Identification of Markers of Resistance During Frontline Therapy and Maintenance

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The researchers are doing this study to look at the health outcomes of people with advanced ovarian cancer who have a second look laparoscopy (SLL) after they complete their first course of chemotherapy. The researchers will compare the health outcomes of people who have minimal residual disease (MRD-small amounts of cancer cells in the body after a person receives treatment) at the time of SLL with the health outcomes of people who do not have MRD at the time of SLL. The researchers are also doing this study to determine if SLL is safe and practical (feasible) in people with advanced ovarian cancer who have completed the first course of therapy for their disease.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients assigned female at birth≥ 18 years of age

• Suspected or known stage III-IV epithelial ovarian cancer for which the patient has undergone, or is planned to undergo, attempted primary or interval debulking surgery

• Homologous Recombination Deficiency testing should be planned to be completed prior to completion of initial platinum/taxane chemotherapy. HRD testing can be determined using :

‣ Confirmation of deleterious Somatic or Germline BRCA mutation

⁃ CLIA certified test for HRD

• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk -Commack (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Rachel Grisham, MD
grishamr@mskcc.org
646-888-4653
Backup
Kara Long Roche, MD
212-639-7043
Time Frame
Start Date: 2024-01-26
Estimated Completion Date: 2026-01
Participants
Target number of participants: 80
Treatments
Experimental: Second Look Laparoscopy (SLL)
Patients will be treated with standard of care observation or maintenance therapy as per investigator decision.The only investigational intervention performed through this study is the SLL.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov