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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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 belowSelect...
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.
FIRST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreFIRST 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
~15850
Niraparib
2018
Completed Phase 4
~1540
Find a Location
Who is running the clinical trial?
Tesaro, Inc.Lead Sponsor
56 Previous Clinical Trials
9,154 Total Patients Enrolled
4 Trials studying Ovarian Cancer
732 Patients Enrolled for Ovarian Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
36 Previous Clinical Trials
15,837 Total Patients Enrolled
11 Trials studying Ovarian Cancer
5,391 Patients Enrolled for Ovarian Cancer
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,142,528 Total Patients Enrolled
3 Trials studying Ovarian Cancer
662 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have active hepatitis B or C.I can provide a specific tissue sample for cancer testing.I have Stage IV cancer and may have surgery or chemotherapy planned.My cancer is of a specific type (mucinous, germ cell, transitional cell, or undifferentiated).My ovarian cancer is at an early stage (low-grade or Grade 1).I am still recovering from a recent major surgery.I have a high risk of bleeding due to recent major surgery or a history of significant bleeding.My immune system is weak.I have advanced ovarian, fallopian tube, or peritoneal cancer.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I am a woman, 18 or older, and agree to participate in the study.I can provide a tissue sample for cancer testing.If you could have a baby, you need to have a negative pregnancy test within 3 days before starting the study treatment.I am postmenopausal, sterilized, or will avoid pregnancy during and 180 days after the study.I have cancer that has spread to my brain or spinal cord.I have a serious heart condition.I have a blockage in my intestines or other serious abdominal issues.I have a history or current diagnosis of MDS or AML.I have not received a live vaccine within the last 14 days.I can take medicine by mouth.I have Stage IV cancer, regardless of my treatment plan.I have Stage III cancer and meet specific study requirements.I was treated for cancer less than 5 years ago and finished certain cancer therapies recently.I am allergic or react badly to certain cancer drugs or their ingredients.I have had treatment for advanced ovarian, fallopian tube, or peritoneal cancer.I had a non-invasive cancer like skin or cervical cancer that was successfully treated.I have a serious health condition that is not under control.I have an autoimmune disease treated with medication in the last 2 years, not including hormone replacements.I will provide a blood sample for a specific DNA test.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.My cancer was Stage IIIC and removed completely, but had spread outside the pelvis over 5 cm.I am a Stage III cancer patient scheduled for chemotherapy before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Participants receiving SOC+niraparib
- Group 2: Participants receiving SOC+dostarlimab+niraparib
- Group 3: Participants receiving SOC+placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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?
1
Why did patients apply to this trial?
Sometimes Cancer responds to a different approach.
PatientReceived no prior treatments
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