (pembrolizumab, pemetrexed)

PSMA PET Scan PROCEDURE

Undergo PSMA PET

Also known as: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

Treatment (pembrolizumab, pemetrexed)

Pembrolizumab BIOLOGICAL

Given IV

Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475

Treatment (pembrolizumab, pemetrexed)

Pemetrexed Disodium DRUG

Given IV

Also known as: Alimta, Almita, LY231514, N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt

Treatment (pembrolizumab, pemetrexed)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (pembrolizumab, pemetrexed)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Salivary Gland Neoplasms; Carcinoma, Adenoid Cystic

Interventions

pembrolizumab; Pemetrexed; Specimen Handling; Magnetic Resonance Spectroscopy; Glutamate Carboxypeptidase II

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Carboxypeptidases; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloexopeptidases; Metalloproteases

Study Officials

• Katherine A. Price, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

• Ashish Chintakuntlawar, MBBS, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 20, 2021
• Study Start: July 23, 2021
• Primary Completion: August 13, 2025
• Study Completion (Estimated): February 28, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

US (2)