Clinical Situation: Newly Diagnosed

Neo adjuvant (before surgery) and first-line treatment with/without extended (maintenance) treatment

Progression Free Survival (months)

Median length of time before the cancer comes back or gets worse

Overall Survival (months)

The length of time where half the patients in the study are still alive

No Prior Therapies

First-line treatment

Progression Free Survival (months)

Median length of time before the cancer comes back or gets worse

Overall Survival (months)

The length of time where half the patients in the study are still alive

No Prior Therapies

First-line treatment with/without extended (maintenance) treatment

Progression Free Survival (months)

Median length of time before the cancer comes back or gets worse

Overall Survival (months)

The length of time where half the patients in the study are still alive

No Prior Therapies

Neo adjuvant (before surgery) and first-line treatment with/without extended (maintenance) 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
Drugs in Clinical Development
Signaling Pathway Inhibitors: PI3K-AKT-mTOR/mTOR NCT01579812 II Carboplatin, Metformin, Paclitaxel A Phase II Evaluation of Metformin, Targeting Cancer Stem Cells for the Prevention of Relapse in Patients With Stage IIC/III/IV Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Metformin treatment before surgery and added to first-line chemotherapy is well tolerated and is associated with a better than expected OS, particularly in patients with stage II-III disease

PFS: 18.0 months
OS: 57.9 months

pub 2020

Immunotherapy: Checkpoint Inhibitors/PD-1 NCT03245892 I Carboplatin, Nivolumab, Paclitaxel A Pilot Study of Nivolumab With or Without Ipilimumab in Combination With Front-Line Neoadjuvant Dose Dense Paclitaxel and Carboplatin Chemotherapy and Post-Surgical Dose Dense Paclitaxel and Carboplatin Chemotherapy in Patients With High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

In high-risk ovarian cancer patients, addition of nivolumab to neoadjuvant chemotherapy and as maintenance shows promising PFS and favorable changes in the tumor microenvironment

20 patients
90% achieved optimal cytoreducation at interval surgery (70% R0, 20% R1)
PFS: 15 months
PFS (12 months): 69.6%
Treatment associated w/ significant increase in CD8+ T cells (P = 0.0002)

abs Mar 2020

Immunotherapy: Checkpoint Inhibitors/PD-L1 NCT02726997 I/II Carboplatin, Durvalumab, Paclitaxel Matched Paired Pharmacodynamics and Feasibility Study of Durvalumab in Combination With Chemotherapy in Frontline Ovarian Cancer (N-Dur)

Durvalumab with chemotherapy in upfront ovarian cancer and continued as maintenance is safe and shows reasonable efficacy

83% obtained optimal cytoreduction at surgery
PFS: 14.5 months

abs Apr 2020

Immunotherapy: Immune Cell Stimulators/Other NCT02480374; OVATION 1 I Carboplatin, GEN-1, Paclitaxel A Phase I Study of the Safety and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered In Combination With Standard Neoadjuvant Chemotherapy in Patients Newly Diagnosed With Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Adding GEN-1 IP to carboplatin+paclitaxel is safe and appears to be active in patients receiving neoadjuvant treatment

18 patients
14 evaluable: ORR (at interval debulking surgery): 85.7% (2CR, 10PR)
R0 resection rate: 64.3%
PFS: 21 months

abs May 2019

First-line 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 GOG-158 III Carboplatin, Cisplatin, Paclitaxel Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group Study.

No PFS or OS difference between cisplatin+paclitaxel and carboplatin+paclitaxel in optimally debulked stage III patients

CisPt+Pac vs CarboPt+Pac:

PFS: 19.4 vs 20.7 months
OS: 48.7 vs 57.4 months

pub 2003

Chemotherapy GOG-172 III Cisplatin, Paclitaxel Randomized phase III study of intravenous (IV) paclitaxel and cisplatin vs. IV paclitaxel, intraperitoneal (IP) cisplatin and IP paclitaxel in optimal stage III epithelial ovarian cancer (OC): a Gynecologic Oncology Group trial (GOG 172).

