OncoMatch/Clinical Trials/NCT06794645
Pembrolizumab and Pemetrexed for Progressive Chordoma
Is NCT06794645 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Pemetrexed Phase 2 for chordomas.
Treatment: Pembrolizumab · Pemetrexed Phase 2 — 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.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: investigational agent or investigational device
Less than 4 weeks for an investigational agent or investigational device
Cannot have received: major surgery
Less than 3 weeks for major surgery
Cannot have received: radiation therapy
Less than 2 weeks for radiation therapy
Cannot have received: cytotoxic agent
Less than 3 weeks for a cytotoxic agent
Cannot have received: targeted therapy
Less than 2 weeks or 5 half-lives, whichever is shorter, for a targeted therapy (e.g. tyrosine kinase inhibitor)
Cannot have received: antibody-based therapy
Less than 3 weeks or 5 half-lives, whichever is shorter, for an antibody-based therapy
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (without erythropoietin dependency and without pRBC transfusion within last 2 weeks)
Kidney function
Serum creatinine ≤ 1.5 x ULN
Liver function
Total bilirubin ≤ 1.5 x ULN (≤ 2.0 x ULN for Gilbert's syndrome); ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN in presence of known hepatic metastasis)
Participant has adequate organ function: ANC ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L (without erythropoietin dependency and without pRBC transfusion within last 2 weeks); Total bilirubin ≤ 1.5 x ULN (≤ 2.0 x ULN for Gilbert's syndrome); ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN in presence of known hepatic metastasis); Serum creatinine ≤ 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Providence Saint John's Health Center · Santa Monica, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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