A Study Designed to Evaluate the Safety and Efficacy of Venetoclax Plus Dexamethasone (VenDex) Compared With Pomalidomide Plus Dexamethasone (PomDex) in Participants With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma.
A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared With Pomalidomide and Dexamethasone in Subjects With t(11;14)-Positive Relapsed or Refractory Multiple Myeloma
2 other identifiers
interventional
265
20 countries
180
Brief Summary
A study designed tocompare progression-free survival (PFS) in participants with t(11;14)-positive MM treated with venetoclax in combination with dexamethasone versus pomalidomide in combination with dexamethasone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 multiple-myeloma
Started Oct 2018
Typical duration for phase_3 multiple-myeloma
180 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2018
CompletedFirst Posted
Study publicly available on registry
May 29, 2018
CompletedStudy Start
First participant enrolled
October 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
June 19, 2025
June 1, 2025
7.8 years
May 17, 2018
June 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
PFS is defined as the time in days from subject randomization to the date of the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Up to approximately 43 months from first randomization
Secondary Outcomes (17)
Overall Response Rate (ORR)
Up to approximately 43 months from first randomization
Very Good Partial Response or Better Response Rate (VGPR)
Up to approximately 43 months from first randomization
Overall survival (OS)
Up to approximately 51 months from first randomization
Minimal Residual Disease (MRD) Negativity Rate
Up to approximately 43 months from first randomization
Time to Deterioration in Disease Symptoms
Up to approximately 51 months from first randomization
- +12 more secondary outcomes
Study Arms (2)
Arm 1 VenDex
EXPERIMENTALVenetoclax administered orally once daily (QD) plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
Arm 2 PomDex
ACTIVE COMPARATORPomalidomide administered orally once daily (QD) on Days 1 - 21 for each 28-day cycle plus dexamethasone administered orally once every week (Q1W) for each 28-day cycle.
Interventions
Eligibility Criteria
You may qualify if:
- Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria.
- Measurable disease at screening as defined per protocol.
- Has received at least 2 prior lines of therapy as described in the protocol.
- Has had documented disease progression on or within 60 days after completion of the last therapy.
- Has received at least 2 consecutive cycles of lenalidomide and be relapsed/refractory to lenalidomide, as defined per protocol.
- Has received at least 2 consecutive cycles of a proteasome inhibitor (PI).
- Has t(11;14)-positive status determined by an analytically validated fluorescent in situ hybridization (FISH) assay per centralized laboratory testing.
- An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
- Laboratory values (liver, kidney and hematology laboratory values) that meet criteria as described per protocol.
You may not qualify if:
- History of treatment with venetoclax or another B-Cell Lymphoma (BCL)-2 inhibitor or pomalidomide.
- History of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years (exceptions described in the protocol).
- Evidence of ongoing graft-versus-host disease (GvHD) if prior stem cell transplant (SCT).
- Prior treatment with any of the following: allogeneic or syngeneic SCT within 16 weeks prior to randomization; or autologous SCT within 12 weeks prior to randomization.
- Known central nervous system involvement of MM.
- Concurrent conditions as listed in the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
- Roche-Genentechcollaborator
Study Sites (180)
Duplicate_University of Arizona Cancer Center - North Campus /ID# 218407
Tucson, Arizona, 85719-1478, United States
VA Central California Health Care System /ID# 200047
Fresno, California, 93703-2223, United States
University of California, Los Angeles /ID# 171524
Los Angeles, California, 90095, United States
Rocky Mountain Regional VA Medical Center/Eastern Colorado Health Care System /ID# 222904
Aurora, Colorado, 80045, United States
Mayo Clinic /ID# 200075
Jacksonville, Florida, 32224, United States
Cleveland Clinic Florida /ID# 208884
Weston, Florida, 33331-3609, United States
Duplicate_Norton Cancer Institute /ID# 200834
Louisville, Kentucky, 40202-3700, United States
University of Maryland, Baltimore /ID# 217422
Baltimore, Maryland, 21201, United States
Boston Medical Center /ID# 223606
Boston, Massachusetts, 02118, United States
Barbara Ann Karmanos Cancer In /ID# 201377
Detroit, Michigan, 48201, United States
Duplicate_Henry Ford Hospital /ID# 171531
Detroit, Michigan, 48202, United States
Mayo Clinic - Rochester /ID# 201091
Rochester, Minnesota, 55905-0001, United States
Columbia University Medical Center /ID# 200715
New York, New York, 10032-3729, United States
Fairview Hospital - Moll Pavilion /ID# 208919
Cleveland, Ohio, 44111-5605, United States
Cleveland Clinic Main Campus /ID# 202247
Cleveland, Ohio, 44195, United States
UPMC Hillman Cancer Ctr /ID# 200063
Pittsburgh, Pennsylvania, 15232, United States
MD Anderson Cancer Center at Texas Medical Center /ID# 200060
Houston, Texas, 77030-4000, United States
Huntsman Cancer Institute /ID# 218406
Salt Lake City, Utah, 84112-5500, United States
VA Puget Sound Health Care System /ID# 222708
Seattle, Washington, 98108-1597, United States
Liverpool Hospital /ID# 202431
Liverpool, New South Wales, 2170, Australia
Sydney Adventist Hospital /ID# 222874
Wahroonga, New South Wales, 2076, Australia
Wollongong Hospital /ID# 205545
Wollongong, New South Wales, 2500, Australia
ICON Cancer Care - Townsville /ID# 206565
Hyde Park, Queensland, 4812, Australia
Icon Cancer Centre /ID# 205663
South Brisbane, Queensland, 4101, Australia
The Queen Elizabeth Hospital /ID# 202432
Woodville South, South Australia, 5011, Australia
Perth Blood Institute Ltd /ID# 206649
Nedlands, Western Australia, 6009, Australia
Arthur J. E. Child Comprehensive Cancer Centre /ID# 218846
Calgary, Alberta, T2N 5G2, Canada
BC Cancer - Vancouver /ID# 222804
Vancouver, British Columbia, V5Z 1L3, Canada
Queen Elizabeth II Health Sciences Centre - Victoria General /ID# 218883
Halifax, Nova Scotia, B3H 2Y9, Canada
CISSS-CA (Centre Integre de sante et de services sociaux de Chaudiere-Appalache) /ID# 218887
Lévis, Quebec, G6V 3Z1, Canada
Beijing Chaoyang Hospital,Capital Medical University /ID# 216014
Beijing, Beijing Municipality, 100020, China
Peking University Third Hospital /ID# 216371
Beijing, Beijing Municipality, 100191, China
Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 216040
Beijing, Beijing Municipality, 100730, China
Sun Yat-Sen University Cancer Center /ID# 223828
Guangzhou, Guangdong, 510060, China
Guangdong Provincial People's Hospital /ID# 215860
Guangzhou, Guangdong, 510080, China
Henan Cancer Hospital /ID# 215987
Zhengzhou, Henan, 450008, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 215850
Wuhan, Hubei, 430022, China
Nanjing Drum Tower Hospital /ID# 223143
Nanjing, Jiangsu, 210008, China
The First Affiliated Hospital of Soochow University /ID# 216094
Suzhou, Jiangsu, 215006, China
The First Affiliated Hospital of Nanchang University /ID# 216954
Nanchang, Jiangxi, 330006, China
The First Hospital of China Medical University /ID# 215996
Shenyang, Liaoning, 110001, China
Shengjing Hospital of China Medical University /ID# 223435
Shenyang, Liaoning, 110022, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 216643
Shanghai, Shanghai Municipality, 200065, China
Shanghai Tongji Hospital /ID# 218865
