A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy

NCT02655016 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 3 other identifiers: 213359PR-30-5017-C2023-508010-42
• Study Type: interventional
• Target: 733
• Locations: 14 countries
• Sites: 116

Brief Summary

This study aims to assess efficacy of Niraparib (GSK3985771) as maintenance treatment in participants with Stage III or IV ovarian cancer. Participants must have completed front-line platinum based regimen with complete response (CR) or partial response (PR). Data collection for Secondary Outcome measures is ongoing and the approximate duration of the study will be 7 years.

Conditions

Ovarian Neoplasms

Keywords

Ovarian Cancer; Niraparib; GSK3985771; Poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP)Inhibitor; Homologous recombination deficiency (HRD); HRD positive; PRIMA; PRIMA Clinical Trial; PRIMA Study

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  Progression free survival was defined as the time from the date of treatment randomization to the date of first documentation of disease progression or death due to any cause in the absence of documented progression, whichever occurs first. It was assessed by the blinded independent central review (BICR). Median and 95% confidence interval (CI) are presented.

  Up to 34 months

Secondary Outcomes (10)

• Overall Survival

  Up to 34 months

• Time to First Subsequent Therapy (TFST)

  Up to 34 months

• Progression-Free Survival-2 (PFS2)

  Up to 34 months

• Change From Baseline in Participant Reported Outcome (PRO): Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI)

  Baseline (Day 1, Pre-dose) and Up to Week 24

• Change From Baseline in PRO: European Quality of Life Scale, 5-dimensions, 5-levels of Severity (EQ-5D-5L) Utility Score

  Baseline (Day 1, Pre-dose) and Up to Week 24

Other Outcomes (4)

• Number of Participants With Any Non-serious Adverse Event (Non-SAE) or Any SAE

  Up to 34 months

• Area Under the Curve (AUC) From 0 to the Last Quantifiable Concentration (AUC[0-last])

  Up to 34 months

• Peak Plasma Concentration (Cmax)

  Up to 34 months

Study Arms (2)

Participants receiving Niraparib

EXPERIMENTAL

Drug: Niraparib

Participants receiving Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Niraparib DRUG

Niraparib will be administered.

Participants receiving Niraparib

Placebo DRUG

Placebo will be administered.

Participants receiving Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically diagnosed high-grade serous or endometrioid, or high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that is Stage III or IV according to Federation Internationale de Gynécologie et d'Obstétrique (FIGO) criteria.
• Participants with inoperable Stage III and IV disease; All Stage IV participants with operable disease; Participants with stage III or IV disease treated with neoadjuvant chemotherapy and interval debulking surgery; and Participants with stage III disease who have visible residual disease after primary debulking surgery.
• Participants who have received intraperitoneal chemotherapy; All participants must have had more than or equal to (\>=)6 and less than or equal to (\<=)9 cycles of platinum-based therapy; Participants must have had \>=2 post-operative cycles of platinum-based therapy following interval debulking surgery; Participants must have physician assessed Complete response (CR) or Partial response (PR) after \>=3 cycles of therapy; and Participants must have either Cancer antigen 125 (CA-125) in the normal range or CA-125 decrease by more than 90 percent(%) during their front-line therapy that is stable for at least 7 days (no increase more than (\>)15% from nadir).
• Participants must be randomized within 12 weeks of the first day of the last cycle of chemotherapy.
• All participants must agree to undergo central tumor HRD testing.
• Participants of childbearing potential must have a negative serum or urine pregnancy test (beta human chorionic gonadotropin \[hCG\]) within 7 days prior to receiving the first dose of study treatment.

