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 | Liposomal doxorubicin, Gemcitabine | 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 | Liposomal doxorubicin, Paclitaxel, Topotecan, Bevacizumab 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 | Liposomal doxorubicin, Paclitaxel, Topotecan, Bevacizumab, Gemcitabine | 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 2022 |
| Antibody Drug Conjugates: FRalpha | NCT04209855; MIRASOL | III | Liposomal doxorubicin, Mirvetuximab soravtansine, Paclitaxel, Topotecan Prescribing Information | MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression | Mirvetuximab soravtansine is the first treatment to demonstrate a PFS and OS benefit in Pt-R OC compared to single agent chemotherapy ORR: 42 vs 16%* pub 2023 |
| Antibody Drug Conjugates: FRalpha | NCT04296890; SORAYA | III | Mirvetuximab soravtansine Prescribing Information | 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% pub 2023, abs Mar 2023 and presentation, pub 2024 |
| Antibody Drug Conjugates: HER2 | NCT04482309 | II | Trastuzumab deruxtecan Prescribing Information | A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02) | Trastuzumab Deruxtecan (T-DXd) has a manageable safety profile and shows encouraging ORR and durable clinical benefit in OC patients with HER2 IHC 3+ expression ORR: 63.6% (n=11) abs Oct 2023, pub 2024 |
| Drugs in NCCN Guidelines | |||||
| 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 | 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: pub 2022, poster Mar 2024 |
| Antibody Drug Conjugates: FRalpha | NCT02606305; FORWARD II | 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 mirvetuximab soravtansine plus bevacizumab doublet is an active and well-tolerated regimen in patients with FRα-expressing platinum-resistant ovarian cancer. Promising activity is observed for patients regardless of level of FRα expression or prior bevacizumab ORR: 44% pub 2023 |
| 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 |
| Chemotherapy | Retrospective Study: Metronomic Oral Cyclophosphamide (MOC) | II | Cyclophosphamide | Metronomic oral cyclophosphamide (MOC) in the salvage therapy of heavily treated recurrent ovarian cancer patients: a retrospective, multicenter study | Metronomic oral cyclophosphamide may provide a valid alternative for the palliative treatment of heavily pretreated recurrent ovarian cancer ORR: 15% pub 2014 |
| Antibody Drug Conjugates: HER2 | NCT04482309 | II | Trastuzumab deruxtecan | A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd, DS-8201a) for the Treatment of Selected HER2 Expressing Tumors (DESTINY-PanTumor02) | Trastuzumab Deruxtecan (T-DXd) has a manageable safety profile and shows encouraging activity in OC patients with HER2 IHC 2+ ORR: 36.8% abs Oct 2023, pub 2024 |
| 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 | 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 | Bevacizumab+pembrolizumab+cyclophosphamide is well tolerated and demonstrates clinical benefit and durable treatment responses ORR: 43.3% pub 2020 |
| Angiogenesis Inhibitors: VEGF | Retrospective Study: Bevacizumab and Cyclophosphamide | II | Cyclophosphamide, Bevacizumab | 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: VEGF | UMIN000016619 | II | Bevacizumab, Gemcitabine | A Feasibility Study of Gemcitabin and Bevacizumab in patients with Platinum-Resistant Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | The combination chemotherapy with gemcitabine and bevacizumab is feasible, effective and safe ORR: 42% pub 2020 |
| 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 | |||||
| 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, pub 2022 |
| 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% pub 2022
|
| DNA Damage Repair Pathway Inhibitors: PARP | NCT03574779 | II | Bevacizumab, Dostarlimab, Niraparib | A Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments And/Or Combinations of Treatments in Participants With Ovarian Cancer (OPAL) | Triplet therapy with niraparib, dostarlimab, and bevacizumab is tolerable and demonstrates moderate clinical activity in patients with BRCA WT Pt-R OC ORR: 17.1% w/ prior Bev: ORR: 6% pub 2024 |
| DNA Damage Repair Pathway Inhibitors: PARP | NCT02657889; TOPACIO | I/II | Pembrolizumab, Niraparib | 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: 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, pub 2024 |
