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

Sponsor
AGO Research GmbH (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03353831
Collaborator
Hoffmann-La Roche (Industry)
550
111
2
74.7
5
0.1

Study Details

Study Description

Brief 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 within 6 months after platinum based chemotherapy or 3rd relapse.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
550 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Atezolizumab in Combination With Bevacizumab and Chemotherapy Versus Bevacizumab and Chemotherapy in Recurrent Ovarian Cancer - a Randomized Phase III Trial
Actual Study Start Date :
Sep 11, 2018
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Arm A: Chemotherapy + Bevacizumab + Placebo

Chemotherapy: Paclitaxel 80 mg/m² d1, 8, 14, 22 q28 or pegylated liposomal doxorubicin 40 mg/m² q28 + Bevacizumab 10 mg/kg q14 + Placebos q14

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

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

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

Experimental: Arm B: Chemotherapy + Bevacizumab + Atezolizumab

Chemotherapy: 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

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

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

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

Outcome Measures

Primary Outcome Measures

  1. Overall Survival (OS) [From date of randomizationrandomization to date of death from any cause assessed up to 40 months]

    regular patient contacts during the trial regarding life status

  2. Progression-free survival [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]

    Progressive Disease based on investigator assessment using RECIST v1.1

Secondary Outcome Measures

  1. patient reported outcomes (QLQ and PRO-CTCAE) [every 4 weeks during the first 3 months, then every 12 weeks until PD#1, assessed up to 40 months]

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

  2. Objective Response Rate (ORR) [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]

    based on investigator assessment using RECIST v1.1

  3. Duration of Response (DOR) [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]

    based on investigator assessment using RECIST v1.1

  4. Efficacy regarding PD-L1 status [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]

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

Other Outcome Measures

  1. Time from randomization to first subsequent therapy (TFST) [at every visit during the trial up to a maximum of 40 months]

    time to first subsequent therapy

  2. Time from randomization to second subsequent therapy (TSST) [at every visit during the trial up to a maximum of 40 months]

    Time to second subsequent therapy

  3. Analysis on LDH levels at baseline [Baseline]

    normal vs. elevated values

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients with histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer

  2. Relapsed disease

  3. 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

  4. Measurable disease, evaluable disease in combination with GCIG CA-125 criteria, or histologically proven relapse/progression

  5. 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.

  6. Availability of a representative archival FFPE tumor sample (preferable from primary diagnosis)

  7. Patient has not progressed on the chosen/planned chemotherapy (PLD or Paclitaxel) in any prior line

  8. 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.

  9. Females aged ≥ 18 years at signing at time of signing informed consent form

  10. Signed written informed consent and ability to comply with the study protocol, in the investigator's judgement

  11. 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.

  1. 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.

  2. Estimated life expectancy of at least 3 months

  3. ECOG performance status 0 - 1

  4. 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

  5. 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.

  6. 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.

  7. 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.

Exclusion Criteria:
  1. Non-epithelial tumor origin of the ovary, the fallopian tube or the peritoneum (i.e. germ cell tumors)

  2. Ovarian tumors of low malignant potential (e.g. borderline tumors)

  3. 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)

  1. More than three prior systemic anticancer regimens; maintenance therapies (e.g. with bevacizumab, olaparib or niraparib) are not calculated as separate line.

  2. Prior systemic anticancer therapy within 28 days before randomization (except bevacizumab: 20 days).

  3. Prior radiotherapy to the pelvis or the abdomen.

  4. 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).

  5. Prior treatment with anti-CD137 or immune checkpoint blockade therapies, anti-PD1, or anti-PD-L1 therapeutic antibodies or anti-CTLA 4

  6. Prior randomization in AGO-OVAR 2.29.

  7. 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.

  8. 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.

  1. 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).

  2. 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

  3. 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.

  4. Previous allogeneic bone marrow transplant or previous solid organ transplantation.

  5. Current treatment with anti-viral therapy for HBV.

  6. 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

  7. Previous Cerebro-Vascular Accident (CVA), Transient Ischemic Attack (TIA) or Sub-Arachnoids Hemorrhage (SAH) within 6 months prior to randomization

  8. History or evidence hemorrhagic disorders within 6 months prior to randomization

  9. 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.

