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Recurrent Ovarian CarcinomaPhase 3ANITANCT03598270

Platinum-based Chemotherapy With Atezolizumab and Niraparib in Patients With Recurrent Ovarian Cancer

A Phase 3 study testing Carboplatin, Paclitaxel and Niraparib in people with Recurrent Ovarian Carcinoma, run by Grupo Español de Investigación en Cáncer de Ovario at 71 sites in 5 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

Atezolizumab in this study is expected to have a positive benefit-risk profile for the treatment of patients with platinum-sensitive relapse of ovarian cancer. Of interest, atezolizumab is being investigated also in combination with platinum-based doublet chemotherapy in second line (2L)/ third line (3L)… 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?
Carboplatin, Paclitaxel and Niraparib
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
417 participants
Where
71 sitesin 5 countries
Study dates
21 Nov 2018to 5 Aug 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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients ≥ 18 years old
  • Life expectancy ≥3 months
  • Signed informed consent and ability to comply with treatment and follow-up
  • Histologically confirmed diagnosis (cytology alone excluded) of high- grade serous or endometrioid ovarian, primary peritoneal or tubal carcinoma.
  • Breast Cancer (BRCA) mutational status is known (germline or somatic)
  • Relapsed disease more than 6 months after the last platinum dose
Show all 28Show fewer
  • No more than 2 prior lines of chemotherapy are allowed, and the last one must contain a platinum-based regimen
  • At least one measurable lesion to assess response by RECIST v1.1 criteria.
  • Mandatory de novo tumor biopsy (collected within 3 months prior to randomization) sent to HistoGene X as a formalin-fixed, paraffin-embedded (FFPE) sample for PD-L1 status determination for randomization. The inclusion of patients with non informative tissue PD-L1 status will be capped to 10% of the whole study population:
  • If the mandatory de novo biopsy is technically not possible or failed to produce enough representative tumor tissue, an FFPE sample from archival tissue may be acceptable after approval of the sponsor.
  • Bone metastases, fine needle aspiration, brushing, cCell pellet from pleural effusion, or ascites or lavage are not acceptable.
  • Two additional tumour samples are needed: Archival tumor sample must be available for exploratory PD-L1 testing in archival tissue and archival or "de novo" tissue sample for biomarkers must also be available.
  • Performance status determined by Eastern Cooperative Oncology Group (ECOG) score of 0-1
  • Normal organ and bone marrow function:
  • Haemoglobin ≥10.0 g/dL
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L
  • Lymphocyte count ≥0.5 × 109/L
  • Platelet count ≥100 x 109/L
  • Total bilirubin ≤1.5 x institutional upper limit of normal (ULN)
  • Serum albumin ≥2.5 g/dL
  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤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 or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
  • Patients not receiving anticoagulant medication must have an International Normalized Ratio (INR) ≤1.5 and an Activated ProThrombin Time (aPTT) ≤1.5 x ULN.
  • Negative Test Results for Hepatitis.
  • Toxicities related to previous treatments must be recovered to < grade 2
  • Female participants must be postmenopausal or surgically sterile or otherwise have a negative serum pregnancy test within 7 days of the first study treatment and agree to abstain from heterosexual intercourse or use single or combined contraceptive methods.
  • Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  • Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.

