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OVARIAN: METASTATIC: Plat Resistant: Chemo+/-Pembro: KEYNOTE-B96

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96/ENGOT-ov65)

Title
Merck MK3475-B96 Ovarian
Study Title

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96/ENGOT-ov65)

Site Link
Malignancy
Ovary, Ovarian, Primary peritoneal, fallopian tube
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
3rd
Investigational Agent
Pembrolizumab
Drug Class
PD-1 inhibitor
PI
Michael Ulm
Sponsor
Merck Sharp and Dohme
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
  • Has received 1 or 2 prior lines of systemic therapy, including at least 1 prior platinum-based therapy. 
  • Patients may have received prior PARPi, anti-PD-1/L1 or bevacizumab and these are not considered prior line of therapy
  • Radiographic evidence of disease progression within 6 months after the lat dose of platinum-based chemo
  • ECOG PS 0-1
  • Radiographically evaluable disease (measurable or non-measurable)
  • Cannot have primary platinum-refractory disease (defined as PD while actively receiving firstline platinum therapy)
  • Cannot have uncontrolled hypertenstion, clinically relevant bowel obstruction, or rectosigmoid involvement of cancer
  • Cannot have received more than 2 lines prior lines of systemic therapy
  • No known active CNS metastases
  • No known HIV/HBV/HCV
Objective
  • Primary
    • PFS
  • Secondary
    • OS
    • PFS by blinded central review
    • Safety
    • QOL
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Epithelial Carcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X