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Anti-PD-1 +/- RT for MSI-H Solid Tumors

NCT04001101 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2021-11-30

No results posted yet for this study

Summary

To determine if the out-of-field ORR is improved with the addition of radiation therapy to anti-PD-1 for patients with MSI-H/dMMR metastatic solid tumors. Determine the rates of in-field tumor control, disease control (stable disease, partial response, complete response), durability of disease response, progression-free survival, overall survival, and to assess quality of life and toxicity. Determine the chronology and profile of the radiation-associated immune response.

Conditions

Interventions

COMBINATION_PRODUCT

RT and Anti-PD-1

limited metastatic site radiation

DRUG

Anti-PD-1

anti-PD-1 therapy alone

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Cancer League of Colorado

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-10
Primary Completion
2021-11-17
Completion
2021-11-17

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04001101 on ClinicalTrials.gov