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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)
Must not have
Pure sarcomas or borderline tumors or mucinous tumors
Active second malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been newly diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer.
Select...
I've had surgery to remove my ovaries and part of the lining of my abdomen.
Select...
I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer is a type of sarcoma, borderline tumor, or mucinous tumor.
Select...
I have another type of cancer that is currently active.
Select...
I am currently taking more than 10 mg of prednisone daily or other immunosuppressive drugs.
Select...
I have lung scarring or inflammation.
Select...
I have brain metastases.
Select...
I have only had the initial platinum treatment for my ovarian cancer.
Select...
I have an autoimmune disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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
9%
Mucosal inflammation
9%
Influenza
9%
Depression
9%
Stomatitis
9%
Erythema
8%
Neutrophil count decreased
8%
Hypercholesterolaemia
8%
Anxiety
8%
Dry mouth
8%
Weight decreased
7%
Myalgia
7%
Oropharyngeal pain
7%
White blood cell count decreased
6%
Gastrooesophageal reflux disease
6%
Influenza like illness
6%
Hot flush
6%
Neck pain
6%
Pain in extremity
6%
Blood alkaline phosphatase increased
5%
Muscle spasms
5%
Sinusitis
5%
Combined Anemia and/or low hemoglobin
1%
General physical health deterioration
1%
Incarcerated hernia
1%
Intestinal obstruction
1%
Sepsis
1%
Muscular weakness
1%
Combined Thrombocytopenia and/or low platelets
1%
Osteoarthritis
1%
Gastrointestinal pain
1%
Pulmonary embolism
1%
Febrile neutropenia
1%
Pancytopenia
1%
Small intestinal obstruction
1%
Dehydration
1%
Combined Netropenia and/or low ANC
1%
Malignant melanoma
1%
Malignant neoplasm progression
1%
Myelodysplastic syndrome
1%
Seizure
1%
Acute kidney injury
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rucaparib 600 mg Tablets
Placebo Tablets

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
Nivolumab
2015
Completed Phase 3
~4010
Rucaparib
2016
Completed Phase 3
~2020
Placebo IV Infusion
2011
Completed Phase 1
~40
Placebo Oral Tablet
2020
Completed Phase 4
~2490

Find a Location

Who is running the clinical trial?

ppharmaand GmbHLead Sponsor
11 Previous Clinical Trials
763 Total Patients Enrolled
pharmaand GmbHLead Sponsor
21 Previous Clinical Trials
3,174 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,691 Previous Clinical Trials
4,096,588 Total Patients Enrolled
Gynecologic Oncology GroupNETWORK
250 Previous Clinical Trials
64,181 Total Patients Enrolled
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
39 Previous Clinical Trials
17,206 Total Patients Enrolled
Foundation MedicineIndustry Sponsor
32 Previous Clinical Trials
15,238 Total Patients Enrolled
Clovis Oncology, Inc.Lead Sponsor
64 Previous Clinical Trials
10,031 Total Patients Enrolled
zr Pharma & GmbHLead Sponsor
20 Previous Clinical Trials
3,091 Total Patients Enrolled
Keiichi Fujiwara, MD, PhDPrincipal InvestigatorLead Investigator for Asia
2 Previous Clinical Trials
710 Total Patients Enrolled
Bradley Monk, MD, FACS, FACOGPrincipal InvestigatorLead Investigator and Coordinating Investigator for North America

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
~132 spots leftby Dec 2025
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