Actively Recruiting
Pembrolizumab and Pemetrexed for Progressive Chordoma
Led by Saint John's Cancer Institute · Updated on 2025-01-27
21
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
S
Saint John's Cancer Institute
Lead Sponsor
C
Chordoma Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pembrolizumab and Pemetrexed for Progressive Chordoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to provide signed informed consent
- Willingness to comply with all study procedures and availability for study duration
- Pathologic diagnosis of chordoma
- Evidence of progressive disease within 6 months before study entry according to RECIST v1.1
- Measurable disease per RECIST v1.1
- Male or female aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at study entry (special allowance for ECOG 2 if due to spinal cord impingement)
- Adequate organ function including ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 9 g/dL without recent transfusion, bilirubin ≤ 1.5 x ULN (up to 2.0 x ULN for Gilbert's syndrome), ALT/AST ≤ 2.5 x ULN (≤ 5 x ULN with hepatic metastasis), and serum creatinine ≤ 1.5 x ULN
- Ability to interrupt NSAIDs before and after pemetrexed administration as required
- Ability to take folic acid, vitamin B12, and dexamethasone per protocol
- Recovery from prior therapy-related toxicity to Grade 1 or baseline at study entry
- For Hepatitis B positive: on antiviral therapy ≥ 4 weeks with undetectable viral load
- For Hepatitis C history: undetectable viral load and completed curative therapy ≥ 4 weeks prior
- Male participants agree to use highly effective contraception during treatment and 120 days after last dose
- Female participants either not of childbearing potential or agree to use highly effective contraception during treatment and 120 days after last dose
You will not qualify if you...
- Insufficient time since prior therapies including investigational agents (<4 weeks), major surgery (<3 weeks), radiation (<2 weeks), cytotoxic agents (<3 weeks), targeted therapies (<2 weeks or 5 half-lives), and antibody therapies (<3 weeks or 5 half-lives)
- Receipt of live or live-attenuated vaccines within 30 days before first dose
- Diagnosis of immunodeficiency or use of chronic systemic steroids >10 mg prednisone equivalent or other immunosuppressive therapy within 7 days prior
- Active autoimmune disease requiring systemic treatment in past 2 years (excluding replacement therapies)
- Active bacterial infection requiring IV antibiotics, fungal infection, or detectable viral infection at treatment start
- History or current pneumonitis
- Known HIV infection
- Active Hepatitis B or C infection
- History of allogeneic tissue or solid organ transplant
- Uncontrolled third space fluid that cannot be drained
- Severe or uncontrolled medical disorders impairing ability to receive intervention including uncontrolled diabetes, dialysis-dependent renal disease, pulmonary disorders requiring oxygen, interstitial lung disease, major prior gastrointestinal surgery, Crohn's disease, ulcerative colitis, uncontrolled vasculitis, baseline Grade 2 or higher diarrhea, or psychiatric/substance abuse issues interfering with trial participation
- Significant cardiovascular conditions including syncope of cardiac cause, pathological ventricular arrhythmias, recent myocardial infarction, unstable angina, sudden cardiac arrest, or congestive heart failure NYHA Class 3 or higher
- Known progressing additional malignancy or requiring active treatment within past 3 years (with exceptions for certain skin cancers and organ-confined prostate cancer)
- Pregnant or nursing women of childbearing potential
- History of severe hypersensitivity (Grade 3 or higher) to pembrolizumab or its excipients
AI-Screening
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Trial Site Locations
Total: 1 location
1
Providence Saint John's Health Center
Santa Monica, California, United States, 90404
Actively Recruiting
Research Team
N
Naveed Wagle, MD
CONTACT
A
Akanksha Sharma, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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