Drug Class: Immunotherapy

Anti-Tumor Antibodies: MUC16 (CA125)

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

Bispecific Antibodies: PD-1, LAG-3

Treatment given for recurrence occurring at any time 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

Prior Therapies Not Reported

Cellular Therapy

Treatment given for recurrence occurring at any time 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

Prior Therapies Not Reported

Checkpoint Inhibitors: CD47

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

Prior Therapies Not Reported

Checkpoint Inhibitors: CTLA-4

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

Prior Therapies Not Reported

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

3 Prior Therapies 4 Prior Therapies Prior Therapies Not Reported

Treatment given for recurrence occurring at any time 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

1 Prior Therapy Prior Therapies Not Reported

Checkpoint Inhibitors: PD-1

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

Maintenance after first-line therapy: Treatment to prevent relapse after complete or partial response to therapy

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

1 Prior Therapy

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

1 Prior Therapy 2 Prior Therapies Prior Therapies Not Reported

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

2 Prior Therapies 3 Prior Therapies 4 Prior Therapies 5 Prior Therapies Prior Therapies Not Reported

Treatment given for recurrence occurring at any time 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

1 Prior Therapy 2 Prior Therapies 3 Prior Therapies Prior Therapies Not Reported

Checkpoint Inhibitors: PD-L1

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 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

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

1 Prior Therapy 2 Prior Therapies

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

2 Prior Therapies 3 Prior Therapies Prior Therapies Not Reported

Treatment given for recurrence occurring at any time 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

3.5 Prior Therapies Prior Therapies Not Reported

Checkpoint Inhibitors: PVRIG

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

4 Prior Therapies

Checkpoint Inhibitors: TIGIT

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

4 Prior Therapies

Treatment given for recurrence occurring at any time 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

3 Prior Therapies

Vaccines: Survivin

Treatment given for recurrence occurring at any time 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

3 Prior Therapies

Vaccine: Tumor Associated Antigens

Platinum-Sensitive (Pt-S): Treatment given for recurrence occurring 6 months or more after last platinum-based 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

1 Prior Therapy

Anti-Tumor Antibodies: MUC16 (CA125)

First-line treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
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

Bispecific Antibodies: PD-1, LAG-3

Treatment given for recurrence occurring at any time after last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT03219268 I Margetuximab, Tebotelimab A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of MGD013, A Bispecific DART® Protein Binding PD-1 and LAG-3 in Patients With Unresectable or Metastatic Neoplasms

Tebotelimab (MGD013) alone or in combination with margetuximab has an acceptable safety profile and shows encouraging early evidence of anti-tumor activity

23 OC in monotherapy expansion
ORR: 8.7% (2PR); DCR: 52.2% (2PR, 10SD)
Baseline LAG-3 expression and inflammatory interferon-gamma signature was associated with response

Tebotelimab+Margituximab: 41 HER2+ patients, median 2 prior therapies (1-7), 5 OC
28 evaluable, 3 OC:
ORR: 28.6% (1CR - CCA, 5PR, 2uPR - 1 OC); DCR: 50% (1CR, 5PR, 2uPR, 6SD) - responses in PD-L1 low patients

abs May 2020 and presentation, abs Nov 2020 and poster

Cellular Therapy

Treatment given for recurrence occurring at any time after last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT02498912 I 4H11-28z/fIL-12/EFGRt+ CAR T, Cyclophosphamide, Fludarabine A Phase I Clinical Trial of Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors

IV and IP CAR T cell therapy is safe in the absence of chemotherapy, but toxicity is observed when the CAR T cells are given post-lymphodepleting chemotherapy

DCR: 44%

abs Mar 2020

Checkpoint Inhibitors: CD47

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.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
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

Treatment given for recurrence occurring at any time after last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT02216409 I Magrolimab A First-in-Human Phase 1 Dose Escalation Trial of Hu5F9-G4 in Patients With Advanced Solid Malignancies

