Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06794645

Study of Pembrolizumab and High-Dose Pemetrexed for Treating Patients With 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

Researchers are evaluating the effectiveness and safety of a combination treatment using pembrolizumab and high-dose pemetrexed in patients with progressive chordoma, a rare type of cancer that occurs along the spine. This Phase II study aims to determine the objective response rate (ORR) to this drug combination, which is not currently approved for chordoma but is approved for other cancers. The study also explores secondary outcomes like adverse events, disease control, survival rates, tumor changes, quality of life, tumor evolution, and molecular effects of treatment. Participants receive pembrolizumab 200 mg through an intravenous infusion and pemetrexed at a higher than usual dose (900 mg/m2) every 21 days, along with supportive medications including folic acid, vitamin B12, and dexamethasone. These treatments are given in cycles, and dosing is carefully monitored to study how the drugs affect chordoma tumor growth and patient health. Treatment continues until disease progression, study completion, or withdrawal. During the study, participants will undergo regular imaging to measure tumor response, blood tests to assess pharmacodynamic effects, and complete quality of life questionnaires. Researchers will track safety by monitoring adverse events and overall survival up to approximately two years. Participants’ organ function, previous treatments, and disease progression are closely evaluated to ensure safety and adherence to the study protocol throughout the treatment period.

CONDITIONS

Official Title

Pembrolizumab and Pemetrexed for Progressive Chordoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Research Team

N

Naveed Wagle, MD

A

Akanksha Sharma, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Frequently Asked Questions

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Published Research Related To This Trial

Phase 1 Study of Ipilimumab Combined With Whole Brain Radiation Therapy or Radiosurgery for Melanoma Patients With Brain Metastases.

Noelle L Williams, Evan J Wuthrick, Hyun Kim...

https://pubmed.ncbi.nlm.nih.gov/28816150