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Monoclonal Antibodies

Platinum-based Therapy + Dostarlimab + Niraparib for Ovarian Cancer (FIRST Trial)

Phase 3
Waitlist Available
Research Sponsored by Tesaro, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with a histologically confirmed diagnosis of high-grade nonmucinous epithelial ovarian (serous, endometrioid, clear cell, carcinosarcoma, and mixed pathologies), fallopian tube, or peritoneal cancer that is Stage III or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria.
Participants must have adequate organ function: Absolute neutrophil count (ANC) >=1500/micro liter (μL;) Platelet count >=100000/μL; Hemoglobin >=9 grams per deciliter (g/dL); Serum creatinine <=1.5 × upper limit of normal (ULN) or calculated creatinine clearance >=60 milliliters per minute (mL/min) using the Cockcroft-Gault equation; total bilirubin <=1.5 × ULN or direct bilirubin <=1.5 × ULN; AST and ALT <=2.5 × ULN unless liver metastases are present, in which case they must be <=5 × ULN.
Must not have
Participant has mucinous, germ cell, transitional cell, or undifferentiated tumor.
Participant has low-grade or Grade 1 epithelial ovarian cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is designed to compare the effectiveness of the current standard of care for ovarian cancer (SOC) with or without the addition of two new potential treatments, dostarlimab and niraparib.

Who is the study for?
This trial is for women aged 18+ with advanced non-mucinous epithelial ovarian cancer (Stage III/IV). They must be postmenopausal, surgically sterilized, or use contraception. Eligible participants should have an ECOG score of 0 or 1, can take oral meds, and have normal blood pressure or controlled hypertension. They cannot join if they've had recent major surgery, uncontrolled medical issues, immunodeficiency, certain past cancers within specific time frames, active hepatitis B/C or autoimmune diseases.Check my eligibility
What is being tested?
The study compares the effectiveness of platinum-based therapy combined with TSR-042 (dostarlimab) and niraparib versus standard chemotherapy in treating ovarian cancer. It's a global Phase 3 trial focusing on progression-free survival rates. Participants will receive standard care initially before being randomly assigned to either the new drug combination or continued standard treatment.See study design
What are the potential side effects?
Potential side effects include allergic reactions to medication components like paclitaxel and carboplatin; complications from conditions such as bowel obstruction; risks associated with immunosuppression; bleeding risks due to concurrent conditions; and general side effects from chemotherapy such as fatigue, nausea, hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced ovarian, fallopian tube, or peritoneal cancer.
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My blood counts and organ functions are within the required ranges for the trial.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can take medicine by mouth.
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My cancer was Stage IIIC and removed completely, but had spread outside the pelvis over 5 cm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is of a specific type (mucinous, germ cell, transitional cell, or undifferentiated).
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My ovarian cancer is at an early stage (low-grade or Grade 1).
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I have a high risk of bleeding due to recent major surgery or a history of significant bleeding.
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My immune system is weak.
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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
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I have cancer that has spread to my brain or spinal cord.
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I have a serious heart condition.
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I have a blockage in my intestines or other serious abdominal issues.
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I have a history or current diagnosis of MDS or AML.
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I have a serious health condition that is not under control.
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I am allergic or react badly to certain cancer drugs or their ingredients.
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I have had treatment for advanced ovarian, fallopian tube, or peritoneal cancer.
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I have an autoimmune disease treated with medication in the last 2 years, not including hormone replacements.

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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PFS for PD-L1 positive participants
PFS for all participants
Secondary outcome measures
Change from Baseline in the EORTC-QLQ Ovarian Cancer Module OV28 (EORTC-QLQ-OV28) assessment among PD-L1 positive participants
Change from Baseline in the EORTC-QLQ-C30 assessment among all the participants
Change from Baseline in the EORTC-QLQ-OV28 assessment among all the participants
+48 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Participants receiving SOC+dostarlimab+niraparibExperimental Treatment3 Interventions
Participants in this arm will receive SOC in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment dostarlimab, and maintenance treatment of +/-bevacizumab with niraparib and dostarlimab.
Group II: Participants receiving SOC+niraparibActive Control3 Interventions
Participants in this arm will receive SOC in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment dostarlimab placebo from cycles 2 to 6 and maintenance treatment of +/- bevacizumab with niraparib and dostarlimab placebo.
Group III: Participants receiving SOC+placeboPlacebo Group3 Interventions
Participants in this arm will receive SOC (carboplatin+paclitaxel+/-bevacizumab) in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment with dostarlimab placebo from cycles 2 to 6 and maintenance treatment of +/-bevacizumab along with niraparib placebo and dostarlimab placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of care
2019
Completed Phase 4
~17730
Niraparib
2018
Completed Phase 4
~1540

Find a Location

Who is running the clinical trial?

Tesaro, Inc.Lead Sponsor
56 Previous Clinical Trials
9,124 Total Patients Enrolled
4 Trials studying Ovarian Cancer
732 Patients Enrolled for Ovarian Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
37 Previous Clinical Trials
16,147 Total Patients Enrolled
11 Trials studying Ovarian Cancer
5,017 Patients Enrolled for Ovarian Cancer
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,596 Previous Clinical Trials
6,142,878 Total Patients Enrolled
3 Trials studying Ovarian Cancer
662 Patients Enrolled for Ovarian Cancer

Media Library

Dostarlimab (TSR-042) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03602859 — Phase 3
Ovarian Cancer Research Study Groups: Participants receiving SOC+niraparib, Participants receiving SOC+dostarlimab+niraparib, Participants receiving SOC+placebo
Ovarian Cancer Clinical Trial 2023: Dostarlimab (TSR-042) Highlights & Side Effects. Trial Name: NCT03602859 — Phase 3
Dostarlimab (TSR-042) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03602859 — Phase 3
Ovarian Cancer Patient Testimony for trial: Trial Name: NCT03602859 — Phase 3
~39 spots leftby Oct 2024
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