AzTrials
AzTrials

Recurrent Ovarian CarcinomaPhase 3NCT03353831

Atezolizumab With Bevacizumab and Chemotherapy vs Bevacizumab and Chemotherapy in Early Relapse Ovarian Cancer

A Phase 3 study testing Bevacizumab, Atezolizumab and Chemotherapy in people with Recurrent Ovarian Carcinoma, run by AGO Research GmbH at 111 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a phase III, randomized, partially blinded, multicenter trial to evaluate the efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared to placebo plus bevacizumab and chemotherapy in patients with recurrent ovarian-, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Recurrent Ovarian Carcinoma
What is being tested?
Bevacizumab, Atezolizumab and Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
574 participants
Where
111 sitesin 12 countries
Study dates
11 Sep 2018to 11 Mar 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer
  • Relapsed disease
  • Patients with up to three prior therapies. In patients with 1 or 2 prior treatment lines, the treatment free interval after platinum has to be less than 6 months; in addition patients with three prior lines of chemotherapy who are not considered for platinum-containing chemotherapy lines are also eligible
  • Measurable disease, evaluable disease in combination with GCIG CA-125 criteria, or histologically proven relapse/progression
  • Mandatory de novo tumor biopsy (not older than 3 months) sent to central laboratory as formalin-fixed, paraffin-embedded (FFPE) sample for determination of PDL1 status prior to randomization for stratification.
  • Availability of a representative archival FFPE tumor sample (preferable from primary diagnosis)
Show all 26Show fewer
  • Patient has not progressed on the chosen/planned chemotherapy (PLD or Paclitaxel) in any prior line
  • Patients previously treated with bevacizumab are eligible, with the exclusion of those patients that has suspended bevacizumab for more than 2 subsequent cycles or permanently discontinued bevacizumab during their previous treatment due to toxicity.
  • Females aged ≥ 18 years at signing at time of signing informed consent form
  • Signed written informed consent and ability to comply with the study protocol, in the investigator's judgement
  • Adequate hematological, renal and hepatic function within 28 days prior to first administration of study treatment:
  • Hemoglobin ≥ 9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10xE^9/L
  • Platelet count ≥ 100 x 10xE^9/L
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT) ≤ 2.5 x ULN, unless liver metastases are present, in case of liver metastases values must be ≤ 5 x ULN
  • Serum creatinine ≤ 1.5 x institutional ULN
  • Patient not receiving anticoagulant medication who has an International Normalized Ratio (INR) ≤ 1.5 and an Activated ProThrombin Time (aPTT) ≤ 1.5 x ULN. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to site medical standard). If the patient is on oral anticoagulants, dose has to be stable for at least two weeks at the time of randomization
  • Urine dipstick for proteinuria < 2+. If urine dipstick is ≥ 2+, 24-hours urine must demonstrate ≤ 1 g of protein in 24 hours.
  • Patients must have adequately controlled blood pressure (BP), with a systolic BP of ≤ 140 mmHg and diastolic BP of ≤ 90 mmHg for eligibility. Patients must have a BP of ≤ 140/90 mmHg taken in the clinic setting by a medical professional within 2 weeks prior to starting study.
  • Estimated life expectancy of at least 3 months
  • ECOG performance status 0 - 1
  • Negative urine or serum pregnancy test within 7 days of study treatment in women of childbearing potential (WOCBP), confirmed prior to treatment on day 1
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 5 months after administration of the last dose of atezolizumab/placebo and 6 months after the last dose of bevacizumab, paclitaxel, or PLD, whichever is later.
  • For countries where this will apply to: a patient will be eligible for randomization in this study only, if either affiliated to, or a beneficiary of a social security category.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, that include the completion of patient-reported outcomes questionnaires.

