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

NCT ID: NCT03353831

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 574 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-11
• Study Completion Date: 2025-03-11

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.

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.

Conditions

Recurrent Ovarian Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Bevacizumab

Intervention Type: DRUG

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

Chemotherapy

Intervention Type: DRUG

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

Placebos

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

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

Atezolizumab

Intervention Type: DRUG

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

Chemotherapy

Intervention Type: DRUG

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

Interventions

Bevacizumab

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

Intervention Type: DRUG

Atezolizumab

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

Intervention Type: DRUG

Chemotherapy

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

Intervention Type: DRUG

Placebos

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

Intervention Type: DRUG

Eligibility Criteria

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.

12. 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.

13. Estimated life expectancy of at least 3 months

14. ECOG performance status 0 - 1

15. 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

16. 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.

17. 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.

18. 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)

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

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

6. Prior radiotherapy to the pelvis or the abdomen.

7. 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).

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

9. Prior randomization in AGO-OVAR 2.29.

10. 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.

11. 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.

12. 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).

13. 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

14. 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.

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

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

17. 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

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

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

20. 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.

21. 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

22. 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

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

24. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV), patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C.

Patients with past hepatitis B virus (HBV) infection or re-solved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.

25. 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.

26. 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.

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

28. 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

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

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

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

32. 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.

33. Patients with evidence of abdominal free air.

34. 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

35. 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

36. 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.

37. 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.

38. 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).

39. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

AGO Research GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philipp Harter, MD, PhD

Role: STUDY_CHAIR

Kliniken Essen-Mitte, Germany

Locations

Medizinische Universität

Innsbruck, , Austria

UZA Edegem

Edegem, , Belgium

AZ Sint Lucas

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

CHU Liège Sart Tilman Grivegnée

Liège, , Belgium

CHU UCL Namur Sainte Elisabeth

Namur, , Belgium

Copenhagen University Hospital, Rigshospitalet

Copenhagen, , Denmark

Herlev University Hospital

Herlev, , Denmark

Odense University Hospital

Odense, , Denmark

Zealand University Hospital

Roskilde, , Denmark

East Tallinn Central Hospital

Tallinn, , Estonia

Tampere University Hospital

Tampere, , Finland

ICO d'Angers

Angers, , France

Institut Sainte Catherine

Avignon, , France

Hôpital Jean Minjoz

Besançon, , France

Blois Hospital (Centre Hospitalier de Blois)

Blois, , France

Clinique TIVOLI-DUCOS

Bordeaux, , France

Institut Bergonié

Bordeaux, , France

Centre François Baclesse

Caen, , France

Médipôle de Savoie

Challes-les-Eaux, , France

SASU Centre d'Oncologie et Radiothérapie 37

Chambray-lès-Tours, , France

Centre Jean Perrin

Clermont-Ferrand, , France

Centre Georges François Leclerc

Dijon, , France

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, , France

Centre Oscar Lambret, Lille

Lille, , France

Centre Léon Bérard

Lyon, , France

ICM Val d'Aurelle

Montpellier, , France

ORACLE Centre d'Oncologie de Gentilly

Nancy, , France

Centre Antoine Lacassagne

Nice, , France

Centre Hospitalier Régional d'Orléans

Orléans, , France

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, , France

Institut Curie Site Paris

Paris, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

Plérin, , France

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, , France

Hôpital Foch

Suresnes, , France

IUCT Oncopole - Institut Claudius Regaud

Toulouse, , France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Gustave Roussy

Villejuif, , France

Hochtaunus-Kliniken

Bad Homburg, , Germany

Charité - Universitätsmedizin Berlin (CVK)

Berlin, , Germany

Helios Klinikum Berlin-Buch

Berlin, , Germany

Klinikum Bremen-Mitte

Bremen, , Germany

Universitätsfrauenklinik Köln

Cologne, , Germany

Städtisches Klinikum Dessau

Dessau, , Germany

Universitätsklinikum Carl Gustav Carus

Dresden, , Germany

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Kliniken Essen-Mitte

Essen, , Germany

Universitätsfrauenklinik Essen

Essen, , Germany

Klinikum Frankfurt Höchst

Frankfurt, , Germany

Universitätsfrauenklinik Frankfurt

Frankfurt, , Germany

Klinikum Gütersloh

Gütersloh, , Germany

Universitätsfrauenklinik Halle/Saale

Halle, , Germany

Mammazentrum Hamburg am Krankenhaus Jerusalem

Hamburg, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Praxisgemeinschaft Frauenärzte am Bahnhofsplatz