Shanghai, Shanghai Municipality, 200065, China
West China Hospital, Sichuan University /ID# 216647
Chengdu, Sichuan, 610041, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 216041
Tianjin, Tianjin Municipality, 300020, China
Tianjin Medical University Cancer Institute & Hospital /ID# 223550
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215989
Hangzhou, Zhejiang, 310003, China
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 218691
Hangzhou, Zhejiang, 310003, China
The First Affiliated Hospital of Wenzhou Medical University /ID# 218953
Wenzhou, Zhejiang, 325000, China
Beijing Chaoyang Hospital, Capital Medical University(West campus) /ID# 234033
Beijing, 100043, China
Fakultní Nemocnice Brno - Jihlavská /ID# 204512
Brno, Brno-mesto, 625 00, Czechia
Fakultní nemocnice Hradec Králové - Sokolská /ID# 221291
Hradec Králové, Hradec Kralove, 500 05, Czechia
Fakultni Nemocnice Ostrava /ID# 204515
Ostrava, Ostrava-mesto, 708 52, Czechia
Fakultni nemocnice Olomouc /ID# 221290
Olomouc, 779 00, Czechia
Vseobecna fakultni nemocnice v Praze /ID# 221166
Prague, 128 08, Czechia
Duplicate_Herlev Hospital /ID# 223221
Herlev, Capital Region, 2730, Denmark
Aalborg University Hospital /ID# 223220
Aalborg, North Denmark, 9000, Denmark
Odense University Hospital /ID# 223217
Odense, Region Syddanmark, 5000, Denmark
Sygehus Lillebalt, Vejle /ID# 223216
Vejle, Region Syddanmark, 7100, Denmark
Duplicate_Roskilde Hospital /ID# 223366
Roskilde, 4000, Denmark
Duplicate_CHU Grenoble - Hopital Michallon /ID# 223182
La Tronche, Isere, 38700, France
CHU Reims - Hôpital Robert Debre /ID# 233907
Reims, Marne, 51092, France
CHRU Nancy - Hopitaux de Brabois /ID# 201076
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France
CHRU Lille - Hopital Claude Huriez /ID# 202213
Lille, Nord, 59037, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 202211
Créteil, Paris, 94010, France
CHU de Nantes, Hotel Dieu -HME /ID# 200099
Nantes, Pays de la Loire Region, 44000, France
HCL - Hopital Lyon Sud /ID# 200097
Pierre-Bénite, Rhone, 69495, France
Centre Henri Becquerel /ID# 223186
Rouen, Seine-Maritime, 76038, France
CH Henri Duffaut /ID# 234154
Avignon, Vaucluse, 84902, France
Hopital Pitie Salpetriere /ID# 214173
Paris, Île-de-France Region, 75013, France
Robert-Bosch-Krankenhaus /ID# 223947
Stuttgart, Baden-Wurttemberg, 70736, Germany
Universitaetsklinikum Tuebingen /ID# 238646
Tübingen, Baden-Wurttemberg, 72076, Germany
Universitaetsklinikum Wuerzburg /ID# 200055
Würzburg, Bavaria, 97080, Germany
Klinikum Chemnitz gGmbH /ID# 233797
Chemnitz, Saxony, 09116, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 201830
Kiel, Schleswig-Holstein, 24105, Germany
Universitaetsklinikum Jena /ID# 201254
Jena, Thuringia, 07747, Germany
Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 200051
Berlin, 12203, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 215495
Hamburg, 20246, Germany
Asklepios Klinik Altona /ID# 222506
Hamburg, 22763, Germany
Alexandra General Hospital /ID# 202386
Athens, Attica, 11528, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 222879
Heraklion, Crete, 71500, Greece
General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 213982
Athens, 10676, Greece
University Gen Hosp of Patra /ID# 201691
Pátrai, 26504, Greece
Theageneio Anticancer Hospital /ID# 213983
Thessaloniki, 54639, Greece
General Hospital of Thessaloniki George Papanikolaou /ID# 201692
Thessaloniki, 57010, Greece
Rambam Health Care Campus /ID# 169678
Haifa, H_efa, 3109601, Israel
Bnai Zion Medical Center /ID# 169466
Haifa, H_efa, 3339419, Israel
The Lady Davis Carmel Medical Center /ID# 222969
Haifa, H_efa, 34362, Israel
Hadassah /ID# 169474
Jerusalem, Jerusalem, 91120, Israel
Duplicate_Assuta Ashdod Medical Center /ID# 222968
Ashdod, Southern District, 7747629, Israel
Soroka University Medical Center /ID# 218768
Beersheba, Southern District, 8443901, Israel
The Chaim Sheba Medical Center /ID# 169778
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 169437
Tel Aviv, Tel Aviv, 6423906, Israel