You may not qualify if:

• Participant has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer.
• Participants with Stage III disease who have had complete cytoreduction (no visible residual disease) after primary debulking surgery.
• Participant has undergone more than two debulking surgeries for the study disease.
• Participant is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for up to 180 days after the last dose of study treatment.
• Participant has a known hypersensitivity to the components of niraparib or its excipients.
• Participant has received prior treatment with a known PARP inhibitor or has participated in a study where any treatment arm included administration of a known PARP inhibitor.
• Participant is to receive bevacizumab as maintenance treatment.
• Participant has had investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.
• Participant has had any known \>=Grade 3 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \>4 weeks.
• Participant has a condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results or interfere with the participation for the full duration of the study treatment, including:
• Participant received a transfusion (platelets or red blood cells) within 2 weeks of the first dose of study treatment.
• Participant received colony-stimulating factors (e.g., granulocyte colony stimulating factor \[G-CSF\], granulocyte macrophage colony-stimulating factor \[GM-CSF\] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment.
• Participant has been diagnosed and/or treated for invasive cancer less than 5 years prior to study enrollment.

Sponsors & Collaborators

• European Network of Gynaecological Oncological Trial Groups (ENGOT): collaborator
• Tesaro, Inc.: lead
• Gynecologic Oncology Group: collaborator
• Myriad Genetics, Inc.: collaborator

Study Sites (116)

GSK Investigational Site

Tempe, Arizona, 85284, United States

Location

GSK Investigational Site

Tucson, Arizona, 85710, United States

Location

GSK Investigational Site

Tucson, Arizona, 85724, United States

Location

GSK Investigational Site

San Francisco, California, 94115, United States

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GSK Investigational Site

San Francisco, California, 94118, United States

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GSK Investigational Site

Santa Rosa, California, 95403, United States

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GSK Investigational Site

New Haven, Connecticut, 06510, United States

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GSK Investigational Site

Jacksonville, Florida, 32224, United States

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GSK Investigational Site

Miami, Florida, 33136, United States

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GSK Investigational Site

Atlanta, Georgia, 30342, United States

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GSK Investigational Site

Savannah, Georgia, 31404, United States

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GSK Investigational Site

Geneva, Illinois, 60555, United States

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GSK Investigational Site

Indianapolis, Indiana, 46237, United States

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GSK Investigational Site

Indianapolis, Indiana, 46260, United States

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GSK Investigational Site

Iowa City, Iowa, 52242, United States

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GSK Investigational Site

Covington, Louisiana, 70433, United States

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GSK Investigational Site

New Orleans, Louisiana, 70121, United States

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GSK Investigational Site

Baltimore, Maryland, 21215-5271, United States

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GSK Investigational Site

Rockville, Maryland, 20910, United States

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GSK Investigational Site

Burlington, Massachusetts, 01805, United States

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GSK Investigational Site

Grand Rapids, Michigan, 49503, United States

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GSK Investigational Site

Minneapolis, Minnesota, 55433, United States

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GSK Investigational Site

Springfield, Missouri, 97477, United States

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GSK Investigational Site

Neptune City, New Jersey, 07753, United States

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GSK Investigational Site

Harrison, New York, 10604, United States

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GSK Investigational Site

Mineola, New York, 11501, United States

Location

GSK Investigational Site

New York, New York, 10016, United States

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GSK Investigational Site

Rochester, New York, 14620, United States

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GSK Investigational Site

Chapel Hill, North Carolina, 27599-7570, United States

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GSK Investigational Site

Wilmington, North Carolina, 28401, United States

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GSK Investigational Site

Columbus, Ohio, 43210, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73104, United States

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GSK Investigational Site

Tulsa, Oklahoma, 74146, United States

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GSK Investigational Site

Portland, Oregon, 97210, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19104, United States

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GSK Investigational Site

Willow Grove, Pennsylvania, 19090, United States

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GSK Investigational Site

Providence, Rhode Island, 02905, United States

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GSK Investigational Site

Charleston, South Carolina, 29425, United States

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Sioux Falls, South Dakota, 57105, United States