Who cannot join

  • Non-epithelial tumor of the ovary, the fallopian tube or the peritoneum.
  • Ovarian tumors of low malignant potential or low grade
  • Other malignancy within the last 5 years except curatively treated non-melanoma skin cancer, in situ cancer of the cervix and ductal carcinoma in situ (DCIS)
  • Major surgery within 4 weeks of starting study treatment or patients who have not completely recovered (Grade ≥ 2) from the effects of any major surgery at randomization
  • Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1, Cycle 1
  • Administration of other chemotherapy drugs, anticancer therapy or anti-neoplastic hormonal therapy, or treatment with other investigational agents or devices within 28 days prior to randomization, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, or anticipation to do it during the trial treatment period (non-investigational hormonal replacement therapy is permitted)
Show all 37Show fewer
  • Palliative radiotherapy (e.g., for pain or bleeding) within 6 weeks prior to randomization or patients who have not completely recovered (Grade ≥ 2) from the effects of previous radiotherapy
  • Current or recent (within 10 days prior to randomization) chronic use of aspirin (>325 mg/day) or clopidogrel (>75 mg/day)
  • Clinically significant (e.g. active) cardiovascular disease
  • Resting ECG with corrected QT interval (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 multigated acquisition/echocardiogram (MUGA/ECHO) below the institutional lower limit of normal
  • 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) disorders (e.g. uncontrolled epileptic seizures) unless adequately treated with standard medical therapy
  • Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying disease
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed
  • Uncontrolled hypercalcemia (>1.5 mmol/L ionized calcium or calcium >12 mg/dL or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
  • 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
  • Pregnant or lactating women
  • Simultaneously receiving therapy in any interventional clinical trial
  • Prior treatment with CD137 agonists or immune checkpoint stimulating or blockade therapies, such as anti-PD1, anti-PDL1 or anti-CTLA4 therapeutic antibodies
  • 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
  • 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
  • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis
  • Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV)
  • Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1
  • Active tuberculosis
  • Administration of a live, attenuated vaccine (including against influenza) within 4 weeks prior to Cycle 1, Day 1 or anticipation that it will be administered at any time during the treatment period of the study or within 5 months after the final dose of atezolizumab.
  • 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 or allergy to any of the other drugs included in the protocol or their solvents (including to Cremophor®)
  • Patient has received prior treatment with a poly (adenosine diphosphate (ADP)-ribose) polymerase (PARP) inhibitor in the recurrent setting or has participated in a study where any treatment arm included administration of a PARP inhibitor in the recurrent setting, unless the patient is unblinded and there is evidence of not having received a PARP inhibitor. Patients that received PARP inhibitor as front line are eligible for the study. The duration of exposure to PARPi following front line therapy needs to be ≥18 months for BRCA mutated patients and ≥ 12 months for BRCA wild type patients.
  • Patient has had any known ≥Grade 3 hematological toxicity anemia, neutropenia or thrombocytopenia due to prior cancer chemotherapy that persisted >4 weeks and was related to the most recent treatment
  • Patient has any known history or current diagnosis of Myelodysplasic syndrome (MDS) or Anaplastic Myeloid Leukemia (AML)
  • Previous allogeneic bone marrow transplant or previous solid organ transplantation
  • Patient has a condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the patient's participation for the full duration of the study treatment
  • Participant has any known hypersensitivity to niraparib components or excipients

Trial locations and contacts

71 sites in 5 countries.