Rabin Medical Center /ID# 244611
Petah Tikva, 4941492, Israel
Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 170952
Bologna, Emilia-Romagna, 40138, Italy
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 170962
Turin, Piedmont, 10126, Italy
Irccs-Crob /Id# 170955
Rionero in Vulture, Potenza, 85028, Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 170950
Ancona, 60020, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 212498
Milan, 20122, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 222988
Palermo, 90146, Italy
Azienda Ospedaliera Santa Maria Terni /ID# 170948
Terni, 05100, Italy
Nagoya City University Hospital /ID# 170880
Nagoya, Aichi-ken, 467-8602, Japan
The Jikei University Kashiwa Hospital /ID# 223031
Kashiwa-shi, Chiba, 277-8567, Japan
Kyushu University Hospital /ID# 171117
Fukuoka, Fukuoka, 812-8582, Japan
Ogaki Municipal Hospital /ID# 171043
Ogaki-shi, Gifu, 503-8502, Japan
Gunma University Hospital /ID# 170966
Maebashi, Gunma, 371-8511, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital /ID# 171255
Hiroshima, Hiroshima, 730-8619, Japan
Kobe City Medical Center General Hospital /ID# 170992
Kobe, Hyōgo, 650-0047, Japan
Duplicate_National Hospital Organization Mito Medical Center /ID# 171187
Higashi Ibaraki-gun, Ibaraki, 311-3193, Japan
Hitachi General Hospital /ID# 200843
Hitachi-shi, Ibaraki, 317-0077, Japan
Iwate Medical University Hospital /ID# 222849
Shiwa-gun, Iwate, 028-3695, Japan
Tohoku University Hospital /ID# 201935
Sendai, Miyagi, 9808574, Japan
Okayama Medical Center /ID# 200119
Okayama, Okayama-ken, 701-1192, Japan
Japanese Red Cross Osaka Hospital /ID# 171493
Osaka, Osaka, 543-8555, Japan
The University of Osaka Hospital /ID# 201966
Suita-shi, Osaka, 565-0871, Japan
Tokushima University Hospital /ID# 202571
Tokushima, Tokushima, 770-8503, Japan
The Jikei University Hospital /ID# 239014
Minato-ku, Tokyo, 105-8471, Japan
Japanese Red Cross Medical Center /ID# 171256
Shibuya-ku, Tokyo, 150-8935, Japan
Yamagata University Hospital /ID# 238329
Yamagata, Yamagata, 990-9585, Japan
Moscow State budget healthcare /ID# 169685
Moscow, Moscow, 125284, Russia
Research Institute of Fundamental and Clinical Immunology /ID# 223594
Novosibirsk, Novosibirsk Oblast, 630099, Russia
LLC Novaya Klinika /ID# 169689
Pyatigorsk, Stavropol Kray, 357500, Russia
City Clinical Hospital #52 /ID# 206289
Moscow, 123182, Russia
Leningrad Regional Clinical Hospital /ID# 202776
Saint Petersburg, 194291, Russia
Almazov National Medical Research Centre /ID# 169681
Saint Petersburg, 197341, Russia
Tula Regional Clinical Hospital /ID# 223226
Tula, 300053, Russia
National University Hospital /ID# 203988
Singapore, 119228, Singapore
Singapore General Hospital /ID# 202131
Singapore, 169608, Singapore
Tan Tock Seng Hospital /ID# 204374
Singapore, 308433, Singapore
Duplicate_Gachon University Gil Medical Center /ID# 202827
Incheon, Gyeonggido, 21565, South Korea
Seoul National University Hospital /ID# 202711
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Samsung Medical Center /ID# 202710
Seoul, Seoul Teugbyeolsi, 06351, South Korea
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 234045
Seoul, Seoul Teugbyeolsi, 06591, South Korea
Ulsan University Hospital /ID# 222716
Ulsan, Ulsan Gwang Yeogsi, 44033, South Korea
Yonsei University Health System Severance Hospital /ID# 202709
Seoul, 03722, South Korea
Hospital Universitari Son Espases /ID# 222889
Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital Costa del Sol /ID# 234083
Marbella, Malaga, 29603, Spain
Complejo Hospitalario Universitario Ourense /ID# 222876
Ourense, Ourense, 32005, Spain
Hospital Universitario Canarias /ID# 238452
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Hospital Universitario Vall d'Hebron /ID# 218106
Barcelona, 08035, Spain
Instituto Catalan de Oncologia (ICO) Girona /ID# 171311
Girona, 17007, Spain
Hospital de Leon /ID# 233878
León, 24071, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 171304
Madrid, 28040, Spain