Hildesheim, , Germany

Universitätsklinikum Jena

Jena, , Germany

ViDia Christliche Kliniken Karlsruhe

Karlsruhe, , Germany

Klinikum Kassel

Kassel, , Germany

Universitätsklinikum Schleswig-Holstein

Kiel, , Germany

Universitätsklinikum Schleswig-Holstein

Lübeck, , Germany

Universitätsmedizin Mainz

Mainz, , Germany

Universitätsfrauenklinik Mannheim

Mannheim, , Germany

Johannes Wesling Klinikum

Minden, , Germany

Klinikum der Universität München

München, , Germany

Rotkreuzklinikum München

München, , Germany

Universitätsklinikum Münster

Münster, , Germany

MVZ Nordhausen

Nordhausen, , Germany

Ortenau Klinikum Offenburg-Gengenbach

Offenburg, , Germany

Onkologie Ravensburg

Ravensburg, , Germany

Universitätsfrauenklinik Regensburg

Regensburg, , Germany

Thüringen Kliniken "Georgius Agricola"

Saalfeld, , Germany

CTS CaritasKlinikum Saarbrücken

Saarbrücken, , Germany

Leopoldina-Krankenhaus

Schweinfurt, , Germany

Klinikum Traunstein

Traunstein, , Germany

Universitätsfrauenklinik Tübingen

Tübingen, , Germany

Universitätsfrauenklinik Ulm

Ulm, , Germany

Helios Dr. Horst Schmidt Kliniken

Wiesbaden, , Germany

Marien-Hospital

Witten, , Germany

AMO MVZ Wolfsburg

Wolfsburg, , Germany

Vilniaus universiteto ligoninė Santaros klinikos

Kaunas, , Lithuania

Nacionalinis vėžio institutas

Vilnius, , Lithuania

Oslo University Hospital

Oslo, , Norway

Hospital Clínic de Barcelona

Barcelona, , Spain

Institut Català d'Oncologia (ICO) d'Hospitalet

Barcelona, , Spain

Vall d'Hebron Instituto de Oncología (VHIO)

Barcelona, , Spain

Hospital Universitario Reina Sofía

Córdoba, , Spain

Institut Català d'Oncologia (ICO) de Girona

Girona, , Spain

Hospital Universitario de Jerez

Jerez de la Frontera, , Spain

Hospital Universitario La Paz

La Paz, , Spain

Clínica Universidad de Navarra (CUN)

Madrid, , Spain

Hospital Regional Universitario de Málaga

Málaga, , Spain

Hospital General Universitario Morales Meseguer

Murcia, , Spain

Hospital Universitario Son Llàtzer

Palma de Mallorca, , Spain

Clínica Universidad de Navarra (CUN)

Pamplona, , Spain

Complejo Hospitalario de Navarra

Pamplona, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Instituto Valenciano de Oncología (IVO)

Valencia, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Linköping University Hospital

Linköping, , Sweden

Skåne University Hospital

Malmo, , Sweden

Karolinska University Hospital

Solna, , Sweden

Kantonsspital Baden

Baden, , Switzerland

Universitätsspital Basel

Basel, , Switzerland

Kantonsspital Graubünden

Chur, , Switzerland

Kantonsspital Frauenfeld

Frauenfeld, , Switzerland

Kantonsspital Luzern

Lucerne, , Switzerland

Kantonsspital Olten

Olten, , Switzerland

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Kantonsspital Winterthur

Winterthur, , Switzerland

Countries

Austria; Belgium; Denmark; Estonia; Finland; France; Germany; Lithuania; Norway; Spain; Sweden; Switzerland

References

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

Reference Type: DERIVED

PMID: 32606097 (View on PubMed)

Other Identifiers

AGO-OVAR 2.29

Identifier Type: -

Identifier Source: org_study_id