Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT07214779

Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Led by Incyte Corporation · Updated on 2026-05-08

466

Participants Needed

162

Research Sites

178 weeks

Total Duration

On this page

Sponsors

I

Incyte Corporation

Lead Sponsor

E

ENGOT Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression.

CONDITIONS

Official Title

Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histological diagnosis of high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Have platinum-resistant disease.
  • Participants with 1 line of platinum-based therapy must have received at least 4 cycles of platinum.
  • Participants with 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after last platinum dose.
  • Archival tumor tissue block or slides no older than 5 years must be available or willingness for pretreatment biopsy.
  • Received between 1 and 4 prior lines of systemic therapy after initial diagnosis.
  • Prior treatment with bevacizumab unless contraindicated.
  • Prior treatment with mirvetuximab soravtansine if tumor is FRα positive unless medically exempt.
  • Measurable disease per RECIST v1.1.
Not Eligible

You will not qualify if you...

  • Have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors with these histologies, or low-grade/borderline ovarian cancer.
  • Have primary platinum-refractory disease (progression on or within 3 months after first line platinum therapy).
  • Clinically significant or uncontrolled cardiac disease within 6 months before first dose.
  • Known active CNS metastases or carcinomatous meningitis.
  • Known progressing additional malignancy or history of other malignancy within 3 years before first dose.
  • Clinically significant gastrointestinal abnormalities.
  • Other protocol-defined inclusion/exclusion criteria may apply.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 162 locations

1

Alaska Womens Cancer Care Akwcc

Anchorage, Alaska, United States, 99508

Not Yet Recruiting

2

City of Hope Medical Center

Duarte, California, United States, 91010

Not Yet Recruiting

3

Valkyrie Clinical Trials

Los Angeles, California, United States, 90067

Actively Recruiting

4

University of Colorado Cancer Center

Aurora, Colorado, United States, 80045

Not Yet Recruiting

5

Georgia Cancer Center

Augusta, Georgia, United States, 30912

Not Yet Recruiting

6

Carle Cancer Center

Effingham, Illinois, United States, 62401-2006

Not Yet Recruiting

7

Northshore University Health System-Evanston Hospital

Evanston, Illinois, United States, 60201

Not Yet Recruiting

8

Women'S Cancer Care

Covington, Louisiana, United States, 70433

Not Yet Recruiting

9

Maine Center For Cancer Medicine

Scarborough, Maine, United States, 04074

Not Yet Recruiting

10

Holy Cross Hospital

Silver Spring, Maryland, United States, 20910

Not Yet Recruiting

11

Mercy Hospital St. Louis - David C. Pratt Cancer Center

St Louis, Missouri, United States, 63141

Not Yet Recruiting

12

Billings Clinic

Billings, Montana, United States, 59101

Actively Recruiting

13

Center of Hope

Reno, Nevada, United States, 89502

Not Yet Recruiting

14

Levine Cancer Center

Charlotte, North Carolina, United States, 28204

Not Yet Recruiting

15

Novant Presbyterian Hospital

Charlotte, North Carolina, United States, 28204

Not Yet Recruiting

16

Novant Health Oncology Specialists

Winston-Salem, North Carolina, United States, 27103

Not Yet Recruiting

17

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States, 27157

Not Yet Recruiting

18

Oncology Associates of Oregon, P.C.

Eugene, Oregon, United States, 97401

Not Yet Recruiting

19

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States, 97213

Not Yet Recruiting

20

University of Pittsburgh Cancer Institute Cancer Services

Pittsburgh, Pennsylvania, United States, 15213

Not Yet Recruiting

21

Wellspan Gynecologic Oncology

York, Pennsylvania, United States, 17403

Not Yet Recruiting

22

Sanford Cancer Center-Sioux Falls

Sioux Falls, South Dakota, United States, 57104-8805

Not Yet Recruiting

23

Erlanger Health, Inc.