71 sites in 5 countries

Spain25 sites

  • Complejo Hospitalario Universitario de A Coruña

    A Coruña

  • ICO Badalona

    Badalona

  • H. Clínic Barcelona

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital de la Vall d'Hebron

    Barcelona

  • H Reina Sofía Cordoba

    Córdoba

  • ICO Girona

    Girona

  • ICO Hospitalet

    Hospitalet Del Llobregat

  • Hospital de León

    León

  • Clinica Universitaria de Navarra

    Madrid

  • Hospital Clínico San Carlos

    Madrid

  • Hospital Gregorio Marañon

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Ramon y Cajal

    Madrid

  • Complejo Hospitalario Regional de Málaga

    Málaga

  • H Morales Meseguer

    Murcia

  • Hospital Son Llatzer

    Palma de Mallorca

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital de Sabadell

    Sabadell, Barcelona

  • Hospital Virgen del Rocio

    Seville

  • H La Fe de Valencia

    Valencia

  • Hospital Clínico Universitario de Valencia

    Valencia

  • Hospital Universitario Miguel Servet

    Zaragoza

Other trials in Spain

France20 sites

  • ICO - Paul Paupin - ANGERS

    Angers, 49055

  • CHU Besançon

    Besançon, 25000

  • Institut Bergonié

    Bordeaux, 33000

  • Centre François Baclesse

    Caen, 14000

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Léon Bérard

    Lyon, 69008

  • Institut Paoli Calmettes

    Marseille, 13009

  • ICM Val d'Aurelle

    Montpellier, 34298

  • Centre Antoine Lacassagne

    Nice, 06100

  • ONCOGARD - Institut de Cancérologie du Gard

    Nîmes, 30900

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Européen Georges Pompidou

    Paris, 75015

  • Groupe Hospitalier Diaconesses-Croix Saint Simon

    Paris, 75020

  • Hôpital Tenon

    Paris, 75020

  • HPCA Cario

    Plérin, 22198

  • Institut Curie - Hopital Claudius Régaud

    Saint-Cloud, 92210

  • Institut Curie - Hôpital René Huguenin- SAINT CLOUD

    Saint-Cloud, 92210

  • ICO Centre René Gauducheau

    Saint-Herblain, 44800

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

  • Gustave Roussy

    Villejuif, 94800

Other trials in France

Germany14 sites

  • Hochtaunus-Kliniken

    Bad Homburg

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden

  • Kliniken Essen-Mitte

    Essen

  • Mammazentrum Hamburg am Krankenhaus Jerusalem

    Hamburg

  • Diakovere Krankenhaus

    Hanover

  • Klinikum Kulmbach

    Kulmbach

  • Universitätsklinikum Mannheim

    Mannheim, 68167

  • Universitätsklinikum Münster

    Münster

  • MVZ Nordhausen

    Nordhausen

  • Klinikum Oldenburg AöR

    Oldenburg

  • ROMed Klinikum Rosenheim

    Rosenheim

  • Universitätsklinikum Tübingen

    Tübingen

  • Universitätsfrauenklinik Ulm

    Ulm

  • HELIOS Dr. Horst Schmidt Kliniken Wiesbaden

    Wiesbaden

Other trials in Germany

Italy7 sites

  • Spedali Civili

    Brescia

  • Asst Lecco

    Lecco

  • Istituto Europeo di Oncologia

    Milan

  • I.R.C.C.S. Istituto Oncologico Veneto

    Padova

  • Arcispedale Santa Maria Nuova

    Reggio Emilia

  • AO Città della Salute e della Scienza- Ospedale Sant'Anna

    Torino

  • Ospedale Mauriziano Umberto I

    Torino

Other trials in Italy

Belgium5 sites

  • Grand Hôpital de Charleroi

    Charleroi

  • UZ Leuven

    Leuven

  • CHU de Liège, site Sart Tilman

    Liège

  • CHU Ambroise Paré

    Mons

  • CHU UCL Namur site St. Elisabeth

    Namur

Other trials in Belgium

About this study

Official title: A Phase III Randomized, Double-blinded Trial of Platinum-based Chemotherapy With or Without Atezolizumab Followed by Niraparib Maintenance With or Without Atezolizumab in Patients With Recurrent Ovarian, Tubal or Peritoneal Cancer and Platinum Treatment-free Interval (TFIp) >6 Months

Atezolizumab in this study is expected to have a positive benefit-risk profile for the treatment of patients with platinum-sensitive relapse of ovarian cancer. Of interest, atezolizumab is being investigated also in combination with platinum-based doublet chemotherapy in second line (2L)/ third line (3L) platinum-sensitive recurrent ovarian cancer patients in ATALANTE (NCT02891824), which also includes bevacizumab in the combination. The study is proceeding as expected after >100 patients enrolled and under independent Data Monitoring Committee (IDMC) supervision.

Platinum-containing therapy is considered the treatment of choice for patients with platinum-sensitive relapse. However the duration of response and the prolongation of the progression free interval with chemotherapy are usually brief, among other because these chemotherapy regimens cannot be continued until progression as they are associated with neurological, renal and hematological toxicity and cannot generally be tolerated for more than about 6 to 9 cycles.

Read more

Niraparib received FDA approval in March 2017 as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Recently, the European Medicines Agency (EMA) has also approved niraparib as maintenance monotherapy. Despite the progress brought about by niraparib, there is a need for a more effective treatment to extend the progression free interval in this patient population. The combination with immune checkpoint inhibitors such as anti-death protein 1 (anti-PD1) or anti-death protein ligand 1 (anti-PD-L1) has a compelling rationale to this aim, especially under the light of the emerging clinical data of this combination.

The use of atezolizumab concurrent to platinum-containing chemotherapy followed by niraparib as maintenance therapy after completion of chemotherapy, as per normal clinical practice, may provide further benefit to patients in terms of prolonging the progression free interval and increasing the interval between lines of chemotherapy, hence delaying further hospitalization and the cumulative toxicities associated with chemotherapy. Additionally, preliminary studies with atezolizumab suggest an acceptable tolerability profile for long term clinical use in recurrent ovarian cancer patients and other indications.

Keywords
Ovarian, Atezolizumab, Niraparib
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • PlaceboDrug

    Also called Placebo of Atezolizumab

    Volume equivalent to 1200 mg of atezolizumab drug product. Intravenous Day 1

  • CarboplatinDrug

    Intravenous. Day 1

  • PaclitaxelDrug

    175 mg/m². Intravenous. Day 1

  • NiraparibDrug

    200 mg or 300 mg. Oral. From day 1 to 21

  • GemcitabineDrug

    1000 mg/m². Intravenous. Day 1 and day 8.