Promising activity with manageable toxicity in OCCC and FTC

ORR: 15.4% (n=13)

Pub 2019

Checkpoint Inhibitors: CTLA-4

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.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
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

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.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
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: 
ORR: 25%

Gotistobart 2 mg/kg+Pem:
ORR: 27.6%

abs Sep 2024 and presentation
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%
DCR: 50%

abs Nov 2022 and poster
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:
ORR: 11.1%

Bot+Bal:
ORR: 33%

abs Nov 2022 and slide from presentation, abs Mar 2023 and presentation

Treatment given for recurrence occurring at any time after last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT02498600; NRG-GY003 II Ipilimumab, Nivolumab Phase II Randomized Trial of Nivolumab With or Without Ipilimumab in Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Encouraging anti-tumor activity of ipilimumab+nivolumab combination with favorable benefit over risk

Ipi+Niv vs Niv:
ORR: 31.4 vs 12.2%*
PFS: 3.9 vs 2.0 months*

pub 2020
NCT03355976; BrUOG 354 II Ipilimumab, Nivolumab BrUOG 354: A Phase II Randomized Trial of Nivolumab +/- Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas

Ipillimumab+nivolumab demonstrates important, meaningful, and durable activity in people with previously treated ovarian and gynecologic clear cell cancer

Ipi+Niv vs Niv:

ORR: 33.3 vs 14.3%
DCR: 66.6 vs 50%
DoR: 22.4 vs 30.6 months
PFS: 5.6 vs 2.2 months
OS: 24.7 vs 17.3 months

abs Jun 2024 and presentation
NCT01975831 I Durvalumab, Tremelimumab A Phase 1 Study to Evaluate the Safety and Tolerability of Anti-PD-L1, MEDI4736, in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

Tremelimumab+durvalumab has a manageable safety profile with preliminary evidence of clinical activity in OC

ORR: 7.4%
DCR: 44.4%

abs May 2017
*Statistically significant result

Checkpoint Inhibitors: PD-1

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.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
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 OC patients, addition of nivolumab to neoadjuvant chemotherapy and as maintenance shows promising PFS and favorable changes in the tumor microenvironment

90% achieved optimal cytoreducation at IDS
(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

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

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
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

Maintenance after first-line therapy: Treatment to prevent relapse after complete or partial response to therapy

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT03522246; ATHENA/GOG-3020 III Nivolumab, Rucaparib ATHENA (A Multicenter, Randomized, Double-Blind, Placebo- Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy)

Nivolumab in combination with rucaparib does not add to the PFS benefit of rucaparib observed in ATHENA-MONO

Ruc+Niv vs Ruc+Placebo:

PFS: 15.0 vs 20.2 months
OS: 49.4 vs 58.0 months

abs Sep 2024 and presentation

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.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
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

Encouraging activity of nivolumab+bevacizumab combination

ORR: 40%
CBR: 70%
PFS: 12.1 months

pub 2019
NCT04519151 II Lenvatinib, Pembrolizumab A Phase II, Open Lable, Single Arm, Trial to Determine Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab for Platinum- Sensitive Recurrent Ovarian Cancer

The combination of lenvatinib and pembrolizumab shows meaningful responses and manageable toxicity in platinum sensitive recurrent high grade serous OC patients thus potentially provides a non chemotherapy alternative

ORR: 54%
DCR: 83.3%
PFS: 5.5 months
DoR: 8 months
OS: 30 months

abs Jun 2024 and poster
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

Tislelizumab+pamiparib is well tolerated and associated with antitumor responses in both BRCA WT and BRCA MUT ovarian cancer

16 evaluable Pt-S:
ORR: 44%
DCR: 63%

pub 2019

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.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
JapicCTI-153004; NINJA III Liposomal doxorubicin, Nivolumab, Gemcitabine 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
OS: 10.1 vs 12.1 months

pub 2021
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%
PFS: 6.7 months
OS: 13.4 months

