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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
Stage IIIC participants with CC0 resection if they meet the following criteria: Aggregate >=5 cm extra-pelvic disease during PDS as assessed by the investigator All participants with inoperable Stage III disease.
Participants must be female, >=18 years of age, able to understand the study procedures, and agree to participate in the study by providing written informed consent.
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

FIRST Trial 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.

FIRST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My cancer was Stage IIIC and removed completely, but had spread outside the pelvis over 5 cm.
I am a woman, 18 or older, and agree to participate in the study.
I have advanced ovarian, fallopian tube, or peritoneal cancer.
I have Stage IV cancer, regardless of my treatment plan.
I have Stage III cancer and meet specific study requirements.
I will provide a blood sample for a specific DNA test.
I can provide a tissue sample for cancer testing.
I am postmenopausal, sterilized, or will avoid pregnancy during and 180 days after the study.
My blood counts and organ functions are within the required ranges for the trial.
I am fully active or restricted in physically strenuous activity but can do light work.
My blood pressure is normal or well-controlled with treatment.
I can take medicine by mouth.

FIRST Trial 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

Awards & Highlights

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

FIRST 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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Standard of care
Completed Phase 4
Completed Phase 4

Find a Location

Who is running the clinical trial?

Tesaro, Inc.Lead Sponsor
56 Previous Clinical Trials
9,148 Total Patients Enrolled
4 Trials studying Ovarian Cancer
732 Patients Enrolled for Ovarian Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
35 Previous Clinical Trials
15,237 Total Patients Enrolled
10 Trials studying Ovarian Cancer
4,791 Patients Enrolled for Ovarian Cancer
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,592 Previous Clinical Trials
6,136,791 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+dostarlimab+niraparib, Participants receiving SOC+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

Frequently Asked Questions

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

Could you please list other investigations that have included Niraparib?

"Niraparib is being researched in 112 different trials, with 14 of them being Phase 3. The locations for these studies are widespread, with 3147 sites running Niraparib trials."

Answered by AI

Are people still being recruited for this experiment?

"This particular study, which was last updated on 8/31/2022, is not looking for new patients at this time. However, based on the data from clinicaltrials.gov, there are 814 other open studies that are currently recruiting."

Answered by AI

In how many different medical institutions is this research project being conducted presently?

"Presently, this trial is recruiting patients from 74 sites. These locations include Dallas, Paoli, New Orleans as well other cities. It may be helpful to select the clinic nearest you to minimize travel if you enroll in the study."

Answered by AI

How many people are a part of this experiment?

"8/31/2022 was the date of the most recent update to this clinical trial's information on clinicaltrials.gov, which means that this study is no longer actively recruiting patients. There are presently 702 studies actively searching for participants with ovary cancer and 112 trials for Niraparib actively recruiting patients."

Answered by AI

Why was this research project undertaken?

"The aim of this trial, which will take place over the course of 5 years, is to assess PFS in PD-L1 positive patients. Additionally, investigators will also evaluate change from baseline in quality of life (QOL) scores as measured by the EORTC-QLQ Ovarian cancer Module OV28 assessment tool among PD-L1 positive participants. Lastly, researchers will track pCR rate and ORR among all participants enrolled in the study."

Answered by AI

What are the most severe side effects of taking Niraparib?

"Niraparib's safety is well supported by both efficacy data from Phase 3 trials as well as multiple rounds of safety testing, so it received a score of 3."

Answered by AI

What is the primary use of Niraparib?

"Niraparib is used as a treatment for primary peritoneal cancer. In addition, it can be administered to patients with advanced endometrial cancer who have progressed during or following platinum-based chemotherapy and those suffering from fallopian tube cancer."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
New Jersey
How many prior treatments have patients received?

Why did patients apply to this trial?

Sometimes Cancer responds to a different approach.
PatientReceived no prior treatments
~22 spots leftby Mar 2024