EPIK-O/ENGOT-OV61: Alpelisib plus olaparib vs cytotoxic chemotherapy in high-grade serous ovarian cancer (phase III study).
Panagiotis A KonstantinopoulosAntonio Gonzalez-MartinFelipe Melo CruzMichael L FriedlanderRosalind M GlasspoolDomenica LorussoChristian MarthBradley J MonkJae-Weon KimPatsy HinsonOlga AjipaVincent PretreYu HanUrsula A MatulonisPublished in: Future oncology (London, England) (2022)
Patients with platinum-resistant or -refractory high-grade serous ovarian cancer (HGSOC) have a poor prognosis, and their management represents a substantial unmet medical need. Preclinical data and results from a phase Ib trial demonstrated the efficacy and tolerability of the combination of the α-specific phosphatidylinositol-3-kinase (PI3K) inhibitor alpelisib plus the poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor olaparib in platinum-resistant, non- BRCA -mutated ovarian cancer. Here, we describe the study design and rationale for the phase III, multicenter, open-label, randomized, active-controlled EPIK-O/ENGOT-OV61 trial investigating alpelisib in combination with olaparib compared with standard-of-care chemotherapy in patients with platinum-resistant or -refractory HGSOC with no germline BRCA mutation. Progression-free survival (blinded independent review committee) is the primary end point. Overall survival is a key secondary end point. Trial registration number : NCT04729387 (ClinicalTrials.gov).
Keyphrases
- phase iii
- high grade
- open label
- placebo controlled
- double blind
- poor prognosis
- phase ii
- free survival
- clinical trial
- low grade
- study protocol
- phase ii study
- healthcare
- long non coding rna
- protein kinase
- dna repair
- palliative care
- electronic health record
- locally advanced
- randomized controlled trial
- dna damage
- squamous cell carcinoma
- big data
- quality improvement
- stem cells
- machine learning
- affordable care act
- breast cancer risk