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/28816150Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06794645
A Phase II Study of Pembrolizumab and High-Dose Pemetrexed for Treatment of Patients With Progressive Chordoma
Led by Saint John's Cancer Institute · Updated on 2025-01-27
21
Participants Needed
1
Research Sites
N/A
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 combination of pembrolizumab and high-dose pemetrexed for treating patients with progressive chordoma, a rare cancer affecting the spine from head to tailbone. This phase II study aims to determine how well this drug combination works by measuring the objective response rate and other outcomes, including safety, disease control, survival, tumor changes, quality of life, and molecular effects. Participants receive pembrolizumab as a 200 mg intravenous infusion and pemetrexed at a higher dose of 900 mg/m2 by intravenous infusion on the first day of each 21-day treatment cycle, along with supportive medications such as folic acid, vitamin B12, and dexamethasone. The treatment continues until disease progression or withdrawal. The study evaluates the effects of this regimen on chordoma growth and safety. During the study, participants will undergo imaging and tumor measurements, blood tests to assess pharmacodynamics, and complete quality of life questionnaires. Researchers will monitor adverse events and progression-free survival for up to two years or until disease progression. The study includes detailed assessments of tumor evolution and molecular profiling to explore how molecular traits relate to treatment response. Participants' involvement averages about two years from start to completion or withdrawal.
CONDITIONS
Brief Title
Pembrolizumab and Pemetrexed for Progressive Chordoma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Ability to understand and provide signed informed consent
- Willingness to comply with all study procedures and availability for study duration
- Pathologic diagnosis of chordoma
- Evidence of disease progression within past 6 months per RECIST v1.1
- Measurable disease according to RECIST v1.1
- Male or female, age 18 years or older
- ECOG performance status of 0 or 1; ECOG 2 allowed if due to spinal cord disease
- Adequate organ function including specified blood counts and liver/kidney tests
- Ability to interrupt NSAIDs around pemetrexed administration
- Ability to take folic acid, vitamin B12, and dexamethasone as scheduled
- Recovery from prior therapy toxicity to grade 1 or baseline
- Hepatitis B and C status per protocol requirements
- Male participants agree to use effective contraception during and 120 days after treatment
- Female participants either not childbearing or agree to use effective contraception during and 120 days after treatment
You will not qualify if you...
- Insufficient time since prior therapies (various minimum intervals specified)
- Receipt of live or live-attenuated vaccine within 30 days before treatment
- Diagnosis of immunodeficiency or recent immunosuppressive therapy
- Active autoimmune disease requiring systemic treatment in past 2 years
- Active infections including bacterial, fungal, or viral
- History or presence of pneumonitis
- Known HIV infection
- Active Hepatitis B or C infection
- History of allogenic tissue or solid organ transplant
- Uncontrolled third space fluid (pleural or peritoneal effusions)
- Severe or uncontrolled medical disorders impairing treatment ability
- Specific cardiovascular conditions including recent myocardial infarction or heart failure class III or IV
- Additional progressing malignancies needing treatment within past 3 years, except certain skin and prostate cancers
- Pregnant or nursing women of childbearing potential
- History of severe hypersensitivity to pembrolizumab or its excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 21-day cycles until disease progression or discontinuation, up to 2 years
Participants receive pembrolizumab and high-dose pemetrexed by intravenous infusion on Day 1 of each 21-day treatment cycle along with supportive medications.
1 visit every 21 days
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
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Published Research Related To This Trial
Pemetrexed: a multitargeted antifolate agent with promising activity in solid tumors.
A A Adjei
https://pubmed.ncbi.nlm.nih.gov/11106124Chordoma: incidence and survival patterns in the United States, 1973-1995.
M L McMaster, A M Goldstein, C M Bromley...
https://pubmed.ncbi.nlm.nih.gov/11227920Chordoma. A clinicopathologic and prognostic study of a Swedish national series.
B Eriksson, B Gunterberg, L G Kindblom
https://pubmed.ncbi.nlm.nih.gov/7211316