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Rucaparib + Nivolumab for Ovarian Cancer (ATHENA Trial)

Phase 3

Waitlist Available

Led By Keiichi Fujiwara, MD, PhD

Research Sponsored by ppharmaand GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

ATHENA Trial Summary

This trial is testing whether two drugs, rucaparib and nivolumab, can help treat ovarian cancer.

Who is the study for?

This trial is for adults with advanced ovarian, fallopian tube, or primary peritoneal cancer who've had surgery and responded to first-line platinum-based chemotherapy. It's not for those with autoimmune diseases, other active cancers, brain metastases, prior treatments besides platinum chemo, lung conditions or on high-dose steroids/immunosuppressants.Check my eligibility

What is being tested?

The study tests Rucaparib and Nivolumab as maintenance treatments after initial success with chemotherapy in ovarian cancer patients. It's a Phase 3 trial where participants are randomly assigned to receive either the drugs or placebo without knowing which one they're getting.See study design

What are the potential side effects?

Rucaparib may cause nausea, fatigue, blood count changes and liver enzyme alterations. Nivolumab can lead to immune-related side effects like inflammation of organs (colitis), skin rash and potential infusion reactions.

ATHENA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been newly diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer.

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I've had surgery to remove my ovaries and part of the lining of my abdomen.

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I am fully active or can carry out light work.

ATHENA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Investigator assessed Progression-free survival (PFS)

Secondary outcome measures

Blinded independent central review (BICR) PFS

Duration of response (DOR)

Number of participants with laboratory abnormalities as a measure of safety and tolerability

+4 more

Side effects data

From 2022 Phase 3 trial • 564 Patients • NCT01968213

76%

Nausea

70%

Combined Asthenia/Fatigue

52%

Fatigue

39%

Combined Anaemia and/or decreased hemoglobin

38%

Constipation

38%

Vomiting

37%

Anaemia

35%

Diarrhoea

35%

Alanine aminotransferase increased

34%

Combined ALT/AST increased

33%

Abdominal pain

31%

Dysgeusia

29%

Combined Thrombocytopenia and/or decreased platelets

27%

Aspartate aminotransferase increased

25%

Decreased appetite

23%

Asthenia

22%

Arthralgia

20%

Headache

19%

Combined Neutropenia and/or decreased ANC

19%

Photosensitivity reaction

18%

Cough

17%

Thrombocytopenia

17%

Blood creatinine increased

16%

Dyspepsia

16%

Insomnia

16%

Dizziness

15%

Pruritus

15%

Rash

15%

Dyspnoea

15%

Abdominal pain upper

15%

Back pain

15%

Pyrexia

14%

Platelet count decreased

14%

Neutropenia

13%

Abdominal distension

13%

Upper respiratory tract infection

12%

Hypertension

12%

Oedema peripheral

12%

Hypomagnesaemia

10%

Nasopharyngitis

10%

Alopecia

10%

Taste disorder

10%

Dry skin

10%

Urinary tract infection

Mucosal inflammation

Influenza

Depression

Stomatitis

Erythema

Anxiety

Neutrophil count decreased

Hypercholesterolaemia

Dry mouth

Weight decreased

Myalgia

Oropharyngeal pain

White blood cell count decreased

Gastrooesophageal reflux disease

Influenza like illness

Hot flush

Neck pain

Pain in extremity

Blood alkaline phosphatase increased

Muscle spasms

Sinusitis

Combined Anemia and/or low hemoglobin

Incarcerated hernia

General physical health deterioration

Intestinal obstruction

Sepsis

Muscular weakness

Combined Thrombocytopenia and/or low platelets

Osteoarthritis

Gastrointestinal pain

Pulmonary embolism

Febrile neutropenia

Pancytopenia

Small intestinal obstruction

Dehydration

Combined Netropenia and/or low ANC

Malignant melanoma

Malignant neoplasm progression

Myelodysplastic syndrome

Seizure

Acute kidney injury

Renal failure

100%

80%

60%

40%

20%

Study treatment Arm

Rucaparib 600 mg Tablets

Placebo Tablets

ATHENA Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm CExperimental Treatment2 Interventions

oral placebo+ IV nivolumab

Group II: Arm BExperimental Treatment2 Interventions

oral rucaparib+IV placebo

Group III: Arm AExperimental Treatment2 Interventions

oral rucaparib + intravenous (IV) nivolumab

Group IV: Arm DPlacebo Group2 Interventions

Oral placebo + IV placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rucaparib

2016

Completed Phase 3

~1990

Nivolumab

2014

Completed Phase 3

~4750

Placebo Oral Tablet

2017

Completed Phase 4

~2250

Placebo IV Infusion

2011

Completed Phase 1

~40

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

ppharmaand GmbHLead Sponsor

11 Previous Clinical Trials

764 Total Patients Enrolled

pharmaand GmbHLead Sponsor

21 Previous Clinical Trials

3,175 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,127,514 Total Patients Enrolled

Media Library

Rucaparib Clinical Trial Eligibility Overview. Trial Name: NCT03522246 — Phase 3

Newly Diagnosed Research Study Groups: Arm A, Arm B, Arm C, Arm D

Newly Diagnosed Clinical Trial 2023: Rucaparib Highlights & Side Effects. Trial Name: NCT03522246 — Phase 3

Rucaparib 2023 Treatment Timeline for Medical Study. Trial Name: NCT03522246 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

When did Rucaparib gain FDA approval?

"There is existing clinical evidence to support the safety of Rucaparib, so it received a score of 3."

Answered by AI

What are the main illnesses that Rucaparib has been shown to be effective against?

"Rucaparib has shown to be an effective treatment for patients with aggressive cancers such as malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

How many different hospitals are participating in this study?

"If you're interested in enrolling, it's worth looking into the 78 sites that are currently recruiting patients. These locations include Tucson, Edmonton and Phoenix as well as other cities. Keep in mind that it might be less disruptive to your life if you choose a site closer to home."

Answered by AI

Are new participants still being sought for this experiment?

"The clinical trial is not recruiting patients at this time. The last update on the website was from November 3rd, 2021. Although no longer enrolling for this particular study, there are 1,371 other medical trials that are still looking for participants."

Answered by AI

Have these methods been used before in other research trials?

"Rucaparib has been researched since 2010 when the first clinical trial, sponsored by Medarex, took place. After the initial study involving 127 people, Phase 1 drug approval was received in 2010. Now, there are 773 active studies being conducted in 2398 cities and 50 countries."

Answered by AI

What else is known about Rucaparib from other research?

"Rucaparib was first studied a decade ago, in 2010, at the H. Lee Moffitt Cancer Center and Research Institute. As of now, there are 433 completed clinical trials. Additionally, there are 773 live trials with many of them taking place in Tucson, Arizona."

Answered by AI