Pembrolizumab and Pemetrexed for Progressive Chordoma

Part of paid clinical trials in Santa Monica, California.

Sponsor
Saint John's Cancer Institute
Study ID
NCT06794645
Phase
PHASE2
Status
Recruiting
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Conditions

  • Chordoma
  • Chordomas

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day treatment cycle
  • Pemetrexed Phase 2 — DRUG
    pemetrexed 900 mg/m2 IV on Day 1 of each 21-day treatment cycle and supportive medications (folic acid, vitamin B12, and dexamethasone).

Study Details

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.

Key Dates

Start date
Jan 31, 2025
Status verified
Jan 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Eligible patients will receive pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle, and pemetrexed 900 mg/m2 by intravenous (IV) infusion on Day 1 of each 21-day treatment cycle and supportive medications (folic acid, vitamin B12, and dexamethasone).

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Day 1 of study treatment until disease progression up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Providence Saint John's Health CenterSanta MonicaCalifornia90404
Bethany I Wendel, RN-BSN,CCRP
[email protected]
310-582-7427
Akanksha Sharma, MD (SUB_INVESTIGATOR)
Santosh MD, PhD, Kesari (SUB_INVESTIGATOR)
Naveed Wagle, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Providence Saint John's Health Center· Santa Monica, CA

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