Press release Feb 2020
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%
PFS: 6.2 months

pub 2021
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%
DCR: 95%
PFS: 7.6 months

pub 2020
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%
CBR: 52.2%

pub 2020
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

Nivolumab+bevacizumab shows activity in Pt-R patients, independent of PD-L1 expression

ORR: 16.7%
CBR: 33.3%
PFS: 7.7 months

pub 2019
NCT02901899 II Guadecitabine, Pembrolizumab An Open Label Phase II Trial of Guadecitabine and Pembrolizumab in Platinum Resistant Recurrent Ovarian Cancer

Pembrolizumab+guadecitabine has modest activity but some patients experience prolonged disease stabilization

ORR: 9.1%
DCR: 54.5%
PFS: 2.8 months

abs May 2020 and poster
NCT03574779; OPAL 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%
DCR: 73.2%
PFS: 7.9 months
OS: 22.1 months

w/ prior Bev: ORR: 6%
w/o prior Bev: ORR: 27%

pub 2024
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%
DoR: 9.2 months
PFS: 6.2 months
OS: 21.3 months

pub 2024
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
treatment for toxicity per protocol or patient preference

ORR: 47%
DoR: 4.2 months
PFS: 4.6 months

abs Mar 2024
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: 
ORR: 25%

Gotistobart 2 mg/kg+Pem:
ORR: 27.6%

abs Sep 2024 and presentation
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%
DCR: 45%
PFS: 3.5 months

pub 2015
NCT02606305; FORWARD II Ib/II Pembrolizumab, 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 pembrolizumab+mirvetuximab soravtansine combination in FRalpha+ patients

ORR: 30%
PFS: 4.2 months

abs Mar 2018; Oct 2018
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
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)
DoR: 12.3 months

abs Jun 2021 and poster, abs Mar 2022, abs Jun 2022 and presentation
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%
PFS: 4.6 months
All 7 PD-L1+ patients achieved PR or SD

pub 2021
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%
DCR: 45%

abs Nov 2023 and poster
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

Tislelizumab+pamiparib is well tolerated and associated with antitumor responses in both BRCA WT and BRCA MUT ovarian cancer

18 evaluable Pt-R:
ORR: 22%
DCR: 50%

pub 2019
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%
DCR: 35%
PFS: 1.9 months

pub 2019
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:
ORR: 26.3%
PFS: 4.7 months

Bev+PLD+Pem:
ORR: 31.6%
PFS: 4.8 months

abs Nov 2021, abs Jun 2022 and poster
NCT03666143 I Sitravatinib, Tislelizumab 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%
PFS: 4.1 months

abs Apr 2021 and presentation
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

Balstilimab in combination with botenlisimab 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

ORR: 33%

abs Nov 2022 and slide from presentation, abs Mar 2023 and presentation

Treatment given for recurrence occurring at any time after last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT02598960 IIa BMS-986156, Nivolumab A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors

Nivolumab+BMS-986156 is safe and has efficacy comparable to historical data reported for nivolumab monotherapy

ORR: 2.7%
DCR: 51.4%

pub 2019
NCT02178722 II Epacadostat, Pembrolizumab A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of MK-3475 in Combination With INCB024360 in Subjects With Selected Cancers (ECHO-202/KEYNOTE-037)

Pembrolizumab and epacadostat combination shows encouraging anti-tumor activity with acceptable safety

ORR: 8%
DCR: 35%

abs Jun 2017
NCT02498600; NRG-GY003 II Ipilimumab, Nivolumab Phase II Randomized Trial of Nivolumab With or Without Ipilimumab in Patients With Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Encouraging anti-tumor activity of ipilimumab+nivolumab combination with favorable benefit over risk

Ipi+Niv vs Niv:
ORR: 31.4 vs 12.2%*
PFS: 3.9 vs 2.0 months*

pub 2020
NCT02674061; KEYNOTE-100 II Pembrolizumab A Phase II, Open-label, Single-arm, Multicenter Study to Evaluate Efficacy and Safety of Pembrolizumab Monotherapy in Subjects With Advanced Recurrent Ovarian Cancer (KEYNOTE-100)

