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A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

NCT03522246

Description:

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
  • Official Title: ATHENA (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)

Clinical Trial IDs

  • ORG STUDY ID: CO-338-087/GOG-3020/ENGOT-ov45
  • NCT ID: NCT03522246

Conditions

  • Epithelial Ovarian Cancer
  • Primary Peritoneal
  • Fallopian Tube Cancer
  • Newly Diagnosed
  • FIGO Stage III-IV
  • Partial Response
  • Complete Response

Interventions

DrugSynonymsArms
RucaparibRubraca, CO-338Arm A
NivolumabOpdivo, BMS-936558Arm A
Placebo Oral TabletArm C
Placebo IV InfusionArm B

Purpose

This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentaloral rucaparib + intravenous (IV) nivolumab
  • Rucaparib
  • Nivolumab
Arm BExperimentaloral rucaparib+IV placebo
  • Rucaparib
  • Placebo IV Infusion
Arm CExperimentaloral placebo+ IV nivolumab
  • Nivolumab
  • Placebo Oral Tablet
Arm DPlacebo ComparatorOral placebo + IV placebo
  • Placebo Oral Tablet
  • Placebo IV Infusion

Eligibility Criteria

        Inclusion Criteria:

          -  Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or
             primary peritoneal cancer.

          -  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)

          -  Completed first-line platinum-based chemotherapy and surgery with a response, in the
             opinion of the Investigator

          -  Sufficient tumor tissue for planned analysis

          -  ECOG performance status of 0 or 1

        Exclusion Criteria:

          -  Pure sarcomas or borderline tumors or mucinous tumors

          -  Active second malignancy

          -  Known central nervous system brain metastases

          -  Any prior treatment for ovarian cancer, other than the first-line platinum regimen

          -  Evidence of interstitial lung disease or active pneumonitis

          -  Active, known or suspected autoimmune disease

          -  Condition requiring active systemic treatment with either corticosteroids (>10 mg
             daily prednisone equivalent) or other immunosuppressive medications
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Investigator assessed Progression-free survival (PFS)
Time Frame:From randomization until disease progression (up to approximately 7 years)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Blinded independent central review (BICR) PFS
Time Frame:Every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:From enrollment to primary study completion of study (up to approximately 10 years)
Safety Issue:
Description:
Measure:Objective response rate (ORR)
Time Frame:For patients with measurable disease, every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years
Safety Issue:
Description:
Measure:Duration of response (DOR)
Time Frame:For patients with measurable disease, every ~12 weeks after the start of combination treatment for ~3 years, then every ~24 weeks thereafter until disease progression. Study data collection expected to last for ~7 years
Safety Issue:
Description:
Measure:Number of participants with treatment-emergent Adverse Events (AEs) as assessed by CTCAE v4 (or higher) as a measure of safety and tolerability
Time Frame:Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years)
Safety Issue:
Description:
Measure:Number of participants with serious AEs as a measure of safety and tolerability
Time Frame:Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years)
Safety Issue:
Description:
Measure:Number of participants with laboratory abnormalities as a measure of safety and tolerability
Time Frame:Collected from the time patient receives first dose of study drug until post treatment safety follow-up period (up to approximately 10 years)
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Clovis Oncology, Inc.

Trial Keywords

  • PARP inhibitor
  • PARPi
  • HRD
  • ATHENA
  • homologous recombination
  • DNA repair
  • LOH
  • DNA defect
  • DNA anomaly
  • Rucaparib
  • Nivolumab
  • PD-1
  • Immuno-
  • oncology
  • Tumor
  • mutational
  • burden
  • BRCA
  • First-line
  • Primary Therapy
  • Primary Treatment

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