A Phase II Study of Pembrolizumab and High-Dose Pemetrexed for the Treatment of Patients With Progressive Chordoma
Saint John's Cancer Institute
Summary
Primary Objective: 1\. To determine objective response rate (ORR) according to RECIST v1.1 of pembrolizumab and high-dose pemetrexed in the treatment of patients with chordoma until disease progression. The OOR will be investigator assessed. Secondary Objectives: 1. To describe the adverse events associated with administering pembrolizumab and high-dose pemetrexed combination treatment. 2. To determine disease control rate based on imaging and overall survival. 3. To determine median PFS and PFS rates at 6, 9, 12, and 18 months. 4. To evaluate changes in volumetric tumor measurements based on imaging. 5. To determine the effects of combination treatment on quality of life, assessed by the EORTC-QLQ-C30 questionnaire. 6. To assess tumor evolution over time in patients with chordoma based on imaging, and molecular profiling. 7. To assess the pharmacodynamic effects of treatment in blood. Exploratory Objective: 1\. To explore the relationship between molecular phenotype and patient response.
Description
This purpose of this study is to test the effectiveness and safety of the research study drug combination of pembrolizumab and high-dose pemetrexed. Both drugs are approved by the U.S. Food and Drug Administration (FDA) for many different types of cancer but is considered investigational because it is not approved by the FDA for use in patients with a rare type of cancer called chordoma. Pembrolizumab (Keytruda) is approved for use in more than ten types of cancer. Pemetrexed (Alimta) is approved for use in patients with certain types of lung cancer called non-squamous non-small cell lung canc…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet the criteria listed below. 1. Participant has the ability to understand and the willingness to provide a signed and dated informed consent form. 2. Participant has the willingness to comply with all study procedures and availability for the duration of the study. 3. Participant has a pathologic diagnosis of chordoma. 4. Evidence of progressive disease within the past six months before study entry, according to RECIST v1.1. 5. Participant has measurable disease, according to RECIST v1.1. 6. Parti…
Interventions
- DrugPembrolizumab
pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day treatment cycle
- DrugPemetrexed Phase 2
pemetrexed 900 mg/m2 IV on Day 1 of each 21-day treatment cycle and supportive medications (folic acid, vitamin B12, and dexamethasone).
Location
- Providence Saint John's Health CenterSanta Monica, California