Modest anti-tumor activity of single-agent pembrolizumab with acceptable safety profile

ORR: 8.5%
CBR: 22.1%

pub 2019, abs May 2020 and presentation
NCT03355976; BrUOG 354 II Ipilimumab, Nivolumab BrUOG 354: A Phase II Randomized Trial of Nivolumab +/- Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas

Ipillimumab+nivolumab demonstrates important, meaningful, and durable activity in people with previously treated ovarian and gynecologic clear cell cancer

Ipi+Niv vs Niv:

ORR: 33.3 vs 14.3%
DCR: 66.6 vs 50%
DoR: 22.4 vs 30.6 months
PFS: 5.6 vs 2.2 months
OS: 24.7 vs 17.3 months

abs Jun 2024 and presentation
NCT02964013 I Pembrolizumab, Vibostolimab A Phase 1 Trial of MK-7684 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Vibostolimab+pembrolizumab is well tolerated and demonstrates anti-tumor activity in anti-PD-1/PD-L1 naive ovarian cancer patients; particularly in patients with PD-L1 CPS ≥1

ORR: 8%
DCR (6 months): 11%
DoR: 19 months
PFS: 2 months

w/ PD-L1 CPS ≥ 1:

ORR: 24%
DCR (6 months): 24%
DoR: 19 months
PFS: 2 months

abs Apr 2022 and poster
*Statistically significant result

Checkpoint Inhibitors: PD-L1

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.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
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

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

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT02718417; JAVELIN Ovarian 100 III Avelumab, Carboplatin, Paclitaxel A Randomized, Open-Label, Multicenter, Phase 3 Study To Evaluate The Efficacy And Safety Of Avelumab (MSB0010718C) In Combination With And/Or Following Chemotherapy In Patients With Previously Untreated Epithelial Ovarian Cancer Javelin Ovarian 100

Avelumab addition to carboplatin+paclitaxel and/or continued as maintenance therapy for newly diagnosed ovarian cancer patients does not improve PFS; PD-L1, CD8, and gBRCA1/2 status did not predict differential clinical benefit 

CarboPt+Pac+Ave+Ave maint vs CarboPt+Pac+Ave maint vs CarboPt+Pac:

ORR: 36.0 vs 30.4 vs 30.4%
PFS: 18.1 vs 16.8 vs NR months

pub 2021
NCT03038100; IMagyn050 III Atezolizumab, Bevacizumab, Carboplatin, Paclitaxel A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Atezolizumab does not significantly improve PFS or OS in the ITT or PD-L1+ population, but the poor prognostic subgroup of patients (unfavorable KELIM score and sub-optimal surgery), might derive a significant PFS benefit from the treatment intensification with atezolizumab

CarboPt+Pac+Bev+Ate vs CarboPt+Pac+Bev+Placebo:
PFS: 19.5 vs 18.4 months
OS: 50.5 vs 46.6 months

w/ unfavorable KELIM score and sub-optimal surgery:
PFS: 14.3 vs 11.3 months*

pub 2021, 2023, abs Mar 2024
NCT03737643; DUO-O III Bevacizumab, Carboplatin, Durvalumab, Olaparib, Paclitaxel A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).

CarboPt+Pac+Bev+Dur followed by maintenance Bev+Dur+Ola in patients with newly diagnosed non-BRCA MUT advanced OC shows a statistically significant and clinically meaningful improvement in PFS vs CarboPt+Pac+Bev followed by maintenance Bev

ITT (excl. tBRCA MUT):
PFS: 25.1 vs 20.6 vs 19.3 months*

HRD+ (excl. tBRCA MUT):
PFS: 45.1 vs 25.1 vs 23.3 months*

HRD-:
PFS: 21.1 vs 15.4 vs 17.5 months*

abs Jun 2023 and presentation, abs Mar 2024
*Statistically significant result

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.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT02891824; ATALANTE III Atezolizumab, Bevacizumab, Carboplatin, Liposomal doxorubicin, Paclitaxel, Gemcitabine A Randomized, Double-blinded, Phase III Study of Atezolizumab Versus Placebo in Patients With Late Relapse of Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer Treated by Platinum-based Chemotherapy and Bevacizumab

