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

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT03428802
Phase
PHASE2
Status
Active Not Recruiting

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pembrolizumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Mar 8, 2018
Status verified
Mar 2026
Primary completion
Nov 24, 2024
Completion
Sep 21, 2027

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pembrolizumab)
    Participants receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Participants with disease progression may continue pembrolizumab for up to 1 year.

Primary Outcome Measure

Overall Response Rate (ORR) Per RECIST v1.1 [ Time Frame: Up to 2.5 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016-

Related coverage on Hipa.ai

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By research site
Rutgers Cancer Institute of New Jersey· New Brunswick, NJLaura & Isaac Perlmutter Cancer Center at NYU Langone Health· New York, NY

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