Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT07166094

Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer

Led by Genmab · Updated on 2026-05-06

660

Participants Needed

74

Research Sites

204 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study. The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected. All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).

CONDITIONS

Official Title

Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be female with histologically or cytologically confirmed recurrent or progressive endometrial cancer, excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma
  • Must have received 1 to 3 prior lines of therapy, including prior platinum-based chemotherapy and PD(L)-1 inhibitor therapy, either separately or in combination
  • If the tumor recurred more than 12 months after platinum chemotherapy, additional platinum-based treatment is required unless ineligible, with documented reason
  • Prior induction plus maintenance therapy counts as one line of therapy
  • Hormonal therapy alone without chemotherapy is not counted as a separate line
  • Therapy changes due to toxicity without progression are considered part of the same line
  • Must have radiographic progression on or after the most recent therapy
Not Eligible

You will not qualify if you...

  • Prior treatment with an antibody-drug conjugate containing a topoisomerase 1 inhibitor
  • Past or current malignancy other than endometrial cancer unless cured for 3 or more years or considered low risk
  • Known active central nervous system metastases or carcinomatous meningitis, unless previously treated and stable for at least 4 weeks without corticosteroids or anticonvulsants for 7 days
  • Hospitalization or symptoms from gastrointestinal obstruction recently or evidence of obstruction at screening
  • Current need for parenteral nutrition unless approved by study medical monitor

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 74 locations

1

MedStar Washington Hospital

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

2

SMH - Sarasota - Main Campus

Sarasota, Florida, United States, 34239

Actively Recruiting

3

Women's Care - 9th Ave

St. Petersburg, Florida, United States, 33713

Actively Recruiting

4

Emory Winship Cancer Inst.

Atlanta, Georgia, United States, 30308

Actively Recruiting

5

Emory Winship Cancer Inst.

Atlanta, Georgia, United States, 30322

Actively Recruiting

6

Emory Winship Cancer Inst./Emory Decatur Hospital

Decatur, Georgia, United States, 30033

Actively Recruiting

7

Trials365, LLC

Shreveport, Louisiana, United States, 71103

Actively Recruiting

8

Sinai Hospital

Baltimore, Maryland, United States, 21215

Actively Recruiting

9

William Kahlert Reg. Can. Ctr

Westminster, Maryland, United States, 21157

Actively Recruiting

10

USOR - Minnesota Oncology-Coon Rapids Clinic

Coon Rapids, Minnesota, United States, 55433

Actively Recruiting

11

USOR - Minnesota Oncology/ Coon Rapids Clinic

Coon Rapids, Minnesota, United States, 55433

Actively Recruiting

12

USOR - Minnesota Oncology - Edina Clinic

Edina, Minnesota, United States, 55435

Actively Recruiting

13

USOR - Minnesota Oncology/Edina Clinic

Edina, Minnesota, United States, 55435

Actively Recruiting

14

USOR - Minnesota Oncology/ Maple Grove Clinic

Maple Grove, Minnesota, United States, 55369

Actively Recruiting

15

USOR - Minnesota Oncology-Maplewood Clinic

Maplewood, Minnesota, United States, 55109

Actively Recruiting

16

USOR - Minnesota Oncology/ Maplewood Clinic

Maplewood, Minnesota, United States, 55109

Actively Recruiting

17

USOR - Minnesota Oncology/ Minneapolis Clinic

Minneapolis, Minnesota, United States, 55404

Actively Recruiting

18

USOR - Minnesota Oncology

Minneapolis, Minnesota, United States, 55404

Actively Recruiting

19

USOR - Minnesota Oncology/ Woodbury Clinic

Woodbury, Minnesota, United States, 55125

Actively Recruiting

20

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

21

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

Actively Recruiting

22

Willamette Valley Cancer Institute and Research Center - Eugene

Eugene, Oregon, United States, 97401

Actively Recruiting

23

NW Cancer Specs. P.C.

Happy Valley, Oregon, United States, 97015

Actively Recruiting

24

USOR - NW Cancer Specs P.C.

Portland, Oregon, United States, 97227

Actively Recruiting

25

USOR - NW Cancer Specs. P.C.

