CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Pembrolizumab +1 morebiological
Likely dose
Pembrolizumab IV (specific dose not stated in provided text)AI-extracted
Key inclusion· 7
  • Newly diagnosed or localized recurrent/oligometastatic soft tissue sarcoma candidates for radiation (≤3 lesions if oligometastatic, all to be radiated)
  • Intermediate-grade tumors ≥3 cm or high-grade tumors ≥1.5 cm in maximum dimension
  • Plans for neoadjuvant radiation (minimum 45 Gy over ≥25 fractions) and curative-intent surgery
  • ECOG 0-1 or Karnofsky >70%
Key exclusion· 16
  • Prior radiation to affected area
  • Sarcoma subtypes with established neoadjuvant chemotherapy: extra-skeletal Ewing's sarcoma, embryonal rhabdomyosarcoma, alveolar rhabdomyosarcoma (pleomorphic RMS allowed; bone sarcomas and osteosarcoma excluded)
  • Prior systemic therapy or radiation for this sarcoma (prior therapy for different cancer allowed)
  • Prior anti-PD-1, anti-PD-L1, anti-CTLA4, anti-PD-L2, or other T-cell checkpoint inhibitor agents

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03338959
NCT03338959Phase 2Completed

A Pilot Study of Pembrolizumab and Neoadjuvant Radiation for Large, High-Risk Soft Tissue Sarcomas

Fred Hutchinson Cancer Center·interventional·Posted Nov 9, 2017·Updated Jul 23, 2024

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and Radiation Therapy for Soft Tissue Sarcoma and Recurrent Soft Tissue Sarcoma. Completed, enrolled 27 participants across 1 site.

Detailed Summary

This phase I/II trial studies pembrolizumab and radiation therapy in treating patients with intermediate or high-grade soft tissue sarcoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy may work better in treating patients with soft tissue sarcoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedNov 9, 2017
Enrollment StartMar 28, 2018
Primary CompletionJun 8, 2023
Study CompletionAug 4, 2023
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 8.6 years ago

Interventions

Pembrolizumabbiological

Given IV

Radiation Therapyradiation

Undergo radiation therapy