Ovarian CancerPhase 3ATALANTENCT02891824
ATALANTE: Atezolizumab vs Placebo Phase III Study in Late Relapse Ovarian Cancer Treated With Chemotherapy+Bevacizumab
A Phase 3 study testing atezolizumab + avastin + platinum-based chemotherapy in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 75 sites in 7 countries.
Trial summary
This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial ovarian cancer (including patients with… Read more about this study
- Who is it for?
- Ages 18 to 95 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- atezolizumab + avastin + platinum-based chemotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 614 participants
- Where
- 75 sitesin 7 countries
- Study dates
- 22 Sep 2016to 22 Feb 2024
- 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 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female Patients must be ≥18 years of age.
- Signed informed consent and ability to comply with treatment and follow-up.
- Patients with histologically confirmed progressive non-mucinous epithelial ovarian cancer, primary peritoneal adenocarcinoma and / or fallopian-tube adenocarcinoma
- Patients with PD-L1 status determined for stratification on mandatory de novo biopsy sent to central laboratory as a formalin-fixed, paraffin-embedded (FFPE) sample.
- Cell pellet from pleural effusion, or ascites or lavage are not acceptable.
- For core needle biopsy specimens, at least three cores should be obtained. Biopsies must be obtained in a manner that minimizes risks. If the location of the tumor renders tumor biopsy medically unsafe or not feasible, patient eligibility should be discussed with the sponsor.
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- Patients whose disease has relapsed more than 6 months from the last dose of platinum before randomization:
- criterion for relapse can be according to RECIST v1.1, CA-125 (GCIG) or clinical symptoms
- the interval between last dose of platinum and entry in the study should be free of new anti-cancer treatment, with the exception of a maintenance therapy which is allowed up to 21 days before study entry.
- Patients with one or 2 prior lines of chemotherapy. The last line of chemotherapy should have included platinum.
- Availability at the study site of representative FFPE tumor sample from surgery during front line therapy, at best before chemotherapy
- Patients must have normal organ and bone marrow function :
- Haemoglobin ≥ 10.0 g/dL.
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
- Platelet count ≥ 100 x 109/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 which case they must be ≤ 5 x ULN.
- Serum creatinine ≤ 1.5 x institutional ULN,
- Patients not receiving anticoagulant medication who have 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) and if the patient is on a stable dose of anticoagulants 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.
- Normal blood pressure or adequately treated and controlled hypertension (systolic BP ≤ 140 mmHg and/or diastolic BP ≤ 90 mmHg).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- For France only: In France, a subject will be eligible for randomization in this study only if either affiliated to, or a beneficiary of, a social security category
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)
- Patients with synchronous primary endometrial cancer unless both of the following criteria are met:
- stage < II,
- Less than 60 years old at the time of diagnosis of endometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3 endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis of endometrial cancer with stage IA grade 1or 2 endometrioid adenocarcinoma.
- Patients with serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium are not eligible.
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- Other malignancy within the last 5 years except cervix or breast in situ carcinoma, breast cancer ≥ 3 years free of disease and treatment, type I stage I endometrial cancer).
- Patients receiving radiotherapy within 6 weeks prior to study treatment.
- Major surgery within 4 weeks of starting study treatment or patients who have not completely recovered from the effects of any major surgery. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1, Cycle 1
- Previous allogeneic bone marrow transplant or previous solid organ transplantation.
- 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 therapy is permitted).
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD1, or anti-PDL1 therapeutic antibodies or anti-CTLA 4.
- Treatment with systemic immunostimulatory agents (including 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 shorter) prior to Cycle 1, Day 1
- Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor 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 obstructive pulmonary disease, mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency are allowed.
- Prophylactic anti-emetic corticosteroids will be avoided if possible in patients treated with pegylated liposomal doxorubicin-carboplatin or gemcitabine-carboplatin regimen. The use of corticosteroids is allowed as premedication for paclitaxel-based regimen and/or premedication in case of carboplatin hypersensitivity.
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Are eligible 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
- History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis. Radiation pneumonitis in the radiation field (fibrosis) detected on screening chest CT scan is permitted
- 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 resolved 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.
- Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
- 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. Influenza vaccination should be given during influenza season only (example approximately October to March in the Northern Hemisphere). Patients must not receive live, attenuated influenza
- Current or recent (within 10 days prior to randomization) chronic use of aspirin > 325 mg/day.
- Prior history of hypertensive crisis (CTC-AE grade 4) or hypertensive encephalopathy.
- Inadequately controlled HTN (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
- Clinically significant (e.g. active) cardiovascular disease, including:
- Myocardial infarction or unstable angina within ≤ 6 months of randomization,
- New York Heart Association (NYHA) ≥ grade 2 congestive heart failure (CHF),
- Poorly controlled cardiac arrhythmia despite medication (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 on 2 or more time points within a 24 hour period or family history of long QT syndrome.
- Left ventricular ejection fraction defined by MUGA/ECHO below the institutional lower limit of normal (only applicable for patients intended to be treated with pegylated liposomal doxorubicin).
- Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization.
- History or evidence of hemorrhagic disorders within 6 months prior to randomization.
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of coagulation).
- 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 suspected brain metastases. Spinal MRI is mandatory (within 4 weeks prior to randomization) in case of suspected spinal cord compression.
- History or evidence upon neurological examination of central nervous system (CNS) disease, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
- Significant traumatic injury during 4 weeks prior to randomization.
- Non-healing wound, active ulcer or bone fracture. Patients with granulating incisions healing by secondary intention with no evidence of facial dehiscence or infection are eligible but require 3 weekly wound examinations.
- History of VEGF therapy related abdominal fistula or gastrointestinal perforation.
- Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease.
- Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure.
- Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment related complications.
- Women of childbearing potential (<2 years after last menstruation and not surgically sterile) not willing to use highly-effective means of contraception (Appendix 1) during the study and for 6 months after the last dose of study medication
- Pregnant or lactating women.
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or to any component of the atezolizumab formulation.
- Known hypersensitivity reaction or allergy to drugs chemically related to bevacizumab, carboplatin, gemcitabine, paclitaxel, pegylated liposomal doxorubicin, or their excipients that contraindicates the subject's participation
Trial locations and contacts
75 sites in 7 countries.
75 sites in 7 countries
France39 sites
ICO Paul Papin
Angers
Sainte-Catherine Institut du Cancer Avignon-Provence
Avignon
CHRU Jean Minjoz
Besançon
Clinique Tivoli
Bordeaux
Institut Bergonié
Bordeaux
Centre François Baclesse
Caen
Centre Jean Perrin
Clermont-Ferrand
Groupe Hospitalier Mutualiste de Grenoble
Grenoble
Hôpital Michallon - Centre Hospitalier Universitaire de Grenoble
Grenoble
Centre Hospitalier Départemental Les Oudairies
La Roche-sur-Yon
Centre Oscar Lambret
Lille
Centre Léon Bérard
Lyon
Institut Paoli Calmettes
Marseille
Hôpital de Mont-de-Marsan
Mont-de-Marsan
ICM Val d'Aurelle
Montpellier
Centre Azuréen de Cancérologie
Mougins
ORACLE - Centre d'Oncologie de Gentilly
Nancy
Hôpital Privé du Confluent, S.A.S.
