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NCT02259231 · ClinicalTrials.gov registry record · Phase 1
RTA 408 Capsules in Patients With Melanoma - REVEAL
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT02259231 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 41 participants.
The verdict
NCT02259231, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
Malignant melanoma is a leading cause of death from cutaneous malignancies, accounting for approximately three-fourths of all skin cancer deaths. For metastatic or unresectable melanomas, standard treatment options include immune checkpoint inhibitors (e.g., ipilimumab and nivolumab) and other therapies, however, approved therapies are rarely curative. It is now well accepted that tumors are able to evade detection and eradication by the immune system, even though many tumor types, particularly melanoma, are capable of eliciting a strong immune response (Swann, 2007). Substantial mechanistic work in recent years has revealed the key role of myeloid-derived suppressor cells (MDSCs) in masking cancer cells from the immune system, promoting both tumor progression and resistance to cancer immunotherapy. The immune-suppressive effect of MDSCs is dependent on the production of reactive oxygen species (ROS) and reactive nitrogen species (RNS). High levels of these reactive molecules and their by-products, such as nitrotyrosine, have been correlated with poor clinical outcomes in melanoma. Currently available melanoma therapies do not target MDSCs. In animals, RTA 408 significantly reduces tumor nitrotyrosine burden, inhibits the activity of MDSCs, and augments T-cell anticancer activity at relevant doses. Thus, through inhibition of MDSC activity and suppression of tumor ROS/RNS, RTA 408 may work in combination with T-cell-activating therapeutics such as ipilimumab to enhance the natural immune anticancer response. RTA 408 also has direct anticancer effects via inhibition of NF-kappa B. Chronic activation of NF-kappa B is associated with tumor progression, metastasis, and resistance to therapy. This proposed study is designed to assess the safety, efficacy, pharmacodynamics, and pharmacokinetics of omaveloxolone (RTA 408) in combination with ipilimumab or nivolumab in patients with unresectable or metastatic melanoma. In this open-label, multicenter, dose-escalation, P
Interventions
- DRUG Omaveloxolone Capsules (2.5 mg/capsule)
- DRUG Ipilimumab (3 mg/kg)
- DRUG Nivolumab (240 mg)
- DRUG Omaveloxolone Capsules (10 mg/capsule)
- DRUG Omaveloxolone Capsules (50 mg/capsule)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2014-10-31 |
| Est. Completion | 2018-07-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02259231
The ClinicalTrials.gov registry entry for NCT02259231 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Omaveloxolone Capsules (2.5 mg/capsule) is the first listed.
NCT02259231 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02259231 about?
NCT02259231 is a clinical study titled "RTA 408 Capsules in Patients With Melanoma - REVEAL". Malignant melanoma is a leading cause of death from cutaneous malignancies, accounting for approximately three-fourths of all skin cancer deaths. For metastatic or unresectable melanomas, standard treatment options include immune checkpoint inhibitors (e.g., ipilimumab and nivolumab) and other thera...
What is the current status of trial NCT02259231?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2014-10-31. Estimated completion is 2018-07-23.
What interventions are being tested in trial NCT02259231?
The interventions under investigation include: Omaveloxolone Capsules (2.5 mg/capsule) (DRUG), Ipilimumab (3 mg/kg) (DRUG), Nivolumab (240 mg) (DRUG), Omaveloxolone Capsules (10 mg/capsule) (DRUG), Omaveloxolone Capsules (50 mg/capsule) (DRUG).
Who is sponsoring clinical trial NCT02259231?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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