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JOURNAL ONKOLOGIE – STUDIE
DUO-E

Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

Rekrutierend

NCT-Nummer:
NCT04269200

Studienbeginn:
Mai 2020

Letztes Update:
08.07.2021

Wirkstoff:
Olaparib, Durvalumab, Durvalumab placebo, olaparib placebo, Carboplatin, Paclitaxel

Indikation (Clinical Trials):
Endometrial Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
The Gynecologic Oncology Group (GOG) Foundation Inc, The European Network for Gynaecological Oncological Trial groups (ENGOT),

Studienleiter

Shannon N. Westin, MD, MPH, FACOG
Principal Investigator
The University of Texas MD Anderson Cancer Center

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com
» Kontaktdaten anzeigen

Studienlocations
(3 von 240)

Research Site
13125 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
13353 Berlin
(Berlin)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
53127 Bonn
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
09116 Chemnitz
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
01307 Dresden
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
65929 Frankfurt am Main
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
76133 Karlsruhe
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
78464 Konstanz
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Research Site
4103 Leipzig
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
85719 Tucson
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
60005 Arlington Heights
United StatesRekrutierend» Google-Maps
Research Site
03756 Lebanon
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
97239-3011 Portland
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
77030 Houston
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
2560 Campbelltown
AustraliaNoch nicht rekrutierend» Google-Maps
Research Site
30130-090 Belo Horizonte
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
30150-274 Belo Horizonte
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
80520-174 Curitiba
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
99010-080 Passo Fundo
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
90020-090 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
90035-003 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
90110-270 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
20231-050 Rio de Janeiro
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
01246-000 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
01317-001 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
15090-000 São José do Rio Preto
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
G7H 5H6 Chicoutimi
CanadaNoch nicht rekrutierend» Google-Maps
Research Site
760043 Teusaquillo
ColombiaNoch nicht rekrutierend» Google-Maps
Research Site
50612 Gyeongsangnam-do
Korea, Republic ofRekrutierend» Google-Maps
Research Site
20116 Aguascalientes
MexicoNoch nicht rekrutierend» Google-Maps
Research Site
01120 Ciudad de Mexico
MexicoNoch nicht rekrutierend» Google-Maps
Research Site
78200 San Luis Potosi
MexicoNoch nicht rekrutierend» Google-Maps
Research Site
454087 Chelyabinsk
Russian FederationRekrutierend» Google-Maps
Research Site
420029 Kazan, Tatarstan
Russian FederationNoch nicht rekrutierend» Google-Maps
Research Site
115682 Moskva
Russian FederationNoch nicht rekrutierend» Google-Maps
Research Site
197341 St Petersburg
Russian FederationRekrutierend» Google-Maps
Research Site
198255 St. Petersburg
Russian FederationRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

This Phase III study will assess the efficacy and safety of durvalumab in combination with

platinum-based chemotherapy (paclitaxel + carboplatin) followed by maintenance durvalumab

with or without olaparib for patients with newly diagnosed advanced or recurrent endometrial

cancer.

Target patient population: Adult female patients with histologically confirmed diagnosis of

epithelial endometrial carcinoma (excluding sarcomas): newly diagnosed Stage III, newly

diagnosed Stage IV, or recurrent endometrial cancer

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age ≥18 years at the time of screening and female.

- Histologically confirmed diagnosis of epithelial endometrial carcinoma. All

histologies, including carcinosarcomas, will be allowed. Sarcomas will not be allowed.

- Patient must have endometrial cancer in one of the following categories:

1. Newly diagnosed Stage III disease (measurable disease per RECIST 1.1 following

surgery or diagnostic biopsy),

2. Newly diagnosed Stage IV disease (with or without disease following surgery or

diagnostic biopsy)

3. Recurrence of disease where the potential for cure by surgery alone or in

combination is poor.

- Naïve to first line systemic anti-cancer treatment. For patients with recurrent

disease only, prior chemotherapy is allowed only if it was administered in the

adjuvant setting and there is at least 12 months from date of last dose of

chemotherapy administered to date of subsequent relapse

- FPPE tumor sample must be available for MMR evaluation.

- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7

days of starting study treatment.

Exclusion Criteria:

- History of leptomeningeal carcinomatosis.

- Brain metastases or spinal cord compression.

- Prior treatment with PARP inhibitors.

- Prior immune checkpoint inhibitors or prior treatment with an agent directed to a

stimulatory or co-inhibitor T-cell receptor other than anti-PD-1, anti-PD-L1, or anti-PD-L2

agent.

Studien-Rationale

Primary outcome:

1. Progression Free Survival (PFS) (Time Frame - upto to 4 years):
Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)



Secondary outcome:

1. Overall Survival (OS) (Time Frame - Up to 6 years):
Defined as the time from randomisation to death due to any cause

2. Second Progression (PFS2) (Time Frame - Up to 6 years):
Defined as time from randomisation to the earliest of the progression event subsequent to first subsequent therapy or death

3. Objective Response Rate (ORR) (Time Frame - Up to 4 years):
Objective response rate is defined as the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR) as determined by the Investigator at local site.

4. Duration of response (DoR) (Time Frame - Up to 4 years):
Defined as the time from the date of first documented confirmed response (CR/PR) until the first progression or death in the absence of disease progression

5. Time to first subsequent therapy (TFST) (Time Frame - Up to 6 years):
Time elapsed from randomisation to first subsequent therapy or death

6. Time to second subsequent therapy (TSST) (Time Frame - Up to 6 years):
Time elapsed from randomisation to second subsequent therapy or death

7. Time to discontinuation or death (TDT) (Time Frame - Up to 6 years):
Time elapsed from randomisation to study treatment discontinuation or death

8. The pharmacokinetics (PK) of durvalumab will be determined after steady state doses (Time Frame - Up to 4 years):
Determination of durvalumab concentration in serum

9. Safety and tolerability of drugs by assessment of AEs/SAEs (Time Frame - Up to 6 years):
Graded according to the National Cancer Institute (NCI CTCAE)

10. The immunogenicity of durvalumab as determined by concentration of Anti-drug antibodies (ADA) to durvalumab (Time Frame - Up to 4 years):
Determination concentration of Anti-drug antibodies (ADA) to durvalumab in serum

Studien-Arme

  • Active Comparator: Arm A (control)
    Platinum-based chemotherapy and durvalumab placebo followed by maintenance durvalumab placebo and olaparib placebo (tablets).
  • Experimental: Arm B (durvalumab+placebo)
    Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib placebo
  • Experimental: Arm C (durvalumab+olaparib)
    Platinum-based chemotherapy and durvalumab followed by maintenance durvalumab and olaparib.

Geprüfte Regime

  • olaparib:
    Olaparib tablets
  • durvalumab:
    Durvalumab by intravenous infusion
  • durvalumab placebo:
    Matching placebo for intravenous infusion
  • olaparib placebo:
    Placebo tablets to match olaparib
  • Carboplatin:
    Standard of care chemotherapy
  • Paclitaxel:
    Standard of care chemotherapy

Quelle: ClinicalTrials.gov


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