Nantes
Centre Antoine Lacassagne
Nice
CHU Nîmes - Institut de Cancérologie du Gard
Nîmes
Centre Hospitalier Régional d'Orléans
Orléans
Groupe Hospitalier Diaconesses-Croix Saint Simon
Paris
Groupe Hospitalier Saint-Joseph
Paris
Hôpital Cochin
Paris
Hôpital Européen Georges Pompidou
Paris
Hôpital Tenon
Paris
Institut Curie - Hopital Claudius Régaud
Paris
Centre Hospitalier Lyon Sud
Pierre-Bénite
Centre CARIO - HPCA
Plérin
Hôpital de la Milétrie - Centre Hospitalier Universitaire de Poitiers - Pôle Régional de Cancérologie
Poitiers
Centre Eugène Marquis
Rennes
Hôpital René Huguenin, Institut Curie
Saint-Cloud
ICO Centre René Gauducheau
Saint-Herblain
Centre Paul Strauss
Strasbourg
Institut de Cancérologie Strasbourg Europe (ICANS)
Strasbourg
Clinique Pasteur
Toulouse
Institut Claudius Regaud
Toulouse
ICL Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy
Gustave Roussy
Villejuif
Germany16 sites
Charité, Campus Virchow-Klinikum, Universitätsmedizin Berlin
Berlin
Universitätsklinikum Carl Gustav Carus
Dresden
Universitatsklinikum Dusseldorf
Düsseldorf
Kliniken Essen Mitte, Evang. Huyssens-Stiftung
Essen, 45136
Universitätsklinikum Essen
Essen
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Medizinische Hochschule Hannover
Hanover
Universitätsklinikum Jena
Jena
Städtisches Klinikum Karlsruhe
Karlsruhe
Klinikum der Universität München - LMU, Campus Großhadern
München
Klinikum rechts der Isar, Technischen Universität München
München
Sana Klinikum Offenbach
Offenbach
Studienzentrum Onkologie Ravensburg
Ravensburg
Universitatsklinikum Tübingen
Tübingen, 72076
Universitätsklinikum Ulm
Ulm
Klinikum Worms
Worms, 67550
Spain12 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clínic Barcelona
Barcelona, 8036
Hospital San Pedro de Alcántara
Cáceres, 10003
Hospital Universitari de Girona ICO Girona (Dr. Josep Trueta)
Girona, 17007
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario HM Sanchinarro
Madrid, 28050
Hospital Central Universitario Virgen de la Arrixaca
Murcia, 30120
Hospital Universitario Son Espases
Palma de Mallorca, 7120
Hospital Universitario Donostia
San Sebastián, 20014
Hospital Universitario Virgen Macarena
Seville, 41009
Hospital Alvaro Cunqueiro
Vigo, 36312
Austria4 sites
Krankenhaus der Barmherzigen Brüder Graz
Graz, 8020
Medical University of Graz
Graz, 8036
Medical University of Innsbruck
Innsbruck, 6020
Medical University of Vienna
Vienna, 1090
About this study
Official title: 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
This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval > 6 months).
Read the detailed description
Approximately 600 patients will be randomized using an Interactive Voice Response System /Interactive web system (IVR/IWR system) in a 1:2 ratio to the treatments as specified below:
- Arm A: Placebo + bevacizumab \& platinum-based chemotherapy.
The placebo arm will include one of 3 following regimens up to investigator choice (chosen prior to randomization)
- Carboplatin (day1)combined with gemcitabine (day1 \& day8) and bevacizumab (day1) + placebo ( day1) x 6 cycles q3weeks followed by maintenance with bevacizumab ( day1) + placebo (day1) q3weeks until disease progression or
- Carboplatin (d1) combined with paclitaxel (day1) and bevacizumab (day1) + placebo (d1) x 6 cycles every 3weeks followed by maintenance with bevacizumab (day1) + placebo (day1) q3weeks until disease progression or
- Carboplatin (day1) combined with pegylated liposomal doxorubicin (PLD) (day1) and bevacizumab (day1 \& 15) + placebo ( day1\& 15) x 6 cycles every 4weeks followed by maintenance with bevacizumab (day1) + placebo (day1) q3weeks until disease progression.
- Arm B: Atezolizumab + bevacizumab \& platinum-based chemotherapy
The atezolizumab arm will include one of 3 following regimens up to investigator choice (chosen prior to randomization)
- Carboplatin (day1) combined with gemcitabine (day1 \& d8) and bevacizumab (day1) + atezolizumab ( day1) x 6 cycles q3weeks followed by maintenance with bevacizumab (day1) + atezolizumab (day1) q3w until disease progression or
- Carboplatin (day1) combined with paclitaxel (day1) and bevacizumab ( day1) + atezolizumab (1200mg, d1) x 6 cycles every 3wk (day1) q3weeks until disease progression or
- Carboplatin (day1) combined with pegylated liposomal doxorubicin (PLD) (day1) and bevacizumab (day1 \& 15) + atezolizumab (day1\& 15) x 6 cycles every 4weeks followed by maintenance with bevacizumab (day1) + atezolizumab ( day1) q3weeks until disease progression.
