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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 7 years

Awards & highlights

Pivotal 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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS)

Secondary study objectives

Change from Baseline in the EORTC-QLQ Ovarian Cancer Module OV28 (EORTC-QLQ-OV28) assessment

Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30) assessment

Change from Baseline in the European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) assessment

+18 more

Awards & Highlights

Pivotal Trial

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

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

2020

Completed Phase 4

~17710

Niraparib

2018

Completed Phase 4

~2400