-
Je něco špatně v tomto záznamu ?
Randomized phase III trial on niraparib-TSR-042 (dostarlimab) versus physician's choice chemotherapy in recurrent ovarian, fallopian tube, or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33)
L. Musacchio, V. Salutari, S. Pignata, E. Braicu, D. Cibula, N. Colombo, JS. Frenel, F. Zagouri, V. Carbone, V. Ghizzoni, S. Giolitto, E. Giudice, MT. Perri, C. Ricci, G. Scambia, D. Lorusso
Jazyk angličtina Země Velká Británie
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
NLK
ProQuest Central
od 2018-01-01 do Před 6 měsíci
Health & Medicine (ProQuest)
od 2018-01-01 do Před 6 měsíci
PubMed
34607820
DOI
10.1136/ijgc-2021-002593
Knihovny.cz E-zdroje
- MeSH
- chemorezistence MeSH
- humanizované monoklonální protilátky aplikace a dávkování MeSH
- indazoly aplikace a dávkování MeSH
- inhibitory kontrolních bodů aplikace a dávkování MeSH
- lidé MeSH
- lokální recidiva nádoru farmakoterapie MeSH
- nádory vaječníků farmakoterapie MeSH
- PARP inhibitory aplikace a dávkování MeSH
- peritoneální nádory farmakoterapie MeSH
- piperidiny aplikace a dávkování MeSH
- protokoly protinádorové kombinované chemoterapie aplikace a dávkování MeSH
- Check Tag
- lidé MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: Platinum-resistant ovarian cancer patients have a poor prognosis and few treatment options are available. Preclinical and clinical data demonstrated that the combination of poly-ADP ribose polymerase inhibitors with immune checkpoint inhibitors could have a synergistic antitumor activity in this setting of patients. PRIMARY OBJECTIVE: The primary objective is to assess the efficacy of niraparib plus dostarlimab compared with chemotherapy in recurrent ovarian cancer patients not suitable for platinum treatment. STUDY HYPOTHESIS: This trial will assess the hypothesis that niraparib plus dostarlimab therapy is effective to increase overall survival, progression-free survival, and time to first subsequent therapy respect to chemotherapy alone, with an acceptable toxicity profile. TRIAL DESIGN: This is a phase III, multicenter trial, where recurrent ovarian cancer patients not eligible for platinum re-treatment will be randomized 1:1 to receive niraparib plus dostarlimab vs physician's choice chemotherapy until disease progression, intolerable toxicity, or withdrawal of patient consent. The study will be performed according to European Network for Gynaecological Oncological Trial groups (ENGOT) model B and patients will be recruited from 40 sites across MITO, CEEGOG, GINECO, HeCOG, MANGO, and NOGGO groups. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients must have recurrent epithelial ovarian cancer not eligible for platinum retreatment. Patients who received previous treatment with poly-ADP ribose polymerase inhibitors and/or immune checkpoint inhibitors will be eligible. No more than two prior lines of treatment are allowed. PRIMARY ENDPOINT: The primary endpoint is overall survival defined as the time from the randomization to the date of death by any cause. SAMPLE SIZE: 427 patients will be randomized. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: June 2024 TRIAL REGISTRATION NUMBER: NCT04679064.
Department of Gynaecologic Oncology Charité Universitätsmedizin Berlin Berlin Germany
Department of Obstetrics and Gynaecology General University Hospital Prague Czech Republic
European Institute of Oncology IRCCS University of Milan Bicocca Milan Italy
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc22012147
- 003
- CZ-PrNML
- 005
- 20220506130527.0
- 007
- ta
- 008
- 220425s2021 xxk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1136/ijgc-2021-002593 $2 doi
- 035 __
- $a (PubMed)34607820
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxk
- 100 1_
- $a Musacchio, Lucia $u Department of Women and Child Health, Division of Gynaecologic Oncology, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS, Rome, Lazio, Italy
- 245 10
- $a Randomized phase III trial on niraparib-TSR-042 (dostarlimab) versus physician's choice chemotherapy in recurrent ovarian, fallopian tube, or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33) / $c L. Musacchio, V. Salutari, S. Pignata, E. Braicu, D. Cibula, N. Colombo, JS. Frenel, F. Zagouri, V. Carbone, V. Ghizzoni, S. Giolitto, E. Giudice, MT. Perri, C. Ricci, G. Scambia, D. Lorusso
- 520 9_
- $a BACKGROUND: Platinum-resistant ovarian cancer patients have a poor prognosis and few treatment options are available. Preclinical and clinical data demonstrated that the combination of poly-ADP ribose polymerase inhibitors with immune checkpoint inhibitors could have a synergistic antitumor activity in this setting of patients. PRIMARY OBJECTIVE: The primary objective is to assess the efficacy of niraparib plus dostarlimab compared with chemotherapy in recurrent ovarian cancer patients not suitable for platinum treatment. STUDY HYPOTHESIS: This trial will assess the hypothesis that niraparib plus dostarlimab therapy is effective to increase overall survival, progression-free survival, and time to first subsequent therapy respect to chemotherapy alone, with an acceptable toxicity profile. TRIAL DESIGN: This is a phase III, multicenter trial, where recurrent ovarian cancer patients not eligible for platinum re-treatment will be randomized 1:1 to receive niraparib plus dostarlimab vs physician's choice chemotherapy until disease progression, intolerable toxicity, or withdrawal of patient consent. The study will be performed according to European Network for Gynaecological Oncological Trial groups (ENGOT) model B and patients will be recruited from 40 sites across MITO, CEEGOG, GINECO, HeCOG, MANGO, and NOGGO groups. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients must have recurrent epithelial ovarian cancer not eligible for platinum retreatment. Patients who received previous treatment with poly-ADP ribose polymerase inhibitors and/or immune checkpoint inhibitors will be eligible. No more than two prior lines of treatment are allowed. PRIMARY ENDPOINT: The primary endpoint is overall survival defined as the time from the randomization to the date of death by any cause. SAMPLE SIZE: 427 patients will be randomized. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: June 2024 TRIAL REGISTRATION NUMBER: NCT04679064.