Tigard, Oregon, United States, 97223

Actively Recruiting

26

TX Onc - Arlington North

Arlington, Texas, United States, 76012

Actively Recruiting

27

USOR - Texas Oncology

Austin, Texas, United States, 78731

Actively Recruiting

28

USOR - Texas Oncology

Austin, Texas, United States, 78745

Actively Recruiting

29

USOR - Texas Oncology- Austin North

Austin, Texas, United States, 78758

Actively Recruiting

30

TX Onc - Bedford

Bedford, Texas, United States, 76022

Actively Recruiting

31

TX Onc - Methodist Dallas

Dallas, Texas, United States, 75203

Actively Recruiting

32

TX Onc - Presbyterian Dallas

Dallas, Texas, United States, 75231

Actively Recruiting

33

TX Onc - Methodist Charlton

Dallas, Texas, United States, 75237

Actively Recruiting

34

TX Onc - Sammons

Dallas, Texas, United States, 75246

Actively Recruiting

35

USOR - Texas Oncology - Dallas Fort Worth (DFW)

Fort Worth, Texas, United States, 76104

Actively Recruiting

36

USOR - Texas Oncology

Harlingen, Texas, United States, 78550

Actively Recruiting

37

USOR - Texas Oncology

McAllen, Texas, United States, 78503

Actively Recruiting

38

USOR - TX Oncology - SA NE

San Antonio, Texas, United States, 78217

Actively Recruiting

39

NEXT San Antonio

San Antonio, Texas, United States, 78240

Actively Recruiting

40

USOR - Texas Oncology- Horizon Circle

Waco, Texas, United States, 76712

Actively Recruiting

41

USOR - Texas Oncology- Waco

Waco, Texas, United States, 76712

Actively Recruiting

42

USOR - Texas Oncology

Weslaco, Texas, United States, 78596

Actively Recruiting

43

USOR - NW Cancer Specs P.C.

Vancouver, Washington, United States, 98684

Actively Recruiting

44

Calvary Mater Newcastle

Waratah, New South Wales, Australia, 2298

Actively Recruiting

45

Grand Hôpital de Charleroi

Gilly, Hainaut, Belgium, 6060

Actively Recruiting

46

VITAZ

Sint-Niklaas, Sint-Niklaas, Belgium, 9100

Actively Recruiting

47

MUHC - Glen Site

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

48

Kuopio Univ. Hospital, PSHVA

Kuopio, Northern Savonia, Finland, 70210

Actively Recruiting

49

Chiba University Hospital- Center for Outpatient

Chiba, Chiba, Japan, 260-8677

Actively Recruiting

50

Gunma Prefectural Cancer Center

Ōta, Gunma, Japan, 373-8550

Actively Recruiting

51

Iwate Medical University Hosp

Shiwa-gun, Iwate, Japan, 028-3695

Actively Recruiting

52

Kitasato University Hospital

Sagamihara-shi, Kanagawa, Japan, 252-0373

Actively Recruiting

53

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan, 241-8515

Actively Recruiting

54

Mie University Hospital

Tsu, Kansai, Japan, 514-8507

Actively Recruiting

55

NUC Tohoku Univ. Hospital

Sendai, Miyagi, Japan, 980-8574

Actively Recruiting

56

Osaka International Cancer Institute - Osaka - Otemae Acti

Osaka, Osaka, Japan, 541-8567

Actively Recruiting

57

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, Japan, 411-8777

Actively Recruiting

58

Keio University Hospital

Tokyo, Tokyo, Japan, 160-8582

Actively Recruiting

59

National Cancer Center Hospital East

Chiba, Japan, 277-8577

Actively Recruiting

60

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan, 811-1347

Actively Recruiting

61

Fukushima Medical University Hospital

Fukushima, Japan, 960-1247

Actively Recruiting

62

Hyogo Cancer Center

Hyōgo, Japan, 673-0021

Actively Recruiting

63

Niigata Cancer Center Hospital

Niigata, Japan

Actively Recruiting

64

Saitama Medical University - International Medical Center

Saitama, Japan, 350-1298

Actively Recruiting

65

Sapporo Medical University Hospital

Sapporo, Japan, 060-8543

Actively Recruiting

66

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, Japan, 569-8686

Actively Recruiting

67

Cancer Institute Hospital of JFCR

Tokyo, Japan, 135-8550

Actively Recruiting

68

Yamagata University Hospital

Yamagata, Japan, 990-9585

Actively Recruiting

69

OUH Radium Hospital

Oslo, Oslofjord, Norway, 0379

Actively Recruiting

70

Haukeland University Hospital

Bergen, Vestland, Norway, NO-5021

Actively Recruiting

71

Siedleckie Centrum Onkologii

Siedlce, Masovian Voivodeship, Poland, 08-110

Actively Recruiting

72

PR Cancer Specialists

San Juan, Puerto Rico, 00917

Actively Recruiting

73

CHU A Coruña

A Coruña, La Coruña, Spain, 15006

Actively Recruiting

74

HM Sanchinarro

Madrid, Madrid, Spain, 28050

Actively Recruiting

Loading map...

Research Team

G

Genmab Trial Information

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here