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Nivolumab and Ipilimumab Treatment in Prostate Cancer With an Immunogenic Signature

NCT03061539 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2022-09-28

No results posted yet for this study

Summary

The primary objective is to test the following hypothesis: Patients with metastatic castrate resistant prostate cancer that have progressed following at least one line of therapy and have an immunogenic signature will respond to combined PD-1 and CTLA4 inhibition.

Conditions

Interventions

DRUG

Nivolumab & Ipilimumab

Combination Therapy: Cohort 1: Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every 3 weeks for a maximum of 4 cycles . Cohort 2 : Nivolumab 3mg/kg + ipilimumab 1mg/kg every 3 weeks for a maximum of 4 cycles. Treatment free gap after last combination dose : Cohort 1: 6 weeks; Cohort 2: 3 weeks Monotherapy: 480 mg flat dose of nivolumab every 4 weeks for up to 10 cycles, or until progression, unacceptable toxicity or withdrawal of consent

Sponsors & Collaborators

Principal Investigators

  • Dr Mark Linch · University College London Hospitals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2022-06-20
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United Kingdom

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 NCT03061539 on ClinicalTrials.gov