About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant has the ability to understand and the willingness to provide a signed and dated informed consent form.
Participant has the willingness to comply with all study procedures and availability for the duration of the study.
Participant has a pathologic diagnosis of chordoma.
Evidence of progressive disease within the past six months before study entry, according to RECIST v1.1.
Disqualifiers
Less than 4 weeks for an investigational agent or investigational device
Less than 3 weeks for major surgery
Less than 2 weeks for radiation therapy
Less than 3 weeks for a cytotoxic agent
Trial design
Single group
Treatments tested in this trial
Pembrolizumab
Drugpembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day treatment cycle
Pemetrexed Phase 2
Drugpemetrexed 900 mg/m2 IV on Day 1 of each 21-day treatment cycle and supportive medications (folic acid, vitamin B12, and dexamethasone).
Treatment groups
Trial outcomes
Primary outcomes
Objective Response Rate (ORR)
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. The OOR will be investigator assessed.
Secondary outcomes
Adverse Events of Combination Therapy
To describe the adverse events associated with administering pembrolizumab and high-dose pemetrexed combination treatment.
Median progression-free survival
To determine the median progression-free survival (PFS).
Other outcomes
Disease Control
To determine Disease Contral Rate according to RECIST v1.1, as determined by appropriate imaging modality (CT scan or MRI scan)
PFS at 6 months
To assess the rate of progression free events at six months from start of treatment.
PFS at 9 months
To assess the rate of progression free survival at 9 months from start of treatment.
PFS at 12 months
To assess the rate of progression free survival at 12 months from start of treatment.
Sponsors and contacts
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Saint John's Cancer Institute
Lead sponsor
Chordoma Foundation
Collaborator