History of Changes for Study: NCT04680052

A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. (InMIND)

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Study Record Versions

Version	Submitted Date	Changes
1	December 17, 2020	None (earliest Version on record)
2	March 2, 2021	Recruitment Status, Study Status, Contacts/Locations and Oversight
3	March 22, 2021	Contacts/Locations and Study Status
4	April 21, 2021	Study Status
5	July 27, 2021	Study Status and Contacts/Locations
6	July 28, 2021	Arms and Interventions, Study Description and Study Status
7	August 3, 2021	Contacts/Locations, Study Status, Conditions and Study Description
8	August 10, 2021	Contacts/Locations, Conditions and Study Status
9	October 4, 2021	Contacts/Locations and Study Status
10	January 26, 2022	Contacts/Locations and Study Status
11	March 8, 2022	Contacts/Locations and Study Status
12	April 6, 2022	Contacts/Locations and Study Status
13	May 3, 2022	Contacts/Locations and Study Status
14	May 18, 2022	Contacts/Locations and Study Status
15	May 25, 2022	Contacts/Locations and Study Status
16	June 2, 2022	Contacts/Locations and Study Status
17	June 27, 2022	Contacts/Locations and Study Status
18	July 25, 2022	Study Status and Contacts/Locations
19	July 28, 2022	Contacts/Locations and Study Status
20	August 25, 2022	Contacts/Locations and Study Status
21	September 7, 2022	Contacts/Locations and Study Status
22	September 15, 2022	Contacts/Locations and Study Status
23	October 6, 2022	Contacts/Locations and Study Status
24	October 17, 2022	Contacts/Locations and Study Status
25	October 25, 2022	Contacts/Locations and Study Status
26	November 7, 2022	Contacts/Locations and Study Status
27	November 14, 2022	Contacts/Locations and Study Status
28	November 23, 2022	Contacts/Locations and Study Status
29	December 1, 2022	Contacts/Locations and Study Status
30	May 11, 2023	Contacts/Locations and Study Status
31	May 31, 2023	Contacts/Locations and Study Status
32	June 7, 2023	Contacts/Locations and Study Status
33	June 23, 2023	Contacts/Locations and Study Status
34	July 26, 2023	Contacts/Locations and Study Status
35	August 15, 2023	Recruitment Status, Study Status, Contacts/Locations and Study Design
36	February 14, 2024	Study Status
37	March 1, 2024	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	INCMOR 0208-301
Brief Title:	A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. (InMIND)
Official Title:	A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
Secondary IDs:

Study Status


Record Verification:	May 2022
Overall Status:	Recruiting
Study Start:	April 16, 2021
Primary Completion:	February 1, 2024 [Anticipated]
Study Completion:	August 9, 2028 [Anticipated]

First Submitted:	December 17, 2020
First Submitted that Met QC Criteria:	December 17, 2020
First Posted:	December 22, 2020 [Actual]

Last Update Submitted that Met QC Criteria:	May 3, 2022
Last Update Posted:	May 5, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Incyte Corporation
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description


Brief Summary:	This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.
Detailed Description:

Conditions


Conditions:	Follicular Lymphoma Marginal Zone Lymphoma
Keywords:	MOR00208 INCMOR00208 tafasitamab

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	618 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Arm A : tafasitamab + rituximab + lenalidomide Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)	Drug: tafasitamab tafasitamab will be administered IV for 12 cycles Other Names: INCMOR00208 MOR00208 Drug: rituximab Rituximab will be administered IV on cycles 1 - 5 Drug: lenalidomide Lenalidomide will be administered PO for 12 cycles
Placebo Comparator: Arm B : placebo+rituximab+lenalidomide Adult patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) Grade 1 to 3a or R/R Marginal Zone Lymphoma (MZL)	Drug: rituximab Rituximab will be administered IV on cycles 1 - 5 Drug: lenalidomide Lenalidomide will be administered PO for 12 cycles Drug: placebo placebo will be administered IV for 12 cycles

