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
Malignancy
Ovarian, Primary Peritoneal Cancer, Fallopian Tube
Stage
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
PI
Adam ElNaggar, MD
Sponsor
Tesaro, Inc.
Phase
Status
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
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Assessment Frequency Link
Path
High grade serous, endometrioid, or clear cell
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X