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GSK Investigational Site

Fort Worth, Texas, 76104, United States

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GSK Investigational Site

The Woodlands, Texas, 77380, United States

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GSK Investigational Site

Tyler, Texas, 75701, United States

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GSK Investigational Site

Salt Lake City, Utah, 84112, United States

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GSK Investigational Site

Kennewick, Washington, 99336, United States

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GSK Investigational Site

Seattle, Washington, 98104, United States

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GSK Investigational Site

Spokane, Washington, 99202, United States

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GSK Investigational Site

Milwaukee, Wisconsin, 53226, United States

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GSK Investigational Site

Bonheiden, 2820, Belgium

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GSK Investigational Site

Brussels, 1000, Belgium

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GSK Investigational Site

Brussels, 1200, Belgium

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GSK Investigational Site

Ghent, 9000, Belgium

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GSK Investigational Site

Hasselt, 3500, Belgium

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GSK Investigational Site

Leuven, 3000, Belgium

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GSK Investigational Site

Libramont, 6800, Belgium

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GSK Investigational Site

Namur, 5000, Belgium

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GSK Investigational Site

Aalborg, 9000, Denmark

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GSK Investigational Site

Copenhagen, 2100, Denmark

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GSK Investigational Site

Herlev, 2730, Denmark

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GSK Investigational Site

Odense C, 5000, Denmark

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GSK Investigational Site

Kuopio, 70210, Finland

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GSK Investigational Site

Oulu, 90029, Finland

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GSK Investigational Site

Tampere, 33521, Finland

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GSK Investigational Site

Turku, 20520, Finland

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GSK Investigational Site

Angers, 49000, France

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Aachen, 52074, Germany

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GSK Investigational Site

Berlin, 13353, Germany

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GSK Investigational Site

Essen, 45136, Germany

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GSK Investigational Site

Fürth, 90766, Germany

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Göttingen, 37075, Germany

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Heidelberg, 69120, Germany

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Hildesheim, 31134, Germany

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GSK Investigational Site

Mannheim, 68167, Germany

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München, 81377, Germany

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GSK Investigational Site

Dublin, 8, Ireland

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Dunmore RoadWaterford, Ireland

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Galway, H91 YR71, Ireland

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Haifa, 38100, Israel

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GSK Investigational Site

Ramat Gan, 52621, Israel

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GSK Investigational Site

Tel Aviv, 64239, Israel

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GSK Investigational Site

Lecce, 73100, Italy

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GSK Investigational Site

Milan, 20132, Italy

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GSK Investigational Site

Milan, 20133, Italy

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GSK Investigational Site

Modena, 41100, Italy

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GSK Investigational Site

Naples, 80131, Italy

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GSK Investigational Site

Oslo, 0310, Norway

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GSK Investigational Site

Badalona, 08916, Spain

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GSK Investigational Site

Barcelona, 08003, Spain

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GSK Investigational Site

Barcelona, 08036, Spain

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GSK Investigational Site

Barcelona, 08907, Spain

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GSK Investigational Site

Barcelona, 8035, Spain

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GSK Investigational Site

Córdoba, 14004, Spain

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GSK Investigational Site

Donostia / San Sebastian, 20014, Spain

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GSK Investigational Site

Elche Alicante, 03203, Spain

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GSK Investigational Site

Girona, 17007, Spain

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GSK Investigational Site

Madrid, 28033, Spain

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GSK Investigational Site

Madrid, 28041, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Seville, 41013, Spain

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GSK Investigational Site

Seville, 41014, Spain

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GSK Investigational Site

Valencia, 46009, Spain

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GSK Investigational Site

Valencia, 46010, Spain

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GSK Investigational Site

Zaragoza, 50009, Spain

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GSK Investigational Site

Stockholm, SE-171 76, Sweden

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GSK Investigational Site

Uppsala, SE-751 85, Sweden

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GSK Investigational Site

Basel, 4031, Switzerland

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GSK Investigational Site

Bern, 3010, Switzerland

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GSK Investigational Site

Frauenfeld, 8501, Switzerland

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GSK Investigational Site

Zurich, 8091, Switzerland

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GSK Investigational Site

Blackburn, BB2 3HH, United Kingdom

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GSK Investigational Site

Edinburgh, G12 0YN, United Kingdom

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GSK Investigational Site

Exeter, EX2 5DW, United Kingdom

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GSK Investigational Site

Glasgow, G12 0YN, United Kingdom

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GSK Investigational Site

London, W12 0HS, United Kingdom

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GSK Investigational Site

Portsmouth, PO6 3LY, United Kingdom

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GSK Investigational Site

Sheffield, S10 2SJ, United Kingdom

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GSK Investigational Site

Truro, TR1 3LJ, United Kingdom

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Related Publications (11)

