ENGOT- ov84/GEICO/MK-2870/022

Leading group: GEICO

Clinical Trial Study: Phase 3 Study (with futility) of MK-2870 vs SoC in BRCAm and BRCAwt PSROC

Planned number of patients: 383

Participating groups: tbc

Planned start October 2024

 

ENGOT- ov83/NOGGO/TORL123-002

Leading group: NOGGO

Clinical Trial Study: A Phase 2 study evaluating the efficacy and safety of TORL-1-23 in Women with advanced platinum resistant epithelial ovarian cancer (including primary peritoneal and fallopian tube cancers) expressing Claudin 6 (CLdn6)

Planned number of patients: 180

Participating groups: tbc

Planned start Q4 2024

 

 ENGOT-ov82/GINECO/EvoPAR-Ovarian01

Leading group: GINECO

Clinical Trial Study: EvoPAR-Ovarian01 : Rechallenge with parpi in 1st platinum sensitive relapse for patients who received parpi in 1st line but did not progressed under parpi therapy 

Planned number of patients: 570

Participating groups: AGO, MITO,MANGO, GEICO,BGOG, TRSGO,CEEGOG,ISGO,AGO-A,BGOG,NSGO-CTU

Planned start Q2 2024

 

ENGOT- ov81/NCRI/RAMP 301

Leading group: UK NCRI (via ICR-CTSU)

Clinical Trial Study: A Phase 3, Randomized, Open-Label Study of Combination Therapy with Avutometinib plus Defactinib Versus Investigator’s Choice of Treatment in Patients with Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)

Planned number of patients: 270

Participating groups: tbc

Planned start tbc

 

ENGOT- ov80/NCRI/DOVE

Leading group: NCRI

Clinical Trial Study: DOVE: A three-arm randomized phase II study of Dostarlimab alone or with Bevacizumab versus nonplatinum chemotherapy in recurrent gynaecological clear cell carcinoma (APGOT-ov7/ ENGOT study)

Planned number of patients: 90

Participating groups: BGOG

Planned start Q1 2024

 

ENGOT-ov78/GINECO/SALVOVAR

Leading group: GINECO

Clinical Trial Study: Phase III trial to assess the utility of adjusting chemotherapy dose & dosing schedule with the SALVage weekly dose-dense regimen in patients with poor prognostic OVARian cancers based on the tumor primary chemosensitivity and incomplete debulking surgery.

Planned number of patients: 240

Participating groups: CEEGOG, ISGO, Mango, DGOG, NCRI-UK

Planned start May 2024

 

ENGOT-ov77/GINECO

Leading group: GINECO

Clinical Trial Study: A Phase 2/3, Multicenter, Randomized Study of DS-6000a, a CDH6-directed Antibody-drug Conjugate, in Subjects with Platinum-Resistant, High-Grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancers

Planned number of patients: 105 for phase II and 450 for phase III

Participating groups: AGO, MITO, MANGO, GEICO, BGOG, TRSGO, CEEGOG

Planned start Q1/2024

 

ENGOT-ov76/MITO/GLORIOSA

Leading group: MITO

Clinical Trial Study: Randomized Phase 3 Trial of Mirvetuximab + Bevacizumab Maintenance In FRα-High PSOC Patients

Planned number of patients: 418

Participating groups: MaNGO, AGO-Germany, GINECO, CTI, BGOG, PGOG, HeCOG, TRSGO, CEEGOG, ISGO, NCRI, GEICO

 

ENGOT-ov75/BGOG/Innovate-5

Leading group: BGOG

Clinical Trial Study: INNOVATE-5: A pivotal, randomized controlled, Open-Label Study of Tumor Treating Fields (TTFields, 200 kHz) in patients with recurrent Ovarian Cancer in Whom platinum is an option

Planned number of patients: 650

Participating groups: HeCOG,  NOGGO, TRSGO, CEEGOG, GINECO, PGOG, DGOG, CTI

 

ENGOT-ov74/Swiss-GO/LoRiO

Leading group: Swiss-GO

Clinical Trial Study: PM1183-C-011-22

Localized Radiotherapy with Olaparib in recurrent Ovarian cancer

Planned number of patients: 159

Participating groups: CEEGOG, ISGO

Planned start 2024

 

ENGOT-ov73/GEICO/PM1183-C-011-22

Leading group: GEICO

Clinical Trial Study: PM1183-C-011-22

A Randomized, Multicenter, Open-label, Phase III Study of Lurbinectedin in Combination with Paclitaxel vs. Platinum-based Chemotherapy or Weekly Paclitaxel as Treatment in Patients with Relapsed Ovarian Cancer (LUPPA-1 Trial)

Planned number of patients: 250-375

Participating groups: TBD

 

ENGOT-ov72/MITO/ROSELLA

Leading group: MITO

Clinical Trial Study: A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Investigator’s choice in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

Planned number of patients: 360

Participating groups: BGOG, CEEGOG, GEICO, GINECO, ISGO, NCRI, TRSGO, Swiss-GO

 