| Antibody Drug Conjugates: FRalpha | NCT05579366 | I/II | Rinatabart sesutecan | Phase 1/2 Study of PRO1184 in Patients With Locally Advanced and/or Metastatic Solid Tumors | Rinatabart sesutecan (Rina-S) is well tolerated with manageable side effects and promising anti-tumor activity is observed in ovarian cancer patients across a wide range of FRalpha expression levels ORR: 50% abs Sep 2024 and presentation |
| Antibody Drug Conjugates: FRalpha | NCT05797168 | I/II | AZD5335 | A Modular Phase I/IIa, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors | AZD5335 demonstrates a manageable safety profile and preliminary signs of anti-tumor efficacy in platinum resistant ovarian cancer ORR: 34.2% abs Sep 2024 and poster |
| Antibody Drug Conjugates: FRalpha | NCT03386942 | I | Farletuzumab ecteribulin | A Phase 1 Study of MORAb-202 in Subjects With Solid Tumors | Anti-tumor activity is seen with both the farletuzumab ecteribulin (MORAb-202) 0.9 mg/kg and 1.2 mg/kg doses and efficacy is observed irrespective of FRalpha-expression levels 0.9 mg/kg (n=24): ORR: 25% 1.2 mg/kg (n=21) ORR: 52.4% Abs Jun 2022 and posters |
| Antibody Drug Conjugates: FRalpha | NCT03748186 | I | Luveltamab tazevibulin | 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 | Luveltamab tazevibulin (STRO-002) is well tolerated with evidence of anti-tumor activity in heavily pretreated patients across a broad range of FRα expression levels. No ocular toxicity signals have been observed. All patients: FR alpha TPS > 25%: abs Jun 2021 and poster, abs Jun 2023 and presentation |
| Antibody Drug Conjugates: TROP2 | NCT05489211 | II | Bevacizumab, Carboplatin, Datopotamab deruxtecan, Saruparib | A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours | Datopotamab deruxtecan (Dato-DXd) monotherapy demonstrates encouraging efficacy and a manageable safety profile in patients with platinum resistant or refractory ovarian cancer ORR: 34.6% abs Sep 2024 and presentation |
| Antibody Drug Conjugates: TROP2 | NCT04152499 | I/II | Sacituzumab tirumotecan | A Phase I-II, First-in-Human Study of SKB264 in Patients With Locally Advanced Unresectable /Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies | Sacituzumab tirumotecan (Sac-TMT) monotherapy shows promising anti-tumor activity with a manageable safety profile in patients with platinum resistant or refractory ovarian cancer ORR: 37.1% abs Sep 2024 and presentation |
| Antibody Drug Conjugates: CLDN6 | NCT05103683 | I | TORL-1-23 | A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants With Advanced Cancer | TORL-1-23 has a favorable safety/tolerability profile with encouraging preliminary anti-tumor activity in heavily-pretreated CLDN6-expressing ovarian cancer Doses of 2.4 mg/kg or 3.0 mg/kg: abs Oct 2023 and poster, abs Sep 2024 and presentation |
| Antibody Drug Conjugates: CDH6 | NCT04707248 | I | Raludotatug deruxtecan | Phase I, Two-Part, Multi-Center, First-in-Human Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors | Raludotatug deruxtecan (DS-6000a) is generally well tolerated and demonstrates encouraging clinical activity in heavily pretreated Pt-R OC without CDH6 preselection abs Oct 2023 and presentation |
| Antibody Drug Conjugates: B7H4 | NCT05123482 | I/IIa | Puxitatug samrotecan | A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR) | Puxitatug samrotecan (AZD8205) has a manageable safety profile consistent with other Topoisomerase 1 inhibitor ADCs and shows preliminary efficacy in heavily pretreated patients with prior progression on standard treatment 47 patients in dose escalation, median 5 prior therapies (2-9), 17 OC 17 evaluable OC: ORR: 17.6%; DCR: 70.6% |
| Antibody Drug Conjugates: B7H4 | NCT05194072 | I | Felmetatug vedotin | A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors | Felmetatug vedotin (SGN-B7H4V) shows a manageable safety profile and durable responses are observed in high grade serous OC ORR: 20% abs Oct 2023 and presentation |
| Angiogenesis Inhibitors: VEGF | NCT02873962 | II | Nivolumab, Bevacizumab | 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/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% pub 2022 |
| Angiogenesis Inhibitors: Multi-targeted RTK | NCT03797326; LEAP-005 | II | Lenvatinib, Pembrolizumab | 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 OC, including those with prior platinum failure and those with previous bevacizumab exposure ORR: 35% pub 2024 |
