West Cancer Center

OVARIAN: RECURRENT: PLATINUM RESISTANT: MOONSTONE

A phase 2 open-label, single-arm study to evaluate the efficacy and safety of the combination of niraparib and TSR-042 in patients with platinum-resistant ovarian cancer (MOONSTONE)

Title

Tesaro 3000-02-006 (MOONSTONE)

Study Title

A phase 2 open-label, single-arm study to evaluate the efficacy and safety of the combination of niraparib and TSR-042 in patients with platinum-resistant ovarian cancer (MOONSTONE)

Site Link

NCT03955471

Malignancy

Ovarian, Primary Peritoneal Cancer, Fallopian Tube

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd, 3rd, or 4th line

Investigational Agent

Niraparib and TSR-042

Drug Class

PARP inhibitor and PD-1 antibody

Adam ElNaggar, MD

Sponsor

Tesaro, Inc.

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Recurrent high-grade serous, endometrioid, or clear-cell ovarian, fallopian tube, or primary peritoneal cancer
Must be considered resistant to the last administered platinum therapy
Must be 2nd, 3rd, or 4th line
Must have been previously treated with platinu-based regimen, taxane, and bevacizumab
Measurable disease
ECOG PS 0-1
Did not have disease progression within 3 months of starting first-line platinum therapy
No known BRCA mutation
No prior therapy with PD-1 or PD-L1 agent
No known immunodeficiency or on steroids >10mg/day prednisone or equivalent
No uncontrolled CNS disease
No other cancers within 2 years
No known HIV, HBV, HCV

Objective

Primary-
- Objective Response Rate (ORR)
Secondary-
- DoR
- PFS
- OS
- DCR

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

High grade serous, endometrioid, or clear cell

Dosing Frequency

Control Agents

Study Protocol

Randomized