The FIRST Study
Research type
Research Study
Full title
A RANDOMIZED, DOUBLE-BLIND, PHASE 3 COMPARISON OF PLATINUM-BASED THERAPY WITH TSR 042 AND NIRAPARIB VERSUS STANDARD OF CARE PLATINUM-BASED THERAPY AS FIRST LINE TREATMENT OF STAGE III OR IV NONMUCINOUS EPITHELIAL OVARIAN CANCER
IRAS ID
247849
Contact name
Rosalind Glasspool
Contact email
Eudract number
2018-000413-20
Clinicaltrials.gov Identifier
126,472, IND Number
Duration of Study in the UK
3 years, 4 months, 1 days
Research summary
Ovarian cancer is the fifth overall cause for cancer death in women, representing 5% of all cancer deaths in women. The current standard of care (SOC) for the first-line treatment of Stage III or IV ovarian cancer is paclitaxel and carboplatin, with or without bevacizumab. This study is being conducted to determine if adding the investigational medications , TSR-042 and niraparib, to SOC delays or prevents ovarian cancer recurrence.
TSR-042 is an investigational medication that belongs to a class of drugs called PD-1 inhibitors that use the body’s own immune system to treat cancer (immuno-therapy). It is given through an intravenous infusion (IV) into the veins. Niraparib belongs to a class of drugs called PARP inhibitors that prevent cancer cells from growing. It is a pill that is taken by mouth. Niraparib has been found to delay the time to progression when given as maintenance therapy after response to platinum chemotherapy for relapsed disease. In this study, the use of niraparib is investigational because it is not yet approved for use in frontline treatment of ovarian cancer.
Up to 960 participants will take part in this study, which will be conducted in multiple countries worldwide.
There are three treatment periods in this study: the first one is the chemotherapy run-in period (cycle 1) during which all participants will receive SOC; the second one is the chemotherapy treatment period. Before the second cycle of chemotherapy, participants will be randomly assigned to one of 3 treatment groups at a randomisation ratio of 1:1:2. The last treatment period is the maintenance treatment period.
It is not known how long participation in this study may last. Niraparib and TSR-042 may be given as maintenance for up to 3 years, or as per other specified circumstances in the study protocol.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/1538
Date of REC Opinion
1 Nov 2018
REC opinion
Further Information Favourable Opinion