• Monk BJ, Barretina-Ginesta MP, Pothuri B, Vergote I, Graybill W, Mirza MR, McCormick CC, Lorusso D, Moore RG, Freyer G, O'Cearbhaill RE, Heitz F, O'Malley DM, Redondo A, Shahin MS, Vulsteke C, Bradley WH, Haslund CA, Chase DM, Pisano C, Holman LL, Perez MJR, DiSilvestro P, Gaba L, Herzog TJ, Bruchim I, Compton N, Shtessel L, Malinowska IA, Gonzalez-Martin A. Niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer: final overall survival results from the PRIMA/ENGOT-OV26/GOG-3012 trial. Ann Oncol. 2024 Nov;35(11):981-992. doi: 10.1016/j.annonc.2024.08.2241. Epub 2024 Sep 14.

  PMID: 39284381 BACKGROUND

• Monk BJ, Romero I, Graybill W, Churruca C, O'Malley DM, Knudsen AO, Yap OWS, Baurain JF, Rose PG, Denys H, Ghamande S, Pisano C, Fabbro M, Braicu EI, Calvert PM, Amit A, Prendergast E, Taylor A, Kheibarshekan L, Zhang ZY, Zajic S, Jewell RC, Gupta D, Gonzalez-Martin A. Niraparib Population Pharmacokinetics and Exposure-Response Relationships in Patients With Newly Diagnosed Advanced Ovarian Cancer. Clin Ther. 2024 Aug;46(8):612-621. doi: 10.1016/j.clinthera.2024.06.001. Epub 2024 Jul 16.

  PMID: 39019698 DERIVED

• Vulsteke C, Chambers SK, Perez MJR, Chan JK, Raaschou-Jensen N, Zhuo Y, Lorusso D, Herzog TJ, de la Motte Rouge T, Thomes Pepin JA, Braicu EI, Chen LM, Levy T, Barter JF, Pilar Barretina-Ginesta M, Joosens E, York W, Malinowska IA, Gonzalez-Martin A, Monk BJ. Tolerability of the niraparib individualized starting dose in the PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib first-line maintenance therapy. Eur J Cancer. 2024 Sep;208:114157. doi: 10.1016/j.ejca.2024.114157. Epub 2024 Jun 10.

  PMID: 39013265 DERIVED

• Graybill WS, Pardo Burdalo B, O'Malley DM, Vergote I, Monk BJ, Auranen A, Copeland LJ, Sabbatini R, Herzog TJ, Follana P, Pothuri B, Braicu EI, McCormick C, Yubero A, Moore RG, Vuylsteke P, Raaschou-Jensen N, York W, Hartman J, Gonzalez-Martin A. Predictors of long-term progression-free survival in patients with ovarian cancer treated with niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study. Int J Gynecol Cancer. 2024 Jul 1;34(7):1041-1050. doi: 10.1136/ijgc-2024-005356.

  PMID: 38950925 DERIVED

• Valabrega G, Pothuri B, Oaknin A, Graybill WS, Sanchez AB, McCormick C, Baurain JF, Tinker AV, Denys H, O'Cearbhaill RE, Hietanen S, Moore RG, Knudsen AO, de La Motte Rouge T, Heitz F, Levy T, York W, Gupta D, Monk BJ, Gonzalez-Martin A. Efficacy and safety of niraparib in patients aged 65 years and older with advanced ovarian cancer: Results from the PRIMA/ENGOT-OV26/GOG-3012 trial. Gynecol Oncol. 2024 Aug;187:128-138. doi: 10.1016/j.ygyno.2024.03.009. Epub 2024 Jun 3.

  PMID: 38833992 DERIVED

• Gonzalez-Martin A, Pothuri B, Vergote I, Graybill W, Lorusso D, McCormick CC, Freyer G, Backes F, Heitz F, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Malinowska IA, Shtessel L, Compton N, Mirza MR, Monk BJ. Progression-free survival and safety at 3.5 years of follow-up: results from the randomized phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer - a plain language summary. Future Oncol. 2024;20(22):1531-1544. doi: 10.2217/fon-2023-0782. Epub 2024 Mar 19.