Chattanooga, Tennessee, United States, 37403

Actively Recruiting

24

Texas Oncology-Abilene

Abilene, Texas, United States, 79606

Not Yet Recruiting

25

Inova Schar Cancer Institute

Fairfax, Virginia, United States, 22031

Not Yet Recruiting

26

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Not Yet Recruiting

27

Chris O'Brien Lifehouse Hospital

Camperdown, New South Wales, Australia, 02050

Not Yet Recruiting

28

North Coast Cancer Institute

Port Macquarie, New South Wales, Australia, 02444

Withdrawn

29

The Wollongong Hospital

Wollongong, New South Wales, Australia, 02500

Not Yet Recruiting

30

Icon Cancer Care - Townsville

Townsville, Queensland, Australia, 04812

Not Yet Recruiting

31

Eastern Health-Box Hill Hospital

Box Hill, Victoria, Australia, 03128

Not Yet Recruiting

32

Hopital Universitaire de Bruxelles (Hub) - Institut Jules Bordet

Brussels, Belgium, 01070

Not Yet Recruiting

33

Cliniques Universitaires St Luc Ucl

Brussels, Belgium, B-1200

Not Yet Recruiting

34

Az Maria Middelares Gent

Ghent, Belgium, 09000

Not Yet Recruiting

35

UZ GENT

Ghent, Belgium, 09000

Not Yet Recruiting

36

Az Groeninge

Kortrijk, Belgium, 08500

Not Yet Recruiting

37

Universitair Ziekenhuis Leuven

Leuven, Belgium, 03000

Not Yet Recruiting

38

Tom Baker Cancer Center-Alberta Health Services (Ahs) - University of Calgary

Calgary, Alberta, Canada, T2N 4N2

Not Yet Recruiting

39

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Not Yet Recruiting

40

British Columbia Cancer Agency (Bcca) - Abbotsford Regional Hospital and Cancer Centre (Arhcc)

Abbotsford British Columbia, British Columbia, Canada, V2S 0C2

Withdrawn

41

Bc Cancer Vancouver

Vancouver, British Columbia, Canada, V5Z 1L3

Withdrawn

42

London Health Sciences Centre

London, Ontario, Canada, N6A 5W9

Not Yet Recruiting

43

Sunnybrook Health Science Centre

Toronto, Ontario, Canada, M4N 3M5

Withdrawn

44

University Health Network (Uhn) - Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Not Yet Recruiting

45

Sir Mortimer B. Davis - Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Not Yet Recruiting

46

Cedars Cancer Centre - McGill University Health Centre (Muhc) - Glen Site

Montreal, Quebec, Canada, H4A 3J1

Not Yet Recruiting

47

Trillium Health Partners - Credit Valley Hospital

Mississauga, Canada, L5M 2N1

Not Yet Recruiting

48

Ch Davignon - Hopital Henri Duffaut

Avignon, France, 84902

Not Yet Recruiting

49

Clinique Tivoli

Bordeaux, France, 33000

Not Yet Recruiting

50

Clinique Pole Sante Leonard de Vinci

Chambray-lès-Tours, France, 37170

Not Yet Recruiting

51

Centre Hospitalier Departemental de Vendee, Hopital de La-Roche-Sur-Yon Les Oudairies