ENGOT-ov71/NSGO-CTU/UP-NEXT

Leading group: NSGO-CTU

Clinical Trial Study: Phase III UpRi maintenance study in PSROC

Planned number of patients: 350

Participating groups: AGO (NOGGO), A-AGO), BGOG, DGOG, GEICO, GINECO, ISGO, MaNGO, MITO, NCRI, NSGO-CTU

 

ENGOT-ov70/BGOG/ALEPRO

Leading group: BGOG

Clinical Trial Study: An open label phase II study of abemaciclib and letrozole in ER-positive rare ovarian cancer

Planned number of patients: 40-100

Participating groups: AGO, GEICO, GINECO, SAKK, NCRI

 

ENGOT-ov68/NOGGO/ARTISTRY-7

Leading group: NOGGO

Clinical Trial Study: A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination with Pembrolizumab Versus Investigator’s Choice Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)

Planned number of patients: 376

Participating groups: A-AGO, CEEGOG, DGOG, GEICO, ISGO, HeCOG, MITO, NCRI, PGOG

 

ENGOT-ov67/A-AGO-OVAR 2.39/UPLIFT

Leading group: A-AGO

Clinical Trial Study: Uplifted expansion cohort in ovarian cancer patient of the open label Phase Ib/II, first-in-human, dose escalation and expansion study of XMT-1536 in patietns with solid tumors likely to express NaPi2

Planned number of patients: 180-240

Participating groups: AGO, BGOG, CEEGOG, GEICO, GINECO, MITO, NCRI, NSGO, PGOG

 

ENGOT-ov66/GEICO/A VB500-OC-004/ARRAVIVE

Leading group: GEICO

Clinical Trial Study: A phase 3, randomized, double-blind, adaptive, placebo/Paclitaxel-controlled study of AVB-S6-500 in combination with Paclitaxel in patients with Platinum-resistant recurrent ovarian cancer

Planned number of patients: 300-500

Participating groups: MITO, MaNGO, GINECO, CEEGOG, HeGOG, BGOG, NCRI, PGOG, NOGGO

 

ENGOT-ov65/MaNGO/KEYNOTE-B96

Leading group: MaNGO

Clinical Trial Study: A phase 3, randomized, double-blind study of Pembrolizumab versus placebo in combination with Paclitaxel with or without Bevacizumab for the treatment of Platinum-resistant recurrent ovarian cancer 

Planned number of patients: 696

Participating groups: GINECO, BGOG, NSGO, NOGGO, ISGO, PGOG, NCRI-UK, TRSGO, DGOG

 

ENGOT-ov64/NSGO-CTU/SOLERO

Leading group: NSGO-CTU

Clinical Trial Study: An early phase randomized trial of APX005M in BRCAwt patients with recurrent ovarian cancer

Planned number of patients: 105

Participating groups: CEEGOG, BGOG, GEICO, SwissGO

 

ENGOT-ov63/GINECO/NIRVANA

Leading group: GINECO

Clinical Trial Study: NIRVANA (NIRaparib with or without beVacizumab in mAintenance after complete cytoreductioN in patients with ovArian cancer)

Planned number of patients: 390

Participating groups: BGOG, MaNGO, GEICO, Gotic, KGOG

 

ENGOT-ov62/NOGGO/N-PLUS

Leading group: NOGGO

Clinical Trial Study: NiraParib in optimaLly debUlked ovarian cancer patientS

Planned number of patients: 536

Participating groups: A-AGO, BGOG, MaNGO

 

ENGOT-ov61/GEICO/EPIK-O

Leading group: GEICO

Clinical Trial Study: EPIK-O: A Phase III, multi-center, randomized (1:1), openlabel, active-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with olaparib as compared to single agent cytotoxic chemotherapy, in participants with no germline BRCA mutation detected, platinum-resistant or refractory, high-grade serous ovarian cancer

Planned number of patients: 358

Participating groups: GINECO, NSGO, NCRI, CEEGOG, AGO, A-AGO, MITO, MaNGO and BGOG

 

ENGOT-ov60/NCRI/GOG-3052/RAMP201

Leading group: NCRI 

Clinical Trial Study: A phase II trial of VS-6766 monotherapy and in combination with Defactinib in recurrent Low Grade Serous Ovarian Cancer

Planned number of patients: 116

Participating groups: NCRI GOG partners, GEICO, BGOG, GINECO, MaNGO, Princess Margaret Consortium Canada

 

ENGOT-ov59/NOGGO/MAMOC

Leading group: NOGGO 

Clinical Trial Study: Rucaparib MAintenance after Bevacizumab Maintenance following Carboplatin based first line chemotherapy in Ovarian Cancer patients

Planned number of patients: 190

Participating groups: AGO

 

ENGOT-ov58/GINECO/TEDOVA

Leading group: GINECO 

Clinical trial Study: Neoepitope vaccine (TEDOPI) in combination with pembolizumab as maintenance treatment for ovarian cancer in platinum sensitive relapse

Planned number of patients: 360

Participating groups: AGO, BGOG

 

ENGOT-ov57/AGO

Leading group: AGO 

Clinical Trial Study: Niraparib vs Niraparib in combination with Bevacizumab in patients with carboplatinum-taxane based chemother-apy in advanced ovarian cancer