Outcome Measures


Primary Outcome Measures:
1.	Progression Free Survival (PFS) in FL population [ Time Frame: Up to 6 years ] Defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.
Secondary Outcome Measures:
1.	Progression Free Survival (PFS) in FL and MZL populations [ Time Frame: Up to 6 years ] Defined as the time from randomization to first documented disease progression, or death from any cause, whichever occurs first.
2.	Complete Response in FL population [ Time Frame: Up to 6 years ] Defined as number of participants with complete response par Positron Emission Tomography(PET) at the end of treatment visit
3.	Minimal Residual Disease-negativity rate in FL and MZL Population [ Time Frame: 14 months ] Defined as less than 1 residual tumor cell per 10^4 normal cells in peripheral blood and bone marrow.
4.	Overall Survival in FL Population [ Time Frame: Up to 6 years ] Defined as survival from time of study randomization to death of any cause.
5.	Complete Response in Overall population [ Time Frame: Up to 6 years ] Defined as number of participants with complete response par Positron Emission Tomography(PET) at the end of treatment visit
6.	Overall Survival in overall Population [ Time Frame: Up to 6 years ] Defined as survival from time of study initiation to death of any cause.
7.	Best Overall Response Rate in FL and overall population [ Time Frame: Up to 6 years ] Defined as proportion of participants whose best overall response was a complete response (CR) or partial response (PR).
8.	Duration of Response in FL and overall population [ Time Frame: Up to 6 years ] Defined as the time to the first response to evidence of progression.
9.	Quality-of-Life Assessments in FL and overall populations [ Time Frame: Up to 6 years ] Defined as a patient self evaluation questionnaire
10.	Safety: Number of participants with TEAE's [ Time Frame: 13 months ] Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 30 days after last dose of study treatment.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Histologically confirmed Grade 1, 2, or 3a FL or nodal MZL, splenic MZL, or extra nodal MZL Willingness to avoid pregnancy or fathering children In the opinion of the investigator, be able and willing to receive adequate mandatory prophylaxis and/or therapy for thromboembolic events (eg, aspirin 70-325 mg daily or low-molecular-weight heparin) Previously treated with at least 1 prior systemic anti-CD20 immunotherapy or chemo-immunotherapy Documented relapsed, refractory, or PD after treatment with systemic therapy ECOG performance status of 0 to 2 Exclusion Criteria: Women who are pregnant or breastfeeding. Any histology other than FL and MZL or clinical evidence of transformed lymphoma Prior non-hematologic malignancy Congestive heart failure HCV positivity, chronic HBV infection or history of HIV infection Active systemic infection CNS lymphoma involvement Any systemic anti-lymphoma and/or investigational therapy within 28 days prior to the start of Cycle 1 Prior use of lenalidomide in combination with rituximab

