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NCT05870761 · ClinicalTrials.gov registry record · Phase 2

Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma

A Phase 2 study of Recurrent Endometrial Serous Adenocarcinoma, sponsored by Casey Cosgrove.

Active
Registry status
Phase 2
Development phase
8
Enrollment target
1
Study location

NCT05870761: Active Phase 2 study of Recurrent Endometrial Serous Adenocarcinoma, sponsored by Casey Cosgrove.

NCT05870761 is a Phase 2 study of Recurrent Endometrial Serous Adenocarcinoma that is active but no longer recruiting, run by Casey Cosgrove. The registered enrollment target is 8 participants, below the 43-participant average among 3 other Recurrent Endometrial Serous Adenocarcinoma trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05870761, a Phase 2 study of Recurrent Endometrial Serous Adenocarcinoma, is active but no longer recruiting, sponsored by Casey Cosgrove.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
8 participants
Enrollment target
1
Study location

Study Summary

This phase II trial tests how well niraparib and dostarlimab work in treating patients with uterine serous carcinoma that has come back (after a period of improvement) (recurrent) and remains despite treatment (persistent). Niraparib belongs to a class of drugs called PARP inhibitors that prevent cancer cells from growing. Dostarlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Dostarlimab belongs to a class of drugs called PD-1 inhibitors that uses the patient's own immune system to treat cancer (immuno-therapy). Giving niraparib and dostarlimab may work better in treating patients with uterine serous carcinoma.

Primary Outcome

Defined as the percentage of patients with complete response (CR), or partial response (PR), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 criteria using investigator's review. Will be estimated and reported with 95% confidence intervals (exact).

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • DRUG Niraparib
  • BIOLOGICAL Dostarlimab

Study Locations (1)

Ohio

  • Ohio State University Comprehensive Cancer Center - Columbus

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2023-10-17
Est. Completion 2025-12-31
Phase Phase 2
Casey Cosgrove

1 total trials

What the registry record for NCT05870761 still lists

NCT05870761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 43-participant average among 3 other Recurrent Endometrial Serous Adenocarcinoma trials with a reported enrollment target (81% lower).

The record links to 1 condition, with Recurrent Endometrial Serous Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05870761 reports a single indexed study location in Ohio.

Frequently Asked Questions

What is clinical trial NCT05870761 about?

NCT05870761 is a clinical study titled "Combination Niraparib and Dostarlimab Therapy for Recurrent or Persistent Uterine Serous Carcinoma". This phase II trial tests how well niraparib and dostarlimab work in treating patients with uterine serous carcinoma that has come back (after a period of improvement) (recurrent) and remains despite treatment (persistent). Niraparib belongs to a class of drugs called PARP inhibitors that prevent ca...

What is the current status of trial NCT05870761?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2023-10-17. Estimated completion is 2025-12-31.

What conditions does trial NCT05870761 study?

This clinical trial studies the following conditions: Recurrent Endometrial Serous Adenocarcinoma.

What interventions are being tested in trial NCT05870761?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Niraparib (DRUG), Dostarlimab (BIOLOGICAL).

Who is sponsoring clinical trial NCT05870761?

This trial is sponsored by Casey Cosgrove, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05870761 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05870761, the US trial registry maintained by the National Library of Medicine. NCT05870761 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.