Cervical Cancer Clinical Trials (as of June 2020)

ENGOT-cx14/CEEGOG/FERTISS

Leading group: CEEGOG

Clinical Trial Study: FERTISS - FERTIility Sparing Surgery in cervical cancer patients (outside trials)  

Number of patients accrued: 300

Planned number of patients: as many as possible

Participating groups: 

AGO, BGOG, GINECO

 

ENGOT-cx13/AGO/FERMATA

Leading group: AGO

Clinical Trial Study: FERMATA Trial: An international randomized double-blind clinical trial of BCD-100 plus platinum-based chemotherapy with and without Bevacizumab versus placebo plus platinum-based chemotherapy with and without Bevacizumab as first-line treatment of subjects with advanced cervical cancer

Number of patients accrued: 0

Planned number of patients: 316

Participating groups: 

A-AGO, BGOG, CEEGOG, NSGO, PGOG, TRSGO

Planned start in 3Q 2019

 

ENGOT-cx12/BGOG-cx12

Leading group: BGOG

Clinical Trial Study: Phase 3, randomized controlled trial of Tisotumab Vedotin vs Investigator’s choice chemotherapy in 2nd or 3rd line recurrent cervical cancer

Number of patients accrued: 0

Planned number of patients: 486

Participating groups: 

NSGO, AGO, MITO, GEICO, GINECO, A-AGO, CEEGOG, CTI, NCRI, DGOG, MaNGO, ISGO, HECOG

Planned start in 2020

 

ENGOT-cx11/MITO/LACC

Leading group: MITO

Clinical Trial Study: A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer

Number of patients accrued: 2

Planned number of patients: 786

Participating groups: 

MITO, MaNGO, BGOG, Cancer Trial Ireland, GINECO, HeCOG, CEEGOG, GEICO, ISGO, NCRI, G-AGO, NOGGO, NSGO, A-AGO

Planned start in 1Q 2020

 

ENGOT-cx10/GEICO/BEATcc

Leading group: GEICO

Clinical Trial Study: A randomized phase III trial of  platinum chemotherapy plus Paclitaxel with Bevacizumab and Atezolizumab versus platinum chemotherapy plus Paclitaxel and Bevacizumab in metastatic (stage IVB), persistent or recurrent carcinoma of the cervix (BEATcc).

Number of patients accrued: 187 

Planned number of patients: 404

Participating groups: 

AGO,GINECO, MaNGO, MITO, NSGO,  JGOG, GOG-F

 

ENGOT-cx9/GEICO/EMPOWER Cervical-1 

Leading group: GEICO

Clinical Trial Study: An open-label, randomized, GOG/ENGOT phase 3 trial of anti-PD1 cemiplimab versus investigator's choice chemotherapy in >2 line recurrent cervical cancer

Number of patients accrued: 607 (162 ENGOT)

Planned number of patients: 534

Participating groups: 

BGOG, HEGOG, MITO, MaNGO, NCRI, PGOG

Recruitment close in May 2020

 

ENGOT-cx8/BGOG-cx8/GCT1015-05

Leading group: BGOG

Clinical Trial Study: A phase 2 open-label trial of Tisotumab Vedotin (HuMax® - TF-ADC) alone or in combination in first line recurrent or stage IVB cervical cancer

Number of patients accrued: 130

Planned number of patients: 170

Participating groups: 

CEEGOG, CTI, DGOG, MITO, NCRI, NOGGO, NSGO, SGCTG, TRSGO

Planned start in 2Q 2018

 

ENGOT-cx7/NSGO/cc1-MaRuC

Leading group: NSGO

Clinical Trial Study: A randomized double-blind placebo-controlled phase II trial of Rucaparib maintenance therapy for patienst with locally advanced cancer - MaRuC

Number of patients accrued: 0

Planned number of patients: 162

Participating groups: 

BGOG, Cancer Trials Ireland, CEEGOG, EORCT, GEICO, ISGO, MITO, NCRI, NOGGO, PGOG

Planned start in 2Q 2019

  

