Using Genetic Profile to Determine the Treatment for Patients With Ovarian Cancer Who Previously Received a PARP-inhibitor

NCT05065021 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-01-17

No results posted yet for this study

Summary

The purpose of this research study is to see how useful it is to look at biomarkers in the blood and tumor tissue of participants with ovarian, fallopian tube or primary peritoneal cancer who have previously received treatment with a drug called a PARP inhibitor, and using the results to determine the best treatment for these participants. Biomarkers are molecules such as genes (molecules that contain instructions for the development and function of cells in the body) and proteins that may be used to see how well a body responds to certain treatments.

Conditions

Interventions

DRUG

Niraparib

Niraparib works by blocking poly(ADP-ribose) polymerases (PARP) 1 and PARP 2 from working. PARP 1 and PARP 2 are proteins that are involved in cell growth, cell survival, and cell death, including cancer cells. It is believed that blocking PARP1 and PARP 2 from working will slow or stop the growth of cancer cells.

DRUG

Dostarlimab

Dostarlimab is a monoclonal antibody. Antibodies are proteins that are naturally found in the blood stream that fight infections. A monoclonal antibody is a special kind of antibody that is created in a laboratory that seeks out specific proteins in the body that may be involved in cancers to stop tumor growth. Dostarlimab attaches to PD-1 and inhibits the interaction of PD-L1 and PD-L2 with PD-1.

DRUG

Bevacizumab

Bevacizumab is a chemotherapy drug commonly used for the treatment of various cancers.

DRUG

Paclitaxel

Paclitaxel is a chemotherapy drug commonly used for the treatment of various cancers.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY
  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Stephanie Lheureux, M.D. · Princess Margaret Cancer Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-23
Primary Completion
2025-06-06
Completion
2025-06-06

Countries

  • Canada

Study Locations

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Entities

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 NCT05065021 on ClinicalTrials.gov