Contacts/Locations


Central Contact Person:	Incyte Corporation Call Center (US) Telephone: 1.855.463.3463 Email: medinfo@incyte.com
Central Contact Backup:	Incyte Corporation Call Center (ex-US) Telephone: +800 00027423 Email: eumedinfo@incyte.com
Locations:	United States, California
	John Muir Health Clinical Research Center [Recruiting] Concord, California, United States, 94520-2266
	Marin Cancer Care [Not yet recruiting] Greenbrae, California, United States, 94904
	Sharp Memorial Hospital [Recruiting] San Diego, California, United States, 92123
	The Oncology Institute of Hope and Innovation [Recruiting] Whittier, California, United States, 90603
	United States, Connecticut
	Middlesex Hospital Cancer Center [Not yet recruiting] Middletown, Connecticut, United States, 06457
	Smilow Cancer Hospital [Not yet recruiting] New Haven, Connecticut, United States, 06510
	United States, Florida
	Cancer Specialists of North Florida [Recruiting] Jacksonville, Florida, United States, 32256
	Brcr Medical Center, Inc [Recruiting] Plantation, Florida, United States, 33322
	Asclepes Research Centers [Recruiting] Weeki Wachee, Florida, United States, 34607
	United States, Georgia
	Northwest Georgia University [Recruiting] Marietta, Georgia, United States, 30060
	United States, Hawaii
	Straub Medical Center [Not yet recruiting] Honolulu, Hawaii, United States, 96813
	United States, Iowa
	Des Moines Oncology Research Association [Recruiting] Des Moines, Iowa, United States, 50309
	United States, Kentucky
	Norton Cancer Institute [Recruiting] Louisville, Kentucky, United States, 40207
	United States, Louisiana
	Tulane University [Recruiting] New Orleans, Louisiana, United States, 70112
	United States, Maryland
	University of Maryland - Greenebaum Cancer Center [Recruiting] Baltimore, Maryland, United States, 21201
	Cancer Center For Blood Disorders [Recruiting] Bethesda, Maryland, United States, 20817
	United States, Michigan
	Barbara Ann Karmanos Cancer Hospital [Not yet recruiting] Detroit, Michigan, United States, 48201
	United States, Minnesota
	Metro-Minnesota Community Oncology Reserch Consortium (Mmcorc) [Not yet recruiting] Saint Louis Park, Minnesota, United States, 55416
	United States, Mississippi
	Hattiesburg Clinic Hematology [Recruiting] Hattiesburg, Mississippi, United States, 39401
	United States, New York
	Roswell Park Cancer Institute [Not yet recruiting] Buffalo, New York, United States, 14263
	Nyu Clinical Cancer Center [Not yet recruiting] New York, New York, United States, 10016
	United States, North Carolina
	Levine Cancer Institute [Not yet recruiting] Charlotte, North Carolina, United States, 28204
	United States, Oklahoma
	Integris Cancer Institute [Recruiting] Oklahoma City, Oklahoma, United States, 73142
	United States, South Carolina
	Charleston Hematology Oncology Associates [Recruiting] Charleston, South Carolina, United States, 29414
	Prisma Health Upstate [Recruiting] Greenville, South Carolina, United States, 29615
	United States, South Dakota
	Prairie Lakes Health Care System, Inc. [Recruiting] Watertown, South Dakota, United States, 57201
	United States, Texas
	Texas Oncology-Baylor Charles A. Sammons [Recruiting] Dallas, Texas, United States, 75246
	The Center For Cancer and Blood Disorders [Recruiting] Fort Worth, Texas, United States, 76104
	Md Anderson Cancer Center [Recruiting] Houston, Texas, United States, 77030
	Renovatio Clinical [Recruiting] Spring, Texas, United States, 77380
	United States, Utah
	Utah Cancer Specialists [Recruiting] Salt Lake City, Utah, United States, 84106
	United States, Virginia
	University of Virginia Medical Center [Recruiting] Charlottesville, Virginia, United States, 22908
	United States, Washington
	Vista Oncology Inc Ps [Recruiting] Olympia, Washington, United States, 98506
