Abstract 816TiP
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.
Trial design
This is a multicenter, prospective, randomized phase III trial to evaluate the efficacy and the safety of niraparib in combination with dostarlimab in recurrent ovarian, fallopian tube or primary peritoneal cancer patients for whom platinum is not an option. (Figure 1) Patients will be randomized to receive (Arm A) physician’s choice chemotherapy or (Arm B) niraparib plus dostarlimab until disease progression, intolerable toxicity, or withdrawal of patient consent. Patients randomized to physician’s choice chemotherapy will receive systemic cytotoxic chemotherapy, including gemcitabine, weekly paclitaxel, pegylated liposomal doxorubicin or topotecan. The use of antiangiogenic therapy in combination with chemotherapy is permitted. Patients randomized in the experimental arm will receive niraparib 300 mg or 200 mg if platelets count <150,000 /uL and/or body weight < 77 kg QD PO q28 and dostarlimab 500 mg every 3 weeks for 4 cycles, then 1000 mg every 6 weeks. Patients will receive dostarlimab for up 2 years in absence of disease relapse. This trial will be performed according to European Network for Gynaecological Oncological Trial groups (ENGOT) model B and patients will be recruited globally from approximately 40 sites across Multicenter Italian Trials in Ovarian Cancer Group (MITO), Central and Eastern European Gynecologic Oncology Group (CEEGOG), Group d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens (GINECO), Hellenic Cooperative Oncology Group (HeCOG), Mario Negri Gynecologic Oncology Group (MANGO) and North-Eastern German Society of Gynecologic Oncology (NOGGO).
Clinical trial identification
NCT04679064.
Editorial acknowledgement
Legal entity responsible for the study
D. Lorusso - MITO GROUP.
Funding
GSK.
Disclosure
D. Lorusso: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Advisory Role: GSK; Financial Interests, Personal, Advisory Role: Clovis-Oncology; Financial Interests, Personal, Advisory Role: Merck; Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Advisory Role: Amgen; Financial Interests, Personal, Advisory Role: Pharmamar; Financial Interests, Institutional, Research Grant: GSK; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: Tesaro; Financial Interests, Institutional, Research Grant: Merck; Financial Interests, Institutional, Research Grant: Clovis; Financial Interests, Institutional, Member of the Board of Directors: GCIG. S. Pignata: Financial Interests, Personal and Institutional, Other: GSK; Financial Interests, Personal and Institutional, Other: Roche; Financial Interests, Personal and Institutional, Other: AstraZeneca; Financial Interests, Personal and Institutional, Other: MSD; Financial Interests, Personal and Institutional, Other: Clovis; Financial Interests, Personal and Institutional, Other: Pharmamar. E.I. Braicu: Financial Interests, Funding: EU; Financial Interests, Other: BMBF; Financial Interests, Other: AstraZeneca; Financial Interests, Other: Roche Diagnostics; Financial Interests, Other: Clovis; Financial Interests, Other: Eisai; Financial Interests, Other: GSK; Financial Interests, Other: Merck; Financial Interests, Other: Seattle Genetics. D. Cibula: Financial Interests, Advisory Role: Roche; Financial Interests, Advisory Role: AstraZeneca; Financial Interests, Other: GSK; Financial Interests, Other: Merck; Financial Interests, Other: Sotio. N. Colombo: Financial Interests, Personal, Other: Pharmamar; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: MSD; Financial Interests, Personal, Other: Clovis; Financial Interests, Personal, Other: GSK; Financial Interests, Personal, Other: Novartis; Financial Interests, Personal, Other: Pfizer; Financial Interests, Personal, Other: Takeda; Financial Interests, Personal, Other: Biocad; Financial Interests, Personal, Other: Immunogen; Financial Interests, Personal, Other: Mersana; Financial Interests, Personal, Other: Eisai; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Pharmamar; Financial Interests, Institutional, Research Grant: Roche. J. Frenel: Financial Interests, Advisory Board: Novartis; Financial Interests, , Advisory Board: Pfizer; Financial Interests, Advisory Board: AstraZeneca; Financial Interests, Advisory Board: Lilly; Financial Interests, Advisory Board: Roche; Financial Interests, Advisory Board: Biocad; Financial Interests, Advisory Board: Daiichi; Financial Interests, Advisory Board: Tesaro; Financial Interests, Advisory Board: GSK; Financial Interests, Advisory Board: Pierre Fabre. F. Zagouri: Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Daiichi; Financial Interests, Personal, Advisory Board: Eli-Lilly; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: Pfizer. V. Salutari: Financial Interests, Personal, Other: Roche; Financial Interests, Personal, Other: Pharmamar; Financial Interests, Personal, Other: AstraZeneca; Financial Interests, Personal, Other: MSD; Financial Interests, Personal, Other: Clovis; Financial Interests, Personal, Other: Tesaro; Financial Interests, Personal, Other: GSK; Financial Interests, Personal, Other: Eisai. G. Scambia: Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Other: Tesaro; Financial Interests, Other: Johnson&Johnson; Financial Interests, Other: AstraZeneca. All other authors have declared no conflicts of interest.