Study study type PathologyT1T0Patientssample sizesROB Results

ovarian cancer (OC) ovarian cancer (OC)

versus bevacizumab plus carboplatin and paclitaxel
atezolizumab plus bevacizumab plus carboplatin plus paclitaxel
AGO-OVAR 2.29/ENGOT-ov34, 2024
  NCT03353831
RCTovarian cancer (OC)atezolizumabSocrecurrent ovarian, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after completing platinum-based chemotherapy or 3rd relapse285 / 289NA
inconclusive
  • inconclusive 17 % decrease in deaths (OS) (PE)
  • inconclusive 13 % decrease in progression or deaths (PFS) (PE)
versus Standard of Care (SoC)
nintedanib
LUME-Ovar 1 (AGO-OVAR 12), 2016
  NCT01015118
RCTovarian cancer (OC)nintedanibplacebohemotherapy-naive patients (aged 18 years or older) with International Federation of Gynecology and Obstetrics (FIGO) IIB-IV ovarian cancer and upfront debulking surgery911 / 455NA
suggested
  • suggested 16 % decrease in progression or deaths (PFS),progression or deaths (PFS)
niraparib
ENGOT-OV16/NOVA, 2017
  NCT01847274
RCTovarian cancer (OC)niraparib (300 mg) once daily as maintenance treatmentplacebo patients with platinum-sensitive, recurrent ovarian cancer with germline BRCA mutation 138 / 65NA
suggested
  • suggested 73 % decrease in progression or deaths (PFS)
olaparib
SOLO 3, 2020
  NCT02282020
RCTovarian cancer (OC)olaparib 300 mg twice a daySOCpatients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy178 / 88NA
safety concern
  • safety concern with 7 % increase in deaths (OS),deaths (OS) (not statistically significant)
  • suggested 38 % decrease in PFS (extension),PFS (extension)
PAOLA-1/ENGOT-ov25, 2019
  NCT02477644
RCTovarian cancer (OC)olaparib plus bevacizumabplacebo plus bevacizumabpatents with newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum-taxane chemotherapy plus bevacizumab537 / 269NA
suggested
  • suggested 41 % decrease in PFS (extension),PFS (extension)
SOLO 1, 2018
  NCT01844986
RCTovarian cancer (OC)olaparib tablets (300 mg twice daily)placeboNewly Diagnosed Advanced Ovarian Cancer with a mutation in BRCA1, BRCA2, or both ( BRCA1/2) who had a complete or partial clinical response after platinum-based chemotherapy260 / 131NA
suggested
  • suggested 45 % decrease in deaths (OS)
  • suggested 70 % decrease in progression or deaths (PFS)
SOLO2/ENGOT-Ov21, 2018
  NCT01874353
RCTovarian cancer (OC)olaparib 300 mg in two 150 mg tablets, twice dailyplacebopatients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation196 / 99NA
suggested
  • suggested 70 % decrease in progression or deaths (PFS)
Ledermann, 2012
  NCT00753545
RCTovarian cancer (OC)olaparib, at a dose of 400 mg twice dailyplacebomaintenance therapy in platinum-sensitive relapsed ovarian cancer136 / 129NA
suggested
  • suggested 65 % decrease in PFS (extension)
rucaparib
ARIEL4, 2022
  NCT02855944
RCTovarian cancer (OC)oral rucaparib (600 mg twice daily)chemotherapy (administered per institutional guidelines)patients with relapsed ovarian cancer and a deleterious BRCA1 or BRCA2 mutation who had received two or more previous chemotherapy regimens who had received two or more previous chemotherapy regimens-/-NA
safety concern
  • safety concern with 31 % increase in deaths (OS) (not statistically significant)
  • suggested 33 % decrease in progression or deaths (PFS)
ARIEL3, 2017
  NCT01968213
RCTovarian cancer (OC)after response to second-line or later platinum-based chemotherapy in patients with high-grade, recurrent, platinum-sensitive ovarian carcinoma375 / 189NA
suggested
  • suggested 64 % decrease in PFS (extension)

metastatic/advanced OC (mOC) - 1st line (L1) metastatic/advanced OC (mOC) - 1st line (L1)

versus bevacizumab plus carboplatin and paclitaxel
atezolizumab plus bevacizumab plus carboplatin plus paclitaxel
AGO-OVAR 2.29/ENGOT-ov34, 2024
  NCT03353831
RCTovarian cancer (OC)atezolizumabSocrecurrent ovarian, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after completing platinum-based chemotherapy or 3rd relapse285 / 289NA
inconclusive
  • inconclusive 17 % decrease in deaths (OS) (PE)
  • inconclusive 13 % decrease in progression or deaths (PFS) (PE)

