NLG2107 P2/3 Study in Adults with Unresectable Stage III/IV Melanoma
Research type
Research Study
Full title
A Phase 2/3 (Adaptive Design) Study of the Concomitant Administration of Indoximod or Placebo plus Pembrolizumab or Nivolumab in Adult Patients with Unresectable Stage III or Stage IV Malignant Melanoma
IRAS ID
236691
Contact name
Sophie Papa
Contact email
Sponsor organisation
NewLink Genetics Corporation
Eudract number
2017-003634-93
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND # 135,600, IND Number
Duration of Study in the UK
7 years, 1 months, 1 days
Research summary
The purpose of this study is to determine the effects (good and/or bad) of immune checkpoint inhibitors with the addition of indoximod (the experimental study drug) to find out if the combination is possibly better than the checkpoint inhibitor alone. The immune checkpoint inhibitors in this study are drugs called nivolumab and pembrolizumab.
Indoximod treatment is experimental at this time, which means that this drug is not yet approved and therefore not available outside studies like this. The checkpoint inhibitors are intravenous (IV; into your vein) drugs that are approved in multiple countries including the UK, for the treatment of metastatic melanoma which occurs when cancer spreads from a skin tumour to other parts of the body.
The experimental drug indoximod is intended to block the ability of cancer cells to escape detection and destruction by the immune system. Cancer cells use multiple ways to escape the immune system including an enzyme called IDO. Indoximod is intended to block cancer cells (tumours) from exploiting IDO thereby allowing the immune system to attack the cancer cells. Indoximod given along with checkpoint inhibitors may increase the effectiveness of the checkpoint inhibitors.Participation in the study will be expected until the study closes for any reason, the participant withdraws consent or passes away. It is unknown exactly how long a participant would stay on the study. The checkpoint inhibitor and indoximod/placebo treatment will continue until the participant’s disease stops responding to the treatment, the participant can no longer tolerate the study therapy or the participant no longer needs the therapy. Even if a participant stops taking study drug, he/she will be asked to continue coming to the site for follow up. Participants are also free to stop participating at any time should they wish.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/0042
Date of REC Opinion
28 Feb 2018
REC opinion
Further Information Favourable Opinion