CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 5 enrolled
Drug / intervention
Stereotactic radiotherapy +2 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT03220854
NCT03220854Phase 2Completed

Phase 2 Clinical Trial of Stereotactic Radiotherapy (SRT) and PD-1 or PD-L1 Inhibiting Therapy for Treatment of Advanced Solid Tumors After Disease Control on PD-1 or PD-L1 Inhibiting Therapy

Virginia Commonwealth University·interventional·Posted Jul 18, 2017·Updated Jan 10, 2022

In Brief

A Phase 2 clinical trial evaluating Stereotactic radiotherapy, Biological: humanized anti-PD-1 monoclonal antibody, and 1 other intervention for Solid Tumor. Completed, enrolled 5 participants across 1 site.

Detailed Summary

The purpose of this study is to find out if having radiation therapy and continuing immunotherapy can improve the benefit of immunotherapy. There have been reports of patients who were treated with radiation therapy that not only caused the treated tumors to shrink or stop growing, but also resulted in tumors that had not been treated in other parts of the body to shrink or stop growing. This effect is thought to be brought about by cells in the body's immune system that become active as a result of the effects of radiation therapy. If radiation therapy can stimulate the immune system, it may be possible for immunotherapy to be helpful again in treating a cancer that the immunotherapy drug helped treat before. This study will also check if receiving immunotherapy at the end of radiation therapy has any effect on the side effects of radiation therapy or immunotherapy.

Study Details

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

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 18, 2017
Enrollment StartOct 10, 2017
Primary CompletionJan 27, 2020
Study CompletionSep 22, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.0 years ago

Interventions

Stereotactic radiotherapyradiation

Treatment will be planned to deliver a total of 18 to 60 Gy to the planning target volume (PTV) in 3 to 5 fractions over 1 to 2 weeks.

Biological: humanized anti-PD-1 monoclonal antibodyother

Standard of Care - patient will continue to be given the same PD-1 inhibitor they were receiving prior to study registration

Biological: humanized anti-PD-L1 monoclonal antibodyother

Standard of Care - patient will continue to be given the same PD-L1 inhibitor they were receiving prior to study registration