Atezolizumab does not improve PFS in the overall population or in the patients with PD-L1 positive tumors

PFS: 13.5 vs 11.3 months

PD-L1+:
PFS: 15.2 vs 13.1 months

pub 2023
NCT03598270; ANITA III Atezolizumab, Carboplatin, Gemcitabine, Liposomal doxorubicin, Niraparib, Paclitaxel A Phase III Randomized, Double-blinded Trial of Platinum-based Chemotherapy With or Without Atezolizumab Followed by Niraparib Maintenance With or Without Atezolizumab in Patients With Recurrent Ovarian, Tubal or Peritoneal Cancer and Platinum Treatment-free Interval (TFIp) >6 Months

Combining atezolizumab with chemotherapy and maintenance niraparib for platinum sensitive recurrent OC does not significantly improve ORR or PFS;  no difference in treatment effect according to PD-L1 status

CarboPt+Gem/Pac/PLD+Aze w/Nir+Aze maint vs CarboPt+Gem/Pac/PLD+Placebo w/ Nir+Placebo maint:

ORR: 45 vs 43%
PFS: 11.2 vs 10.1 months, HR: 0.89 (0.71-1.10, p=0.28)

pub 2024
NCT02734004; MEDIOLA I/II Bevacizumab, 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 gBRCA MUT OC patients; olaparib+durvalumab+bevacizumab shows promising activity in non-gBRCA MUT patients regardless of LOH score and mutation status of common DDR genes

Ola+Dur, gBRCA MUT:
ORR: 92.2%
DCR (7 months): 65.6%
PFS: 11.1 months

Ola+Dur, non-gBRCA MUT:
ORR: 34%
CBR: 28%
PFS: 5.5 months
OS: 26.1 months

Ola+Dur+Bev, non-gBRCA MUT:
ORR: 87%
CBR: 74%
PFS: 14.7 months
DoR: 11 months
OS: 31.9 months

abs Oct 2019, abs Sep 2020, pub 2020, abs Sep 2022, pub 2024

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.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT03699449 II Durvalumab, Olaparib An uMbrella Study of BIomarker-driven Targeted Therapy In Patients With Platinum-resistant Recurrent OvariaN Cancer(AMBITION)

Durvalumab+olaparib shows promising activity in BRCA MUT patients

ORR: 35.7%

abs Jun 2021 and poster, pub 2022
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%
PFS: 3.7 vs 1.9 vs 3.5 months
OS: 15.7 vs 11.8 vs 13.1 months

pub 2021
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%
PFS: 6.4 vs 6.7 months
DoR: 8.6 vs 6.1 months
OS: 14.2 vs 13.0 months

abs Jun 2024 and presentation
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%
PFS: 5.5 months
OS: 17.6 months

abs Mar 2020
NCT02659384; EORTC-1508 II Acetylsalicylic acid, Atezolizumab, Bevacizumab A Phase II Study of the Anti-PDL1 Antibody Atezolizumab, Bevacizumab and Acetylsalicylic Acid to Investigate Safety and Efficacy of This Combination in Recurrent Platinum-resistant Ovarian, Fallopian Tube or Primary Peritoneal Adenocarcinoma

The addition of atezolizumab to bevacizumab (with or without acetylsalicylic acid) improves PFS and TFST

Bev vs Bev+Ate vs Bev+Ate+Asa:

