Pembrolizumab and Pemetrexed for Progressive Chordoma

This study is testing a combination of two FDA-approved drugs, pembrolizumab (Keytruda) and pemetrexed (Alimta), for people with chordoma that is getting worse. While these drugs are approved for other cancers, they are not yet approved for chordoma. The study will use a higher dose of pemetrexed than typically approved to see if it's more effective for chordoma. Researchers want to see how many people respond to the treatment, how safe it is, and how it affects quality of life. You may be able to join if you are 18 or older, can understand and sign a consent form, and are willing to follow all study procedures. The study aims to enroll 21 participants.

Study design
This is an interventional study with a planned enrollment of 21 participants. It is testing the effectiveness and safety of a drug combination.
What's involved
You would receive pembrolizumab and pemetrexed by IV infusion on Day 1 of each 21-day treatment cycle, along with supportive medications. Outcome measures will be monitored until disease progression, through study completion (estimated average of 2 years), or withdrawal from the study.
Compensation
Not stated in the trial record.
Follow-up
Outcome measures will be monitored until disease progression, through study completion (estimated average of 2 years), or withdrawal from the study.

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NCT06794645

Pembrolizumab and Pemetrexed for Progressive Chordoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Saint John's Cancer Institute
~21 participants
Updated 2025-01-27 on ClinicalTrials.gov
What's tested:PembrolizumabPemetrexed Phase 2

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over Day 1 of study treatment until disease progression up to 2 years
Chordomas
Chordoma

NCT06794645

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Providence Saint John's Health Center

    Santa Monica, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.
Participants must have completed curative anti-viral therapy at least 4 weeks prior to study intervention 13. Male participant: agrees to use highly effective contraception as detailed in Section 4.3.2 of this protocol during the treatment period and for at least 120 days after the last dose of study intervention and refrain from donating sperm during this period.
  • Objective Response Rate (ORR)Day 1 of study treatment until disease progression up to 2 years

    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.