Endometrial Cancer Clinical Trials (as of May 2023)

 

ENGOT-en22/AGO-OP.11/STREAM-I

Clinical Trial Study: AGO-OP.11/STREAM-I, Surgical Treatment in Endometrial CAncer Management, Evaluation of preoperative clinical and translational selection criteria for cytoreductive surgery in endometrial cancer, A retrospective multicenter trial with an accompanying translational project

Leading group: AGO

Planned number of patients: 800

Participating groups: A-AGO, NOGGO, MaNGO, GINECO, ISGO NSGO, CEEGOG, PGOG

Planned start in Q2/2023

 

ENGOT-en21/A-AGO/EURUS

Clinical Trial Study: A Two-part, Randomized Phase 2/3 Study of Navtemadlin in Subjects with TP53WT Advanced or Recurrent Endometrial Cancer Who Responded after Chemotherapy 

Leading group: A-AGO

Planned number of patients: 63 in part I, 188 in part II

Participating groups: TBD

 

ENGOT-en20/BGOG/XPORT-EC

Clinical Trial Study: ENGOT-EN-X/GOG-X XPORT-EC-042 a Phase 3, randomized, placebo-controlled, double-blind, multicenter trial of Selinexor in maintenance therapy after systemic therapy for patients with P53 wild-type, advanced or advanced or recurrent endometrial carcinoma

Leading group: BGOG

Planned number of patients: 220

Participating groups: TBD

 

ENGOT-en19/NSGO-CTU/ALPACA

Leading group: NSGO-CTU

Clinical Trial Study: A Randomized Phase II Trial of Alpelisib in Combination with Letrozole for Patients with Advanced or Recurrent Endometrial Cancer

Planned number of patients: 600

Participating groups: MaNGO, BGOG, DGOG

 

ENGOT-en18/NSGO-CTU

Leading group: NSGO-CTU

Clinical Trial Study: Phase 3 Study of NUV-422 in combination with letrozole versus physician’s choice of letrozole or chemotherapy in recurrent endometrial cancer

Planned number of patients: 600

Participating groups: TBD

 

ENGOT-en17/GINECO/EQ132-303

Leading group: GINECO

Clinical Trial Study: A Randomized, Double-Blinded, Placebo-Controlled Phase 3 Study of EQ132 (Lerociclib) with Letrozole, versus Placebo in Combination with Letrozole, in Participants with Advanced or Recurrent Grade 1 or 2 Endometrioid Endometrial Carcinoma

Planned number of patients: 320

Participating groups: TBD

 

ENGOT-en16/NOGGO/ESPRESSION XI/IMPROVE

Leading group: NOGGO

Clinical Trial Study: Expression XI - Improve Survey

Planned number of patients: 1000

Participating groups: SwissGO, COGI, PGOG, GEICO, NSGO-CTU, GOTIC, CEEGOG, AGO Austria, PARSGO, MEMAGORG, CentEast

 

ENGOT-en15/MITO

Leading group: MITO

Clinical Trial Study: A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab vs. Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting

Planned number of patients: 350

Participating groups: GOG-F lead, NSGO-CTU, NOGGO, BGOG, CEEGOG, DGOG, MaNGO, GEICO, ISGO, CTI, NCRI, TRSGO, PGOG

 

ENGOT-en14/DGOG/RAINBO

Leading group: DGOG

Clinical Trial Study: Refining Adjuvant treatment IN endometrial cancer Based On molecular features, the RAINBO plateform trial

Planned number of patients: differs from cohorts

TP53: 575; MSI: 316, NSMP: 600, POLE: 120 

Participating groups: GINECO, NCRI, CCTG, AGO, SAKK, CEEGOG, ANZGOG

 

ENGOT-en13/GINECO/DOMENICA 

Leading group: GINECO

Clinical Trial Study: Randomized phase III trial in MMR deficient endometrial cancer patients comparing chemotherapy alone versus Dostarlimab in first line advanced/metastatic setting

Planned number of patients: 142

Participating groups: GEICO, MITO, MaNGO, BGOG, AGONCRI, PHMC

 

ENGOT-en12/NOGGO/INCYTE

Leading group: NOGGO

Clinical Trial Study: An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)

Planned number of patients: 260

Participating groups: GINECO, BGOG, HECOG, MITO, MaNGO, CEEGOG

 

ENGOT-en11/BGOG/KEYNOTE-B21

Leading group: BGOG

Clinical Trial Study: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Adjuvant Chemotherapy With or Without (Chemo)Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Carcinoma After Surgery With Curative Intent

Planned number of patients: 990

Participating groups: A-AGO, AGO, CEEGOG, GEICO, GINECO, HECOG, ISGO, PGOG, TRSGO, MITO, NCRI, NSGO

 

ENGOT-en8/GINECO/ROCSAN

Leading group: GINECO

Clinical Trial Study: ROCSAN study: A multicentric randomized phase II/III evaluating TSR-042 (anti-PD-1 mAb) in combination with Niraparib (parpi) versus Niraparib alone compared to chemotherapy in the treatment of metastatic or recurrent endometrial or ovarian carcinosarcoma after at least one line of chemotherapy

Planned number of patients: 63 in phase 1, 170 in phase 2

Participating groups: AGO, GEICO, MITO

 

ENGOT-en7/MaNGO/atTEnd

Leading group: MaNGO

Clinical Trial Study: AtTEnd trial: Phase III double-blind randomized placebo controlled trial of Atezolizumab in combination with paclitaxel and carboplatin in women with advanced/recurrent endometrial cancer

Planned number of patients: 550

Participating groups: GEICO, SAKK, A-AGO, AGO, NCRI, JGOG, ANZGOG, TGOG, KGOG

 

ENGOT-en6/NSGO/RUBY (Part II)

Leading group: NSGO-CTU

Clinical Trial Study: A phase III, randomized, open-label study of TSR-042, an Anti-PD-1 monoclonal antibody, versus investigator´s choice chemotherapy in patients with advanced/recurrent endometrial cancer

Planned number of patients: 270

Participating groups: BGOG, CEEGOG, DGOG, ISGO, PGOG, MITO, NCRI, TRSGO, AGO, GEICO