PFS and OS increased with IP treatment in optimally debulked stage III patients, but IP had more severe side effects

CisPt+Pac (IV) vs CisPt+Pac (IP):

PFS: 18.3 vs 23.8 months*
OS: 49.7 vs 65.6 months*

pub 2006

Chemotherapy NCT00326456; MITO-2 III Carboplatin, Paclitaxel, Liposomal doxorubicin Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer

No significant PFS or OS difference when paclitaxel or liposomal doxorubicin is added to carboplatin, but different toxicity profiles

CarboPt+Pac vs CarboPt+PLD:

PFS: 16.8 vs 19.0 months
OS: 53.2 vs 61.6 months

pub 2011

Drugs in Clinical Development
Chemotherapy NCT01654146; ICON8 III Carboplatin, Paclitaxel An International Phase III Randomised Trial of Dose Fractionated Chemotherapy Compared to Standard Three Weekly Chemotherapy, Following Immediate Primary Surgery or as Part of Delayed Primary Surgery, for Women With Newly Diagnosed Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (ICON8)

No significantly improved PFS with weekly dose-dense chemotherapy compared to standard chemotherapy every 3 weeks

SoC vs CarboPt q3w+Pac qw vs CarboPt+Pac qw:

PFS: 24.5 vs 24.9 vs 25.4 months
(restricted mean survival time)

pub 2019

Hormonal Therapy: Aromatase Retrospective Study: Adjuvant Hormone Therapy in LGSC Two sites Letrozole, Tamoxifen, Anastrozole Primary cytoreductive surgery and adjuvant hormone therapy in women with advanced low-grade serous carcinoma: Reducing overtreatment without compromising survival?

Promising PFS and OS in Low Grade Serous Cancer patients treated with letrozole, anastrozole, or tamoxifen following cytoreductive surgery

PFS: Not Reached (41 months follow up)
OS: Not Reached (41 months follow up)

Pub 2017

Hormonal Therapy: Anti-Estrogens Retrospective Study: Adjuvant Hormone Therapy in LGSC Two sites Letrozole, Tamoxifen, Anastrozole Primary cytoreductive surgery and adjuvant hormone therapy in women with advanced low-grade serous carcinoma: Reducing overtreatment without compromising survival?

Promising PFS and OS in Low Grade Serous Cancer patients treated with hormone therapy following cytoreductive surgery

PFS: Not Reached (41 months follow up)
OS: Not Reached (41 months follow up)

Pub 2017

Signaling Pathway Inhibitors: PI3K-AKT-mTOR/mTOR IRCT2016- 022726788N1 II Carboplatin, Metformin, Paclitaxel Evaluation of the clinical efficacy of adding metformin to chemotherapy regimen for patients with ovarian cancers

Improved RFS with addition of metformin to carboplatin+paclitaxel in stage I-III patients

CarboPt+Pac+Met vs CarboPt+Pac:

RFS: 48.0 vs 25.7 months

pub 2018

*Statistically significant result

First-line treatment with/without extended (maintenance) 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 Targeted Drugs
Angiogenesis Inhibitors: VEGF NCT00262847; GOG-218 III Bevacizumab, Carboplatin, Paclitaxel Prescribing Information A Phase III Trial of Carboplatin and Paclitaxel Plus Placebo Versus Carboplatin and Paclitaxel Plus Concurrent Bevacizumab (NSC # 704865) Followed by Placebo, Versus Carboplatin and Paclitaxel Plus Concurrent and Extended Bevacizumab, in Women With Newly Diagnosed, Previously Untreated, Stage III or IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer (GOG218)

Improved PFS, but no OS difference with addition of bevacizumab to carboplatin+paclitaxel; potential benefit for patients with stage IV disease

CarboPt+Pac+Bev w/ Bev maint vs CarboPt+Pac+Bev vs CarboPt+Pac:

All:
PFS: 14.1 vs 11.2 vs 10.3 months*
OS: 43.4 vs 40.8 vs 41.1 months

Stage IV patients:
OS: 42.8 vs 34.5 vs 32.6 months

pub 2019

Angiogenesis Inhibitors: VEGF NCT00483782; ICON7 III Bevacizumab, Carboplatin, Paclitaxel ICON7 - A Randomised, Two-Arm, Multi-Centre Gynaecologic Cancer InterGroup Trial of Adding Bevacizumab to Standard Chemotherapy (Carboplatin and Paclitaxel) in Patients With Epithelial Ovarian Cancer

