At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed recurrent or metastatic salivary gland cancer not amenable to curative-intent therapy
- ✓Measurable disease by RECIST v1.1 criteria
- ✓ECOG performance status 0 or 1
- ✓Age ≥18 years
- ✕Active CNS metastases (previously treated and stable brain metastases allowed)
- ✕Known leptomeningeal disease
- ✕Active autoimmune disease requiring systemic treatment within 2 years
- ✕Uncontrolled intercurrent illness including active infection, interstitial lung disease, hepatitis B/C, or tuberculosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Pemetrexed and Pembrolizumab in Recurrent and/or Metastatic Salivary Gland Malignancies
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab, Pemetrexed Disodium, and 5 other interventions for Metastatic Salivary Gland Carcinoma and 3 related conditions. Active but no longer recruiting, targeting 45 participants across 2 sites.
Signals
Detailed 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.
Study Details
Timeline
Arms & 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.
Interventions
Given IV
Given IV
Undergo blood sample collection
Undergo CT or PET/CT
Undergo PET
Undergo MRI
Undergo PSMA PET