mOC - L1 - all population metastatic/advanced OC (mOC) - 1st line (L1) mOC - L1 - all population

versus placebo plus SoC
atezolizumab plus SoC
IMagyn-050 (all population), 2021
  NCT03038100
RCTmOC - L1 - all populationatezolizumab plus paclitaxel carboplatin and bevacizumalbplaceb plus paclitaxel carboplatin and bevacizumalbpatients with stage III or stage IV epithelial ovarian, fallopian tube, or primaryperitoneal cancer with either macroscopic residual disease or who will undergo neoadjuvant chemotherapy followed by interval surgery651 / 650low
inconclusive
  • inconclusive 4 % decrease in deaths (OS) (PE)
  • inconclusive 8 % decrease in progression or deaths (PFS) (PE)

mOC - L1 - PDL1 positive metastatic/advanced OC (mOC) - 1st line (L1) mOC - L1 - PDL1 positive

versus placebo plus SoC
atezolizumab plus SoC
IMagyn-050 (PDL1 >1%), 2021
  NCT03038100
RCTmOC - L1 - PDL1 positiveatezolizumab plus paclitaxel carboplatin and bevacizumalbplaceb plus paclitaxel carboplatin and bevacizumalbpatients with stage III or stage IV epithelial ovarian, fallopian tube, or primaryperitoneal cancer with either macroscopic residual disease or who will undergo neoadjuvant therapy followed by interval surgery, PDL1 positive population391 / 393low
suggested
  • inconclusive 2 % decrease in deaths (OS) (PE)
  • suggested 20 % decrease in progression or deaths (PFS) (PE)

metastatic/advanced OC (mOC) - 2nd line (L2) metastatic/advanced OC (mOC) - 2nd line (L2)

versus nivolumab alone
nivolumab plus ipilimumab
NRG GY003, 2020
  NCT02498600
RCTmetastatic/advanced OC (mOC) - 2nd line (L2)nivolumab plus ipilimumabnivolumabpatients with recurrent or persistent ovarian,primary peritoneal, or fallopian tube carcinoma of all histologic types except mucinous adenocarcinoma andcarcinosarcoma with history of primary platinum-basedchemotherapy with a maximum of three prior cytotoxicregimens and with at least one regimen for recurrentdisease containing a platinum or a taxane49 / 51some concern
inconclusive
  • suggested 47 % decrease in progression or deaths (PFS)
  • suggested 2.3-fold increase in objective responses (ORR) (PE)
  • statistically significant 1.3-fold increase in TRAE (grade 3-4)
versus pegylated liposomal doxorubicin
avelumab alone
JAVELIN ovarian 200 (A vs doxorubicin), 2021
  NCT02580058
RCTmetastatic/advanced OC (mOC) - 2nd line (L2)avelumabPegylated liposomal doxorubicinPatients with platinum-resistant/refractory epithelial ovarian, fallopian tube, or peritoneal cancer, unselected for PD-L1 expression (ovarian cancer) a maximum of three previous lines for platinum-sensitive disease (most recent line containing platinum) with no previous systemic therapy for platinum-resistant disease188 / 190some concern
inconclusive
  • inconclusive 14 % increase in deaths (OS) (PE)
  • statistically significant 68 % increase in progression or deaths (PFS) (PE)
avelumab plus pegylated liposomal doxorubicin
JAVELIN ovarian 200 (A/doxorubicin vs doxorubicin), 2021
  NCT02580058
RCTmetastatic/advanced OC (mOC) - 2nd line (L2)avelumab plus PLDPegylated liposomal doxorubicinPatients with platinum-resistant/refractory epithelial ovarian, fallopian tube, or peritoneal cancer, unselected for PD-L1 expression (ovarian cancer) a maximum of three previous lines for platinum-sensitive disease (most recent line containing platinum) with no previous systemic therapy for platinum-resistant disease188 / 190some concern
inconclusive
  • inconclusive 11 % decrease in deaths (OS) (PE)
  • inconclusive 22 % decrease in progression or deaths (PFS) (PE)

metastatic/advanced OC (mOC) - maintenance (M) metastatic/advanced OC (mOC) - maintenance (M)

versus rucaparib
nivolumab based treatment, rucaparib
ATHENA-COMBO (GOG-3020/ENGOT-ov45), 2021
  NCT03522246
RCTmetastatic/advanced OC (mOC) - maintenance (M)combination of rucaparib (Rubraca®) andnivolumab as maintenance treatmentrucaparib alonewomen with newly diagnosed ovarian cancer who responded to their first-line chemotherapy.-/-NA
no results
    no results
from press release May 31 2024 : The primary endpoint of investigator-assessed progression-free survival (PFS) comparing the combination of rucaparib and nivolumab with rucaparib monotherapy was not met in the intent-to-treat (ITT) population