Planned number of patients: 970

Participating groups: BGOG, CEEGOG, GEICO, MANGO

 

ENGOT-ov56/NSGO-CTU/DOVACC

Leading group: NSGO-CTU

Clinical Trial Study: A three-arm randomized study of olaparib, durvalumab and UV1 as maintenance therapy in BRCAwt patients in with relapsed ovarian cancer where platatinum combination therapy is an option

Planned number of patients: 184

Participating groups: BGOG, NOGGO, HeCOG, DGOG, A-AGO

 

ENGOT-ov55/BGOG/MIRASOL

Leading group: BGOG 

Clinical trial Study: MIRASOL: A phase 3 registration trial for Mirvetuximab-Soravtansine using PS2+ scoring in FRα high platinum resistant ovarian cancer patients

Planned number of patients: 430

Participating groups: GEICO, DGOG, CEEGOG, ISGO, PGOG, MANGO, NCRI, AGO, GINECO

 

ENGOT-ov54/Swiss-GO/MATAO

Leading group: Swiss-GO 

Clinical Trial Study: MAintenance Therapy with Aromatase inhibitor in epithelial Ovarian cancer: a Randomized Double-blinded Placebo-controlled Phase III Trial

Planned number of patients: 540

Participating groups: AGO, A-AGO

 

ENGOT-ov52/DGOG/OVHIPEC-2

Leading group: DGOG

Clinical Trial Study: OVHIPEC-2 Randomized phase 3 trial comparing primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy for stage III epithelial ovarian cancer

Planned number of patients: 538

Participating groups: Cancer trials Ireland, ANZGOG, NSGO-CTU, MITO, GINECO, NCRI, USA (as guest member of the DGOG)

 

ENGOT-ov51/MITO/NItCHE

Leading group: MITO

Clinical Trial Study: Randomized phase III trial on Niraparib-TSR 042 vs TSR 042 vs physician's choice chemotherapy in recurrent ovarian, fallopian tube or primary peritoneal cancer patients not candidate for further platinum treatment

Planned number of patients: 422

Participating groups: MaNGO, GINECO, HeCOG, CEEGOG, NOGGO

 

ENGOT-ov49/MaNGO/NEWTON

Leading group: MaNGO

Clinical Trial Study: A multicenter, open-label phase II trial of customized dosing (Rapid Adjustment of Dose to reduce Adverse Reactions “RADAR” dosing) of niraparib as maintenance therapy in platinum sensitive ovarian, fallopian tube or primary peritoneal recurrent cancer patients.

Planned number of patients: 105

Participating groups: NOGGO

 

ENGOT-ov47-TR /NOGGO-AGO TR2/HELPER

Leading group: NOGGO

Clinical Trial Study: Prospective study of HE4 serum level in patients with first platinum sensitive relapsed ovarian cancer

Planned number of patients: 500

Participating groups: A-AGO, AGO, BGOG, GEICO, MaNGO, MITO, NCRI

 

ENGOT-ov45/NCRI/ATHENA

Leading group: NCRI

Clinical Trial Study: ATHENA - A multicenter, randomized, double-blind, placebo-controlled phase 3 study in ovarian cancer patients evaluating Rucaparib and Nivolumab as maintenance treatment following response to front-line Platinum-based chemotherapy

Planned number of patients: 1000

Participating groups: AGO, BGOG, CEEGOG, CTI, GEICO, HeCOG, ISGO, MITO, NSGO, PGOG, TRSGO, (GOG Foundation Partners and other global groups)

 

ENGOT-ov41/GEICO/ANITA

Leading group: GEICO

Clinical Trial Study: ANITA (Atezolizumab and NIraparib Treatment Association in recurrent ovarian cancer): A randomized phase III trial of platinum-based chemotherapy followed by niraparib maintenance with or without atezolizumab in patients with recurrent ovarian, tubal or peritoneal cancer and platinum treatment-free interval (TFIp) >6 Months

Planned number of patients: 414

Participating groups: AGO, BGOG, GINECO, ISGO, MaNGO

 

ENGOT-ov40/NOGGO/Expression VI

Leading group: NOGGO

Clinical Trial Study: Holistic Analysis of longterm survivors with ovarian cancer

Planned number of patients: 100-200 per country

Participating groups: A-AGO, BGOG, CEEGOG, GEICO, TRSGO, Swiss-GO, (Romania, PASGO)

 

ENGOT-ov35/NCRI/ICON 9

Leading group: NCRI

Clinical Trial Study: An international phase III randomised study to evaluate the efficacy of maintenance therapy with olaparib and cediranib or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy

Planned number of patients: 330

Participating groups: SGCTG (ANZGOG, NCIC), GCIG, Canadian cancer trials group

 

ENGOT-ov34/AGO Ovar 2.29

Leading group: AGO

Clinical Trial Study: Atezolizumab in combination with Bevacizumab +/- Chemotherapy versus Chemo-BEV standard in recurrent ovarian cancer – a randomised trial

Planned number of patients: 664

Participating groups:  A-AGO, BGOG, GEICO, GINECO, NSGO, SAKK, NSGO-CTU