Platinum-Resistant/Refractory (Pt-R/Rf): Treatment given for recurrence occurring less than 6 months after last platinum-based treatment or for progression during 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-Resistant/Refractory (Pt-R/Rf): Treatment given for recurrence occurring less than 6 months after last platinum-based treatment or for progression during 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 | NCT00191607 | III | Gemcitabine, Liposomal doxorubicin | A Randomized Phase III Trial of Gemzar Versus Doxil With Crossover Treatment Option for Patients With Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer Undergoing Second or Third-Line Chemotherapy | Comparable efficacy for liposomal doxorubicin and gemcitabine with different toxicity profiles PLD vs Gem: ORR: 8.3 vs 6.1% pub 2007 |
| Chemotherapy | Study 30-49; Trial 4 | III | Liposomal doxorubicin, Topotecan Prescribing Information | Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan | Liposomal doxorubicin and topotecan have similar efficacy, but very different toxicity profiles PLD vs Top: ORR: 12.3 vs 6.5% pub 2001 |
| Chemotherapy | NCT00023907 | II | Paclitaxel | A Phase II Evaluation of Weekly Paclitaxel in the Treatment of Recurrent or Persistent Platinum and Paclitaxel-Resistant Ovarian or Primary Peritoneal Cancer | Weekly paclitaxel shows promising activity in Pt-R and Pt-Rf patients ORR: 20.9% pub 2006 |
| Standard of Care Targeted Drugs | |||||
| Angiogenesis Inhibitors: VEGF | NCT00976911; AURELIA | III | Bevacizumab, Liposomal doxorubicin, Paclitaxel, Topotecan Prescribing Information | AURELIA: A Multi-center, Open-label, Randomised, Two-arm Phase III Trial of the Effect on Progression Free Survival of Bevacizumab Plus Chemotherapy Versus Chemotherapy Alone in Patients With Platinum-resistant, Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer | Improved ORR and PFS with addition of bevacizumab to liposomal doxorubicin, paclitaxel or topotecan (most evident with paclitaxel), but no OS benefit Pac/PLD/Top+Bev vs Pac/PLD/Top: ORR: 28.2 vs 12.5%* pub 2014; 2015 |
| Angiogenesis Inhibitors: VEGF | UMIN000017247; JGOG3023 | II | Bevacizumab, Gemcitabine, Liposomal doxorubicin, Paclitaxel, Topotecan | An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without Bevacizumab in Platinum-resistant ovarian cancer patients previously treated with Bevacizumab for front-line or Platinum-sensitive ovarian cancer: -JGOG3023 trial- | Retreatment with bevacizumab is effective and AEs are manageable for platinum resistant recurrent ovarian cancer previously treated with bevacizumab for front-line or platinum sensitive recurrence Gem/Pac/PLD/Top+Bev vs Gem/Pac/PLD/Top: ORR: 25.0 vs 13.7% pub 2021 |
| 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-R gBRCA MUT patients ORR: 30% 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 platinum resistant patients in late-line treatment setting 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: 25% pub 2018 |
| Drugs in NCCN Guidelines | |||||
| Chemotherapy | NCT00002478 | II | Etoposide | Phase II Study of Prolonged Oral VP-16 for Advanced Ovarian Epithelial and Cervical Cancer | Prolonged etoposide regimen shows activity, but has hematologic toxicity ORR: 26.8% pub 1998 |
| Chemotherapy | NCT00004037 | II | Docetaxel | Evaluation of Docetaxel in Recurrent, Platinum Resistant, Refractory and Paclitaxel Refractory Ovarian Cancer and Primary Peritoneal Carcinoma | Docetaxel shows activity, but with significant hematologic toxicity ORR: 22.4% pub 2003 |
