JOURNAL ONKOLOGIE – STUDIE
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:
25.03.2021
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
Principal Investigator
The University of Texas MD Anderson Cancer Center
Kontakt
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com» Kontaktdaten anzeigen
Studienlocations
(3 von 212)
13125 Berlin
(Berlin)
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13353 Berlin
(Berlin)
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53127 Bonn
(Nordrhein-Westfalen)
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09116 Chemnitz
(Sachsen)
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01307 Dresden
(Sachsen)
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65929 Frankfurt am Main
(Hessen)
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76133 Karlsruhe
(Baden-Württemberg)
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78464 Konstanz
(Baden-Württemberg)
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4103 Leipzig
(Sachsen)
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94520-2278 Concord
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92093 La Jolla
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90806 Long Beach
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94158 San Francisco
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93105 Santa Barbara
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80012 Aurora
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33316 Fort Lauderdale
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32610-3003 Gainesville
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33612 Tampa
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31404 Savannah
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96826 Honolulu
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60005-2355 Arlington Heights
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60612 Chicago
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60637 Chicago
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60521 Hinsdale
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46237 Indianapolis
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07666 Teaneck
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8000 Bruges
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1200 Bruxelles
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6000 Charleroi
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9000 Gent
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30130-090 Belo Horizonte
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1131 Tallinn
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124 62 Chaidari
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Tun Mun
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1062 Budapest
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903-0215 Nakagami-gun
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951-8520 Niigata-shi
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637086 Osaka
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160-8582 Shinjuku-ku
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10408 Goyang-si
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50612 Gyeongsangnam-do
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01812 Seoul
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06351 Seoul
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06591 Seoul
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138-736 Seoul
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443380 Suwon
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08661 Vilnius
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8660 Vilnius
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20116 Aguascalientes
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01120 Ciudad de Mexico
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34000 Durango
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44600 Guadalajara
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76090 Queretaro
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78200 San Luis Potosi
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91910 Veracruz
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80-214 Gdansk
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10-228 Olsztyn
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10-560 Olsztyn
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93-513 Łódź
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361350 Anzorey
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454087 Chelyabinsk
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420029 Kazan, Tatarstan
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350040 Krasnodar
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115682 Moskva
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430032 Saransk
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354000 Sochi
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197341 St Petersburg
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198255 St. Petersburg
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119228 Singapore
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169610 Singapore
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258499 Singapore
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329563 Singapore
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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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