Improved PFS and OS with addition of bevacizumab to carboplatin+paclitaxel in high risk patients

CarboPt+Pac+Bev w/ Bev maint vs CarboPt+Pac:

All:
PFS: 19.9 vs 17.5 months
OS: 45.5 vs 44.6 months (restricted mean survival)
High risk:
PFS: 16.0 vs 10.5 months*
OS: 39.3 vs 34.5 months* (restricted mean survival)

pub 2011; 2015

Angiogenesis Inhibitors: VEGF NCT00951496; GOG-252 III Bevacizumab, Carboplatin, Cisplatin, Paclitaxel A Phase III Clinical Trial of Bevacizumab With IV Versus IP Chemotherapy in Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

Compared to the IV reference arm, PFS was not significantly increased with either IP regimen

IV CarboPt+Pac+Bev w/ Bev maint vs IP CarboPt+Pac+Bev w/ Bev maint vs IP CisPt+Pac+Bev w/ Bev maint:

PFS: 24.9 vs 27.4 vs 26.2 months
OS: 75.5 vs 78.9 vs 72.9 months

pub 2019

Drugs in Clinical Development
DNA Damage Repair Pathway Inhibitors: PARP NCT02470585; VELIA III Carboplatin, Paclitaxel, Veliparib A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Veliparib added to chemotherapy and continued as maintenance significantly extends PFS in all newly diagnosed patients, but shows most benefit in BRCA MUT patients

CarboPt+Pac+Vel w/Vel maint vs CarboPt+Pac+Vel vs CarboPt+Pac:

All patients:
PFS: 23.5 vs 15.2 vs 17.3 months*
BRCA MUT:
PFS: 34.7 vs 21.1 vs 22.0 months*
BRCA WT:
PFS: 18.2 vs 14.5 vs 15.1 months

pub 2019

DNA Damage Repair Pathway Inhibitors: PARP NCT00989651; GOG-9923 I Bevacizumab, Carboplatin, Cisplatin, Paclitaxel, Veliparib A Phase I Study of Intravenous Carboplatin/Paclitaxel or Intravenous and Intraperitoneal Paclitaxel/Cisplatin in Combination With Continuous or Intermittent /CTEP-Supplied Agent ABT-888 (NSC #737664) and CTEP-Supplied Agent Bevacizumab (NSC #704865) in Newly Diagnosed Patients With Previously Untreated Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Patients receiving IP cisplatin + IV/IP paclitaxel show promising PFS and OS when compared to patients receiving IV carboplatin+paclitaxel, however differences may be reflective of selection bias toward patients enrolled on the IP chemotherapy arm

IV vs weekly IV vs IP (all w/ Vel cont):

PFS: 24.5 vs 23.5 vs 43.2 months
OS: 65.2 vs 66.5 vs NR months

pub 2020, abs Mar 2020

Immunotherapy: Checkpoint Inhibitors/PD-1 NCT02766582 II Carboplatin, Paclitaxel, Pembrolizumab Phase II Open Label Nonrandomized Trial of the Anti PD 1 Therapy Pembrolizumab With First Line Platinum Based Chemotherapy Followed by 12 Months Pembrolizumab Monotherapy for Patients With Stage III/IV Epithelial Ovarian Cancer

Pembrolizumab with carboplatin+paclitaxel on a weekly schedule is overall well tolerated and 12 months PFS is promising

28 patients
PFS (6 months): 82%
PFS (9 months): 77%
PFS (12 months): 59%

abs Mar 2020

Immunotherapy: Antibodies/MUC16 (CA125) NCT01616303 II Carboplatin, Oregovomab, Paclitaxel Phase 2: A Randomized Controlled Study on Effectiveness of Chemotherapy (Carboplatin-Paclitaxel) Versus Chemo-immunotherapy (Carboplatin-Paclitaxel-Oregovomab) in Patients With Advanced Epithelial Ovarian, Adnexal or Peritoneal Carcinoma

Addition of oregovomab to carboplatin+paclitaxel significantly increases PFS and OS

CarboPt+Pac+Ore vs CarboPt+Pac:

PFS: 41.8 vs 12.2 months*
OS: NR vs 43.2 months*

pub 2020

*Statistically significant result

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