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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT04895735
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Pemetrexed Disodium — DRUG
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • PSMA PET Scan — PROCEDURE
    Undergo PSMA PET

Study Details

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 Dates

Start date
Jul 23, 2021
Status verified
May 2026
Primary completion
Aug 13, 2025
Completion
Feb 28, 2028

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pembrolizumab, pemetrexed)
    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.

Primary Outcome Measure

Confirmed Response Rate [ Time Frame: 24 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Mayo Clinic in RochesterRochesterMinnesota55905-

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