Before randomization to the study:
- A tumor biopsy should have been obtained and sent to the central laboratory
- PD-L1 status should be determined
- Conditions
- Ovarian Cancer
- Being tested
- atezolizumab + avastin + platinum-based chemotherapy, placebo + avastin + platinum-based chemotherapy
- Keywords
- PD-L1, Atezolizumab, Randomized, double blinded, first or second late relapse, progressive non-mucinous epithelial ovarian cancer, primary peritoneal adenocarcinoma and / or fallopian-tube adenocarcinoma, progression-free survival
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atezolizumab + avastin + platinum-based chemotherapyDrug
Also called Tecentriq
- atezolizumab will be administrated by intraveinous route at dose of 1200 mg or 800 mg during the induction period and will be continued in maintenance period at a dose of 1200mg until progression
- avastin will be administrated by intraveinous route at dose of 15mg/kg or 10 mg/kg during the induction period and will be continued in maintenance period of at a dose of 15mg/kg until progression
- platinum-based chemotherapy (Carboplatin combined with gemcitabine or paclitaxel or pegylated liposomal doxorubicin) will be administrated by intraveinous route at different doses during the induction period x 6 cycles
placebo + avastin + platinum-based chemotherapyDrug
- placebo will be administrated by intraveinous route at dose of 1200 mg or 800 mg during the induction period and will be continued in maintenance period at a dose of 1200mg until progression
- avastin will be administrated by intraveinous route at dose of 15mg/kg or 10 mg/kg during the induction period and will be continued in maintenance period of at a dose of 15mg/kg until progression
- platinum-based chemotherapy (Carboplatin combined with gemcitabine or paclitaxel or pegylated liposomal doxorubicin) will be administrated by intraveinous route at different doses during the induction period x 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Placebo + Avastin + platinum-based chemotherapy | Placebo comparator | The placebo arm:
Placebo 1200 mg x 6 cycles q3wk or 800mg x 6 cycles q4wk during treatment with chemotherapy and Avastin, followed by placebo 1200mg q3wk until progression Receives: Drug: placebo + avastin + platinum-based chemotherapy |
| Arm B: Atezolizumab + Avastin+ platinum-based chemotherapy | Experimental | The atezolizumab arm:
Atezolizumab 1200 mg x 6 cycles q3wk or 800mg x 6 cycles q4wk during treatment with chemotherapy and Avastin, followed by atezolizumab 1200mg q3wk until progression
. Receives: Drug: atezolizumab + avastin + platinum-based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Progression free survival, where the date of progression is based on investigator assessment using the RECIST version 1.1
Measured: An average of 19 months
Secondary outcomes (4)
Efficacy: Overall survival (OS)
Measured: To be assessed around 73 months
Efficacy: Time from date randomization to second subsequent therapy or date of death (TSST) whichever come first
Measured: To be assessed around 73 months
patient reported outcome variables
questionnaire to be completed by patients and collected frequently during the study
Measured: to be assessed 19 months
Adverse events
frequency of adverse events according to MedRA terms
Measured: to be assessed 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start22 Sep 2016
- Primary completion15 Oct 2021
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Jean-Emmanuel KURTZ, Principal investigator, GINECO - Institut de cancérologie Strasbourg Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891824
- Sponsor's protocol ID
- GINECO-OV236b
- Acronym
- ATALANTE
- Status last verified
- Feb 2025
- First submitted
- 25 May 2016
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kurtz JE, Pujade-Lauraine E, Oaknin A, Belin L, Leitner K, Cibula D, Denys H, Rosengarten O, Rodrigues M, de Gregorio N, Martinez Garcia J, Petru E, Kocian R, Vergote I, Pautier P, Schmalfeldt B, Gaba L, Polterauer S, Mouret Reynier MA, Sehouli J, Churruca C, Selle F, Joly F, D'Hondt V, Bultot-Boissier E, Lebreton C, Lotz JP, Largillier R, Heudel PE, Heitz F; ATALANTE/ENGOT-ov29 Investigators. Atezolizumab Combined With Bevacizumab and Platinum-Based Therapy for Platinum-Sensitive Ovarian Cancer: Placebo-Controlled Randomized Phase III ATALANTE/ENGOT-ov29 Trial. J Clin Oncol. 2023 Oct 20;41(30):4768-4778. doi: 10.1200/JCO.23.00529. Epub 2023 Aug 29.