ENGOT-cx5/A-AGO/ADVANCE

Leading group: A-AGO

Clinical Trial Study: ADVANCE (ADVAxis Immunotherapy with Nivolumab to treat recurrent or metastatic CErvical Cancer), A randomized phase II study to evaluate the safety and efficacy of ADXS-602 in combination with Nivolumab

Number of patients accrued: 0

Planned number of patients: 460

Participating groups: TBA

Planned start in 2018

 

ENGOT-cx4/GINECO/SENTICOL

Leading group: GINECO

Clinical Trial Study: International prospective validation trial of sentinel node biopsy in cervical cancer

Number of patients accrued: 125

Planned number of patients: 950

Participating groups: 

AGO, MaNGO, NSGO, DGOG, CEEGOG

Planned start in 2018

 

ENGOT-cx2/CEEGOG/SENTIX

Leading group: CEEGOG

Clinical Trial Study: SENTIX (SENTinel lymph node in cervIX cancer) - a prospective observational trial on sentinel lymph node biopsy in patients with early stage cervical cancer

Number of patients accrued: 562

Planned number of patients: 600

Participating groups:

BGOG

Publications: 

• A prospective multicentre trial on sentinel lymph node biopsy in patients with early-stage cervical cancer (SENTIX)

Cibula D, Dusek J, Jarkovsky J, Dundr P, Querleu D, van der Zee A, Kucukmetin A, Kocian R.

Int J Gynecol Cancer. 2019 Jan;29(1):212-215

• Central Pathology Review in SENTIX, A Prospective Observational International Study on Sentinel Lymph Node Biopsy in Patients with Early-Stage Cervical Cancer (ENGOT-CX2)

Kristyna Nemejcova, Roman Kocian, Christhardt Kohler, Jiri Jarkovsky, Jaroslav Klat, Alberto Berjon, Radovan Pilka, Borek Sehnal, Blanca Gil-Ibanez, Ezequiel Lupo, Almerinda Petiz, Octavio Arencibia Sanchez, Peter Kascak, Fabio Martinelli, Alessandro Buda, Jiri Presl, Marc Barahona, Luc van Lonkhuijzen, Wiktor Szatkowski, Lubos Minar, Maja Pakiz, Pavel Havelka, Cristina Zorrero, Marcin Misiek, Leon Cornelius Snyman, Dariusz Wydra, Ignace Vergote, Alla Vinnytska, Mikulas Redecha, Martin Michal, Solveig Tingulstad, Barbara Kipp, Grzegorz Szewczyk, Robert Toth, Francisco Javier de Santiago Garcia, Pluvio Jesus Coronado Martin, Robert Poka, Karl Tamussino, Mathieu Luyckx, Maxime Fastrez, Juan Carlos Staringer, Anna Germanova, Andrea Plaikner, Sylva Bajsova, Pavel Dundr, Nina Mallmann-Gottschalk, David Cibula.

Cancers journal (Cancers (Basel). 2020 Apr; 29;12(5): E1115

• Sentinel lymph node mapping and intraoperative assessment in a prospective, international, multicentre, observational trial of patients with cervical cancer: The SENTIX trial

David Cibula, Roman Kocian, Andrea Plaikner, Jiri Jarkovsky, Jaroslav Klat, Ignacio Zapardiel, Radovan Pilka, Aureli Torne, Borek Sehnal, Marcela Ostojich, Almerinda Petiz, Octavio Arencibia Sanchez, Jiri Presl, Alessandro Buda, Francesco Raspagliesi, Peter Kascak, Luc van Lonkhuijzen, Marc Barahona, Lubos Minar, Pawel Blecharz, Maja Pakiz, Dariusz Wydra, Leon Cornelius Snyman, Kamil Zalewski, Cristina Zorrero, Pavel Havelka, Mikulas Redecha, Alla Vinnytska, Ignace Vergote, Solveig Tingulstad, Martin Michal, Barbara Kipp, Jiri Slama, Simone Marnitz, Sylva Bajsova, Alicia Hernandez, Daniela Fischerova, Kristyna Nemejcova, Christhardt Kohler.

Eur J Cancer (Accepted)