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Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients

NCT03650894 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-13

No results posted yet for this study

Summary

The goal of this protocol is to evaluate the safety and efficacy of an alternative systemic combination approach that omits or delays the use of chemotherapy in metastatic disease, while improving efficacy and durability of response. The approach combines two potentially effective and previously studied strategies: androgen receptor blockade and immune checkpoint therapy.

Conditions

  • Breast Neoplasm Female
  • Breast Cancer
  • Breast Carcinoma
  • Breast Tumor

Interventions

DRUG

Nivolumab

Nivolumab 240 mg IV every 2 weeks

DRUG

Ipilimumab

Ipilimumab 1 mg/kg IV every 6 weeks.

DRUG

Bicalutamide

Oral bicalutamide 150mg (3 x 50mg tablets) daily

Sponsors & Collaborators

Principal Investigators

  • David B. Page, MD · Providence Health & Services

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2023-03-10
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT03650894 on ClinicalTrials.gov