| Chemotherapy | NCT00087087 | II | Pemetrexed | A Phase II Evaluation of Pemetrexed (Alimta, LY231514l, IND # 40061) in the Treatment of Recurrent or Persistent Platinum Resistant Ovarian or Primary Peritoneal Carcinoma | Pemetrexed has favorable antitumor activity with mild and non-cumulative toxicity ORR: 21.4% pub 2009 |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT02354586; QUADRA | II | Niraparib | 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 some activity in platinum resistant patients in late-line treatment setting HRD+ (incl. BRCA MUT): HRD+ (excl. BRCA MUT): pub 2019 |
| Angiogenesis Inhibitors: VEGF | NCT00097019 | II | Bevacizumab | A Multicenter, Single-Arm, Phase II Trial of Bevacizumab in Subjects With Platinum-Resistant Epithelial Carcinoma of the Ovary or Primary Peritoneal Carcinoma for Whom Subsequent Doxil or Topotecan Therapy Has Failed | Bevacizumab has single-agent activity, but risk of GI-related adverse events ORR: 15.9% pub 2007 |
| Angiogenesis Inhibitors: VEGF | Retrospective Study: Bevacizumab and Cyclophosphamide | II | Bevacizumab, Cyclophosphamide | The combination of intravenous bevacizumab and metronomic oral cyclophosphamide is an effective regimen for platinum-resistant recurrent ovarian cancer | Cyclophosphamide+bevacizumab is an effective, well-tolerated combination in heavily pretreated patients ORR: 42.4% pub 2013 |
| Angiogenesis Inhibitors: Multi-targeted RTK | NCT01047891 | II | Sorafenib, Topotecan | A Randomized, Double-blind, Placebo Controlled, Multicenter Phase II Study to Assess the Efficacy and Safety of Sorafenib Added to Standard Treatment With Topotecan in Patients With Platinum-resistant Recurrent Ovarian Cancer | Sorafenib given with topotecan (5-day schedule) and continued as maintenance therapy results in a significant improvement in ORR, PFS and OS ORR: 31 vs 12%* pub 2018 |
| Drugs in Clinical Development | |||||
| Chemotherapy | NCT03093155 | II | Bevacizumab, Ixabepilone | A Randomized Phase II Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab in Recurrent or Persistent Platinum-resistant/Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers | Ixabepilone+bevacizumab is a well-tolerated, effective combination for treatment of platinum/taxane resistant ovarian cancer that extends both PFS/OS relative to ixabepilone monotherapy and prior receipt of bevacizumab should not preclude use of ixabepilone+bevacizumab Ixa+Bev vs Ixa: abs Mar 2021 |
| Chemotherapy | Rose (2003) CisPt+Gem | II | Cisplatin, Gemcitabine | Phase II study of cisplatin plus gemcitabine in platinum-resistant and platinum-refractory ovarian cancer | Cisplatin+gemcitabine is active in Pt-R and Pt-Rf patients ORR: 42.9% pub 2003 |
| Chemotherapy | UMIN000004449 | II | Gemcitabine, Irinotecan | Phase I/II Trial of Gemcitabine and Irinotecan in Patients with Platinum Refractory and Resistant Ovarian cancer | Tailored-dose chemotherapy with gemcitabine+irinotecan is effective and well tolerated in patients with platinum-refractory/resistant ovarian cancer ORR: 20% pub 2021 |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT01891344; ARIEL2 | 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) | In platinum resistant patients rucaparib is most effective in patients that have BRCA1/2 mutations BRCA MUT vs BRCA WT LOH high vs BRCA WT LOH low: ORR: 23.4 vs 4.1 vs 5.4% pub 2021 |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT03699449 | II | Cediranib, Olaparib | An uMbrella Study of BIomarker-driven