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avelumab

Phase 3

Ovarian Cancer | Monoclonal antibody | Oncology |Pfizer, Inc.|Last Updated: Jun 22, 2026

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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment566
FDA Designations
No designations recorded
Clinical trial landscape

avelumab · 6 trials · 7 indications

Phase 3 4Phase 1 2
NCT05059522Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are ClosingAdvanced Malignancies
ACTIVE NOT_RECRUITING77 Analytics
NCT02603432A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)Urothelial Cancer
COMPLETED700 Analytics
NCT02684006A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)Renal Cell Cancer
COMPLETED886 Analytics
NCT02580058A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)Ovarian Cancer
COMPLETED566 Analytics
PHASE3ACTIVE NOT_RECRUITING
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
Advanced MalignanciesUnlock trial analytics
PHASE3COMPLETED
A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100)
Urothelial CancerUnlock trial analytics
PHASE3COMPLETED
A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
Renal Cell CancerUnlock trial analytics
PHASE3COMPLETED
A Study Of Avelumab Alone Or In Combination With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer (JAVELIN Ovarian 200)
Ovarian CancerUnlock trial analytics
Study Endpoints
Primary Endpoints
Number of participants with adverse events leading to permanent discontinuation of study intervention
Baseline up to approximately 5 years
Number serious adverse events reported for all participants
Baseline up to approximately 5 years
Overall Survival (OS)
From randomization to discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)

Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.

Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) in Programmed Death-Ligand 1 (PD-L1) Positive Participants
From date of randomization to the first documentation of PD or death due to any cause or censoring date, whichever occurred first (maximum up to approximately 26 months)

PFS: time from the date of randomization to the date of the first documentation of progressive disease (PD) according to Response Evaluation Criteria in Solid Tumours (RECIST version \[v\] 1.1) or death due to any cause, whichever occurred first as assessed by BICR. PFS data was censored on date of last adequate tumor assessment for participants who did not have an event (PD or death), who started new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. PD was defined as at least a 20 percent (%), increase in the sum of all the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to relative increase of 20 %, sum must have also demonstrated an absolute more than (\>) of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression.

Overall Survival (OS) in PD-L1 Positive Participants
From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)

OS was defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.

Progression Free Survival (PFS) Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
From randomization to date of first documentation of PD or death due to any cause whichever was first (up to 30 months); based on cutoff date: 19 September 2018.

PFS is defined as the time from date of randomization to the date of the first documentation of progression of disease (PD) or death due to any cause, whichever occurs first. PFS time was summarized by treatment arm using the Kaplan-Meier method. PFS based on BICR assessment was evaluated for this endpoint.

Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity as Graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version (v.) 4.03
From first dose of study drug up to 30 days after last dose of study drug or initiation of new anti-cancer drug therapy, whichever occurred first (maximum up to 21 months)

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were graded by investigator according to NCI CTCAE v.4.03 as follows: Grade 1: mild AE, Grade 2: moderate AE, Grade 3: severe AE, Grade 4: life-threatening consequences and urgent intervention indicated, Grade 5: death related to AE.

Number of Participants With Abnormal Laboratory Parameter Values (Hematology) as Graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Version 4.03
From first dose of study drug up to 30 days after last dose of study drug or initiation of new anti-cancer drug therapy, whichever occurred first (maximum up to 21 months)

As per NCI-CTCAE v 4.03, anemia Grade 1= Less than (\<) lower limit of normal (LLN) to 100 gram per liter (g/L),Grade 2= \<100 to 80 g/L; hemoglobin increased: Grade 1= increase of greater than (\>) 0 to 2 gram per deciliter(g/dL) above upper limit of normal \[ULN\]; lymphocyte count decreased: Grade 1= \<LLN to 0.8\*10\^9/L, Grade 2= \<0.8\*10\^9/L to 0.5\*10\^9/L, Grade 3= \<0.5\*10\^9/L to 0.2\*10\^9/L ; lymphocyte count increased: Grade 2= \>4\*10\^9/L to 20\*10\^9/L; neutrophil count decreased: Grade 1= \<LLN to 1.5\*10\^9/L ,Grade 2= \<1.5\*10\^9/L to 1.0\*10\^9/L; platelet count decreased: Grade 1= \<LLN to 75.0\*10\^9/L, Grade 2= \<75.0\*10\^9/L to 50.0\*10\^9/L; white blood cell decreased: Grade 1= \<LLN to 3\*10\^9/L, Grade 2= \<3\*10\^9/L to 2\*10\^9/L.

