Platinum-Sensitive (Pt-S): Treatment given for recurrence occurring 6 months or more after last platinum-based treatment
Objective Response Rate (%)
Percentage of patients whose tumors shrink or go away after treatment
Progression Free Survival (months)
Median length of time before the cancer comes back or gets worse
Platinum-Sensitive (Pt-S): Treatment given for recurrence occurring 6 months or more after last platinum-based treatment
For more detailed information, please click on the clinical trial ID number.
| Drug Class | Trial ID # | Phase | Drugs | Clinical Trial Title | Key Conclusion and Results |
|---|---|---|---|---|---|
| Standard of Care Chemotherapy | |||||
| Chemotherapy | NCT00002894; ICON4 | III | Carboplatin, Cisplatin, Paclitaxel | A Randomized Trial of Paclitaxel (Taxol) in Combination With Platinum Chemotherapy vs. Conventional Platinum-Based Chemotherapy in the Treatment of Women With Relapsed Ovarian Cancer (ICON4) | Improved PFS and OS with addition of paclitaxel to platinum CisPt/CarboPt+Pac vs CisPt/CarboPt: ORR: 66 vs 54% pub 2003 |
| Chemotherapy | NCT00102414; NCIC OV15 | III | Carboplatin, Gemcitabine | A Randomized Phase III Study Comparing Gemcitabine Plus Carboplatin Versus Carboplatin Monotherapy in Patients With Advanced Epithelial Ovarian Carcinoma Who Failed First-Line Platinum-Based Therapy (NCIC OV15) | Improved PFS with addition of gemcitabine to carboplatin CarboPt+Gem vs. CarboPt: ORR: 47.2 vs 30.9%* pub 2006 |
| Chemotherapy | NCT00538603; CALYPSO | III | Carboplatin, Liposomal doxorubicin, Paclitaxel | Multi-national, Randomized, Phase III, GCIG Intergroup Study Comparing Pegylated Liposomal Doxorubicin (CAELYX) and Carboplatin vs. Paclitaxel and Carboplatin in Patients With Epithelial Ovarian Cancer in Late Relapse. (CALYPSO) | Carboplatin+liposomal doxorubicin has similar PFS and OS to carboplatin+paclitaxel with less sensory neuropathy CarboPt+PLD vs CarboPt+Pac: PFS: 11.3 vs 9.4 months* pub 2012 |
| Chemotherapy | GOTIC003; Intergroup study | II | Carboplatin, Gemcitabine, Liposomal doxorubicin | A phase II randomized controlled study of pegylated liposomal doxorubicin and carboplatin vs. gemcitabine and carboplatin for platinum-sensitive recurrent ovarian cancer (GOTIC003/intergroup study) | Carboplatin with liposomal doxorubicin or gemcitabine are comparable; however, the liposomal doxorubicin combo has a more favorable risk-benefit profile than that of the gemcitabine combo CarboPt+PLD vs CarboPt+Gem: ORR: 57.1 vs 56.4% pub 2019 |
| Standard of Care Targeted Drugs | |||||
| Angiogenesis Inhibitors: VEGF | NCT00434642; OCEANS | III | Bevacizumab, Carboplatin, Gemcitabine Prescribing Information | A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma (OCEANS) | Improved ORR and PFS with addition of bevacizumab to carboplatin and gemcitabine, but no OS difference CarboPt+Gem+Bev vs CarboPt+Gem+Placebo: ORR: 78.5 vs 57.4%* pub 2012; 2015 |
| Angiogenesis Inhibitors: VEGF | NCT00565851; GOG-213 | III | Bevacizumab, Carboplatin, Paclitaxel Prescribing Information | A Phase III Randomized Controlled Clinical Trial of Carboplatin and Paclitaxel (or Gemcitabine) Alone or in Combination With Bevacizumab (NSC #704865) Followed by Bevacizumab and Secondary Cytoreductive Surgery in Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary and Fallopian Tube Cancer. NCI-Supplied Agents: Bevacizumab (NSC #704865) (GOG 0213) | Improved ORR, PFS and OS with the addition of bevacizumab to carboplatin+paclitaxel CarboPt+Pac+Bev vs CarboPt+Pac: ORR: 78 vs 59%* pub 2017 |
| Angiogenesis Inhibitors: VEGF | NCT01837251 | III | Bevacizumab, Carboplatin, Gemcitabine, Liposomal doxorubicin | A Prospective Randomized Phase III Trial of Carboplatin/Gemcitabine/Bevacizumab vs. Carboplatin/Pegylated Liposomal Doxorubicin/Bevacizumab in Patients With Platinum-sensitive Recurrent Ovarian Cancer | Improved PFS and OS with addition of liposomal doxorubicin to carboplatin+bevacizumab compared to gemcitabine CarboPt+Gem+Bev vs CarboPt+PLD+Bev: PFS: 11.7 vs 13.3 months* pub 2020 |