PubMed 37643382
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02891824
- Acronym / sponsor ID
- ATALANTE / GINECO-OV236b
- Conditions
- Ovarian Cancer
- Keywords
- PD-L1, Atezolizumab, Randomized, double blinded, first or second late relapse, progressive non-mucinous epithelial ovarian cancer, primary peritoneal adenocarcinoma and / or fallopian-tube adenocarcinoma, progression-free survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- 22 Sep 2016 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase III, randomized, double-blinded, comparative, multi-centre study to assess the efficacy of atezolizumab in combination with platinum-based chemotherapy plus bevacizumab administered concurrent to chemotherapy and in maintenance, in patients presenting epithelial ovarian cancer (including patients with primary peritoneal and / or fallopian tube adenocarcinoma) who have platinum-sensitive relapse (platinum-free interval > 6 months).
Detailed description
Approximately 600 patients will be randomized using an Interactive Voice Response System /Interactive web system (IVR/IWR system) in a 1:2 ratio to the treatments as specified below:
- Arm A: Placebo + bevacizumab \& platinum-based chemotherapy.
The placebo arm will include one of 3 following regimens up to investigator choice (chosen prior to randomization)
- Carboplatin (day1)combined with gemcitabine (day1 \& day8) and bevacizumab (day1) + placebo ( day1) x 6 cycles q3weeks followed by maintenance with bevacizumab ( day1) + placebo (day1) q3weeks until disease progression or
- Carboplatin (d1) combined with paclitaxel (day1) and bevacizumab (day1) + placebo (d1) x 6 cycles every 3weeks followed by maintenance with bevacizumab (day1) + placebo (day1) q3weeks until disease progression or
- Carboplatin (day1) combined with pegylated liposomal doxorubicin (PLD) (day1) and bevacizumab (day1 \& 15) + placebo ( day1\& 15) x 6 cycles every 4weeks followed by maintenance with bevacizumab (day1) + placebo (day1) q3weeks until disease progression.
- Arm B: Atezolizumab + bevacizumab \& platinum-based chemotherapy
The atezolizumab arm will include one of 3 following regimens up to investigator choice (chosen prior to randomization)
- Carboplatin (day1) combined with gemcitabine (day1 \& d8) and bevacizumab (day1) + atezolizumab ( day1) x 6 cycles q3weeks followed by maintenance with bevacizumab (day1) + atezolizumab (day1) q3w until disease progression or
- Carboplatin (day1) combined with paclitaxel (day1) and bevacizumab ( day1) + atezolizumab (1200mg, d1) x 6 cycles every 3wk (day1) q3weeks until disease progression or
- Carboplatin (day1) combined with pegylated liposomal doxorubicin (PLD) (day1) and bevacizumab (day1 \& 15) + atezolizumab (day1\& 15) x 6 cycles every 4weeks followed by maintenance with bevacizumab (day1) + atezolizumab ( day1) q3weeks until disease progression.
Before randomization to the study:
- A tumor biopsy should have been obtained and sent to the central laboratory
- PD-L1 status should be determined
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Placebo + Avastin + platinum-based chemotherapy | Placebo comparator | Drug: placebo + avastin + platinum-based chemotherapyThe placebo arm: Placebo 1200 mg x 6 cycles q3wk or 800mg x 6 cycles q4wk during treatment with chemotherapy and Avastin, followed by placebo 1200mg q3wk until progression |
| Arm B: Atezolizumab + Avastin+ platinum-based chemotherapy | Experimental | Drug: atezolizumab + avastin + platinum-based chemotherapyThe atezolizumab arm: Atezolizumab 1200 mg x 6 cycles q3wk or 800mg x 6 cycles q4wk during treatment with chemotherapy and Avastin, followed by atezolizumab 1200mg q3wk until progression . |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Female Patients must be ≥18 years of age.
- Signed informed consent and ability to comply with treatment and follow-up.