  • Pegylated liposomal doxorubicin (PLD)Drug

    30 mg/m². Intravenous. Day 1

  • AtezolizumabDrug

    Also called Tecentriq

    1200 mg. Intravenous. Day 1

Study groups in NCT03598270
Study groupRoleWhat they receive
Arm A (Control Arm)Placebo comparatorPlacebo of atezolizumab in combination with one of the platinum based regimens below (investigator's choice) followed by maintenance niraparib with placebo: * Carboplatin (AUC = 5, d1) plus paclitaxel and placebo every 3 weeks. Non-progressing patients will be switched to maintenance niraparib in combination with placebo every 3 weeks * Carboplatin (AUC = 4, d1) plus gemcitabine and placebo every 3 weeks. Non-progressing patients will be switched to maintenance niraparib in combination with placebo every 3 weeks. * Carboplatin (AUC = 5, d1) plus pegylated liposomal doxorubicin (PLD) and placebo every 4 weeks. Non-progressing patients will be switched to maintenance niraparib in combination with placebo every 3 weeks.
Receives: Drug: Placebo; Drug: Carboplatin; Drug: Paclitaxel; Drug: Niraparib; Drug: Gemcitabine; Drug: Pegylated liposomal doxorubicin (PLD)
Arm B (experimental arm)ExperimentalAtezolizumab in combination with one of the platinum based regimens below (investigator's choice) followed by maintenance niraparib with atezolizumab: * Carboplatin (AUC = 5, d1) plus paclitaxel and atezolizumab every 3 weeks. Non-progressing patients will be switched to maintenance niraparib in combination with atezolizumab every 3 weeks. * Carboplatin (AUC = 4, d1) plus gemcitabine and atezolizumab every 3 weeks. Non-progressing patients will be switched to maintenance niraparib in combination with atezolizumab every 3 weeks. * Carboplatin (AUC = 5, d1) plus pegylated liposomal doxorubicin (PLD) and atezolizumab every 4 weeks. Non-progressing patients will be switched to maintenance niraparib in combination with atezolizumab every 3 weeks.
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Niraparib; Drug: Gemcitabine; Drug: Pegylated liposomal doxorubicin (PLD); Drug: Atezolizumab

What is being measured

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

  1. Progression-free survival (PFS)

    Period from study entry (day of randomization) until disease progression, death or date of last contact. Progression will be based on tumor assessment made by the investigators according to the RECIST v1.1 criteria.

    Measured: 30 months

Secondary outcomes (21)

  1. Overall survival (OS)

    The observed length of life from entry into the study (day of randomization) to death due to any cause, or the date of last contact if patient alive.

    Measured: 60 months

  2. Time to first subsequent therapy or death (TFST)

    Time from the date of randomization in the current study to the start date of the first subsequent anticancer therapy.

    Measured: 60 months

  3. Time to second subsequent therapy or death (TSST)

    Time from the date of randomization in the current study to the start date of the second subsequent anticancer therapy

    Measured: 60 months

  4. Time to second progression or death (PFS2)

    Time from treatment randomization to the earliest date of assessment of progression on the next anticancer therapy following study treatment or death by any cause.

    Measured: 60 months

  5. Incidence of Treatment Adverse Events

    Frequency and severity of adverse events as assessed by CTCAE version 5.0 for the regimens administered on this study

    Measured: 60 months

  6. Patient-reported abdominal symptoms

    Clinically-meaningful improvement in patient-reported abdominal pain or bloating, defined as a 10-point decrease from the baseline score on either of the two items of the EORTC quality of life questionnaire-ovarian cancer module (QLQ-OV28) abdominal/GI symptom scale (items 31 and 32)

    Measured: 60 months

  7. Patient-reported outcomes (PROs) of function and health related quality of life (HRQoL)

    Clinical improvement, remaining stable, or deterioration in patient-reported function and HRQoL, defined as a 10-point increase, changes within 10 points, and a 10-point decrease, respectively, from the baseline score on each of the functional (physical, role, emotional, and social) and global health status/HRQoL scales of EORTC QLQ-C30

    Measured: 60 months

  8. Objective Response Rate (ORR)

    Based on investigator assessment by RECIST v1.1 during the chemotherapy phase and during the maintenance phase

    Measured: 60 months

  9. Duration of response (DOR)

    Based on investigator assessment by RECIST v1.1 during the chemotherapy phase and during the maintenance phase

    Measured: 60 months

  10. Progression-free survival (PFS) from the beginning of the maintenance phase in all patients, in patients in complete or partial response after completing chemotherapy and in patients with stable disease after completing chemotherapy

