A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy (ATHENA)
Lara Maloney
pharmaand GmbH.
remote base
+81-01-303-588-5162
lara.maloney@pharmaand.com
KAGIYAMA Shoji
CMIC Co., Ltd.
Hamamatsucho Building, 1-1-1, Minato-ku, Shibaura, Tokyo
1. Have newly diagnosed, advanced (FIGO stage III-IV),high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
2. Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking).
3. Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator.
4. Have sufficient tumor tissue for planned analyses.
5. Have an ECOG performance status of 0 to 1.
1.Pure sarcomas or borderline tumors or mucinous tumors.
2.Active second malignancy
3.Known central nervous system brain metastases.
4.Any prior treatment for ovarian cancer, other than the first-line platinum regimen,
5.Evidence of interstitial lung disease, active pneumonitis,
6.Active, known or suspected autoimmune disease
7.Condition requiring active systemic treatment with either corticosteroids (more than 10 mg daily prednisone equivalent) or other immunosuppressive medications
20age old over
No limit
Female
ovarian cancer
investigational material(s)
Generic name etc : Nivolumab
INN of investigational material : Nivolumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : An open-label safety cohort:Rucaparib 600 mg is administered orally BID in combination with nivolumab (genetical recombination) 480 mg with IV administration at 4-week cycle. Double-blind Treatment Phase:Rucaparib 600 mg is administered orally BID in combination with nivolumab (genetical recombination) 480 mg with IV administration at 4-week cycle. Arm A:Oral rucaparib+IV nivolumab. Arm B:Oral rucaparib+IV nivolumab placebo. Arm C:Oral rucaparib placebo+IV nivolumab. Arm D:Oral rucaparib placebo+IV nivolumab placebo. 28 days (1 cycle).In addition, in consideration of ensuring the safety of subjects, the clinical trial will be conducted with a standard for dose reduction of the oral IP.
Generic name etc : Rucaparib
INN of investigational material : Rucaparib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : An open-label safety cohort:Rucaparib 600 mg is administered orally BID in combination with nivolumab (genetical recombination) 480 mg with IV administration at 4-week cycle. Double-blind Treatment Phase:Rucaparib 600 mg is administered orally BID in combination with nivolumab (genetical recombination) 480 mg with IV administration at 4-week cycle. Arm A:Oral rucaparib+IV nivolumab. Arm B:Oral rucaparib+IV nivolumab placebo. Arm C:Oral rucaparib placebo+IV nivolumab. Arm D:Oral rucaparib placebo+IV nivolumab placebo. 28 days (1 cycle).In addition, in consideration of ensuring the safety of subjects, the clinical trial will be conducted with a standard for dose reduction of the oral IP.
control material(s)
Generic name etc : placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Double-blind Treatment Phase:Oral Placebo is administered orally BID in combination with IV placebo administration at 4-week cycle. Arm A:Oral rucaparib+IV nivolumab Arm B:Oral rucaparib+IV placebo. Arm C:Oral placebo+IV nivolumab Arm D:Oral placebo+IV placebo.28 days (1 cycle).In addition, in consideration of ensuring the safety of subjects, the clinical trial will be conducted with a standard for dose reduction of the oral IP.
safety
efficacy
1.PFS by RECIST, as assessed by the Blinded Independent central review (BICR), in molecularly-defined HRD subgroups
2.Overall Survival (OS)
3.Objective response rate (ORR) and Duration of response (DOR), as assessed by the investigator, in patients with measurable disease at baseline
4.Number of participants with treatment-emergent Adverse events (AEs) as assessed by CTCAE v4 (or higher) as a measure of safety and tolerability
5.Number of participants with serious AEs as a measure of safety and tolerability
6.Number of participants with laboratory abnormalities as a measure of safety and tolerability
pharmaand GmbH/ CMIC Co., Ltd.
ONO PHARMACEUTICAL CO., LTD./ Bristol-myers squibb
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Nippon Medical School Musashikosugi Hospital Institutional Review Board