	Virginia Mason Medical Center [Recruiting] Seattle, Washington, United States, 98101
	University of Washington - Seattle Cancer Care Alliance [Recruiting] Seattle, Washington, United States, 98109-4405
	Northwest Medical Specialties Pllc [Recruiting] Tacoma, Washington, United States, 98405
	Australia
	Eastern Health [Recruiting] Box Hill, Australia, 3128
	Royal Hobart Hospital [Recruiting] Hobart, Australia, 07000
	Australia, New South Wales
	St George Hospital [Recruiting] Kogarah, New South Wales, Australia, 02217
	Liverpool Hospital [Recruiting] Sydney, New South Wales, Australia, 02170
	Wollongong Hospital - Illawarra Regional Hospital [Recruiting] Wollongong, New South Wales, Australia, 02500
	Australia, Queensland
	Gold Coast Hospital [Recruiting] Southport, Queensland, Australia, 04215
	Australia, South Australia
	Royal Adelaide Hospital [Recruiting] Adelaide, South Australia, Australia, 05000
	Flinders Medical Centre [Recruiting] Bedford Park, South Australia, Australia, 05042
	Australia, Victoria
	The Alfred Hospital [Recruiting] Melbourne, Victoria, Australia, 03004
	Northern Hospital [Recruiting] Melbourne, Victoria, Australia, 03076
	Western Health [Recruiting] St. Albans, Victoria, Australia, 03021
	Australia, Western Australia
	Perth Blood Institute [Recruiting] West Perth, Western Australia, Australia, 06005
	Austria
	Kepler Universitat Klinikum [Recruiting] Linz, Austria, 04020
	Medizinische Universitat Wien Allgemeines Krankenhaus Der Stadt Wien [Recruiting] Wien, Austria, 01090
	Belgium
	Zna Stuivenberg [Recruiting] Antwerpen, Belgium, 02060
	A.Z. St.-Jan-Dienst Hematologie [Recruiting] Brugge, Belgium, 8000
	Institut Jules Bordet [Recruiting] Brussels, Belgium, 01000
	Cliniques Universitaires Ucl Saint-Luc [Recruiting] Brussels, Belgium, 01200
	Universitair Ziekenhuis Antwerpen, Dienst Hematologie [Recruiting] Edegem, Belgium, 2650
	Ghent University Hospital [Recruiting] Gent, Belgium, 09000
	Centre Hospitalier Universitaire de Liege - Sart Tilman [Recruiting] LIï¿½GE, Belgium, 04000
	Universitair Ziekenhuis (Uz) Leuven [Recruiting] Leuven, Belgium, 03000
	AZ Delta [Recruiting] Roeselare, Belgium, 8800
	Chu Ucl Namur University Hospital Mont-Godinne [Recruiting] Yvoir, Belgium, 05530
	Canada, Alberta
	Cross Cancer Institute [Recruiting] Edmonton, Alberta, Canada, T6G 1Z2
	Canada, British Columbia
	British Columbia Cancer Agency [Recruiting] Vancouver, British Columbia, Canada, V5Z 1L3
	Canada, Ontario
	London Health Sciences Centre [Recruiting] London, Ontario, Canada, N6A 5W9
	Canada, Quebec
	Hospital Maisonneuve Rosemont [Not yet recruiting] MONTRï¿½AL, Quebec, Canada, H1T 2M4
	McGill University Jewish General Hospital [Recruiting] MONTRï¿½AL, Quebec, Canada, H3T 1E2
	Chu de Quebec - Universite Laval (Chul) [Recruiting] QUï¿½BEC, Quebec, Canada, G1J 1Z4
	Czechia
	University Hospital Hradec Kralove [Recruiting] Hradec Kralove, Czechia, 50333
	University Hospital Ostrava [Recruiting] Ostrava, Czechia, 70800
	Vseobecna Fakultni Nemocnice [Recruiting] Prague, Czechia, 128 08
	University Hospital Motol [Recruiting] Praha, Czechia, 15000
	Denmark
	Aalborg University Hospital [Recruiting] Aalborg, Denmark, 09000
	Odense University Hospital [Recruiting] Odense, Denmark, 05000
	Finland
	Kuopio University Hospital [Recruiting] Kuopio, Finland, 70210
	Oulu University Hospital [Recruiting] Oulu, Finland, 90220
	Tampere University Hospital [Recruiting] Tampere, Finland, 33520
	Turku University Hospital [Recruiting] Turku, Finland, 20520
	France
	Chu Amiens Picardie - Hopital Sud [Recruiting] Amiens, France, 80054
	Chu Angers Hotel Dieu Nord [Recruiting] Angers, France, 49933
	Centre Hospitalier Universitaire Chu Dijon Bourgogne - Hopital Francois Mitterrand [Recruiting] Dijon, France, 21000
	Centre Hospitalier de Versailles - Hopital Andre Mignot [Recruiting] Le Chesnay, France, 78150