Targeted Therapy In Patients With Platinum-resistant Recurrent OvariaN Cancer(AMBITION) | Olaparib+cediranib shows promising activity in BRCA MUT patients ORR: 50% abs Jun 2021 and poster |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT02889900; CONCERTO | II | Cediranib, Olaparib | A Single Arm, Open-label, Phase IIb Study to Assess the Efficacy and Safety of the Combination of Cediranib and Olaparib Tablets in Women With Recurrent Platinum Resistant Epithelial Ovarian Cancer, Including Fallopian Tube and/or Primary Peritoneal Cancer Who do Not Carry a Deleterious or Suspected Deleterious Germline BRCA Mutation | Olaparib+cediranib has manageable toxicity and shows evidence of anti-tumor activity in heavily pretreated platinum resistant non-gBRCA MUT patients ORR: 15.6% abs May 2020 and poster
|
| DNA Damage Repair Pathway Inhibitors: PARP | NCT03314740; BAROCCO | II | Olaparib, Cediranib | The BAROCCO Study (Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib): an Italian Multicenter Randomized Phase II Study of Weekly Paclitaxel vs. Cediranib-Olaparib With Continuous Schedule vs. Cediranib-Olaparib With Intermittent Schedule in Patients With Platinum Resistant High Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. | Olaparib+cediranib (continuous dosing) shows a promising trend towards improved PFS in comparison with weekly paclitaxel, in particular in BRCA WT patients Ola+Ced (continuous) vs Ola+Ced (intermittent) vs Pac: gBRCA WT: abs Oct 2019 |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT03574779; OPAL | II | Bevacizumab, Niraparib, Dostarlimab | Phase 2 Multicohort Study to Evaluate the Safety and Efficacy of Novel Treatment Combinations in Patients With Recurrent Ovarian Cancer | Triplet therapy with niraparib, dostarlimab, and bevacizumab is tolerable and demonstrates clinical activity in patients with BRCA WT platinum resistant ovarian cancer without HRR gene mutations ORR: 17.9% w/ prior Bev: ORR: 6% abs Mar 2021 |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT02657889; TOPACIO | I/II | Niraparib, Pembrolizumab | Phase 1/2 Clinical Study of Niraparib in Combination With Pembrolizumab (MK-3475) in Patients With Advanced or Metastatic Triple-Negative Breast Cancer and in Patients With Recurrent Ovarian Cancer (TOPACIO) | Promising activity of niraparib+pembrolizumab in platinum resistant patients independent of BRCA status, HRD status and PD-L1 expression ORR: 21% pub 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 18 evaluable Pt-R: pub 2019 |
| DNA Damage Repair Pathway Inhibitors: ATR | NCT02595892 | II | Berzosertib, Gemcitabine | Phase 2 Study of M6620 (VX-970) in Combination With Gemcitabine Versus Gemcitabine Alone in Subjects With Platinum-Resistant Recurrent Ovarian or Primary Peritoneal Fallopian Tube Cancer | Addition of berzosertib to gemcitabine increases PFS without additional toxicity, the benefit was observed mainly in patients with platinum-free interval less than 3 months Ber+Gem vs Gem: PFS: 5.7 vs 3.7 months* pub 2020, pub 2021 |
| Antibody Drug Conjugates: FRalpha | NCT02631876; FORWARD I | III | Liposomal doxorubicin, Mirvetuximab soravtansine, Paclitaxel, Topotecan | FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer | Mirvetuximab soravtansine has favorable tolerability and benefit-risk profile compared to chemotherapy in FRalpha high patients Mir vs TPC (PLD, Pac, Top): FRalpha high (10X scoring method): ORR: 24 vs 10%* FRalpha high (PS2+ scoring method): ORR: 26 vs 6%* pub 2021 |