| Angiogenesis Inhibitors: VEGF | NCT01802749; MITO16B-MaNGO OV2B | III | Bevacizumab, Carboplatin, Gemcitabine, Liposomal doxorubicin, Paclitaxel | Multicenter Phase III Randomized Study With Second Line Chemotherapy Plus or Minus Bevacizumab in Patients With Platinum Sensitive Epithelial Ovarian Cancer Recurrence After a Bevacizumab/Chemotherapy First Line | Rechallenge with bevacizumab in combination with platinum-based doublets is associated with a significantly prolonged PFS CarboPt+Pac+Bev vs CarboPt+Pac: ORR: 74.6 vs 65.7% abs Jun 2018 |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT01078662; Study 42 | II | Olaparib Prescribing Information | A Phase II, Open Label, Non Randomised, Non Comparative, Multicentre Study to Assess the Efficacy and Safety of Olaparib Given Orally Twice Daily in Patients With Advanced Cancers Who Have a Confirmed Genetic BRCA 1 and/or BRCA2 Mutation (Study 42) | Olaparib shows promising responses in heavily pretreated Pt-S gBRCA MUT patients ORR: 46% pub 2016 |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT02354586; QUADRA | II | Niraparib Prescribing Information | A Phase 2, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Niraparib in Patients With Advanced, Relapsed, High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Have Received Three or Four Previous Chemotherapy Regimens (QUADRA) | Niraparib shows promising activity in late-line treatment setting BRCA MUT: HRD+ (excl. BRCA MUT): pub 2019 |
| DNA Damage Repair Pathway Inhibitors: PARP | Rucaparib FDA Approval Data | II | Rucaparib Prescribing Information | Treatment of BRCA-mutated Ovarian Cancer After 2 or More Chemotherapies | Rucaparib shows promising responses in BRCA MUT patients ORR: 66% pub 2018 |
| Drugs in NCCN Guidelines | |||||
| DNA Damage Repair Pathway Inhibitors: PARP | NCT02354131; AVANOVA | II | Bevacizumab, Niraparib | Part 1: AVANOVA1 - A Phase I Study to Evaluate the Safety and Tolerability of Bevacizumab-niraparib Combination Therapy and Determine the Recommended Phase 2 Dose (RP2D) in Women With Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Part 2: AVANOVA2 - A Two-arm, Open-label, Phase II Randomized Study to Evaluate the Efficacy of Niraparib Versus Niraparib-bevacizumab Combination in Women With Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer. | Promising improvement of activity with niraparib+bevacizumab compared to niraparib alone Nir+Bev vs Nir: ORR: 62 vs 30%* pub 2019, abs May 2020 and poster |
| Angiogenesis Inhibitors: VEGF | NCT01305213 | II | Bevacizumab, Fosbretabulin | A Randomized Phase II Evaluation of Single-Agent Bevacizumab (NSC #704865) and Combination Bevacizumab With Fosbretabulin Tromethamine (CA4P) (NSC #752293) in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma | Improved PFS with addition of fosbretabulin to bevacizumab Bev+Fos vs Bev: PFS: 7.6 vs 6.1 months pub 2016 |
| Drugs in Clinical Development | |||||
| DNA Damage Repair Pathway Inhibitors: PARP | NCT02282020; SOLO-3 | III | Gemcitabine, Liposomal doxorubicin, Olaparib, Paclitaxel, Topotecan | A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physician's Choice Single Agent Chemotherapy in the Treatment of Platinum Sensitive Relapsed Ovarian Cancer in Patients Carrying Germline BRCA1/2 Mutations. | Improved ORR and PFS for gBRCA MUT patients treated with olaparib vs nonplatinum chemotherapy Ola vs TPC: ORR: 72 vs 51%* pub 2020 |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT02446600; NRG-GY004 | III | Carboplatin, Cediranib, Gemcitabine, Liposomal doxorubicin, Olaparib, Paclitaxel | A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | Cediranib+olaparib