Number of Participants With Abnormal Laboratory Parameter Values (Chemistry) as Graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Version (v) 4.03
From first dose of study drug up to 30 days after last dose of study drug or initiation of new anti-cancer drug therapy, whichever occurred first (maximum up to 21 months)

ALT,ALP,AST increased grades(g):g1\>ULN-3.0\*ULN,g2\>3.0-5.0\*ULN,g3\>5.0-20.0\*ULN; blood bilirubin increased:g1\>ULN-1.5\*ULN, g2\>1.5-3.0\*ULN, g3\>3.0-10.0\*ULN; \[cholesterol high:g1\>ULN-7.75, g2 \>7.75-10.34,g4 \>12.92\]millimoles per liter(mmol/L);creatine phosphokinase, gamma-glutamyl transferase(ggt) increased g1\>ULN-2.5\*ULN, g2\>2.5\*ULN-5\*ULN; Ggt increased g3 \>5.0-20.0\*ULN; Creatinine increased: g1\>ULN-1.5\*ULN; \[hypoalbuminemia:g1\<LLN-30,g2\<30-20\] grams per liter(g/L);\[hyperglycemia:g1\> ULN-8.9,g2\> 8.9-13.9,g3\> 13.9-27.8;hypermagnesemia:g1\>ULN-1.23;hypercalcemia:g1\>ULN -2.9;hyperkalemia:g1\>ULN-5.5,hypernatremia:g1\>ULN-150;hypertriglyceridemia g1:1.71-3.42,g2 \>3.42-5.7;hypocalcemia:g1\<LLN-2.0,hypoglycemia:g1\<LLN-3.0, g2\<3.0-2.2;hypokalemia:g2\<LLN-3.0,g4\<2.5,hypomagnesemia:g1\<LLN-0.5,hyponatremia:g1\<LLN-130, g3\<130-120,hypophosphatemia:g1\<LLN-0.8,g2\<0.8-0.6\]mmol/L;lipase increased:g1\>ULN-1.5\*ULN,g3 \>2.0-5.0\*ULN;serum amylase increased:g1\>ULN-1.5\*ULN, g2\>1.5-2.0\*ULN,g3\>2.0-5.0\*ULN.

Number of Participants With Dose Limiting Toxicities (DLTs)
DLT observation period (from the beginning of Cycle 1 up to the end of Cycle 2 [28 days])

DLT: greater than or equal to (\>=) Grade 3 hematologic/non-hematologic toxicity, Grade 3-4 liver-related laboratory test elevation (alanine aminotransferase, aspartate aminotransferase) with Grade 2 elevation of total bilirubin, non-hematologic Grade 3 laboratory abnormality (required medical intervention to treat participant/led to hospitalization), inability to complete \>=75% of first 2 cycles doses of axitinib (from Cycle 1 Day 1 after completion of lead-in period) or 2 infusions of avelumab within DLT observation period due to investigational product related toxicity.