La Roche-sur-Yon, France, 85925

Not Yet Recruiting

52

Centre Hospitalier Universitaire de Grenoble- Hopital Albert Michallon

La Tronche, France, 38700

Not Yet Recruiting

53

Hopital Prive Jean Mermoz

Lyon, France, 69008

Not Yet Recruiting

54

Institut Paoli Calmettes

Marseille, France, 13009

Not Yet Recruiting

55

Centre Antoine Laccassagne

Nice, France, 06189

Not Yet Recruiting

56

Tenon - Aphp

Paris, France, 75020

Not Yet Recruiting

57

Centre Eugene Marquis

Rennes, France, 35042

Not Yet Recruiting

58

Hopital de Hautepierre

Strasbourg, France, 67098

Not Yet Recruiting

59

Institut Gustave Roussy-Gustave Roussy Cancer Center -Ditep

Villejuif, France, 94805

Not Yet Recruiting

60

Universitätsklinikum Bonn

Bonn, Germany, 53127

Not Yet Recruiting

61

University Clinic Carl Gustav Carus Technical University Dresden

Dresden, Germany, 01307

Not Yet Recruiting

62

Vidia Christliche Kliniken Karlsruhe

Karlsruhe, Germany, 76135

Withdrawn

63

Klinikum Kassel

Kassel, Germany, 34125

Not Yet Recruiting

64

Universitatsklinikum Schleswig Holstein

Kiel, Germany, 24105

Not Yet Recruiting

65

Universitätsmedizin Mannheim

Mannheim, Germany, 68167

Not Yet Recruiting

66

Johannes Wesling Klinikum Minden

Minden, Germany, 32429

Not Yet Recruiting

67

Lmu - Klinikum Der Universitaet Muenchen - Campus Grosshadern

München, Germany, 81377

Not Yet Recruiting

68

Universitaetsklinikum Tuebingen (Ukt)

Tübingen, Germany, 72076

Not Yet Recruiting

69

Universitätsklinikum Ulm

Ulm, Germany, 89075

Not Yet Recruiting

70

St. Vincent'S University Hospital

Dublin, Ireland, D04 Y8V0

Not Yet Recruiting

71

Mater Misericordiae University Hospital

Dublin, Ireland, D07 R2WY

Not Yet Recruiting

72

St. James Hospital

Dublin, Ireland, D08 NHY1

Not Yet Recruiting

73

University Hospital Waterford

Waterford, Ireland, X91 ER8E

Not Yet Recruiting

74

Azienda Ospedaliero-Universitaria Di Alessandria Ss.Antonio E Biagio E Cesare Arrigo

Alessandria, Italy, 15121

Withdrawn

75

Ss Antonio & Biagio and C. Arrigo Hospital

Alessandria, Italy, 15121

Not Yet Recruiting

76

Centro Di Riferimento Oncologico Di Aviano

Aviano, Italy, 33081

Not Yet Recruiting

77

Azienda Ospedaliero-Universitaria Orsola-Malpighi - Universita Degli Studi Di Bologna

Bologna, Italy, 40138

Not Yet Recruiting

78

Ospedale Careggi

Florence, Italy, 50134

Not Yet Recruiting

79

Azienda Socio Santaria Territoriale de Lecco - Ospedale A. Manzoni

Lecco, Italy, 23900

Not Yet Recruiting

80

Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) - Ospedale San Raffaele (Hsr) (Istituto

Milan, Italy, 20132

Not Yet Recruiting

81

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, Italy, 20133

Not Yet Recruiting

82

Humanitas San Pio X

Milan, Italy, 20159

Not Yet Recruiting

83

Azienda Ulss 3 Serenissima - Ospedale Di Mirano

Mirano, Italy, 30035

Not Yet Recruiting

84

Istituto Nazionale Tumori Irccs Fondazione Pascale

Naples, Italy, 80131

Not Yet Recruiting

85

Comitato Etico Irccs Istituto Oncologico Veneto Di Padova

Padova, Italy, 35128

Not Yet Recruiting

86

Universita Degli Studi Di Pavia-Fondazione Irccs Policlinico San Matteo

Pavia, Italy, 27100

Not Yet Recruiting

87

Ausl Di Placenza Ospedale Guglielmo Da Saliceto

Placenza, Italy, 29121

Not Yet Recruiting

88

Ospedale Santa Maria Delle Croci

Ravenna, Italy, 48121

Not Yet Recruiting

89

Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena (Ire)

Rome, Italy, 00144

Not Yet Recruiting

90

Fondazione Policlinico Universitario Agostino Gemelli Irccs - Universita Cattolica Del Sacro Cuore