has similar activity to standard of care in relapsed platinum sensitive ovarian cancer but does not improve PFS; in gBRCA MUT patients cediranib+olaparib and olaparib alone shows substantial activity Ola+Ced vs Ola vs Treatment of Physician's Choice (TPC): ORR: 69.4 vs 52.4 vs 71.3% abs May 2020 and presentation |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT01891344; ARIEL2 Part1 | II | Rucaparib | A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2 Part1) | Improved ORR and PFS with rucaparib treatment in BRCA MUT patients; long term responders most often have homozygous deletion or rearrangements, which would not be susceptible to somatic reversion mutations BRCA MUT vs BRCA WT LOH high vs BRCA WT LOH low: ORR: 80 vs 29 vs 10%* pub 2017, abs May 2020 and poster |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT02983799; LIGHT | II | Olaparib | Non-Randomized, Open-Label Phase II Study to Assess Olaparib Tablets as a Treatment for Subjects With Different HRD Tumor Status and With Platinum-Sensitive, Relapsed, High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer That Have Received at Least 1 Prior Line of Chemotherapy | Olaparib treatment has activity across all cohorts with similar efficacy in the gBRCA MUT and sBRCA MUT cohorts. For non-BRCA MUT patients, longer median PFS and higher ORR are observed in the HRD+ cohort gBRCA MUT: abs May 2020 and poster |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT02734004; MEDIOLA | I/II | Durvalumab, Olaparib | A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors | Promising activity of olaparib+durvalumab in Pt-S gBRCA MUT ovarian cancer patients ORR: 71.9% abs Oct 2019 |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT02660034 | I/Ib | Pamiparib, Tislelizumab | A Phase 1/1b, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activity of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Combination With the PARP Inhibitor BGB-290 in Subjects With Advanced Solid Tumors | Pamiparib+tislelizumab is well tolerated and associated with antitumor responses in both BRCA WT and BRCA MUT ovarian cancer 16 evaluable Pt-S: pub 2019 |
| Antibody Drug Conjugates: FRalpha | NCT02606305; FORWARD II-2 | Ib/II | Bevacizumab, Mirvetuximab Soravtansine | A Phase 1b/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Mirvetuximab Soravtansine (IMGN853) in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab+Carboplatin in Adults With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer | The combination of mirvetuximab soravtansine with bevacizumab demonstrates an encouraging ORR in platinum sensitive patients with high FRalpha expression ORR: 69% abs May 2020 and presentation |
| Angiogenesis Inhibitors: VEGF | NCT02873962 | II | Bevacizumab, Nivolumab | A Phase II Study With a Safety lead-in of Nivolumab in Combination With Bevacizumab or in Combination With Bevacizumab and Rucaparib for the Treatment of Relapsed Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer | Encouraging activity of bevacizumab+nivolumab combination in platinum sensitive patients ORR: 40% pub 2019 |
| Immunotherapy: Checkpoint Inhibitors/CTLA-4 | NCT01611558 | II | Ipilimumab | A Phase II Safety and Efficacy Study of Ipilimumab Monotherapy in Recurrent Platinum Sensitive Ovarian Cancer Subjects | Ipilimumab shows encouraging anti-tumor activity, but with serious side effects ORR: 10.3% pub 2017 |
| Immunotherapy: Vaccine/TAA | NCT02107950 | II | Carboplatin, DCVAC/OvCa, Gemcitabine | A Randomized, Open-label, Parallel Group, Multi-center Phase II Clinical Trial DCVAC/OvCa Added to Standard Chemotherapy in Women With Relapsed Platinum Sensitive Epithelial Ovarian Carcinoma | Significantly prolonged OS with addition of DCVAC/OvCa to carboplatin+gemcitabine Carbo+Gem+DCVAC/OvCa vs Carbo+Gem: PFS: 11.3 vs 10.1 months abs Mar 2019 |