	CHU Nantes [Recruiting] Nantes, France, 44093
	Hospital Saint-Louis Service Oncologie Medicale [Recruiting] Paris, France, 75010
	A.P.H. Paris Hopital Cochin [Recruiting] Paris, France, 75014
	Hôpital Pitié Salpêtrière [Recruiting] Paris, France, 75651
	Centre Hospitalier de Pontoise [Recruiting] Pontoise, France, 95303
	Centre Hospitalier Annecy-Genevois [Recruiting] Pringy, France, 74374
	Chru Hopitaux de Tours Hospital Bretonneau [Recruiting] Tours, France, 37044
	Germany
	University Clinic Giessen Und Marburg Ukgm [Not yet recruiting] GIEï¿½EN, Germany, 35392
	Universitaetsklinikum Wuerzburg [Not yet recruiting] Wï¿½RZBURG, Germany, 97080
	Greece
	251 Air Force General Hospital [Recruiting] Athens, Greece, 11525
	General Hospital of Athens Laiko [Recruiting] Athens, Greece, 11527
	University Hospital of West Attica - Attikon [Recruiting] Athens, Greece, 12462
	University General Hospital of Patras [Recruiting] Patras, Greece, 26504
	Hungary
	Semmelweis Egyetem [Recruiting] Budapest, Hungary, 01083
	National Institute of Oncology [Recruiting] Budapest, Hungary, 01122
	Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika [Recruiting] Debrecen, Hungary, 04032
	Markhot Ferenc Korhaz [Recruiting] Eger, Hungary, 03300
	Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz [Recruiting] NYï¿½REGYHï¿½ZA, Hungary, 04400
	University of Szeged [Recruiting] Szeged, Hungary, 06725
	Israel
	Shaare Zedek Mc [Recruiting] Jerusalem, Israel, 9103102
	"Laiko" General Hospital of Athens, Hematology of the First Propaedeutic Internal Medicine Clinic [Recruiting] Jerusalem, Israel, 91120
	Hadassah [Recruiting] Jerusalem, Israel, 91120
	Rabin Medical Center - Beilinson Hospital [Recruiting] Petah Tikva, Israel, 49100
	Sheba Medical Center [Recruiting] Tel Hashomer, Israel, 5265601
	Italy
	Presidio Ospedaliero Vito Fazzi [Recruiting] Lecce, Italy, 73100
	Fondazione Irccs Istituto Nazionale Dei Tumori [Recruiting] Milano, Italy, 20133
	Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda [Recruiting] Milano, Italy, 20162
	Universita Di Napoli Federico Ii [Recruiting] Napoli, Italy, 80131
	Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara [Recruiting] Novara, Italy, 28100
	Ausl Di Placenza Ospedale Guglielmo Da Saliceto [Recruiting] Piacenza, Italy, 29100
	Ospedale Santa Maria Delle Croci [Recruiting] Ravenna, Italy, 48121
	Arcispedale Santa Maria Nuova [Recruiting] Reggio Emilia, Italy, 42100
	Ausl Della Romagna [Recruiting] Rimini, Italy, 47923
	Ospedale Sant. Eugenio [Recruiting] Rome, Italy, 00144
	Japan
	National Hospital Organization Kyushu Cancer Center [Recruiting] Fukuoka-shi, Japan, 811-1395
	Gifu Municipal Hospital [Recruiting] Gifu-shi, Japan, 500-8513
	Kagoshima University Hospital [Recruiting] Kagoshima-shi, Japan, 890-8520
	National Cancer Center Hospital East [Recruiting] Kashiwa-shi, Japan, 277-8577
	Kobe City Medical Center General Hospital [Recruiting] Kobe-shi, Japan, 650-0047
	Japanese Red Cross Nagoya Daini Hospital [Recruiting] Nagoya-shi, Japan, 466 8650
	Kindai University Hospital [Recruiting] Osakasayama-shi, Japan, 589-8511
	Saitama Medical University Hospital [Recruiting] Saitama, Japan, 350-0495
	Osaka University Hospital [Recruiting] Suita-shi, Japan, 565-0871
	Juntendo University Hospital [Recruiting] Tokyo, Japan, 113-8431
	Yamagata University Hospital [Recruiting] Yamagata-shi, Japan, 990-9585
	Korea, Republic of
	Dong-A University Hospital [Recruiting] Busan, Korea, Republic of, 49201
	Pusan National University Yangsan Hospital [Recruiting] Busan-si, Korea, Republic of, 602-739
	Kyungpook National University Hospital [Recruiting] Daegu, Korea, Republic of, 41944
	Keimyung University Dongsan Medical Center [Recruiting] Daegu, Korea, Republic of, 42601
	Gacheon University Gil Medical Center [Recruiting] Incheon, Korea, Republic of, 21565