Who cannot join

  • Non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors)
  • Ovarian tumors of low malignant potential (e.g. borderline tumors)
  • Malignancies other than ovarian cancer within 5 years prior to randomisation, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer)
  • More than three prior systemic anticancer regimens; maintenance therapies (e.g. with bevacizumab, olaparib or niraparib) are not calculated as separate line.
  • Prior systemic anticancer therapy within 28 days before randomization (except bevacizumab: 20 days).
  • Prior radiotherapy to the pelvis or the abdomen.
Show all 55Show fewer
  • Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement thera-py is permitted).
  • Prior treatment with anti-CD137 or immune checkpoint blockade therapies, anti-PD1, or anti-PD-L1 therapeutic antibodies or anti-CTLA 4
  • Prior randomization in AGO-OVAR 2.29.
  • Treatment with systemic immunostimulatory agents (in-cluding but not limited to interferon-alpha (IFN-α) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to cycle 1, day 1.
  • Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophos-phamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor [TNF] agents) within 2 weeks prior to cycle 1, day 1, or anticipated requirement for systemic immunosuppressive medications during the trial.
  • The use of inhaled corticosteroids for chronic obstruc-tive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
  • Patients with a history of allergic reaction to IV contrast requiring steroid pre-treatment should have screening and subsequent tumor assessments performed using magnetic resonance imaging (MRI).
  • Administration of a live, attenuated vaccine within 4 weeks prior to cycle 1, day 1 or anticipation that such a live attenuated vaccine will be required during the study or within 5 months after the last dose of atezolizumab/placebo. Influenza vaccination should be given during influenza season only. Patients must not receive live, attenuated influenza vaccination
  • Major surgery within 4 weeks of starting study treatment or patient who has not completely recovered from the effects of any major surgery. Core biopsy or other minor surgical procedure within 7 days prior to day 1, cycle 1 is permitted.
  • Previous allogeneic bone marrow transplant or previous solid organ transplantation.
  • Current treatment with anti-viral therapy for HBV.
  • History of idiopathic pulmonary fibrosis (including pneumonitis), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evi-dence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) detected on screening chest CT scan is permitted
  • Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization
  • History or evidence hemorrhagic disorders within 6 months prior to randomization
  • Patients are excluded if having a history or evidence of thrombosis as follows:
  • Any Grade 4 thrombosis
  • Arterial thrombosis within 6 months prior to ran-domization
  • Grade ≤ 3 venous thrombosis within 3 months prior to randomization Patients with central venous access thrombosis are eligi-ble.
  • History or clinical suspicion of brain metastases or spinal cord compression. CT/MRI of the brain is mandatory (within 4 weeks prior to randomization) in case of sus-pected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of sus-pected spinal cord compression
  • History of autoimmune disease, including but not limited to dermatomyositis, myasthenia gravis, myositis, auto-immune hepatitis, systemic lupus erythematosus, rheu-matoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guil-lain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Except patients with:
  • a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone
  • controlled type 1 diabetes mellitus on a stable insulin regimen
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
  • Rash must cover < 10% of body surface area
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
  • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months
  • Any prior history of hypertensive crisis (CTCAE grade 4) or hypertensive encephalopathy.
  • Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV), patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C.
  • Patients with past hepatitis B virus (HBV) infection or re-solved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  • Persistent toxicities (≥ CTCAE grade 2) with the exception of alopecia, caused by previous cancer treatment. Neurotoxicity CTCAE grade 2 is permitted in case the patient is planned for PLD treatment.
  • Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomization, including but not limited to active tuberculosis or hospitalization for complications of infection, bacteremia, or severe pneumonia. Patients receiving prophylactic antibiotics (e.g., to prevent urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
  • Current or recent (within 10 days prior randomization) chronic use of aspirin > 325 mg/day.
  • Clinically significant (e.g. active) cardiovascular disease, including:
  • Myocardial infarction or unstable angina pectoris within ≤ 6 months of randomization
  • New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF)
  • Poorly controlled cardiac arrhythmia despite medica-tion (patients with rate controlled atrial fibrillation are eligible)
  • Peripheral vascular disease grade ≥ 3 (e.g. symptomatic and interfering with activities of daily living [ADL] requiring repair or revision)
  • Resting ECG with QTc >470 msec or family history of long QT syndrome
  • For patients with PLD treatment: Left ventricular ejection fraction defined by ECHO below the institutional lower limit of normal
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation).
  • Non-healing wound, active ulcer or bone fracture.
  • History of bowel obstruction (including subocclusive disease) related to underlying disease, a history of ab-dominal fistula, GI perforation, or intra-abdominal abscess, or evidence of deep infiltration of the bowel by pelvic examination or on computed tomography, or clinical symptoms of bowel obstruction.
  • Patients with evidence of abdominal free air.
  • Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications
  • Known hypersensitivity or allergy to drugs containing Chinese hamster (CHO) ovary cells or history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity reaction or allergy to drugs chemically related to bevacizumab, paclitaxel, pegylated liposomal doxorubicin, or their excipients that contra-indicates the subject's participation.
  • Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. This includes also any psychiatric disorder that prohibits obtaining informed consent.
  • Pregnancy, lactation, or intention to become pregnant during the study or within 5 months after the last dose of atezolizumab/placebo as well as breastfeeding women or intended to breastfeed during the study and up to 6 months after treatment with paclitaxel, bevacizumab and pegylated liposomal doxorubicin (PLD).
  • For France only: Patients deprived of their liberty by judicial or administrative decision and patients under a legal protection measure or unable to express their consent.

