Table 1

Ongoing clinical trials investigating the use of PARPi for systemic therapy de-escalation strategies in ovarian cancer

(NCT identifier)
DesignPARPiAdjuvant therapyBiomarker statusPrimary endpointsEstimated enrollmentStatus
Upfront: neoadjuvant
 NOW (NCT03943173)Monocenter, single-arm, phase IOlaparib 300 mg orally twice daily for two 28-day cyclesEither surgery → CHT for up to four cycles or NACT for up to four cycles → surgery, followed by olaparib, at the physician’s discretion BRCA-mutatedFeasibility17Recruiting
Multicenter, single-arm, phase IIOlaparib 300 mg orally twice daily for two 21-day cycles ± pembrolizumabNRHRDORR30Active, not recruiting
Multicenter, single-arm, phase IIOlaparib 300 mg orally twice daily for three consecutive days (D1-D3), every week for each cycle plus weekly carboplatin and paclitaxel for three cyclesCarboplatin and paclitaxel BRCA-mutatedPathological complete response35Unknown
Monocenter, single-arm, phase I, randomized window-of-opportunity studyOlaparib for 10–14 daysNRNRChanges in the expression of biomarkersOlaparib: 32
Control: 16
Multicenter, single-arm, phase IINiraparib 100–300 mg once dailyNRHRDORR, R0 resection rate53Recruiting
Multicenter, phase II, multicohort umbrella, randomizedNiraparib 100–300 mg once daily for three 21-day cycles vs standard of care plus one run-in cycle of carboplatin-paclitaxel during pre-screeningUp to three 21-day cycles of platinum-taxane doublet ± bevacizumab followed by niraparib ± bevacizumabHRDORR125Recruiting
Upfront: adjuvant
 N-PLUS (NCT05460000)Multicenter, phase III, randomized (1:1)Niraparib 100–300 mg once daily following PDS with R0Six cycles vs three cycles of carboplatin and paclitaxelHRDRFS640Recruiting
Recurrence (platinum-eligible)
Multicenter, phase II, randomizedOlaparib 300 mg orally twice daily for six weeks (± two weeks) prior to surgeryOlaparib, 300 mg orally twice daily ± standard chemotherapyAll-comersDifference in levels of PAR or PARP-1 before and after olaparib. Mutations in HR genes in germline tissue compared with tumor tissue.71Active, not recruiting
  • BRCA, BReast CAncer genes; CHT, chemotherapy; HR, homologous recombination; HRD, homologous recombination deficiency; NACT, neoadjuvant chemotherapy; NCT, National Clinical Trial identifier number; NR, not reported; ORR, overall response rate; PAR, poly(ADP-ribose); PARPi, poly(ADP-ribose) polymerase inhibitors; PDS, primary debulking surgery; R0, no gross residual tumor after surgery; RFS, recurrence-free survival.