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Study of PD1 Blockade by Pembrolizumab With Stereotactic Body Radiotherapy in Advanced Solid Tumors

NCT02608385 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2025-06-08

No results posted yet for this study

Summary

Phase I to determine safety of combining stereotactic body radiotherapy (SBRT) with pembrolizumab in patients with advanced solid tumors. The study will determine safe doses of radiation by organ site when used together with pembrolizumab. The study will also provide the opportunity to evaluate changes in the tumor caused by SBRT.

The study will include 2 expansion cohorts:

* Partially Irradiated Large Volume Tumors Cohort: Patients with at least one lesion greater than 65cc amenable to SBRT followed by pembrolizumab.
* Oligometastatic Cohort: Patients with limited metastatic disease (4 or fewer lesions)

Conditions

Interventions

RADIATION

Stereotactic body radiotherapy (SBRT)

Patients will receive 3 or 5 doses of SBRT to the chosen metastases.

DRUG

Pembrolizumab

Pembrolizumab (200 mg) given every 3 weeks.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Steven Chmura, M.D. · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2022-04-01
Completion
2026-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT02608385 on ClinicalTrials.gov