Trial locations and contacts

111 sites in 12 countries.

111 sites in 12 countries

Germany42 sites

  • Hochtaunus-Kliniken

    Bad Homburg

  • Charité - Universitätsmedizin Berlin (CVK)

    Berlin

  • Helios Klinikum Berlin-Buch

    Berlin

  • Klinikum Bremen-Mitte

    Bremen

  • Universitätsfrauenklinik Köln

    Cologne

  • Städtisches Klinikum Dessau

    Dessau

  • Universitätsklinikum Carl Gustav Carus

    Dresden

  • Universitätsklinikum Düsseldorf

    Düsseldorf

  • Kliniken Essen-Mitte

    Essen

  • Universitätsfrauenklinik Essen

    Essen

  • Klinikum Frankfurt Höchst

    Frankfurt

  • Universitätsfrauenklinik Frankfurt

    Frankfurt

  • Klinikum Gütersloh

    Gütersloh

  • Universitätsfrauenklinik Halle/Saale

    Halle

  • Mammazentrum Hamburg am Krankenhaus Jerusalem

    Hamburg

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

  • Universitätsklinikum Heidelberg

    Heidelberg

  • Praxisgemeinschaft Frauenärzte am Bahnhofsplatz

    Hildesheim

  • Universitätsklinikum Jena

    Jena

  • ViDia Christliche Kliniken Karlsruhe

    Karlsruhe

  • Klinikum Kassel

    Kassel

  • Universitätsklinikum Schleswig-Holstein

    Kiel

  • Universitätsklinikum Schleswig-Holstein

    Lübeck

  • Universitätsmedizin Mainz

    Mainz

  • Universitätsfrauenklinik Mannheim

    Mannheim

  • Johannes Wesling Klinikum

    Minden

  • Klinikum der Universität München

    München

  • Rotkreuzklinikum München

    München

  • Universitätsklinikum Münster

    Münster

  • MVZ Nordhausen

    Nordhausen

  • Ortenau Klinikum Offenburg-Gengenbach

    Offenburg

  • Onkologie Ravensburg

    Ravensburg

  • Universitätsfrauenklinik Regensburg

    Regensburg

  • Thüringen Kliniken "Georgius Agricola"

    Saalfeld

  • CTS CaritasKlinikum Saarbrücken

    Saarbrücken

  • Leopoldina-Krankenhaus

    Schweinfurt

  • Klinikum Traunstein

    Traunstein

  • Universitätsfrauenklinik Tübingen

    Tübingen

  • Universitätsfrauenklinik Ulm

    Ulm

  • Helios Dr. Horst Schmidt Kliniken

    Wiesbaden

  • Marien-Hospital

    Witten

  • AMO MVZ Wolfsburg

    Wolfsburg

Other trials in Germany

France27 sites

  • ICO d'Angers

    Angers

  • Institut Sainte Catherine

    Avignon

  • Hôpital Jean Minjoz

    Besançon

  • Blois Hospital (Centre Hospitalier de Blois)

    Blois

  • Clinique TIVOLI-DUCOS

    Bordeaux

  • Institut Bergonié

    Bordeaux

  • Centre François Baclesse

    Caen

  • Médipôle de Savoie

    Challes-les-Eaux

  • SASU Centre d'Oncologie et Radiothérapie 37

    Chambray-lès-Tours

  • Centre Jean Perrin

    Clermont-Ferrand

  • Centre Georges François Leclerc

    Dijon

  • Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon

  • Centre Oscar Lambret, Lille

    Lille

  • Centre Léon Bérard

    Lyon

  • ICM Val d'Aurelle

    Montpellier

  • ORACLE Centre d'Oncologie de Gentilly

    Nancy

  • Centre Antoine Lacassagne

    Nice

  • Centre Hospitalier Régional d'Orléans

    Orléans

  • Groupe Hospitalier Diaconesses Croix Saint Simon

    Paris

  • Institut Curie Site Paris

    Paris

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite

  • Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

    Plérin

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez

  • Hôpital Foch

    Suresnes

  • IUCT Oncopole - Institut Claudius Regaud

    Toulouse

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy

  • Gustave Roussy

    Villejuif

Other trials in France

Spain16 sites

  • Hospital Clínic de Barcelona

    Barcelona

  • Institut Català d'Oncologia (ICO) d'Hospitalet

    Barcelona

  • Vall d'Hebron Instituto de Oncología (VHIO)

