Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

All Drugs and Chemicals

Antineoplastic Agents

Herbal and Botanical

Antibodies

Antibodies, Monoclonal

Paclitaxel

Carboplatin

Bevacizumab

Niraparib

Albumin-Bound Paclitaxel

Angiogenesis Inhibitors

Immunoglobulins

Endothelial Growth Factors

Mitogens

Immunoglobulins, Intravenous

Taxane

Myeloma Proteins

Paraproteins

Poly(ADP-ribose) Polymerase Inhibitors

Dostarlimab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Growth Inhibitors

Enzyme Inhibitors

Cola

PARP Inhibitor-Naive Platinum-Resistant Ovarian Cancer Treatment Cohort with TSR-042, Bevacizumab, and Niraparib. TSR-042 administered 500 milligrams (mg) on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning on Cycle 5 Day 1 until progressive disease (PD) or toxicity. Bevacizumab administered 15 milligram per kilogram (mg/kg) every 3 weeks for up to 15 months. Niraparib 200 or 300 mg per day until PD or toxicity.

Participants are expected to receive 1 run-in cycle (up to 5 weeks) of carboplatin-paclitaxel during pre-screening. After confirmation that the tumor is homologous recombination-deficient (HRd). Participants will then be randomized to three 21-day cycles of platinum-taxane doublet chemotherapy (carboplatin plus paclitaxane). After interval debulking surgery (IDS), all participants will receive up to three 21-day cycles of adjuvant platinum-taxane doublet chemotherapy (and optional bevacizumab for participants deemed high-risk; third cycle is optional) followed by niraparib (and optional bevacizumab or bevacizumab biosimilar for participants deemed high- risk) maintenance treatment.

Participants are expected to receive 1 run-in cycle (up to 5 weeks) of carboplatin-paclitaxel during pre-screening. After confirmation that the tumor is HRd, participants will be randomized to three 21-day cycles of neoadjuvant niraparib therapy. After IDS, all participants will receive up to three 21-day cycles of adjuvant platinum-taxane doublet chemotherapy (and optional bevacizumab for participants deemed high-risk; third cycle is optional) followed by niraparib (and optional bevacizumab or bevacizumab biosimilar for participants deemed high- risk) maintenance treatment.

Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for participants with tumors that harbor defects in the homologous recombination deoxyribonucleic acid (DNA) repair pathway or that are driven by PARP-mediated transcription factors.

TSR-042 is a humanized monoclonal antibody that binds with high affinity to Programmed cell death protein 1 (PD-1) resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2).

TSR-042

Bevacizumab is an Food Drug and Administration (FDA) approved antiangiogenic recombinant humanized monoclonal Immunoglobulin (Ig) G1 antibody against the vascular endothelial growth factor protein, which has been shown to be efficacious against a variety of different cancer types, including colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma.

Carboplatin will be infused intravenously over 60 minutes at the prescribed dose of area under the concentration versus time curve of 5 to 6 mg/milliliters (mL) per minute on Day 1 of every 21-day cycle

Paclitaxel will be administered intravenously over 180 minutes at the prescribed dose of 175 mg/meter square (m\^2) on Day 1 of every 21-day cycle

US GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Center

EU GSK Clinical Trials Call Centre

Gottfried Konecny

John Chan

John Moroney

Leslie Bradford

Joyce Liu

Andrea Wahner-Hendrickson

Kathleen Moore

Luis Rojas

Fernanda Musa

Johanne Weberpals

Amit M. Oza

Diane Provencher

Xing Zeng

María Quindos Varela

Antonio González Martín

Lucía González Cortijo

Raúl Márquez Vázquez

Arancha Barquín García

Ana Godoy Ortiz

Nuria Lainez Milagro

GSK Clinical Trials

This study will evaluate the efficacy and safety of niraparib and novel treatment combinations of niraparib as described within each cohort-specific supplement in participants with ovarian, fallopian tube, or primary peritoneal cancer. Cohort A (single arm) includes participants with recurrent ovarian cancer. Cohort B will not be initiated. Cohort C (randomized-2 arms) includes participants with newly diagnosed ovarian cancer.

A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer

A Phase 1B/2 Multicohort Umbrella Study to Evaluate the Safety and Efficacy of Novel Treatments And/Or Combinations of Treatments in Participants With Ovarian Cancer (OPAL)

Objective Response Rate is defined as percentage of participants who have achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on investigator assessment.

ORR is defined as the percentage of participants with unconfirmed complete or partial response on study treatment pre-IDS as assessed per RECIST v1.1 by the investigator.

PFS is defined as the time from the date of the first dose of study treatment to the earliest date of assessment of progression or death by any cause in the absence of progression by RECIST version 1.1.

OS is defined as the time from the date of the first dose of study treatment to the date of death by any cause.

DOR is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 based on Investigator's assessment or death by any cause.

DCR is defined as the percentage of participants who have achieved best overall response of CR, PR, or stable disease (SD) per RECIST version 1.1 based on Investigator's assessment.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

Serum samples will be collected to determine CA-125 progression by Gynecological Cancer InterGroup (GCIG) CA-125 response criteria.

PFS is defined as the time from the date of treatment randomization to the date of first documentation of progression of disease (PD) per RECIST v1.1 or death by any cause, whichever occurs first, as determined by the investigator.

PFS12 is defined as the percentage of participants without documented PD per RECIST v1.1 or death within 12 months after the date of treatment randomization.

PFS18 is defined as the percentage of participants without documented PD per RECIST v1.1 or death within 18 months after the date of treatment randomization.

PFS24 is defined as the percentage of participants without documented PD per RECIST v1.1 or death within 24 months after the date of treatment randomization.

OS will be defined as the time from the date of treatment randomization to the date of death by any cause.

TFST will be defined as the time from the date of treatment randomization to the date of first subsequent anticancer therapy or death.

Spots Global Cancer Trial Database for A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer

Trial Identification

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Interventions

Study Description

Keywords

Eligibility

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Contact Details

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