    Period from start of maintenance treatment until disease progression, death or date of last contact assessed by the investigator according to RECIST v1.1 criteria, in all patients receiving maintenance treatment as well as in the subgroup of patients with complete response/partial response (CR/PR) of stable disease (SD) after completing chemotherapy

    Measured: 60 months

  11. Progression Free Survival (PFS) and BRCA status.

    Relationship of PFS with BRCA mutational status

    Measured: 60 months

  12. Overall Survival (OS) and BRCA status.

    Relationship of OS with BRCA mutational status

    Measured: 60 months

  13. Time to first subsequent therapy or death (TFST) and BRCA status.

    Relationship of TFST with BRCA mutational status

    Measured: 60 months

  14. Objective Response Rate (ORR) and BRCA status.

    Relationship of ORR with BRCA mutational status

    Measured: 60 months

  15. Duration of Response (DOR) and BRCA status.

    Relationship of DOR with BRCA mutational status

    Measured: 60 months

  16. Progression Free Survival (PFS) and PD-L1 status

    Relationship of PFS with PD-L1 expression status

    Measured: 60 months

  17. Overall Survival (OS) and PD-L1 status

    Relationship of OS with PD-L1 expression status

    Measured: 60 months

  18. Time to first subsequent therapy or death (TFST) and PD-L1 status

    Relationship of TFST with PD-L1 expression status

    Measured: 60 months

  19. Objective Response Rate (ORR) and PD-L1 status

    Relationship of ORR with PD-L1 expression status

    Measured: 60 months

  20. Duration of Response (DOR) and PD-L1 status

    Relationship of DOR with PD-L1 expression status

    Measured: 60 months

  21. Efficacy of atezolizumab compared to placebo in the PD-L1 negative and PD-L1 positive subgroups

    To evaluate the immune response to atezolizumab

    Measured: 60 months

Timeline

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

  1. First posted26 Jul 2018
  2. Study start21 Nov 2018
  3. Primary completion5 Aug 2024
  4. Study completion5 Aug 2024

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
Model description
Randomized, double-blinded, multi-center study
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
417 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03598270
Sponsor's protocol ID
ENGOT-Ov41/GEICO 69-O/ANITA
Other IDs
2018-000366-11, ENGOT-Ov41, GEICO 69-O, 2018
Acronym
ANITA
Status last verified
Aug 2024
First submitted
2 Jun 2018
Last updated
30 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gonzalez-Martin A, Rubio MJ, Heitz F, Depont Christensen R, Colombo N, Van Gorp T, Romeo M, Ray-Coquard I, Gaba L, Leary A, De Sande LM, Lebreton C, Redondo A, Fabbro M, Barretina Ginesta MP, Follana P, Perez-Fidalgo JA, Rodrigues M, Santaballa A, Sabatier R, Bermejo-Perez MJ, Lotz JP, Pardo B, Marquina G, Sanchez-Lorenzo L, Quindos M, Estevez-Garcia P, Guerra Alia E, Manso L, Casado V, Kommoss S, Tognon G, Henry S, Bruchim I, Oaknin A, Selle F. Atezolizumab Combined With Platinum and Maintenance Niraparib for Recurrent Ovarian Cancer With a Platinum-Free Interval >6 Months: ENGOT-OV41/GEICO 69-O/ANITA Phase III Trial. J Clin Oncol. 2024 Dec 20;42(36):4294-4304. doi: 10.1200/JCO.24.00668. Epub 2024 Sep 18.

    PubMed 39292975

  • Gonzalez Martin A, Sanchez Lorenzo L, Colombo N, dePont Christensen R, Heitz F, Meirovitz M, Selle F, van Gorp T, Alvarez N, Sanchez J, Marques C. A phase III, randomized, double blinded trial of platinum based chemotherapy with or without atezolizumab followed by niraparib maintenance with or without atezolizumab in patients with recurrent ovarian, tubal, or peritoneal cancer and platinum treatment free interval of more than 6 months: ENGOT-Ov41/GEICO 69-O/ANITA Trial. Int J Gynecol Cancer. 2021 Apr;31(4):617-622. doi: 10.1136/ijgc-2020-001633. Epub 2020 Dec 14.

    PubMed 33318079

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carboplatin, Paclitaxel and Niraparib in people with Recurrent Ovarian Carcinoma, run by Grupo Español de Investigación en Cáncer de Ovario at 71 sites in 5 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 28 inclusion and 37 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 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in Spain, France, Germany, Italy, Belgium. 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?

Progression-free survival (PFS) (time frame: 30 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 NCT03598270, 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 30 Aug 2024.

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