    Barcelona

  • Hospital Universitario Reina Sofía

    Córdoba

  • Institut Català d'Oncologia (ICO) de Girona

    Girona

  • Hospital Universitario de Jerez

    Jerez de la Frontera

  • Hospital Universitario La Paz

    La Paz

  • Clínica Universidad de Navarra (CUN)

    Madrid

  • Hospital Regional Universitario de Málaga

    Málaga

  • Hospital General Universitario Morales Meseguer

    Murcia

  • Hospital Universitario Son Llàtzer

    Palma de Mallorca

  • Clínica Universidad de Navarra (CUN)

    Pamplona

  • Complejo Hospitalario de Navarra

    Pamplona

  • Hospital Clínico Universitario de Valencia

    Valencia

  • Instituto Valenciano de Oncología (IVO)

    Valencia

  • Hospital Universitario Miguel Servet

    Zaragoza

Other trials in Spain

Switzerland8 sites

  • Kantonsspital Baden

    Baden

  • Universitätsspital Basel

    Basel

  • Kantonsspital Graubünden

    Chur

  • Kantonsspital Frauenfeld

    Frauenfeld

  • Kantonsspital Luzern

    Lucerne

  • Kantonsspital Olten

    Olten

  • Kantonsspital St. Gallen

    Sankt Gallen

  • Kantonsspital Winterthur

    Winterthur

Other trials in Switzerland

Belgium5 sites

  • UZA Edegem

    Edegem

  • AZ Sint Lucas

    Ghent

  • UZ Leuven

    Leuven

  • CHU Liège Sart Tilman Grivegnée

    Liège

  • CHU UCL Namur Sainte Elisabeth

    Namur

Other trials in Belgium

Denmark4 sites

  • Copenhagen University Hospital, Rigshospitalet

    Copenhagen

  • Herlev University Hospital

    Herlev

  • Odense University Hospital

    Odense

  • Zealand University Hospital

    Roskilde

Other trials in Denmark

Sweden3 sites

  • Linköping University Hospital

    Linköping

  • Skåne University Hospital

    Malmö

  • Karolinska University Hospital

    Solna

Other trials in Sweden

Lithuania2 sites

  • Vilniaus universiteto ligoninė Santaros klinikos

    Kaunas

  • Nacionalinis vėžio institutas

    Vilnius

Other trials in Lithuania

Austria1 site

  • Medizinische Universität

    Innsbruck

Other trials in Austria

Estonia1 site

  • East Tallinn Central Hospital

    Tallinn

Other trials in Estonia

Finland1 site

  • Tampere University Hospital

    Tampere

Other trials in Finland

Norway1 site

  • Oslo University Hospital

    Oslo

Other trials in Norway

About this study

Official title: Atezolizumab in Combination With Bevacizumab and Chemotherapy Versus Bevacizumab and Chemotherapy in Recurrent Ovarian Cancer - a Randomized Phase III Trial

This is a phase III, randomized, partially blinded, multicenter trial to evaluate the efficacy and safety of atezolizumab plus bevacizumab and chemotherapy compared to placebo plus bevacizumab and chemotherapy in patients with recurrent ovarian-, fallopian tube, or primary peritoneal cancer with 1st or 2nd relapse within 6 months after platinum based chemotherapy or 3rd relapse.

Read the detailed description

Approximately 550 patients will be randomized in a 1:1 ratio to the treatments as specified below:

Arm A: Chemotherapy + Bevacizumab + Placebo Arm B: Chemotherapy + Bevacizumab + Atezolizumab

Study treatment will continue until disease progression per RECIST v1.1, unacceptable toxicity, or patient or investigator decision to discontinue treatment. Atezolizumab/placebo, chemotherapy and bevacizumab may be discontinued for toxicity independently of each other in the absence of disease progression.

For each patient, chemotherapy (PLD or Paclitaxel weekly) will be selected by the investigator prior to randomization.

Recruitment to an individual chemotherapy cohort will be closed once 50% of patients are recruited to this cohort. In such case the remaining cohort will remain open for recruitment.