Secondary Endpoints
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)
Progression-Free Survival (PFS) as Assessed by Investigator
From randomization to date of progression of disease, discontinuation from the study, death or date of censoring, whichever occurred first (for a maximum duration of 41 months)
Percentage of Participants With Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
From randomization to progression of disease, start of new anti-cancer therapy or discontinuation from study or death, whichever occurred first (for a maximum duration of 41 months)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTALAvelumab monotherapy as specified by sub-study protocol B9991001C
Arm 2EXPERIMENTALAvelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C
Arm 3EXPERIMENTALAvelumab in combination with Loratanib as specified by sub-study protocol B9991005C
Arm 4EXPERIMENTALAvelumab monotherapy as specified by sub-study protocol B9991009C
Arm 5EXPERIMENTALAvelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C
Arm 6EXPERIMENTALAvelumab in combination with Talazoparib as specified by sub-study B9991025C.
Arm 7EXPERIMENTALAvelumab in combination with Axitinib as specified by sub-study B9991027C.
Arm 8EXPERIMENTALAvelumab in combination with Talazoparib as specified by sub-study B9991032C.
Arm 9EXPERIMENTALAvelumab in combination with Axitinib as specified by sub-study protocol B9991003C
Arm AEXPERIMENTALAvelumab plus Best Supportive Care (BSC)
Arm BOTHERBest Supportive Care (BSC) alone Following the planned interim analysis for this study, eligible patients in Arm B whose cancer has not worsened and are still in the "watch and wait" part of the study will be given the option to receive Avelumab plus BSC. Prior to this, Arm B patients received BSC alone. All patients who choose not to receive Avelumab will be discontinued.
Avelumab in combination with axitinibEXPERIMENTALAvelumab administered at 10 mg/kg IV every two weeks in combination with axitinib, 5 mg PO BID.
SunitinibACTIVE_COMPARATORSunitinib given at 50 mg PO QD on schedule 4/2
avelumabEXPERIMENTALArm A: avelumab alone
avelumab plus pegylated liposomal doxorubicin (PLD)EXPERIMENTALArm B: avelumab plus PLD
PLDACTIVE_COMPARATORArm C: PLD alone
Experimental 1EXPERIMENTALAvelumab (MSB0010718C) in combination with axitinib (AG-013736)
Dose finding phase and dose expansion phase.EXPERIMENTALTo test the maximum tolerated dose of avelumab (MSB0010718C) in combination with axitinib (AG-013736)
Interventions
NameTypeDescription
AvelumabDRUGoral
LorlatanibDRUGoral
TalazoparibDRUGoral
PemetrexedDRUGIV (intravenous) infusion
AxitinibDRUGoral
CMP 001DRUGIT (intratumoral) or SC (subcutaneous)
UtomilumabDRUGIV infusion
PF04518600DRUGIV infusion
Best Supportive CareOTHERBSC will be administered as deemed appropriate by the treating physician, and could include treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including palliative radiotherapy), etc. BSC does not include any active anti-tumor therapy, however local radiotherapy of isolated lesions with palliative intent is acceptable.
Following the planned interim analysis for this study: AvelumabBIOLOGICAL1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles
Avelumab (MSB0010718C)DRUGIV treatment Avelumab administered at 10 mg/kg IV every two weeks
Axitinib (AG-013736)DRUGOral treatment Axitinib given 5 mg PO BID
SunitinibDRUGOral treatment Sunitinib given at 50 mg PO QD on schedule 4/2
PLDDRUGPLD (Arm B, Arm C) 40 mg/m2 will be given as a 1 hour IV infusion every 4 weeks (Q4W) in 4 week cycles
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites71

Inclusion Criteria: 1. Any participant who is receiving study treatment and deriving significant clinical benefit or is in the safety and/or survival follow-up period in a Pfizer-sponsored Avelumab Parent Study. 2. Participants must agree to follow the reproductive criteria. 3. Participants must be...

Countries:United StatesAustraliaBelgiumCanadaDenmarkFranceHungaryIsraelItalyJapanMexicoNew ZealandPolandRussiaSerbiaSouth KoreaSpainTaiwanUnited KingdomArgentinaBrazilCzechiaGreeceHong KongIndiaNetherlandsNorwayPortugalSwedenAustriaGermanyRomaniaIrelandSingaporeSwitzerland
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Competitive Landscape -Ovarian Cancer 178 trials

Top 20 of 61 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel /m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Exelixis, Inc.EXEL2PHASE2Cabozantinib
Xencor, Inc.XNCR3PHASE2vudalimab
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Recent Changes (Last 90 Days)
MEDIUMJun 22, 2026NCT05059522Enrollment: 68 → 77
MEDIUMJun 22, 2026NCT05059522Enrollment: 68 → 77
LOWMay 26, 2026NCT05059522primaryCompletionDate: changed
LOWMay 24, 2026NCT05059522studyFirstPostDate: changed