Rome, Italy, 00168

Not Yet Recruiting

91

Ordine Mauriziano - Ospedale Umberto I Di Torino

Torino, Italy, 10128

Not Yet Recruiting

92

Ospedale Ca' Foncello

Treviso, Italy, 31100

Not Yet Recruiting

93

Azienda Sanitaria Universitaria Friuli Centrale Asu Fc

Udine, Italy, 33100

Not Yet Recruiting

94

Ospedale Ferrero

Verduno, Italy, 12060

Not Yet Recruiting

95

Hyogo Cancer Center

Akashi-shi, Japan, 673-8558

Not Yet Recruiting

96

Saitama Medical University International Medical Center

Hidaka-shi, Japan, 350-1298

Not Yet Recruiting

97

The Cancer Institute Hospital of Jfcr

Kōtoku, Japan, 135-8550

Not Yet Recruiting

98

Kurume University Hospital

Kurume, Japan, 830-0011

Not Yet Recruiting

99

Nho Shikoku Cancer Center

Matsuyama, Japan, 791-0280

Not Yet Recruiting

100

The Jikei University Hospital

Minatoku, Japan, 105-8471

Actively Recruiting

101

Aichi Cancer Center

Nagoya, Japan, 464-8681

Not Yet Recruiting

102

Okayama University Hospital

Okayama, Japan, 700-8558

Actively Recruiting

103

Osaka International Cancer Institute

Osaka, Japan, 541-8567

Actively Recruiting

104

Sapporo Medical University Hospital

Sapporo, Japan, 060-8543

Actively Recruiting

105

Hokkaido University Hospital

Sapporo, Japan, 060-8648

Not Yet Recruiting

106

Tohoku University Hospital

Sendai, Japan, 980-8574

Actively Recruiting

107

Iwate Medical University Hospital

Shiwa-gun, Japan, 028-3695

Not Yet Recruiting

108

Shizuoka Cancer Center

Sunto-gun, Japan, 411-8777

Not Yet Recruiting

109

National Cancer Center Hospital

Tokyo, Japan, 104-0045

Not Yet Recruiting

110

Nki-Avl (Nederlands Kanker Instituut-Anthonie Van Leeuwenhoek)

Amsterdam, Netherlands, 1066 CX

Not Yet Recruiting

111

University Medical Center Groningen

Groningen, Netherlands, 9713 GZ

Not Yet Recruiting

112

Radboud University Medical Center

Nijmegen, Netherlands, 6525 GA

Not Yet Recruiting

113

Erasmus Medisch Centrum 1

Rotterdam, Netherlands, 3015 GD

Not Yet Recruiting

114

Universitair Medisch Centrum Utrecht (Umc Utrecht)

Utrecht, Netherlands, 3584 CX

Not Yet Recruiting

115

Uniwersyteckie Centrum Onkologii

Bialystok, Poland, 15-276

Not Yet Recruiting

116

Gdanski Uniwersytet Medyczny

Gdansk, Poland, 80-214

Not Yet Recruiting

117

Swietokrzyskie Centrum Onkologii Spzoz

Kielce, Poland, 25-734

Not Yet Recruiting

118

Mazowiecki Szpital Wojewodzki, Siedleckie Centrum Onkologii

Siedlce, Poland, 08-110

Not Yet Recruiting

119

Uniwersytecki Szpital Kliniczny Nr 2 Pomorskiego Uniwersytetu Medycznego W Szczecinie

Szczecin, Poland, 70-111

Not Yet Recruiting

120

Samsung Changwon Hospital

Changwon-si, South Korea, 51353

Not Yet Recruiting

121

National Cancer Center

Goyang-si, South Korea, 10408

Not Yet Recruiting

122

Cha University Bundang Cha Medical Center

Seongnam-si, South Korea, 13520

Not Yet Recruiting

123

Seoul National University Bundang Hospital (Snubh)

