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 |
| 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 Prescribing Information | 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 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* abs Oct 2018 |
| Angiogenesis Inhibitors: VEGF | NCT01802749; MITO16B-MaNGO OV2B | III | Bevacizumab, Carboplatin, Gemcitabine, Liposomal doxorubicin, Paclitaxel Prescribing Information | 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 | |||||
| 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 | |||||
| Chemotherapy | NCT01846611; OVC-3006 | III | Liposomal doxorubicin, Trabectedin | A Randomized, Open-Label Study Comparing the Combination of YONDELIS and DOXIL/CAELYX With DOXIL/CAELYX Monotherapy for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | Trabectedin+liposomal doxorubicin shows antitumor activity in gBRCA MUT patients Tra+PLD vs PLD: PFS: 7.5 vs 7.3 months gBRCA MUT: abs Mar 2019 |
| 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 | NCT01116648 | II | Cediranib, Olaparib | Phase I/II Study of Cediranib and Olaparib in Combination for Treatment of Recurrent Papillary-Serous Ovarian, Fallopian Tube, or Peritoneal Cancer or for Treatment of Recurrent Triple-Negative Breast Cancer | Improved ORR, PFS and OS for olaparib+cediranib combination in patients with gBRCA WT or unknown BRCA status Ola+Ced vs Ola: gBRCA WT or UNK: gBRCA MUT: pub 2014; 2019 |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT01540565 | II | Veliparib | A Phase II Evaluation of the Poly (ADP-Ribose) Polymerase (PARP)-1 and -2 Inhibitor Veliparib (ABT-888) (NSC#737664) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Who Carry a Germline BRCA1 or BRCA2 Mutation | Veliparib shows encouraging activity in gBRCA MUT cancer ORR: 35% pub 2015 |
| 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 BRCA MUT vs BRCA WT LOH high vs BRCA WT LOH low: ORR: 80 vs 29 vs 10%* pub 2017 |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT02345265 | II | Cediranib, Olaparib | A Phase 2 Study of Olaparib and Cediranib for the Treatment of Recurrent Ovarian Cancer | Olaparib+cediranib is effective independent of gBRCA status ORR: 74.3% abs Jun 2018 |
| 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 activity of niraparib+bevacizumab Nir+Bev vs Nir: ORR: 62 vs 30% pub 2019 |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT02734004 | 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 | Ib/II | Bevacizumab, Carboplatin, 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 | Encouraging activity of mirvetuximab soravtansine combinations in FRalpha-positive patients Mir+CarboPt: ORR: 71% Mir+CarboPt+Bev: 1-2 prior therapies: pub 2018, abs Oct 2019 |
| 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 Pt-S patients ORR: 40% pub 2019 |
| Signaling Pathway Inhibitors: PI3K-AKT-mTOR/mTOR | NCT01010126 | II | Bevacizumab, Temsirolimus | A Phase 2 Trial of Temsirolimus and Bevacizumab in Patients With Endometrial, Ovarian, Hepatocellular Carcinoma, Carcinoid or Islet Cell Cancer | Temsirolimus+bevacizumab has activity in Pt-S ovarian cancer but with substantial toxicity ORR: 24% abs Jun 2013 and poster |
| Signaling Pathway Inhibitors: PI3K-AKT-mTOR/mTOR | NCT01031381 | II | Bevacizumab, Everolimus | Phase II Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer An Investigator-initiated, Single-institution Trial at Magee-Womens Hospital | Everolimus+bevacizumab does not improve responses compared to bevacizumab alone in Pt-S ovarian cancer patients, but selected patients with alterations in the PI3K/mTOR pathway may have benefit ORR: 16.7% pub 2020 |
| Cell Cycle Inhibitors: p53 | NCT02098343 | II | APR-246, Carboplatin, Liposomal doxorubicin | PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246 | Encouraging activity of APR-246+carboplatin+liposomal doxorubicin in TP53-mutated Pt-S and partially Pt-S patients ORR: 62% abs Jun 2016 |
| 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: Antibodies/FRalpha | NCT00849667 | III | Carboplatin, Farletuzumab, Paclitaxel | A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse | PFS and OS benefit with addition of farletuzumab to carboplatin+paclitaxel in patients with baseline CA125 levels ≤3xULN CarboPt+Pac+Far vs CarboPt+Pac+Placebo: PFS: 13.6 vs 8.8 months* pub 2016 |
| Immunotherapy: Vaccine/TAA | NCT02107950 | II | Carboplatin, Gemcitabine, DCVAC/OvCa | 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 |