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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
Full description
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.
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Inclusion criteria
Participant must have recurrent ovarian, Fallopian tube or primary peritoneal cancer not candidate for platinum retreatment; and in particular
Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Participants must have measurable disease or evaluable based on RECIST 1.1 (patients with only CA 125 increase without evidence of disease are not included).
Participant must be ≥ 18 years of age
Participant must have adequate organ function
Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
Participants must agree to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1.
Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen.
Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of nonchildbearing potential.
Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.
Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
427 participants in 2 patient groups
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Central trial contact
Domenica Lorusso, MD; Serena Giolitto, MSc
Data sourced from clinicaltrials.gov
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