| Angiogenesis Inhibitors: Multi-targeted RTK | NCT04781088 | II | Lenvatinib, Paclitaxel, Pembrolizumab | Phase II Study With Safety Lead-In of Lenvatinib, Pembrolizumab, and Weekly Paclitaxel for Recurrent Endometrial, Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer | Encouraging activity is seen in ovarian cancer; the regimen is tolerable with manageable side effects; however, a high number of patients discontinued ORR: 47% abs Mar 2024 |
| Angiogenesis Inhibitors: Multi-targeted RTK | NCT02584478 | Ia/II/III | Anlotinib, Liposomal doxorubicin, Paclitaxel, Topotecan | A Phase 1/2a/3 Evaluation of the Safety and Efficacy of Adding AL3818 (Anlotinib, INN: Catequentinib), a Dual Receptor Tyrosine Kinase Inhibitor, to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma | Anlotinib demonstrates positive combined synergic efficacy with chemotherapy in platinum resistant ovarian cancer Anl+Pac, PLD or Top: abs Oct 2022 |
| Angiogenesis Inhibitors: Multi-targeted RTK | NCT02788708 | I | Lenvatinib, Paclitaxel | 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 Pt-R OC, also in patients with rare histologies ORR: 71% (incl. 1 LGS, 2 OCCC, 1 carcinosarcoma) pub 2021 |
| 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, DoR and OS and has a favorable safety profile in recurrent platinum resistant ovarian cancer patients who have received prior bevacizumab Intermittent Rel+Nab vs Nab: ORR: 35.7 vs 35.8% Subgroup of patients similar to patient in ROSELLA Phase III: pub 2023, abs Mar 2024 |
| Cell Cycle Inhibitors: CHK1/2 | NCT03414047 | II | ACR-368 | A Phase 2 Study of Prexasertib in Platinum-Resistant or Refractory Recurrent Ovarian Cancer | ACR-368 (prexasertib) demonstrates durable single agent activity in a subset of patients with platinum resistant HGSOC regardless of clinical characteristics or prior therapy ORR: 12.1% pub 2022 |
| Cell Cycle Inhibitors: WEE1 | NCT01164995 | II | Adavosertib, Carboplatin | Phase II Pharmacological Study With Wee-1 Inhibitor MK-1775 Combined With Carboplatin in Patients With p53 Mutated Epithelial Ovarian Cancer and Early Relapse (< 3 Months) or Progression During Standard First Line Treatment | Promising activity of adavosertib+carboplatin combination in TP53-mutated primary platinum resistant and platinum refractory ovarian cancer; a large proportion of responding patient had CCNE1 AMP ORR: 41% pub 2016, pub 2023 |
| Cell Cycle Inhibitors: WEE1 | NCT04516447 | I | Azenosertib, Carboplatin, Liposomal doxorubicin, Paclitaxel, Gemcitabine | A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer | Azenosertib (ZN-c3), combined with chemotherapy, is well-tolerated and demonstrates clinical activity in patients with Pt-R or Pt-Rf OC Aze+CarboPt: Aze+Pac: Aze+Gem: (n=13) Aze+PLD: abs Jun 2023 and poster |
| 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, Pembrolizumab, Gemcitabine | 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 maintenance treatment results in promising response rates, however the median duration of response is modest and the addition of pembrolizumab does not appear to provide benefit beyond the use of chemotherapy alone in most patients ORR: 61.1% pub 2021 |
| 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 | NCT05446298; PRESERVE-004 | II | Gotistobart, Pembrolizumab | Phase 2 Randomized Open-label Multicenter Study of Combination of ONC-392 and Pembrolizumab for the Treatment of Patients With Platinum Resistant Ovarian Cancer (PROC) | Early results show encouraging safety and clinical activity in platinum resistant ovarian cancer patients receiving gotistobart + pembrolizumab Gotistobart 1 mg/kg+Pem: Gotistobart 2 mg/kg+Pem: abs Sep 2024 and presentation |
| Immunotherapy: Checkpoint Inhibitors/PD-1 | NCT02799095; ARTISTRY-1 | I/II | Nemvaleukin alfa, Pembrolizumab | A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-1 | Pembrolizumab with Nemvaleukin alfa (ALKS 4230) is well tolerated with encouraging clinical benefit ORR: 28.6% (n=14) abs Jun 2021 and poster, abs Mar 2022, abs Jun 2022 and presentation |
| 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 Pt-R OC. 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-1 | NCT03596281; PEMBOV | I | Liposomal doxorubicin, Pembrolizumab, Bevacizumab | An Open-label Phase 1 of Pembrolizumab in Combination With Bevacizumab and Pegylated Liposomal Doxorubicin in Patients With Platinum Resistant Epithelial Ovarian Cancer | Pembrolizumab+bevacizumab with or without liposomal doxorubicin is well tolerated and demonstrate durable responses in Pt-R OC patients Bev+Pem: Bev+PLD+Pem: abs Nov 2021, abs Jun 2022 and poster |