  1. 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

  2. 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

  1. Any prior history of hypertensive crisis (CTCAE grade 4) or hypertensive encephalopathy.

  2. 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

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.

  1. 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.

  2. 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.

  3. Current or recent (within 10 days prior randomization) chronic use of aspirin > 325 mg/day.

  4. 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

  1. For patients with PLD treatment: Left ventricular ejection fraction defined by ECHO below the institutional lower limit of normal

  2. Evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation).

  3. Non-healing wound, active ulcer or bone fracture.

  4. 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.

  5. Patients with evidence of abdominal free air.

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. 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).

  11. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medizinische Universität Innsbruck Austria
2 UZA Edegem Edegem Belgium
3 AZ Sint Lucas Gent Belgium
4 UZ Leuven Leuven Belgium
5 CHU Liège Sart Tilman Grivegnée Liège Belgium
6 CHU UCL Namur Sainte Elisabeth Namur Belgium
7 Copenhagen University Hospital, Rigshospitalet Copenhagen Denmark
8 Herlev University Hospital Herlev Denmark
9 Odense University Hospital Odense Denmark
10 Zealand University Hospital Roskilde Denmark
11 East Tallinn Central Hospital Tallinn Estonia
12 Tampere University Hospital Tampere Finland
13 ICO d'Angers Angers France
14 Institut Sainte Catherine Avignon France
15 Hôpital Jean Minjoz Besançon France
16 Blois Hospital (Centre Hospitalier de Blois) Blois France
17 Clinique TIVOLI-DUCOS Bordeaux France
18 Institut Bergonié Bordeaux France
19 Centre François Baclesse Caen France
20 Médipôle de Savoie Challes-les-Eaux France
21 SASU Centre d'Oncologie et Radiothérapie 37 Chambray-lès-Tours France
22 Centre Jean Perrin Clermont-Ferrand France
23 Centre Georges François Leclerc Dijon France
24 Centre Hospitalier Départemental Vendée La Roche-sur-Yon France
25 Centre Oscar Lambret, Lille Lille France
26 Centre Léon Bérard Lyon France
27 ICM Val d'Aurelle Montpellier France
28 ORACLE Centre d'Oncologie de Gentilly Nancy France
29 Centre Antoine Lacassagne Nice France
30 Centre Hospitalier Régional d'Orléans Orléans France
31 Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
32 Institut Curie Site Paris Paris France
33 Centre Hospitalier Lyon Sud Pierre-Bénite France
34 Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie Plérin France
35 Institut de Cancérologie Lucien Neuwirth Saint-Priest-en-Jarez France
36 Hôpital Foch Suresnes France
37 IUCT Oncopole - Institut Claudius Regaud Toulouse France
38 Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy France
39 Gustave Roussy Villejuif France
40 Hochtaunus-Kliniken Bad Homburg Germany
41 Charité - Universitätsmedizin Berlin (CVK) Berlin Germany
42 Helios Klinikum Berlin-Buch Berlin Germany
43 Klinikum Bremen-Mitte Bremen Germany
44 Städtisches Klinikum Dessau Dessau Germany
45 Universitätsklinikum Carl Gustav Carus Dresden Germany
46 Universitätsklinikum Düsseldorf Düsseldorf Germany
47 Kliniken Essen-Mitte Essen Germany
48 Universitätsfrauenklinik Essen Essen Germany
49 Klinikum Frankfurt Höchst Frankfurt Germany
50 Universitätsfrauenklinik Frankfurt Frankfurt Germany
51 Klinikum Gütersloh Gütersloh Germany