| Antibody Drug Conjugates: FRalpha | NCT04296890; SORAYA | III | Mirvetuximab soravtansine | SORAYA: A Phase 3, Single Arm Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression | Mirvetuximab shows impressive activity and tolerability in FRα-high platinum resistant ovarian cancer ORR: 32.4% press release Nov 2021 |
| 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 resistant patients with high FRalpha expression ORR: 59% abs Jun 2021 and presentation |
| Antibody Drug Conjugates: FRalpha | NCT02996825 | I | Gemcitabine, Mirvetuximab soravtansine | A Phase I Dose-Escalation Safety and Tolerability Study of MirvetuximabSoravtansine (IMGN853) and Gemcitabine in Patients With FRa-positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial Cancer, or Triple Negative Breast Cancer (TNBC) | Mirvetuximab soravtansine+gemcitabine can be combined at clinically relevant doses with promising efficacy, particularly in FRalpha med/high tumors ORR: 40.9% abs Jun 2021 and poster |
| Antibody Drug Conjugates: FRalpha | NCT03748186 | I | STRO-002 | A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody-Drug Conjugate (ADC), in Patients With Advanced Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) and Endometrial Cancers | STRO-002 is well tolerated with evidence of anti-tumor activity in heavily pretreated patients. No ocular toxicity signals have been observed. Durable responses and anti-tumor activity have been demonstrated across a broad range of FRα expression levels Results from dose escalation, doses 2.9 mg/kg and above: ORR: 32% abs Jun 2021 and poster |
| Antibody Drug Conjugates: Axl | NCT02988817 | I/II | Enapotamab vedotin | First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of Axl-specific Antibody-drug Conjugate (Enapotamab Vedotin, HuMax®-AXL-ADC) in Patients With Solid Tumors | Enapotamab Vedotin has a manageable safety profile and encouraging anti-tumor activity in heavily pretreated ovarian cancer patients ORR: 13% (n=15) abs Jun 2019 |
| Antibody Drug Conjugates: CD166 | NCT03149549 | I/II | Praluzatamab ravtansine | A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors (PROCLAIM-CX-2009) | CX-2009 is well tolerated with early evidence of biological activity in Pt-R/Pt-Rf ovarian cancer ORR: 11.1% (2PR) abs May 2020 and poster |
| Antibody Drug Conjugates: NaPi2b | NCT03319628 | Ib/II | Upifitamab rilsodotin | A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients With Solid Tumors Likely to Express NaPi2b | UpRi (XMT-1536) is well tolerated and shows promising signs of anti-tumor activity in platinum resistant ovarian cancer ORR: 23% NaPi2b High (TPS≥75): abs Oct 2020 and presentation, press release Jan 2021, press release Nov 2021 |
| Angiogenesis Inhibitors: VEGF | NCT01091259 | II | Bevacizumab, Irinotecan | Phase II Study of Irinotecan in Combination With Bevacizumab for the Treatment of Recurrent Ovarian Cancer | Bevacizumab+irinotecan shows encouraging activity in heavily pre-treated platinum resistant patients, including those treated with topotecan and/or avastin ORR: 21% pub 2017 |
| 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 | Bevacizumab+nivolumab shows activity in Pt-R patients, independent of PD-L1 expression ORR: 16.7% pub 2019 |
| Angiogenesis Inhibitors: VEGF | NCT03596281; PEMBOV | I | Bevacizumab, Liposomal doxorubicin, Pembrolizumab | An Open-label Phase 1 of Pembrolizumab in Combination With Bevacizumab and Pegylated Liposomal Doxorubicin in Patients With Platinum Resistant Epithelial Ovarian Cancer | Bevacizumab+liposomal doxorubicin+pembrolizumab is well tolerated and demonstrate durable responses in platinum resistant ovarian cancer patients Bev+Pem: Bev+PLD+Pem: abs Jun 2021 and poster, abs Nov 2021 |