  PMID: 38501262 DERIVED

• Pothuri B, Han S, Chase DM, Heitz F, Burger RA, Gaba L, Van Le L, Guerra E, Bender D, Korach J, Cloven N, Churruca C, Follana P, DiSilvestro P, Baurain JF, Jardon K, Pisano C, Peen U, Maenpaa J, Gupta D, Bacque E, Li Y, Compton N, Antonova J, Monk BJ, Gonzalez-Martin A. Health-related quality of life in patients with newly diagnosed advanced ovarian cancer treated with niraparib vs placebo: Results from the phase 3 randomized PRIMA/ENGOT-OV26/GOG-3012 trial. Gynecol Oncol. 2024 May;184:168-177. doi: 10.1016/j.ygyno.2024.01.021. Epub 2024 Feb 6.

  PMID: 38325276 DERIVED

• Gonzalez-Martin A, Pothuri B, Vergote I, Graybill W, Lorusso D, McCormick CC, Freyer G, Backes F, Heitz F, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Malinowska IA, Shtessel L, Compton N, Mirza MR, Monk BJ. Progression-free survival and safety at 3.5years of follow-up: results from the randomised phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer. Eur J Cancer. 2023 Aug;189:112908. doi: 10.1016/j.ejca.2023.04.024. Epub 2023 May 3.

  PMID: 37263896 DERIVED

• Barretina-Ginesta MP, Monk BJ, Han S, Pothuri B, Auranen A, Chase DM, Lorusso D, Anderson C, Abadie-Lacourtoisie S, Cloven N, Braicu EI, Amit A, Redondo A, Shah R, Kebede N, Hawkes C, Gupta D, Woodward T, O'Malley DM, Gonzalez-Martin A. Quality-adjusted time without symptoms of disease or toxicity and quality-adjusted progression-free survival with niraparib maintenance in first-line ovarian cancer in the PRIMA trial. Ther Adv Med Oncol. 2022 Sep 22;14:17588359221126149. doi: 10.1177/17588359221126149. eCollection 2022.

  PMID: 36172173 DERIVED

• O'Cearbhaill RE, Perez-Fidalgo JA, Monk BJ, Tusquets I, McCormick C, Fuentes J, Moore RG, Vulsteke C, Shahin MS, Forget F, Bradley WH, Hietanen S, O'Malley DM, Dorum A, Slomovitz BM, Baumann K, Selle F, Calvert PM, Artioli G, Levy T, Kumar A, Malinowska IA, Li Y, Gupta D, Gonzalez-Martin A. Efficacy of niraparib by time of surgery and postoperative residual disease status: A post hoc analysis of patients in the PRIMA/ENGOT-OV26/GOG-3012 study. Gynecol Oncol. 2022 Jul;166(1):36-43. doi: 10.1016/j.ygyno.2022.04.012. Epub 2022 May 9.

  PMID: 35550709 DERIVED

• Gonzalez-Martin A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR, McCormick C, Lorusso D, Hoskins P, Freyer G, Baumann K, Jardon K, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Lund B, Backes F, Barretina-Ginesta P, Haggerty AF, Rubio-Perez MJ, Shahin MS, Mangili G, Bradley WH, Bruchim I, Sun K, Malinowska IA, Li Y, Gupta D, Monk BJ; PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. 2019 Dec 19;381(25):2391-2402. doi: 10.1056/NEJMoa1910962. Epub 2019 Sep 28.

  PMID: 31562799 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: January 13, 2016
• Study Start: July 11, 2016
• Primary Completion: May 17, 2019
• Study Completion: May 29, 2026
• Last Updated: March 10, 2026
• Results First Posted: June 11, 2020

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (47); IL (3); FI (4); SE (2); NO (1); DK (4); DE (9); IT (5); BE (8); ES (17); CH (4); GB (8); FR (1); IE (3)