	Seoul National University Hospital [Recruiting] Seoul, Korea, Republic of, 03080
	Severance Hospital Yonsei University Health System [Recruiting] Seoul, Korea, Republic of, 03722
	Samsung Medical Center [Recruiting] Seoul, Korea, Republic of, 06351
	Netherlands
	Amsterdam University Medical Centre [Recruiting] Amsterdam, Netherlands, 1105 AZ
	Hospital Rijnstate [Recruiting] Arnhem, Netherlands, 6815 AD
	Medisch Centrum Leeuwarden [Recruiting] Leeuwarden, Netherlands, 8934 AD
	HMC [Recruiting] Leidschendam, Netherlands, 2622BA
	Norway
	Innlandet Hospital Trust [Not yet recruiting] Brumunddal, Norway, 02381
	Poland
	Sp Zoz Szpital Uniwersytecki [Recruiting] Krakow, Poland, 31-501
	Specjalistyczny Szpital Onkologiczny [Recruiting] Lï¿½DZ/ Hospital Adress Tomaszow Mazowiecki, Poland, 97200
	Spain
	Complejo Hospitalario Universitario A Coruna [Recruiting] A CORUï¿½A, Spain, 15006
	Hospital General Unviersitario de Alicante [Recruiting] Alicante, Spain, 03010
	Ico Hospital Germans Trias I Pujol [Recruiting] Badalona, Spain, 08916
	Hospital Del Mar [Recruiting] Barcelona, Spain, 08003
	Hospital General Universitario Vall D Hebron [Recruiting] Barcelona, Spain, 08007
	Hospital de La Santa Creu I Sant Pau [Recruiting] Barcelona, Spain, 08041
	Hospital Universitario de Cabuenes [Recruiting] Gijon, Spain, 33394
	Institut Catala Doncologia Ico - Hospital Duran I Reynals Location [Recruiting] Hospitalet de Llobregat, Spain, 08908
	Hospital General Universitario Gregorio Maranon [Recruiting] Madrid, Spain, 28007
	Hospital Universitario Ramon Y Cajal [Recruiting] Madrid, Spain, 28034
	Fundacion Jimenez Diaz University Hospital [Recruiting] Madrid, Spain, 28040
	Hospital Universitario 12 de Octubre [Recruiting] Madrid, Spain, 28041
	Hospital Universitario Quironsalud Madrid [Recruiting] Madrid, Spain, 28223
	Hospital Puerta de Hierro [Recruiting] Majadahonda, Spain, 28222
	Hospital Universitario Virgen de La Victoria [Recruiting] Malaga, Spain, 29010
	Hospital Son Llatzer [Recruiting] Palma de Mallorca, Spain, 07198
	Consorci Hospitalari Parc Tauli de Sabadell [Recruiting] Sabadell, Spain, 08208
	Hospital Universitario Marques de Valdecilla [Recruiting] Santander, Spain, 39008
	Hospital Universitario Virgen del Rocio Sevilla [Recruiting] Sevilla, Spain, 41005
	Hospital Universitari Mutua Terrassa [Recruiting] Terrassa, Spain, 08221
	Hospital Universitario Doctor Peset [Recruiting] Valencia, Spain, 46017
	Hospital Universitario de Alava [Recruiting] Vitoria-gasteiz, Spain, 01009
	Switzerland
	University Hospital of Basel Department of Oncology [Recruiting] Basel, Switzerland, 04031
	Oncological Institute of Southern Switzerland [Recruiting] Bellinzona, Switzerland, 06500
	Inselspital - Universitaetsspital Bern [Recruiting] Bern, Switzerland, 03010
	Taiwan
	Kaohsiung Chang Gung Memorial Hospital [Recruiting] Kaohsiung, Taiwan, 00833
	China Medical University Hospital [Recruiting] Taichung, Taiwan, 40447
	National Cheng Kung University (Ncku) Hospital [Recruiting] Tainan, Taiwan, 00704
	National Taiwan University Hospital [Recruiting] Taipei, Taiwan, 00100
	Tri Service General Hospital [Recruiting] Taipei, Taiwan, 00114
	Taipei Veterans General Hospital [Recruiting] Taipei, Taiwan, 11217
	Hematology and Medical Oncology Too Foundation Sun Yat Sen Cancer Center [Recruiting] Taipei City, Taiwan, 11251
	United Kingdom
	The Royal Marsden Nhs Foundation Trust - Chelsea [Not yet recruiting] London, United Kingdom, SW3 6JJ

IPDSharing


Plan to Share IPD:	Yes Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
	Supporting Information: Study Protocol Statistical Analysis Plan (SAP)
	Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
	Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
	URL: https://www.incyte.com/our-company/compliance-and-transparency

References


Citations:
Links:
Available IPD/Information: