engot-ov24-nsgo/avanova phase 2 oct nsgo slides phase ii.pdf · sahlgrenska maria dimoula...
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ARM ABevacizumab 15mg/kg q3w
Switch over toNiraparib
300mg OD d1-21
Investigator’s choice (without niraparib)
ARM BNiraparib
300mg OD d1-21
ARM CBevacizumab 15mg/kg
q21d+
Niraparib 300mg OD d1-21
Platinum-sensitive
Ovarian Cancer
Homologous Recombination
Deficiency (HRD) positive score
Treat to PD/toxicity
RandomizeTreat to
PD/toxicity
Treat to PD/toxicity
Phase 2
Randomization: 1:1:1n=132
ENGOT-OV24-NSGO/AVANOVA
• BRCA status: BRCA mutated vs. non-carrier• Prior receipt of anti-angiogenic therapy (yes/no)• Prior lines of therapy: 1-3 vs > 3 lines
StratificationsSponsor: NSGOProject Manager: Louisa Boufercha
Statistitian: DePont ChristensenPI: Mirza
ENGOT-OV24-NSGO/AVANOVA (Phase 2) - Trial Status
Country Sites PI Submission status SIV Randomized
DK Rigshospitalet Mansoor R. Mirza (NC) • CA: Approved: 18.12.2015• EC: Approved: 01.03.2016
03.12.2015 3Herlev Trine Juhler-Nøttrup 30.03.2015 2Odense Jørn Herrstedt 08.03.2016 -Aarhus Ranva Hassel 19.08.2016 -Aalborg Bente Lund 16.12.2015 3
FI Tampere Johanna Mäenpää (NC) • CA: Approved: 19.07.2016• EC: Approved: 06.06.2016
30.09.2016 -TBD -Kuopio Maarit Anttila
Turku Sakari Hietanen TBD -NO Haukeland Line Bjørge (NC) • CA: Approved: 29.09.2016
• EC: Approved: Oct 2016TBD -
Stavanger Bent Fiane TBD -
SE Lund Susanne Malander (NC) • CA: Approved 22.04.2016• EC: Approved: 22.03.2016
16.09.2016 -Linköping Per Rosenberg 26.09.2016 -Sahlgrenska Maria Dimoula 16.09.2016 (web-based)
On site monitoring visit pending-
Uppsala Hanna Dahlstrand 16.09.2016 (web-based)On-site monitoring visit: 11.11.2016 (Planned)
-
US MGH Michael Birrer (NC) • Hard copies were submitted by GSO to FDA and were received the 09.09.2016.
• Re-submission to FDA done 20.09.2016.• The 16.09.2016 Myriad submitted the risk
determination letter and the acknowledgement letter to FDA. It was received on 19.09.2016.
• Reply with comments received from FDA on05.10.2016.The IND was clinically reviewed and following a response were send to FDA to answer their criticisms. Currently waiting for a response from FDA.
TBD -Huntsman Cancer Institute
Theresa Werner TBD -
Total 8
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)
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
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
OX40 + Durvalumab Coordinating Group
(days: 29 – PD) SGCTG
OX40 + CTLA4 Coordinating Group
(days: 29 – PD) PMHC
Tre
atm
ent
un
til
dis
eas
e
pro
gre
ssio
n
NSGO-OV-UMB1: A Phase 2 Umbrella Trial in Recurrent Ovarian Cancer
CT, blood, serum
samples
Simon 2-stage design for each
cohort
CD73 + Durvalumab Coordinating Group
(days: 29 – PD) NSGO
biopsyDay: < 0
Re
lap
sed
ova
rian
can
cer
CD73(days: 0 – 28)
biopsyDay: 56
Days: 0 28 56 140
Cohort C
OX40(days: 0 – 28)
Cohort B
Cohort A
OX40(days: 0 – 28)
CT, blood, serum
samples
CT, blood, serum
samples
biopsyDay: 28