Randomized phase 3 trial evaluating niraparib plus dostarlimab vs chemotherapy at physician's choice in the treatment of recurrent ovarian, fallopian tube or primary peritoneal cancer patients for which platinum is not an option
Randomized phase 3 trial evaluating niraparib plus dostarlimab vs chemotherapy at physician's choice in the treatment of recurrent ovarian, fallopian tube or primary peritoneal cancer patients for which platinum is not an option. The patients must have received no more than 2 previous chemotherapy lines. Stratification factors will include HRD status, previous treatment with parp and anti PD-1/PDL-1 inhibitors, Bevacizumab treatment and PDL1 expression. Patients will continue to receive niraparib until disease progression (determined using RECIST v.1.1 criteria and clinical criteria), unacceptable toxicity, death, withdrawal of consent, or lost to follow-up, whichever comes first. Patients will continue to receive dostarlimab for a maximum of 2 years, or until disease progression (determined using RECIST v1.1 criteria and clinical criteria), unacceptable toxicity, death, withdrawal of consent, lost to follow-up, whichever may come first. Dose interruption and/or reduction may be implemented at any time for any grade toxicity considered intolerable by the patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
427
Azienda Ospedaliera Spedali Civili
Brescia, Italy
RECRUITINGIstituto Tumori della Romagna IRST IRCCS
Meldola, Italy
RECRUITINGIEO-Istituto Europeo di Oncologia
Milan, Italy
Overall Survival
The length of time from tfrom the date of randomization to the date of death by any cause
Time frame: 4 years
Progression free survival
the length of time from the date of randomization to the earlier date of assessment of progression or death by any cause in the absence of progression.
Time frame: 4 years
Time to first subsequent therapy
The length of the time interval from the date of randomization to earliest date of fist subsequent therapy or death
Time frame: 4 years
Response rate
the percentage of patients with CR or PR, as assessed by RECIST (Response Evaluation Criteria on Solid Tumor) v.1.1 criteria evaluated by the investigator.
Time frame: 4 years
Number and type of adverse events
Safety and tolerability of patients receiving chemotherapy or dostarlimab plus niraparib evaluated according to CTCAE vers 5.0.
Time frame: 4 years
Patient-reported outcomes for physical well-being
quality of life of patients, in terms of physical well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) QLQ C30 (Quality of life Questionnaires C30). "1" is the minimum score and is the better outcome, "4" is the maximum score and is the worse outcome.
Time frame: 4 years
Patient-reported outcomes for physical well-being
quality of life of patients, in terms of physical well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) QLQ OV28 (Quality of life Questionnaires OV28). "1" is the minimum score and is the better outcome, "4" is the maximum score and is the worse outcome.
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Chemotherapy drug
Chemotherapy drug
Chemotherapy drug
Chemotherapy drug
IRCCS Ospedale San Raffaele
Milan, Italy
RECRUITINGIstituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, Italy
RECRUITINGNuovo Ospedale degli Infermi
Ponderano, Italy
RECRUITINGFondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
RECRUITINGIstituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena
Rome, Italy
RECRUITINGTime frame: 4 years
Patient-reported outcomes for physical well-being
quality of life of patients, in terms of physical well-being, evaluated using EQ-5DL (EURO-QOL). "0" is the minimum score and is the worse outcome, "100" is the maximum score and is the better outcome.
Time frame: 4 years
Patient-reported outcomes for social/family well-being
quality of life of patients, in terms of social/family well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) QLQ C30 (Quality of life Questionnaires C30). "1" is the minimum score and is the better outcome, "4" is the maximum score and is the worse outcome.
Time frame: 4 years
Patient-reported outcomes for social/family well-being
quality of life of patients, in terms of social/family well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) QLQ OV28 (Quality of life Questionnaires OV28). "1" is the minimum score and is the better outcome, "4" is the maximum score and is the worse outcome.
Time frame: 4 years
Patient-reported outcomes for social/family well-being
quality of life of patients, in terms of social/family well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) EQ-5DL (EURO-QOL). "0" is the minimum score and is the worse outcome, "100" is the maximum score and is the better outcome.
Time frame: 4 years
Patient-reported outcomes for emotional well-being
quality of life of patients, in terms of emotional well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) QLQ C30 (Quality of life Questionnaires C30). "1" is the minimum score and is the better outcome, "4" is the maximum score and is the worse outcome.
Time frame: 4 years
Patient-reported outcomes for emotional well-being
quality of life of patients, in terms of emotional well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) QLQ OV28 (Quality of life Questionnaires OV28). "1" is the minimum score and is the better outcome, "4" is the maximum score and is the worse outcome.
Time frame: 4 years
Patient-reported outcomes for emotional well-being
quality of life of patients, in terms of emotional well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) EQ-5DL (EURO-QOL). "0" is the minimum score and is the worse outcome, "100" is the maximum score and is the better outcome.
Time frame: 4 years