Disc_Hospital Universitario 12 de Octubre /ID# 171288
Madrid, 28041, Spain
Hospital Universitario La Paz /ID# 218107
Madrid, 28046, Spain
Hospital Universitario de Salamanca /ID# 171294
Salamanca, 37711, Spain
Hospital Universitario Virgen del Rocio /ID# 171286
Seville, 41013, Spain
Hospital General Universitario de Toledo /ID# 222887
Toledo, 45007, Spain
Hospital Universitario y Politecnico La Fe /ID# 234019
Valencia, 46026, Spain
Sunderby sjukhus /ID# 201314
Luleå, Norrbotten County, 971 80, Sweden
Sodra Alvsborgs sjukhus /ID# 213061
Borås, Västra Götaland County, 501 82, Sweden
Duplicate_Universitetssjukhuset Linköping /ID# 200789
Linkoping, Västra Götaland County, 581 85, Sweden
Uddevalla sjukhus /ID# 201315
Uddevalla, Västra Götaland County, 451 80, Sweden
Cukurova Universitesi Tip Fakultesi /ID# 201955
Saricam Adana, Adana, 01330, Turkey (Türkiye)
Izmir Ekonomi Universitesi Ozel Medicalpoint Hastanesi /ID# 201954
Cordaleo, İzmir, 35575, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 201956
Ankara, 06200, Turkey (Türkiye)
Gazi University Medical Faculty /ID# 222698
Ankara, 06560, Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 201881
Ankara, 06590, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty /ID# 201953
Istanbul, 34093, Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi /ID# 222914
Istanbul, 34214, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 201952
Istanbul, 34899, Turkey (Türkiye)
Ege University Medical Faculty /ID# 222697
Izmir, 35040, Turkey (Türkiye)
Communal Nonprofit Enterprise Cherkasy Regional Oncology Dispensary /ID# 223943
Cherkasy, Cherkasy Oblast, 18009, Ukraine
Communal non-profit enterprise Regional Center of Oncology /ID# 223945
Kharkiv, Kharkivs’ka Oblast’, 61070, Ukraine
MNI Khmelnytskyi Regional Hospital of Khmelnytskyi Regional Council /ID# 223942
Khmelnytskyi, 29000, Ukraine
National Cancer Institute /ID# 223944
Kyiv, 03022, Ukraine
SI Institute of Blood Pathology and Transfusion Medicine of NAMS of Ukraine /ID# 223941
Lviv, 79044, Ukraine
Addenbrooke's Hospital /ID# 223097
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Hammersmith Hospital /ID# 171446
London, England, W12 0HS, United Kingdom
University College London Hospital /ID# 171428
London, Greater London, NW1 2BU, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 218213
Norwich, Norfolk, NR4 7UY, United Kingdom
Duplicate_Nottingham University Hospitals NHS Trust /ID# 223292
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
Duplicate_NHS Greater Glasgow and Clyde /ID# 202199
Glasgow, Scotland, G12 0XH, United Kingdom
Duplicate_University Hospitals North Midlands - Royal Stoke University Hospital /ID# 218355
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
Duplicate_Duplicate_Lewisham and Greenwich NHS Trust /ID# 171445
London, SE13 6LH, United Kingdom
Manchester University NHS Foundation Trust /ID# 171440
Manchester, M9 2AA, United Kingdom
Portsmouth Hospitals University NHS Trust /ID# 171444
Portsmouth, PO6 3LY, United Kingdom
Royal Berkshire NHS Foundation Trust /ID# 217835
Reading, RG1 5AN, United Kingdom
Duplicate_Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire /ID# 171447
Sheffield, S5 7AT, United Kingdom
Related Publications (1)
Popat R, Beksac M, Dimopoulos MA, Gatt ME, Gay F, Jo JC, Kapoor P, Katodritou E, Kortum KM, Ling S, Nagarajan C, Suzuki K, Qiu L, Onishi M, Ku G, Dail M, Mukherjee N, Ross JA, Badawi MA, Fusco MJ, Dobkowska E, Arriola E, Bueno OF, Bahlis NJ, Iida S, Moreau P, Valent J, Mateos MV. Venetoclax-Dexamethasone Versus Pomalidomide-Dexamethasone in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma: Primary Results of the Randomized, Phase III CANOVA Study. J Clin Oncol. 2025 Dec 10:JCO2500924. doi: 10.1200/JCO-25-00924. Online ahead of print.
PMID: 41370738DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
May 17, 2018
First Posted
May 29, 2018
Study Start
October 22, 2018
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
November 1, 2027
Last Updated
June 19, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.