- Patients with histologically confirmed progressive non-mucinous epithelial ovarian cancer, primary peritoneal adenocarcinoma and / or fallopian-tube adenocarcinoma
- Patients with PD-L1 status determined for stratification on mandatory de novo biopsy sent to central laboratory as a formalin-fixed, paraffin-embedded (FFPE) sample.
- Patients whose disease has relapsed more than 6 months from the last dose of platinum before randomization:
Key exclusion criteria (50 listed)
- 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)
- Patients with synchronous primary endometrial cancer unless both of the following criteria are met:
- Other malignancy within the last 5 years except cervix or breast in situ carcinoma, breast cancer ≥ 3 years free of disease and treatment, type I stage I endometrial cancer).
- Patients receiving radiotherapy within 6 weeks prior to study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atezolizumab + avastin + platinum-based chemotherapyAlso: Tecentriq* atezolizumab will be administrated by intraveinous route at dose of 1200 mg or 800 mg during the induction period and will be continued in maintenance period at a dose of 1200mg until progression * avastin will be administrated by intraveinous route at dose of 15mg/kg or 10 mg/kg during the induction period and will be continued in maintenance period of at a dose of 15mg/kg until progression * platinum-based chemotherapy (Carboplatin combined with gemcitabine or paclitaxel or pegylated liposomal doxorubicin) will be administrated by intraveinous route at different doses during the induction period x 6 cycles | Drug | Arm B: Atezolizumab + Avastin+ platinum-based chemotherapy |
| placebo + avastin + platinum-based chemotherapy* placebo will be administrated by intraveinous route at dose of 1200 mg or 800 mg during the induction period and will be continued in maintenance period at a dose of 1200mg until progression * avastin will be administrated by intraveinous route at dose of 15mg/kg or 10 mg/kg during the induction period and will be continued in maintenance period of at a dose of 15mg/kg until progression * platinum-based chemotherapy (Carboplatin combined with gemcitabine or paclitaxel or pegylated liposomal doxorubicin) will be administrated by intraveinous route at different doses during the induction period x 6 cycles | Drug | Arm A: Placebo + Avastin + platinum-based chemotherapy |
Primary outcome
Efficacy: Progression free survival, where the date of progression is based on investigator assessment using the RECIST version 1.1
Time frame: An average of 19 months
4 secondary outcomes
Efficacy: Overall survival (OS)
Time frame: To be assessed around 73 months
Efficacy: Time from date randomization to second subsequent therapy or date of death (TSST) whichever come first
Time frame: To be assessed around 73 months
patient reported outcome variables
Time frame: to be assessed 19 months
Adverse events
Time frame: to be assessed 19 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Derived from this study: PubMed 37643382Kurtz JE, Pujade-Lauraine E, Oaknin A, Belin L, Leitner K, Cibula D, Denys H, Rosengarten O, Rodrigues M, de Gregorio N, Martinez Garcia J, Petru E, Kocian R, Vergote I, Pautier P, Schmalfeldt B, Gaba L, Polterauer S, Mouret Reynier MA, Sehouli J, Churruca C, Selle F, Joly F, D'Hondt V, Bultot-Boissier E, Lebreton C, Lotz JP, Largillier R, Heudel PE, Heitz F; ATALANTE/ENGOT-ov29 Investigators. Atezolizumab Combined With Bevacizumab and Platinum-Based Therapy for Platinum-Sensitive Ovarian Cancer: Placebo-Controlled Randomized Phase III ATALANTE/ENGOT-ov29 Trial. J Clin Oncol. 2023 Oct 20;41(30):4768-4778. doi: 10.1200/JCO.23.00529. Epub 2023 Aug 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Emmanuel KURTZ principal investigator
GINECO - Institut de cancérologie Strasbourg Europe
75 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing atezolizumab + avastin + platinum-based chemotherapy in people with Ovarian Cancer, run by ARCAGY/ GINECO GROUP at 75 sites in 7 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 23 inclusion and 50 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 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in France, Germany, Spain, Austria, Belgium and 2 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?
Efficacy: Progression free survival, where the date of progression is based on investigator assessment using the RECIST version 1.1 (time frame: An average of 19 months). 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 NCT02891824, which also lists 1 linked publication.
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 11 Feb 2025.