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Checkpoint Inhibitors and SBRT for MCRPC

NCT05655715 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-10-16

No results posted yet for this study

Summary

The goal of this investigator-initiated, single-center, and randomized phase II trial is to investigate the potential synergistic effect of combining stereotactic body radiotherapy of a single soft tissue- or bone metastasis with ipilimumab and nivolumab in patients with mCRPC and perform translational analyses on tissue and blood, searching for predictive biomarkers of efficacy and toxicity.

Participants will be randomized to receive ipilimumab and nivolumab with or without stereotactic body radiotherapy (SBRT).

Conditions

Interventions

RADIATION

Stereotactic body radiotherapy

8 Gray x 3

DRUG

Ipilimumab Injection [Yervoy]

1 mg/kg IV Q3W for four doses,

DRUG

Nivolumab Injection [Opdivo]

Nivolumab 3mg/kg IV Q3W for four doses, then then Nivolumab 480mg IV Q4W

PROCEDURE

Biopsies

From soft tissue metastases.

Sponsors & Collaborators

Principal Investigators

  • Rikke HL Eefsen, MD, PhD · Department of Oncology, Herlev and Gentofte Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2024-08-30
Completion
2024-08-30

Countries

  • Denmark

Study Locations

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Entities

Diseases
Companies

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 NCT05655715 on ClinicalTrials.gov