Being tested
Bevacizumab, Atezolizumab, Chemotherapy, Placebos
Keywords
Recurrent Ovarian Cancer, Atezolizumab, Bevacizumab
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Bevacizumab will be administered by intravenouse route at a dose of 10mg/kg q14 during the treatment period

  • AtezolizumabDrug

    Atezolizumab will be administered by intravenous route at a dose of 840 mg q14 during the treatment period

  • ChemotherapyDrug

    Chemotherapy (Paclitaxel or PLD) will be administered by intravenous route at different doses during the treatment period q28

  • PlacebosDrug

    Placebo will be administered by intravenous route q14 during the treatment period

Study groups in NCT03353831
Study groupRoleWhat they receive
Arm A: Chemotherapy + Bevacizumab + PlaceboPlacebo comparatorChemotherapy: Paclitaxel 80 mg/m² d1, 8, 14, 22 q28 or pegylated liposomal doxorubicin 40 mg/m² q28 + Bevacizumab 10 mg/kg q14 + Placebos q14
Receives: Drug: Bevacizumab; Drug: Chemotherapy; Drug: Placebos
Arm B: Chemotherapy + Bevacizumab + AtezolizumabExperimentalChemotherapy: Paclitaxel 80 mg/m² d1, 8, 14, 22 q28 or pegylated liposomal doxorubicin 40 mg/m² q28 + Bevacizumab 10 mg/kg q14 + Atezolizumab 840 mg q14
Receives: Drug: Bevacizumab; Drug: Atezolizumab; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    regular patient contacts during the trial regarding life status

    Measured: From date of randomizationrandomization to date of death from any cause assessed up to 40 months

  2. Progression-free survival

    Progressive Disease based on investigator assessment using RECIST v1.1

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months

Secondary outcomes (4)

  1. patient reported outcomes (QLQ and PRO-CTCAE)

    questionnaires to be completed by patients and collected frequently during the trial

    Measured: every 4 weeks during the first 3 months, then every 12 weeks until PD#1, assessed up to 40 months

  2. Objective Response Rate (ORR)

    based on investigator assessment using RECIST v1.1

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months

  3. Duration of Response (DOR)

    based on investigator assessment using RECIST v1.1

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months

  4. Efficacy regarding PD-L1 status

    Efficacy regarding PD-L1 positivity defined by the VENTANA SP142 assay (negative: IC 0 versus positive IC: 1/2/3)

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever occurs earlier, assessed up to 40 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2017
  2. Study start11 Sep 2018
  3. Primary completion11 Mar 2025
  4. Study completion11 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
574 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03353831
Sponsor's protocol ID
AGO-OVAR 2.29
Status last verified
Apr 2025
First submitted
14 Nov 2017
Last updated
6 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Harter P, Marme F, Redondo A, Reuss A, Lindemann K, Kurzeder C, Van Nieuwenhuysen E, Marth C, Pietzner K, Ray-Coquard I, Garcia-Duran C, Jonuskiene G, Heitz F, Bellier C, Perez-Fidalgo JA, El-Balat A, Selle F, Romero I, Wimberger P, Follana P, Pardo B, de Gregorio N, Joly F, Gaba L, Burges A, Fabbro M, Hasenburg A, Fehm T, Schmalfeldt B, Pautier P. Atezolizumab With Bevacizumab and Nonplatinum Chemotherapy for Recurrent Ovarian Cancer: Final Results From the Placebo-Controlled AGO-OVAR 2.29/ENGOT-ov34 Phase III Trial. J Clin Oncol. 2026 Jan 10;44(2):103-116. doi: 10.1200/JCO-25-01210. Epub 2025 Dec 3.

    PubMed 41337696

  • Harter P, Pautier P, Van Nieuwenhuysen E, Reuss A, Redondo A, Lindemann K, Kurzeder C, Petru E, Heitz F, Sehouli J, Degregorio N, Wimberger P, Burges A, Cron N, Ledermann J, Lorusso D, Paoletti X, Marme F. Atezolizumab in combination with bevacizumab and chemotherapy versus bevacizumab and chemotherapy in recurrent ovarian cancer - a randomized phase III trial (AGO-OVAR 2.29/ENGOT-ov34). Int J Gynecol Cancer. 2020 Dec;30(12):1997-2001. doi: 10.1136/ijgc-2020-001572. Epub 2020 Jun 30.

    PubMed 32606097

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, Atezolizumab and Chemotherapy in people with Recurrent Ovarian Carcinoma, run by AGO Research GmbH at 111 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 55 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 111 sites in Germany, France, Spain, Switzerland, Belgium and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: From date of randomizationrandomization to date of death from any cause assessed up to 40 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03353831, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in