- 650 _2
- $a humanizované monoklonální protilátky $x aplikace a dávkování $7 D061067
- 650 _2
- $a protokoly protinádorové kombinované chemoterapie $x aplikace a dávkování $7 D000971
- 650 _2
- $a chemorezistence $7 D019008
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a inhibitory kontrolních bodů $x aplikace a dávkování $7 D000082082
- 650 _2
- $a indazoly $x aplikace a dávkování $7 D007191
- 650 _2
- $a lokální recidiva nádoru $x farmakoterapie $7 D009364
- 650 _2
- $a nádory vaječníků $x farmakoterapie $7 D010051
- 650 _2
- $a peritoneální nádory $x farmakoterapie $7 D010534
- 650 _2
- $a piperidiny $x aplikace a dávkování $7 D010880
- 650 _2
- $a PARP inhibitory $x aplikace a dávkování $7 D000067856
- 655 _2
- $a klinické zkoušky, fáze III $7 D017428
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a Salutari, Vanda $u Department of Women and Child Health, Division of Gynaecologic Oncology, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS, Rome, Lazio, Italy
- 700 1_
- $a Pignata, Sandro $u Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Naples, Italy
- 700 1_
- $a Braicu, Elena $u Department of Gynaecologic Oncology, Charité Universitätsmedizin Berlin, Berlin, Germany
- 700 1_
- $a Cibula, David $u Department of Obstetrics and Gynaecology, General University Hospital, Prague, Czech Republic
- 700 1_
- $a Colombo, Nicoletta $u Gynecologic Oncology Program; European Institute of Oncology, IRCCS, University of Milan-Bicocca, Milan, Italy
- 700 1_
- $a Frenel, Jean Sebastien $u Department of Medical Oncology, Institut de Cancerologie de l'Oust site Renè Gauducheau, Saint Herblain, France
- 700 1_
- $a Zagouri, Flora $u Oncology Unit, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece
- 700 1_
- $a Carbone, Vittoria $u Department of Women and Child Health, Division of Gynaecologic Oncology, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS, Rome, Lazio, Italy
- 700 1_
- $a Ghizzoni, Viola $u Department of Women and Child Health, Division of Gynaecologic Oncology, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS, Rome, Lazio, Italy
- 700 1_
- $a Giolitto, Serena $u Department of Women and Child Health, Division of Gynaecologic Oncology, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS, Rome, Lazio, Italy
- 700 1_
- $a Giudice, Elena $u Department of Women and Child Health, Division of Gynaecologic Oncology, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS, Rome, Lazio, Italy
- 700 1_
- $a Perri, Maria Teresa $u Department of Women and Child Health, Division of Gynaecologic Oncology, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS, Rome, Lazio, Italy
- 700 1_
- $a Ricci, Caterina $u Department of Women and Child Health, Division of Gynaecologic Oncology, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS, Rome, Lazio, Italy
- 700 1_
- $a Scambia, Giovanni $u Department of Women and Child Health, Division of Gynaecologic Oncology, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS, Rome, Lazio, Italy $u Department of Life Science and Public Health, Catholic University of Sacred Heart, Largo Agostino Gemelli, Rome, Italy
- 700 1_
- $a Lorusso, Domenica $u Department of Women and Child Health, Division of Gynaecologic Oncology, Policlinico Universitario Fondazione Agostino Gemelli, IRCCS, Rome, Lazio, Italy domenica.lorusso@policlinicogemelli.it $u Department of Life Science and Public Health, Catholic University of Sacred Heart, Largo Agostino Gemelli, Rome, Italy
- 773 0_
- $w MED00009896 $t International journal of gynecological cancer : official journal of the International Gynecological Cancer Society $x 1525-1438 $g Roč. 31, č. 10 (2021), s. 1369-1373
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/34607820 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y p $z 0
- 990 __
- $a 20220425 $b ABA008
- 991 __
- $a 20220506130519 $b ABA008
- 999 __
- $a ok $b bmc $g 1789651 $s 1163348
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2021 $b 31 $c 10 $d 1369-1373 $e - $i 1525-1438 $m International journal of gynecological cancer $n Int J Gynecol Cancer $x MED00009896
- LZP __
- $a Pubmed-20220425
