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Pembrolizumab and Pemetrexed for Progressive Chordoma

NCT06794645 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-01-27

No results posted yet for this study

Summary

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

  • Chordomas
  • Chordoma

Interventions

DRUG

Pembrolizumab

pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day treatment cycle

DRUG

Pemetrexed Phase 2

pemetrexed 900 mg/m2 IV on Day 1 of each 21-day treatment cycle and supportive medications (folic acid, vitamin B12, and dexamethasone).

Sponsors & Collaborators

  • Chordoma Foundation

    collaborator OTHER

  • Saint John's Cancer Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06794645 on ClinicalTrials.gov