metaEvidence - study list


	Study	study type RCT OBS RCT + OBS	Pathology	T1	T0	Patients	sample sizes	ROB	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 Int J Gynecol Cancer 2020 Dec;30(12):1997-2001. NCT03353831	RCT	ovarian cancer (OC)	atezolizumab	Soc	recurrent ovarian, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after completing platinum-based chemotherapy or 3rd relapse	285 / 289	NA	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 Lancet Oncol. 2016; 17:78-89 NCT01015118	RCT	ovarian cancer (OC)	nintedanib	placebo	hemotherapy-naive patients (aged 18 years or older) with International Federation of Gynecology and Obstetrics (FIGO) IIB-IV ovarian cancer and upfront debulking surgery	911 / 455	NA	suggested	suggested 16 % decrease in progression or deaths (PFS),progression or deaths (PFS)
	niraparib
	ENGOT-OV16/NOVA, 2017 N Engl J Med 2016;375:2154-2164 Lancet Oncol. 2018; 19:1117-1125 NCT01847274	RCT	ovarian cancer (OC)	niraparib (300 mg) once daily as maintenance treatment	placebo	patients with platinum-sensitive, recurrent ovarian cancer with germline BRCA mutation	138 / 65	NA	suggested	suggested 73 % decrease in progression or deaths (PFS)
	olaparib
	SOLO 3, 2020 J Clin Oncol 2020 Apr 10;38(11):1164-1174. NCT02282020	RCT	ovarian cancer (OC)	olaparib 300 mg twice a day	SOC	patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at least 2 prior lines of platinum-based chemotherapy	178 / 88	NA	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 N Engl J Med 2019 Dec 19;381(25):2416-2428. Eur J Cancer 2022 Oct;174:221-231. NCT02477644	RCT	ovarian cancer (OC)	olaparib plus bevacizumab	placebo plus bevacizumab	patents with newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum-taxane chemotherapy plus bevacizumab	537 / 269	NA	suggested	suggested 41 % decrease in PFS (extension),PFS (extension)
	SOLO2/ENGOT-Ov21, 2018 Lancet Oncol 2017;: Lancet Oncol. 2018; 19:1126-1134 Lancet Oncol 2021 May;22(5):620-631. NCT01874353	RCT	ovarian cancer (OC)	olaparib 300 mg in two 150 mg tablets, twice daily	placebo	patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation	196 / 99	NA	suggested	suggested 70 % decrease in progression or deaths (PFS)
	SOLO 1, 2018 N. Engl. J. Med. 2018; 379:2495-2505 Lancet Oncol 2021 Dec;22(12):1721-1731. NCT01844986	RCT	ovarian cancer (OC)	olaparib tablets (300 mg twice daily)	placebo	Newly 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 chemotherapy	260 / 131	NA	suggested	suggested 45 % decrease in deaths (OS) suggested 70 % decrease in progression or deaths (PFS)
	Ledermann, 2012 N Engl J Med 2012;366:1382-92 Lancet Oncol. 2016; 17:1579-1589 Cancer 2016; 122:1844-52 Lancet Oncol. 2014; 15:852-61 Br. J. Cancer 2016; 115:1313-1320 NCT00753545	RCT	ovarian cancer (OC)	olaparib, at a dose of 400 mg twice daily	placebo	maintenance therapy in platinum-sensitive relapsed ovarian cancer	136 / 129	NA	suggested	suggested 65 % decrease in PFS (extension)
	rucaparib
	ARIEL4, 2022 The Lancet Oncology NCT02855944	RCT	ovarian 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 Lancet 2017; 390:1949-1961 NCT01968213	RCT	ovarian cancer (OC)			after response to second-line or later platinum-based chemotherapy in patients with high-grade, recurrent, platinum-sensitive ovarian carcinoma	375 / 189	NA	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 Int J Gynecol Cancer 2020 Dec;30(12):1997-2001. NCT03353831	RCT	ovarian cancer (OC)	atezolizumab	Soc	recurrent ovarian, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after completing platinum-based chemotherapy or 3rd relapse	285 / 289	NA	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 Int J Gynecol Cancer 2019 Jan 10;ijgc-2018-000071. J Clin Oncol 2021 Apr 23;JCO2100306. NCT03038100	RCT	mOC - L1 - all population	atezolizumab plus paclitaxel carboplatin and bevacizumalb	placeb plus paclitaxel carboplatin and bevacizumalb	patients 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 surgery	651 / 650	low	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 Int J Gynecol Cancer 2019 Jan 10;ijgc-2018-000071. J Clin Oncol 2021 Apr 23;JCO2100306. NCT03038100	RCT	mOC - L1 - PDL1 positive	atezolizumab plus paclitaxel carboplatin and bevacizumalb	placeb plus paclitaxel carboplatin and bevacizumalb	patients 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 population	391 / 393	low	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 J Clin Oncol 2020; 38:1814-1823 NCT02498600	RCT	metastatic/advanced OC (mOC) - 2nd line (L2)	nivolumab plus ipilimumab	nivolumab	patients 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 taxane	49 / 51	some 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 Future Oncol 2018 Sep;14(21):2103-2113. Lancet Oncol 2021 Jun 15;S1470-2045(21)00216-3. NCT02580058	RCT	metastatic/advanced OC (mOC) - 2nd line (L2)	avelumab	Pegylated liposomal doxorubicin	Patients 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 disease	188 / 190	some 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 Future Oncol 2018 Sep;14(21):2103-2113. Lancet Oncol 2021 Jun 15;S1470-2045(21)00216-3. NCT02580058	RCT	metastatic/advanced OC (mOC) - 2nd line (L2)	avelumab plus PLD	Pegylated liposomal doxorubicin	Patients 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 disease	188 / 190	some 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 Int J Gynecol Cancer 2021 Sep 30;ijgc-2021-002933. NCT03522246	RCT	metastatic/advanced OC (mOC) - maintenance (M)	combination of rucaparib (Rubraca®) andnivolumab as maintenance treatment	rucaparib alone	women 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

ovarian cancer (OC) ovarian cancer (OC)

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

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

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

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

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