ORR: 24.1 vs 20.7 vs 27.6%
PFS: 2.3 vs 4.1 vs 4.0 months
TFST: 3.0 vs 5.3* vs 5.8 months*

abs Sep 2021
NCT04739800; NRG-GY023 II Cediranib, Durvalumab, Liposomal doxorubicin, Olaparib, Paclitaxel, Topotecan A Randomized Phase II Trial of Triplet Therapy (A PD-L1 Inhibitor Durvalumab (MEDI4736) in Combination With Olaparib and Cediranib) Compared to Olaparib and Cediranib or Durvalumab (MEDI4736) and Cediranib or Standard of Care Chemotherapy in Women With Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Primary Peritoneal or Fallopian Cancer Who Have Received Prior Bevacizumab

The non-chemo triplet of olaparib, cediranib and durvalumab does not improve PFS compared to standard chemotherapy

Ola+Ced+Dur vs TPC (Pac, PLD, or Top):

PFS: 2.9 vs 4.3 months

abs Oct 2023 and presentation
NCT01633970 Ib Atezolizumab, Bevacizumab A Phase Ib Study of the Safety and Pharmacology of Atezolizumab (Anti-PD-L1 Antibody) Administered With Bevacizumab and/or Chemotherapy in Patients With Advanced Solid Tumors

Atezolizumab+bevacizumab induces durable responses and/or disease stabilization in some patients with Pt-R OC; the safety profiles are consistent with those of each agent

ORR: 15%
PFS: 4.9 months
OS: 10.2 months

pub 2020
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

Avelumab+magrolimab is a novel, well-tolerated combination with a 56% stable disease rate in ovarian cancer patients

DCR: 56% (10SD)

abs Feb 2020
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%
DCR: 52.0%
PFS: 2.6 months

pub 2019
*Statistically significant result

Treatment given for recurrence occurring at any time after last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT02484404 I/II Cediranib, Durvalumab, Olaparib Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody Durvalumab (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancers

Promising response rates for durvalumab, cediranib and olaparib in OC

Dur+Ola: 34 evaluable:
ORR: 15%
DCR (4 months): 53%

Dur+Ced: 7 evaluable:
ORR: 42.9%
DCR (4 months): 71.4%

Dur+Ola+Ced: 7 evaluable:
ORR: 42.9%
DCR: 71.4%
most patients Pt-R, BRCA WT

pub 2017; abs Oct 2018, pub 2019
NCT01375842 I Atezolizumab A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) Administered Intravenously as a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

Atezolizumab shows encouraging activity with acceptable safety profile in PD-L1+ patients

9 evaluable ovarian:
ORR: 22%

pub 2019
NCT01975831 I Durvalumab, Tremelimumab A Phase 1 Study to Evaluate the Safety and Tolerability of Anti-PD-L1, MEDI4736, in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

Durvalumab+tremelimumab has a manageable safety profile with preliminary evidence of clinical activity in OC

ORR: 7.4%
DCR: 44.4%

abs May 2017

Checkpoint Inhibitors: PVRIG

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.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
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%
DCR: 45%

abs Nov 2023 and poster

Checkpoint Inhibitors: TIGIT

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.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
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%
DCR: 45%

abs Nov 2023 and poster

Treatment given for recurrence occurring at any time after last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT02964013 I Pembrolizumab, Vibostolimab A Phase 1 Trial of MK-7684 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Vibostolimab+pembrolizumab is well tolerated and demonstrates anti-tumor activity in anti-PD-1/PD-L1 naive ovarian cancer patients; particularly in patients with PD-L1 CPS ≥1

ORR: 8%
DCR (6 months): 11%
DoR: 19 months
PFS: 2 months

w/ PD-L1 CPS ≥ 1:

ORR: 24%
DCR (6 months): 24%
DoR: 19 months
PFS: 2 months

abs Apr 2022 and poster

Immune Cell Stimulators: IDO

Treatment given for recurrence occurring at any time after last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT02178722 II Epacadostat, Pembrolizumab A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of MK-3475 in Combination With INCB024360 in Subjects With Selected Cancers (ECHO-202/KEYNOTE-037)

Epacadostat+pembrolizumab combination shows encouraging anti-tumor activity with acceptable safety

