A Study of Second Look Laparoscopy (SLL) in People With Ovarian Cancer Who Have Completed Their First Course of Chemotherapy

Phase 2

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Procedure: Second Look Laparoscopy

• Registration Number: NCT06240598
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-26
• Study First Submitted: 2024-01-26
• Study First Submitted QC: 2024-01-26
• Study First Posted: 2024-02-05
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

• Patients with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or drainage gastrostomy tube
• Patients receiving standard of care or investigational protocol directed treatment are eligible for this study, with the exception of protocol directed treatment which would prohibit the SLL surgery from being performed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Second Look Laparoscopy (SLL)	Second Look Laparoscopy	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.

Primary Outcome Measures

Name	Time	Method
minimal residual disease (MRD) status	up to 12 weeks	will be based on surgicopathological findings from multiple biopsies and peritoneal cytology obtained during the SLL procedure

Trial Locations

Locations (7)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Suffolk -Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States