| Immunotherapy: Checkpoint Inhibitors/PD-L1 | NCT03353831; AGO-OVAR2.29 | III | Atezolizumab, Bevacizumab, Liposomal doxorubicin, Paclitaxel | Atezolizumab in Combination With Bevacizumab and Chemotherapy Versus Bevacizumab and Chemotherapy in Recurrent Ovarian Cancer - a Randomized Phase III Trial | The addition of atezolizumab to single agent chemotherapy with bevacizumab does not significantly improve PFS or OS in platinum resistant recurrent ovarian cancer patients or recurrent ovarian cancer patients who are not candidates for platinum therapy Pac/PLD+Bev+Ate vs Pac/PLD+Bev+Placebo: ORR: 39.6 vs 43.5% abs Jun 2024 and presentation |
| 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/CTLA-4 | NCT05446298; PRESERVE-004 | II | Gotistobart, Pembrolizumab | Phase 2 Randomized Open-label Multicenter Study of Combination of ONC-392 and Pembrolizumab for the Treatment of Patients With Platinum Resistant Ovarian Cancer (PROC) | Early results show encouraging safety and clinical activity in platinum resistant ovarian cancer patients receiving gotistobart + pembrolizumab Gotistobart 1 mg/kg+Pem: Gotistobart 2 mg/kg+Pem: abs Sep 2024 and presentation |
| Immunotherapy: Checkpoint Inhibitors/CTLA-4 | NCT04140526 | Ia/Ib | Gotistobart | Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001) | Gotistobart as monotherapy shows encouraging anti-tumor activity in ovarian cancer ORR: 21% abs Nov 2022 and poster |
| Immunotherapy: Checkpoint Inhibitors/CTLA-4 | NCT03860272 | I | Balstilimab, Botensilimab | A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination With AGEN2034 (Balstilimab), an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancer | Botenlisimab alone or in combination with balstilimab demonstrates clinical activity in platinum resistant OC. Activity is seen both in patients with the low and high affinity FcγRIIIA alleles, unlike first generation anti-CTLA-4 molecules that generally benefit only those patients who express the high affinity allele Bot: Bot+Bal: abs Nov 2022 and slide from presentation, abs Mar 2023 and presentation |
| Immunotherapy: Bispecifics/PD-1, VEGF | NCT04047290 | Ia/Ib | Ivonescimab | A Phase 1a/1b, Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK112 in Subjects With Advanced Solid Tumors | Ivonescimab shows encouraging anti-tumor activity and a favorable safety profile in patients with platinum resistant/refractory ovarian cancer, including patients who had progressed after prior ICI and anti-VEGF therapy ORR: 26.3% pub 2024 |
| Immunotherapy: Bispecifics/PD-L1, VEGF | NCT05918445 | I/II | BNT327 | Phase Ib/IIa Safety and Efficacy of PM8002, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients With Advanced Solid Tumors | BNT327 (PM8002) shows promising anti-tumor activity in previously treated patients with Pt-R OC ORR: 20.6% abs Jun 2024 and poster |
| Immunotherapy: Checkpoint Inhibitors/PVRIG | NCT04570839 | I/II | BMS-986207, COM701, Nivolumab | A Phase 1/2 Study Evaluating the Safety, Tolerability and Preliminary Antitumor Activity of COM701 in Combination With BMS-986207 (Anti-TIGIT Antibody) and Nivolumab in Subjects With Advanced Solid Tumors. | The combination of COM701 + BMS-986207 + nivolumab is well tolerated and has encouraging durable anti-tumor activity with immune activation in patients with platinum resistant HGSOC and OCCC ORR: 20% abs Nov 2023 and poster |
| Immunotherapy: Immune Cell Stimulators/IL-2R | NCT02799095; ARTISTRY-1 | I/II | Nemvaleukin alfa, Pembrolizumab | A Phase 1/2 Study of ALKS 4230 Administered Intravenously as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors - ARTISTRY-1 | Nemvaleukin alfa (ALKS 4230) with pembrolizumab is well tolerated with encouraging clinical benefit ORR: 28.6% (n=14) abs Jun 2021 and poster, abs Mar 2022, abs Jun 2022 and presentation |
| Oncolytic Viruses | NCT02759588; VIRO-15 | Ib/II | Bevacizumab, Carboplatin, Docetaxel, Liposomal doxorubicin, Olvimulogene nanivacirepvec, Paclitaxel, Gemcitabine | Phase 1b & 2 Study With GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent or Refractory Ovarian Cancer (VIRO-15) | Patients treated with IP 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 ORR: 54% pub 2023 |