| Angiogenesis Inhibitors: VEGF/DLL4 | NCT03030287 | Ib | Navicixizumab, Paclitaxel | A Phase 1b Study of OMP-305B83 Plus Weekly Paclitaxel in Subjects With Platinum Resistant Ovarian, Primary Peritoneal or Fallopian Tube Cancer | Promising activity of navicixizumab+paclitaxel in heavily pretreated patients ORR: 43.2% abs Mar 2020, poster Oct 2021 |
| Angiogenesis Inhibitors: VEGFR | NCT00275028 | II | Cediranib | A Phase 2 Study of AZD2171 in Patients With Recurrent Ovarian, Primary Peritoneal Serous or Fallopian Tube Cancer | Cediranib has promising activity but with significant toxicity (hypertension) ORR: 20% pub 2007 |
| Angiogenesis Inhibitors: Multi-targeted RTK | NCT03797326 | II | Pembrolizumab, Lenvatinib | A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005) | Lenvatinib+pembrolizumab demonstrates encouraging efficacy and manageable safety in patients with heavily pretreated ovarian cancer, including those with prior platinum failure and those with previous bevacizumab exposure ORR: 24% abs Sep 2020 |
| Angiogenesis Inhibitors: Multi-targeted RTK | Retrospective Study: Pazopanib and Oral Cyclophosphamide | II | Cyclophosphamide, Pazopanib | Pazopanib and Oral Cyclophosphamide in Women With Platinum-Resistant or -Refractory Epithelial Ovarian Cancer | Pazopanib+cyclophosphamide is a well-tolerated regimen with clinically relevant benefit in patients with platinum-resistant or -refractory ovarian cancer ORR: 45% pub 2020 |
| Angiogenesis Inhibitors: Multi-targeted RTK | NCT02788708 | I | Paclitaxel, Lenvatinib | Phase I Evaluation of Lenvatinib and Weekly Paclitaxel in Patients With Recurrent Endometrial, Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | Lenvatinib+weekly paclitaxel is tolerable with manageable side effects and shows promising response rates in platinum resistant ovarian cancer, also in patients with rare histologies ORR: 71% (incl. 1 LGS, 2 clear cell, 1 carcinosarcoma) pub 2021 |
| Angiogenesis Inhibitors: Multi-targeted RTK | NCT03666143 | I | Tislelizumab, Sitravatinib | A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors | Combination treatment with sitravatinib and tislelizumab is manageable and shows promising anti-tumor activity ORR: 26% abs Apr 2021 and presentation |
| Growth Factor Inhibitors: Gas6 | NCT03639246 | Ib/II | Batiraxcept, Liposomal doxorubicin, Paclitaxel | A Phase 1b/2 Randomized, Controlled Study of AVB-S6-500 in Combination With Pegylated Liposomal Doxorubicin (PLD) or Paclitaxel (Pac) in Patients With Platinum-resistant Recurrent Ovarian Cancer | AVB-S6-500+paclitaxel or liposomal doxorubicin is safe; the combination of AVB-S6-500+paclitaxel is most effective and best response is seen in patients without prior bevacizumab AVB-S6-500+Pac vs AVB-S6-500+PLD: AVB-S6-500+Pac; no prior Bev vs prior Bev: AVB-S6-500+Pac; trough levels above MEC vs below MEC: abs Jun 2021and poster, pub 2021 |
| Signaling Pathway Inhibitors: PI3K-AKT-mTOR/AKT | NCT01653912 | I/II | Afuresertib, Carboplatin, Paclitaxel | An Open-Label Phase I/II Study of GSK2110183 in Combination With Carboplatin and Paclitaxel in Subjects With Platinum-Resistant Ovarian Cancer | Afuresertib mediated AKT kinase inhibition in combination with carboplatin+paclitaxel demonstrates promising efficacy in platinum resistant ovarian cancer ORR: 32.1% pub 2019 |
