A phase III Trial of postoperative chemotherapy or no further treatment for patients with

node-negative stage I-II intermediate or high risk endometrial cancer.

ENGOT-EN2-DGCG / EORTC-55102

Supported by

Endometrioid:Stage I - G3; II

Non-endometrioid:Stage I-II

ChemotherapyCarboplatin-Paclitaxel x 6+ Brachytherapy

Observation+ Brachytherapy

Sponsor: DGCGProject Manager: Eva RønnengartStatistitian: DePont Christensen

PI: Mirza

Randomization: 1:1N=678

GROUP NATIONAL COORDINATOR No. SITES/ no of open

SITES

SUBMISSION STATUS SIV No. of patients

included

DGCG

DenmarkMansoor Raza Mirza, Copenhagen

6/ 6 CA Approved

EC ApprovedDone 53

NSGO

Finland

Annika Auranen, Tampere 6/ 5 CA Approved

EC ApprovedDone 5

NSGO

Sweden

Caroline Lundgren, Stockholm 4/ 4 CA Approved

EC PendingDone 26

EORTC Frederic Amant, U.Z.Gasthuisberg 27/ 27CA Approved

EC ApprovedDone 45

BGOG Frederic Kridelka, CHU de Liège 10/ 8CA Approved

EC ApprovedDone 8

MITO Stefano Greggi, Naples 8-10/ 1CA Approved

EC Approved2

MaNGO Annamaria Ferrero, Torino 6/ 1CA Approved

EC partly submitted1

C-GOG Pamela Soliman, MD Anderson 1/ 1CA Approved

EC ApprovedDone 1

GEICOAna Santaballa, Hosiptal

Universitario Le Fe10/ 5

CA Approved

EC partly submitted2

ISGO Tally Levy, Wolfson Medical Centre 7/ 0CA Approved

EC Approved

Planned November

2nd 2016

CEEGOG David Cibula, Prague 5/ 0CA Approved

EC not submitted

NOGGODr Jalid Sehouli, Charité Campus

Virchow-Klinikum Berlin5/ 0

CA Approved

EC partly submitted

Total 97/58 143

ARM ACarboplatin + Paclitaxel

+Nintedanib

Investigator’s

choice (without

niraparib)

ARM BCarboplatin + Paclitaxel

+Placebo

Endometrial Cancer

Stage 3 or

Stage 4 or

First relapse

Treat to PD/toxicity

Randomize

Treat to PD/toxicity

Randomization: 1:1

n=148

Stratifications

• stage of disease (stage 3 vs. stage 4 vs. recurrent disease)

• Prior adjuvant chemotherapy (yes/no)

• Disease status (no macroscopic dis vs. macroscopic dis)

mansoor@rh.regionh.dk

A randomized double-blind placebo-controlled phase II trial of first-line combination

chemotherapy with Nintadenib for patients with advanced or recurrent endometrial cancer

ENGOT-EN1 / FANDANGO

Sponsor: NSGOProject Manager: Kicki JederudStatistitian: DePont Christensen

PI: Mirza

mansoor@rh.regionh.dk

GROUP NATIONAL COORDINATOR No. SITES SUBMISSION STATUS SIV performed/planned

NSGODenmark

Mansoor Raza Mirza, Copenhagen 4 CA Approved

EC Approved3 SIVs performed

NSGOFinland

Johanna Mäenpää, Tampere 3 CA Pending

EC ApprovedPlanned Oct/Nov 2016

NSGONorway

Gunnar Kristensen, Oslo1 CA Approved

EC PendingPlanned Oct 2016

NSGOSweden

Per Rosenberg, Linköping 4

CA Approved

EC ApprovedPlanned Oct/Nov 2016

NOGGODr Jalid Sehouli, Charité Campus Virchow-

Klinikum Berlin12

CA Approved

EC ApprovedPlanned Nov 2016

BGOGDr Sevilay Altintas UZ Antwerpen

6CA Submitted 30th Sep 2016

EC Submitted 4th Oct 2016

GINECODr Dominique Bertron-Rigaud

ICO Centre René Gauducheau Saint-Herblain11

CA Submitted 28th Sep 2016

EC Submitted 29th 2016

Total 41

Endometrial Cancer

Primary stage 4 or relapsed disease

ER positive endometrioid

adenocarcinoma

Randomize

Randomization: 1:1N=78

ARM ALetrozole, 2.5mg d 1-28 every 28 daysPlacebo 125mg d 1-21 every 28 days

Until progression

ARM BLetrozole, 2.5mg d 1-28 every 28 days

Palbociclib 125mg d 1-21 every 28 days Until progression

Stratification:• Number of prior lines of therapy (primary advanced disease vs. 1st

relapse vs. ≥2 relapses)• Measurable vs. evaluable disease• Prior use of MPA/Megace (prior MPA/Megace use capped to a

maximum of 50%)

A randomized, double-blind, placebo-controlled, phase II trial of Palbociclib in combination

with Letrozole versus Placebo in combination with Letrozole for patients with Estrogen

receptor Positive advanced or recurrent Endometrial cancer.

ENGOT-EN3-NSGO/PALEO

Sponsor: NSGO

Sponsor: NSGOProject Manager: Joan LøhndorfStatistitian: DePont Christensen

PI: Mirza

GROUP NATIONAL COORDINATOR No. SITES SUBMISSION STATUS

NSGO

Denmark

Mansoor Raza Mirza, Copenhagen 3 CA Approved

EC Approved

NSGO

Finland

Annika Auraen, Tampere 3 CA planned submission mid October

EC planned submission mid October

NSGO

NorwayLine Bjørge, Bergen

2 CA planned submission start November

EC planned submission start November

NOGGO

GermanyJalid Sehouli, Berlin 5

CA planned submission during November

EC planned submission during November

MITO

ItalyGiovanni Scambia, Rome 6

CA planned submission during November

EC planned submission during November

GEICO

SpainDr. Cesar Mendiola, HU 12 de Octubre 5

CA planned submission during November

EC planned submission during November

Total 24