ORR: 8%
DCR: 35%

abs Jun 2017

Immune Cell Stimulators: IL-2R

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.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
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)
DoR: 12.3 months

abs Jun 2021 and poster, abs Mar 2022, abs Jun 2022 and presentation

Vaccines: NY-ESO-1

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.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT00887796 I Decitabine, Liposomal doxorubicin, NY-ESO-1 protein / MIS416 vaccine A Phase I Clinical Trial of NY-ESO-1 Protein Immunization in Combination With 5-AZA-2'-Deoxycytidine (Decitabine) in Patients Receiving Liposomal Doxorubicin for Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

Encouraging anti-tumor activity of NY-ESO-1 vaccine+liposomal doxorubicin combination

ORR: 10% (n=10)
DCR: 60% (n=10)

pub 2014

Vaccines: Survivin

Treatment given for recurrence occurring at any time after last platinum-based treatment

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT02785250; DeCidE1 Ib/II Cyclophosphamide, Epacadostat, Maveropepimut-S A Phase 1b/2 Study of an Immunotherapeutic Vaccine, DPX-Survivac With Low Dose Cyclophosphamide and Epacadostat (INCB024360) in Patients With Recurrent Ovarian Cancer

Encouraging anti-tumor activity of immunotherapy combination with limited side effects

ORR: 26.3%
DCR: 78.9%
PFS: 4.5 months
CBR: 37%
OS: 19.9 months

Patients with Baseline Tumor Burden (BTB) <5 cm:
CBR: 55% (n=11)

abs Jun 2019 and poster, abs May 2020 and poster, pub 2023

Vaccine: TGFbeta

Maintenance after first-line therapy: Treatment to prevent relapse after complete or partial response to therapy

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT01309230 II Gemogenovatucel-T Open-label Phase II Trial of Adjuvant bishRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) for High Risk Stage III/IV Ovarian Cancer

FANG vaccine shows encouraging anti-tumor activity and increased RFS with remarkable safety

FANG vs Placebo:

RFS (from time of procurement, mean/median):
27.5/20.1 (n=31) vs 16.0/12.6 (n=11) months

pub 2016
NCT02346747; VITAL II Gemogenovatucel-T A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects With Stage IIIb-IV Ovarian Cancer in Clinical Complete Response Following Surgery and Primary Chemotherapy

Vigil immunotherapy as maintenance after first-line therapy in stage III–IV ovarian cancer is well tolerated and shows clinical benefit, particularly for BRCA WT and HRP patients that have high levels of CD39 RNA

VIGIL vs Placebo:
RFS (from time of randomization): 11.5 vs 8.4 months

BRCA WT patients:
RFS (from time of randomization): 12.7 vs 8.0 months*
OS: NR vs 41.4 months*

HRP patients:
RFS (from time of randomization): 10.6 vs 5.7 months*
OS: NR vs 26.9 months*

HRP and CD39 RNA levels above median:
RFS (from time of randomization): 21.1 vs 5.6 months*
OS: NR vs 27 months*

pub 2020, pub 2021, pub 2022
*Statistically significant result

Vaccine: Tumor Associated Antigens

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

For more detailed information, please click on the clinical trial ID number.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT02107937; SOVO1 II DCVAC/OvCa A Randomized, Open-label, Three-arm, Multi-center Phase II Trial of Addition of DCVAC/OvCa to First Line Standard Chemotherapy in Women With Newly Diagnosed Epithelial Ovarian Carcinoma

DCVAC/OvCa sequential to chemo is associated with a statistically significant improvement in PFS in patients undergoing first-line treatment

DCVAC sequential to chemo vs chemo alone:
PFS: NR vs 21.4 months*

pub 2022
*Statistically significant result

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.

Trial ID # Phase Drugs Clinical Trial Title Key Conclusion and Results
Drugs in Clinical Development
NCT02107950; SOVO2 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
OS: 35.5 vs. 22.1 months*

pub 2021
*Statistically significant result

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