| Signaling Pathway Inhibitors: PI3K-AKT-mTOR/PI3Kalpha | NCT01623349 | I | Alpelisib, Olaparib | Phase I Study of the Oral PI3kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer | Encouraging activity of alpelisib+olaparib combination, also in BRCA WT patients ORR: 34.6% gBRCA WT: ORR: 31.3% 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 platinum resistant ovarian cancer but with substantial toxicity ORR: 32.1% abs Jun 2013 and poster |
| Cell Cycle Inhibitors: Other | NCT02244502; INNOVATE-3 | II | Paclitaxel, TTfields | An Open Label Pilot Study of the NovoTTF-100L(O) System (NovoTTF Therapy) (200 kHz) Concomitant With Weekly Paclitaxel for Recurrent Ovarian Carcinoma | TTfields in combination with weekly paclitaxel is well tolerated and shows encouraging responses ORR: 25% pub 2018 |
| Immunotherapy: Checkpoint Inhibitors/PD-1 | JapicCTI-153004; NINJA | III | Gemcitabine, Liposomal doxorubicin, Nivolumab | Multicenter, open-label, randomized study in patients with ovarian cancer(ONO-4538-23) | Nivolumab does not improve OS compared with gemcitabine/liposomal doxorubicin in patients with platinum resistant ovarian cancer PFS: 2.0 vs 3.8 months pub 2021 |
| Immunotherapy: Checkpoint Inhibitors/PD-1 | NCT02440425 | II | Paclitaxel, Pembrolizumab | Phase 2 Trial of Dose Dense (Weekly) Paclitaxel With Pembrolizumab (MK-3475) in Platinum Resistant Recurrent Ovarian Cancer | Pembrolizumab+paclitaxel shows improved ORR and PFS compared to historical results with paclitaxel ORR: 51.4% Press release Feb 2020 |
| Immunotherapy: Checkpoint Inhibitors/PD-1 | NCT02608684 | II | Cisplatin, Gemcitabine, Pembrolizumab | A Phase II Study of Pembrolizumab With Cisplatin and Gemcitabine Treatment in Patients With Recurrent Platinum-resistant Ovarian Cancer | Adding pembrolizumab to cisplatin+gemcitabine and continuing as single-agent maintenance treatment results in promising response rates ORR: 61.1% pub 2021 |
| Immunotherapy: Checkpoint Inhibitors/PD-1 | NCT02853318 | II | Bevacizumab, Cyclophosphamide, Pembrolizumab | A Phase II Evaluation of Pembrolizumab in Combination With IV Bevacizumab and Oral Metronomic Cyclophosphamide in the Treatment of Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | Pembrolizumab+bevacizumab+cyclophosphamide is well tolerated and demonstrates clinical benefit and durable treatment responses ORR: 43.3% pub 2020 |
| Immunotherapy: Checkpoint Inhibitors/PD-1 | NCT02865811 | II | Liposomal doxorubicin, Pembrolizumab | A Phase II Study of Pembrolizumab Combined With Pegylated Liposomal Doxorubicin (PLD) For Recurrent Platinum Resistant Ovarian, Fallopian Tube Or Peritoneal Cancer | Encouraging anti-tumor activity of pembrolizumab+liposomal doxorubicin with acceptable safety profile ORR: 26.1% pub 2020 |
| Immunotherapy: Checkpoint Inhibitors/PD-1 | UMIN000005714 | II | Nivolumab | A Phase II trial of immunotherapy with an anti-PD-1 antibody in advanced / relapsed, Platinum - resistant Ovarian Cancer | Encouraging anti-tumor activity of single-agent nivolumab with acceptable safety profile ORR: 15% pub 2015 |
| Immunotherapy: Checkpoint Inhibitors/PD-1 | NCT03029598 | I/II | Carboplatin, Pembrolizumab | Anti-PD-1 Therapy in Combination With Platinum Chemotherapy for Platinum Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer | Pembrolizumab+carboplatin is well-tolerated and active in recurrent platinum-resistant ovarian cancer. A ratio of peripheral T-cell exhaustion to radiographic tumor burden may identify patients more likely to benefit from this chemoimmunotherapy ORR: 10.3%; DCR: 63% pub 2021 |
