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Pembrolizumab in Treating Participants With Metastatic, Recurrent or Locally Advanced Cancer and Genomic Instability

NCT03428802 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-04-03

Study results available
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Summary

This phase II trial studies how well pembrolizumab works in treating participants with cancer that has spread to other places in the body, has come back or has spread to nearby tissues or lymph nodes. Monoclonal antibodies such as, pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Conditions

  • BRCA1 Gene Mutation
  • BRCA2 Gene Mutation
  • Locally Advanced Solid Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • POLD1 Gene Mutation
  • POLE Gene Mutation
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Ovarian Carcinoma
  • Stage III Breast Cancer AJCC v7
  • Stage III Ovarian Cancer AJCC v8
  • Stage IIIA Breast Cancer AJCC v7
  • Stage IIIA Ovarian Cancer AJCC v8
  • Stage IIIB Breast Cancer AJCC v7
  • Stage IIIB Ovarian Cancer AJCC v8
  • Stage IIIC Breast Cancer AJCC v7
  • Stage IIIC Ovarian Cancer AJCC v8
  • Stage IV Breast Cancer AJCC v6 and v7
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IVA Ovarian Cancer AJCC v8
  • Stage IVB Ovarian Cancer AJCC v8

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Pembrolizumab

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Eugenia Girda, MD · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-08
Primary Completion
2024-11-24
Completion
2027-09-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03428802 on ClinicalTrials.gov