52 Universitätsfrauenklinik Halle/Saale Halle Germany
53 Mammazentrum Hamburg am Krankenhaus Jerusalem Hamburg Germany
54 Universitätsklinikum Hamburg-Eppendorf Hamburg Germany
55 Universitätsklinikum Heidelberg Heidelberg Germany
56 Praxisgemeinschaft Frauenärzte am Bahnhofsplatz Hildesheim Germany
57 Universitätsklinikum Jena Jena Germany
58 ViDia Christliche Kliniken Karlsruhe Karlsruhe Germany
59 Klinikum Kassel Kassel Germany
60 Universitätsklinikum Schleswig-Holstein Kiel Germany
61 Universitätsfrauenklinik Köln Köln Germany
62 Universitätsklinikum Schleswig-Holstein Lübeck Germany
63 Universitätsmedizin Mainz Mainz Germany
64 Universitätsfrauenklinik Mannheim Mannheim Germany
65 Johannes Wesling Klinikum Minden Germany
66 Klinikum der Universität München München Germany
67 Rotkreuzklinikum München München Germany
68 Universitätsklinikum Münster Münster Germany
69 MVZ Nordhausen Nordhausen Germany
70 Ortenau Klinikum Offenburg-Gengenbach Offenburg Germany
71 Onkologie Ravensburg Ravensburg Germany
72 Universitätsfrauenklinik Regensburg Regensburg Germany
73 Thüringen Kliniken "Georgius Agricola" Saalfeld Germany
74 CTS CaritasKlinikum Saarbrücken Saarbrücken Germany
75 Leopoldina-Krankenhaus Schweinfurt Germany
76 Klinikum Traunstein Traunstein Germany
77 Universitätsfrauenklinik Tübingen Tübingen Germany
78 Universitätsfrauenklinik Ulm Ulm Germany
79 Helios Dr. Horst Schmidt Kliniken Wiesbaden Germany
80 Marien-Hospital Witten Germany
81 AMO MVZ Wolfsburg Wolfsburg Germany
82 Vilniaus universiteto ligoninė Santaros klinikos Kaunas Lithuania
83 Nacionalinis vėžio institutas Vilnius Lithuania
84 Oslo University Hospital Oslo Norway
85 Hospital Clínic de Barcelona Barcelona Spain
86 Institut Català d'Oncologia (ICO) d'Hospitalet Barcelona Spain
87 Vall d'Hebron Instituto de Oncología (VHIO) Barcelona Spain
88 Hospital Universitario Reina Sofía Córdoba Spain
89 Institut Català d'Oncologia (ICO) de Girona Girona Spain
90 Hospital Universitario de Jerez Jerez De La Frontera Spain
91 Hospital Universitario La Paz La Paz Spain
92 Clínica Universidad de Navarra (CUN) Madrid Spain
93 Hospital General Universitario Morales Meseguer Murcia Spain
94 Hospital Regional Universitario de Málaga Málaga Spain
95 Hospital Universitario Son Llàtzer Palma De Mallorca Spain
96 Clínica Universidad de Navarra (CUN) Pamplona Spain
97 Complejo Hospitalario de Navarra Pamplona Spain
98 Hospital Clínico Universitario de Valencia Valencia Spain
99 Instituto Valenciano de Oncología (IVO) Valencia Spain
100 Hospital Universitario Miguel Servet Zaragoza Spain
101 Linköping University Hospital Linköping Sweden
102 Skåne University Hospital Malmö Sweden
103 Karolinska University Hospital Solna Sweden
104 Kantonsspital Baden Baden Switzerland
105 Universitätsspital Basel Basel Switzerland
106 Kantonsspital Graubünden Chur Switzerland
107 Kantonsspital Frauenfeld Frauenfeld Switzerland
108 Kantonsspital Luzern Luzern Switzerland
109 Kantonsspital Olten Olten Switzerland
110 Kantonsspital St. Gallen Saint Gallen Switzerland
111 Kantonsspital Winterthur Winterthur Switzerland

Sponsors and Collaborators

  • AGO Research GmbH
  • Hoffmann-La Roche

Investigators

  • Study Chair: Philipp Harter, MD, PhD, Kliniken Essen-Mitte, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AGO Research GmbH
ClinicalTrials.gov Identifier:
NCT03353831
Other Study ID Numbers:
  • AGO-OVAR 2.29
First Posted:
Nov 27, 2017
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by AGO Research GmbH
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022