| Immunotherapy: Checkpoint Inhibitors/PD-1 | NCT02054806; KEYNOTE-028 | I | Pembrolizumab | Phase IB Study of Pembrolizumab (MK-3475) in Subjects With Select Advanced Solid Tumors | Pembrolizumab shows encouraging anti-tumor activity with acceptable safety profile ORR:12% pub 2019 |
| Immunotherapy: Checkpoint Inhibitors/PD-L1 | NCT02580058; JAVELIN Ovarian 200 | III | Avelumab, Liposomal doxorubicin | A Phase 3, Multicenter, Randomized, Open-Label Study Of Avelumab (MSB0010718C) Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum-Resistant/Refractory Ovarian Cancer | No significant improvement in ORR, PFS or OS with avelumab+liposomal doxorubicin (PLD) compared to avelumab or PLD alone Ave+PLD vs Ave vs PLD: ORR: 13.3 vs 3.7 vs 4.2% pub 2021 |
| Immunotherapy: Checkpoint Inhibitors/PD-L1 | NCT02431559 | II | Durvalumab, Liposomal doxorubicin | Phase 1/2 Study of Chemoimmunotherapy With Toll-like Receptor 8 Agonist Motolimod (VTX-2337) + Anti-PD-L1 Antibody MEDI4736 in Subjects With Recurrent, Platinum-Resistant Ovarian Cancer for Whom Pegylated Liposomal Doxorubicin is Indicated | Durvalumab+liposomal doxorubicin has a tolerable safety profile and promising efficacy ORR: 22.5% abs Mar 2020 |
| Immunotherapy: Checkpoint Inhibitors/PD-L1 | NCT01772004 | I | Avelumab | A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab (MSB0010718C) in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications | Avelumab shows encouraging activity with acceptable safety profile in ovarian cancer ORR: 9.6% pub 2019 |
| Hormonal Therapy: GR | NCT03776812 | II | nab-Paclitaxel, Relacorilant | A Phase 2, Randomized, Open-Label, 3-arm Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | Intermittent relacorilant+nab-paclitaxel improves PFS and DoR and has a favorable safety profile in recurrent platinum resistant and/or platinum refractory ovarian cancer patients Continuous Rel+Nab vs Intermittent Rel+Nab vs Nab: ORR: 35.2 vs 35.7 vs 35.8% abs Sept 2021 |
| Immunotherapy: Checkpoint Inhibitors/CD47 | NCT03558139 | Ib | Avelumab, Magrolimab | A Phase 1b Trial of Hu5F9-G4 in Combination With Avelumab in Solid Tumor Patients and Checkpoint-Inhibitor-Naive Ovarian Cancer Patients Who Progress Within 6 Months of Prior Platinum Chemotherapy | Magrolimab+avelumab is a novel, well-tolerated combination with a 56% stable disease rate in ovarian cancer patients DCR: 56% (10SD) abs Feb 2020 |
| Oncolytic Viruses | NCT02759588; VIRO-15 | Ib/II | Bevacizumab, Docetaxel, Gemcitabine, Liposomal doxorubicin, Olvimulogene nanivacirepvec, Paclitaxel | Phase 1b & 2 Study With GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (VIRO-15) | Patients treated with Olvi-Vec-primed immunochemotherapy combined with standard carboplatinum based therapy shows ORR and PFS exceeding historical comparisons and patients’ own last prior therapy. The majority of patients benefit from apparent reversal of platinum resistance Olvi-Vec: Olvi-Vec+CarboPt-based therapy +/- Bev: abs Sep 2020, pub 2021 |
| Oncolytic Viruses | NCT00408590 | I | MV-NIS | Phase I Trial of Intraperitoneal Administration of a) a CEA-Expressing Derivative, and b) a NIS-Expressing Derivative Manufactured From a Genetically Engineered Strain of Measles Virus in Patients With Recurrent Ovarian Cancer | Intraperitoneal administration of MV-NIS is safe with early evidence of antitumor activity and treatment with MV-NIS augments endogenous immunity against tumor antigens DCR: 81.3% pub 2015 |