Phase 2 Randomization: 1:1:1 Switch over to ARM A n=132 Treat - - PowerPoint PPT Presentation

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Phase 2 Randomization: 1:1:1 Switch over to ARM A n=132 Treat - - PowerPoint PPT Presentation

Jul 05, 2023 241 likes •319 views

ENGOT-OV24-NSGO/AVANOVA Phase 2 Randomization: 1:1:1 Switch over to ARM A n=132 Treat to Niraparib Bevacizumab PD/toxicity 300mg OD d1-21 15mg/kg q3w Platinum- sensitive Ovarian Cancer ARM B Treat to Randomize Niraparib

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SLIDE 1

ARM A Bevacizumab 15mg/kg q3w Switch over to Niraparib 300mg OD d1-21 Investigator’s choice (without niraparib) ARM B Niraparib 300mg OD d1-21 ARM C Bevacizumab 15mg/kg q21d + Niraparib 300mg OD d1-21

Platinum- sensitive Ovarian Cancer Homologous Recombination Deficiency (HRD) positive score

Treat to PD/toxicity Randomize Treat to PD/toxicity Treat to PD/toxicity

Phase 2

Randomization: 1:1:1 n=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

Stratifications

Sponsor: NSGO Project Manager: Louisa Boufercha Statistitian: DePont Christensen PI: Mirza

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SLIDE 2

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

3

Herlev Trine Juhler-Nøttrup 30.03.2015

2

Odense 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 2016

TBD

  • 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 on

05.10.2016.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

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SLIDE 3

ARM A

Carboplatin + Paclitaxel + Nintedanib Investigator’s choice (without niraparib)

ARM B

Carboplatin + Paclitaxel + Placebo

Endometrial Cancer Stage 3

  • r

Stage 4

  • r

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: NSGO Project Manager: Kicki Jederud Statistitian: DePont Christensen PI: Mirza

slide-4
SLIDE 4

mansoor@rh.regionh.dk

GROUP NATIONAL COORDINATOR

  • No. SITES

SUBMISSION STATUS SIV performed/planned

NSGO Denmark

Mansoor Raza Mirza, Copenhagen

4

CA Approved EC Approved 3 SIVs performed

NSGO Finland

Johanna Mäenpää, Tampere

3

CA Pending EC Approved Planned Oct/Nov 2016

NSGO Norway

Gunnar Kristensen, Oslo

1

CA Approved EC Pending Planned Oct 2016

NSGO Sweden

Per Rosenberg, Linköping

4

CA Approved EC Approved Planned Oct/Nov 2016

NOGGO

Dr Jalid Sehouli, Charité Campus Virchow- Klinikum Berlin

12

CA Approved EC Approved Planned Nov 2016

BGOG

Dr Sevilay Altintas UZ Antwerpen

6

CA Submitted 30th Sep 2016 EC Submitted 4th Oct 2016

GINECO

Dr Dominique Bertron-Rigaud ICO Centre René Gauducheau Saint-Herblain

11

CA Submitted 28th Sep 2016 EC Submitted 29th 2016

Total 41

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SLIDE 5

Endometrial Cancer

Primary stage 4 or relapsed disease ER positive endometrioid adenocarcinoma

Randomize

Randomization: 1:1 N=78 ARM A Letrozole, 2.5mg d 1-28 every 28 days Placebo 125mg d 1-21 every 28 days Until progression ARM B Letrozole, 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: NSGO Project Manager: Joan Løhndorf Statistitian: DePont Christensen PI: Mirza

slide-6
SLIDE 6

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 Norway

Line Bjørge, Bergen

2

CA planned submission start November EC planned submission start November

NOGGO Germany

Jalid Sehouli, Berlin

5

CA planned submission during November EC planned submission during November

MITO Italy

Giovanni Scambia, Rome

6

CA planned submission during November EC planned submission during November

GEICO Spain

  • Dr. Cesar Mendiola, HU 12 de Octubre

5

CA planned submission during November EC planned submission during November

Total 24

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SLIDE 7

OX40 + Durvalumab

Coordinating Group

(days: 29 – PD)

SGCTG OX40 + CTLA4

Coordinating Group

(days: 29 – PD)

PMHC Treatment until disease progression NSGO-OV-UMB1: A Phase 2 Umbrella Trial in Recurrent Ovarian Cancer

mansoor@rh.regionh.dk

CT, blood, serum samples Simon 2-stage design for each cohort

CD73 + Durvalumab

Coordinating Group

(days: 29 – PD)

NSGO biopsy

Day: < 0

Relapsed ovarian cancer CD73

(days: 0 – 28)

biopsy

Day: 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

biopsy

Day: 28