Seongnam-si, South Korea, 13620

Not Yet Recruiting

124

Korea University Anam Hospital

Seoul, South Korea, 02841

Not Yet Recruiting

125

Seoul National University Hospital

Seoul, South Korea, 03080

Not Yet Recruiting

126

Konkuk University Medical Center

Seoul, South Korea, 05030

Not Yet Recruiting

127

Asan Medical Center

Seoul, South Korea, 05505

Not Yet Recruiting

128

Samsung Medical Center

Seoul, South Korea, 06351

Not Yet Recruiting

129

Seoul St. Mary'S Hospital

Seoul, South Korea, 06591

Not Yet Recruiting

130

Ewha Womans University Mokdong Hospital

Seoul, South Korea, 07985

Not Yet Recruiting

131

Hospital Universitario de Alava

Alava, Spain, 01009

Not Yet Recruiting

132

Ico-Badalona

Badalona, Spain, 89016

Not Yet Recruiting

133

Hospital Clinic de Barcelona

Barcelona, Spain, 08036

Not Yet Recruiting

134

Clinica Universidad de Navarra

Madrid, Spain, 28022

Not Yet Recruiting

135

Hospital Universitario La Paz

Madrid, Spain, 28046

Not Yet Recruiting

136

Hospital Universitario Virgen de La Victoria

Málaga, Spain, 29010

Not Yet Recruiting

137

Hospital Universitario Central de Asturias

Oviedo, Spain, 33011

Not Yet Recruiting

138

Hospital Son Espases. Mallorca

Palma de Mallorca, Spain, 07120

Not Yet Recruiting

139

Corporacio Sanitaria Universitaria Parc Tauli

Sabadell, Spain, 08208

Not Yet Recruiting

140

Hospital Universitario Virgen Del Rocío Sevilla

Seville, Spain, 41013

Not Yet Recruiting

141

Hospital Universitario Virgen de Valme

Seville, Spain, 41014

Not Yet Recruiting

142

Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)

Valencia, Spain, 46010

Not Yet Recruiting

143

Ospedale Regionale Di Bellinzona

Bellinzona, Switzerland, 06500

Not Yet Recruiting

144

Kantonsspital Graubunden

Chur, Switzerland, 07000

Not Yet Recruiting

145

Kantonsspital Frauenfeld

Frauenfeld, Switzerland, 08501

Not Yet Recruiting

146

Hopitaux Universitaires de Geneve (Hug) (Hopital Cantonal)

Geneva, Switzerland, 01205

Not Yet Recruiting

147

Centre Hospitalier Universitaire Vaudois Lausanne (Chuv) - Centre Du Cancer Lausanne-Batiment Hospit

Lausanne, Switzerland, 01011

Not Yet Recruiting

148

University Hospital of Zurich

Zurich, Switzerland, 08032

Not Yet Recruiting

149

Addenbrooke'S Hospital - Cambridge University Hospitals Nhs Foundation Trust

Cambridge, United Kingdom, CB2 0QQ

Not Yet Recruiting

150

Velindre Nhs Trust, Velindre Cancer Centre

Cardiff, United Kingdom, CF14 2TL

Not Yet Recruiting

151

Edinburgh Cancer Centre Western General Hospital

Edinburgh, United Kingdom, EH4 2XU

Withdrawn

152

Royal Surrey County Hospital - Royal Surrey County Hospital Nhs Foundation Trust

Guildford, United Kingdom, GU2 7XX

Not Yet Recruiting

153

St James'S University Hospital - Leeds Teaching Hospitals Nhs Trust

Leeds, United Kingdom, LS9 7TF

Not Yet Recruiting

154

Clatterbridge Cancer Center

Liverpool, United Kingdom, L7 8YA

Not Yet Recruiting

155

University College London Hospitals - University College London Hospitals Nhs Foundation Trust

London, United Kingdom, NW1 2BU

Not Yet Recruiting

156

Guy'S Hospital - Guy'S & St Thomas' Nhs Foundation Trust

London, United Kingdom, SE1 9RT

Not Yet Recruiting

157

Hammersmith Hospital - Imperial College Healthcare Nhs Trust

London, United Kingdom, W12 0HS

Not Yet Recruiting

158

The Christie Nhs Foundation Trust

Manchester Greater, United Kingdom, M204BX

Not Yet Recruiting

159

Northampton General Hospital - Northampton General Hospital Nhs Trust

Northampton, United Kingdom, NN1 5BD

Not Yet Recruiting

160

Mount Vernon Cancer Centre

Northwood, United Kingdom, HA6 2RN

Not Yet Recruiting

161

Royal Marsden Hospital

Sutton, United Kingdom, SM2 5PT

Not Yet Recruiting

162

Musgrove Park Hospital - Somerset Nhs Foundation Trust

Taunton, United Kingdom, TA1 5DA

Not Yet Recruiting

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Research Team

I

Incyte Corporation Call Center (US)

CONTACT

I

Incyte Corporation Call Center (ex-US)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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