Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Melanoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

RTA 408 capsules, beginning dose 2.5 mg once daily, 28-day cycle, up to 12 cycles. Doses will increase by 100% of previous dose (e.g., 5 mg, 10 mg, 20 mg, etc.) until such time the Protocol Safety Review Committee decreases the escalation rate to 50% of the previous dose (e.g., 20 mg, 30 mg, 45 mg, etc). Dose escalation will continue until Maximum Tolerated Dose is identified.

omaveloxolone

This proposed first-in-human study (408-C-1303) is designed to assess the safety, maximum tolerated dose, pharmacodynamics, and pharmacokinetics of omaveloxolone (RTA 408) in patients with advanced solid tumors that are refractory after standard of care therapy for the disease. The results of this study will help provide clinical information for the design and conduct of further clinical studies with RTA 408 in cancer patients.

Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER

An Open-Label, Single-Center, Dose-Escalation, Phase 1 Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RTA 408 in the Treatment of Patients With Advanced Solid Tumors

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

To determine the recommended Phase 2 dose of RTA 408 following oral administration to patients with metastatic or incurable NSCLC or melanoma that is relapsed, refractory after standard of care therapy, or for which standard of care therapy is not appropriate.

AbbVie

Reata, a wholly owned subsidiary of Biogen

Intraocular Melanoma

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Pembrolizumab

Carboplatin

Pemetrexed

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

SEA-CD40 + pembrolizumab + pemetrexed + carboplatin

Given into the vein (IV; intravenously); schedule is cohort-specific

SEA-CD40

Given by IV; schedule is cohort-specific.

pembrolizumab

Given by IV on Day 1 of each 21-day cycle.

pemetrexed

Given by IV on Day 1 of Cycles 1-4. Each cycle will be 21 days long.

carboplatin

Jonathan Hayman, MD

This trial is being done to see if an experimental drug (SEA-CD40) works when it's given with other cancer drugs to treat some types of cancer. It will also study side effects from the drug.

There are 2 parts in this trial. In one part, participants have melanoma that has come back after treatment or can't be removed by surgery. Participants in this part will get SEA-CD40 and pembrolizumab. In the other part, participants have non-small cell lung cancer (NSCLC) that has spread through their body. These participants will get SEA-CD40, pembrolizumab, carboplatin, and pemetrexed.

A Study of SEA-CD40 Given With Other Drugs in Cancers

An Open-label, Phase 2 Basket Study of SEA-CD40 Combination Therapies in Advanced Malignancies

The proportion of participants who achieve a confirmed complete response (CR) or partial (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by the investigator.

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

To be summarized using descriptive statistics

The proportion of participants who achieve a confirmed CR or PR according to RECIST v1.1 as assessed by the investigator or meet the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 5 weeks.

The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of progressive disease (PD) or death due to any cause

The time from the start of study treatment to the first documentation of PD by RECIST v1.1 or death due to any cause

The time from the start of study treatment to date of death due to any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER	NCT02029729	Metastatic or I... Relapsed, Refra...	omaveloxolone	18 Years - 75 Years	Biogen
RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER	NCT02029729	Metastatic or I... Relapsed, Refra...	omaveloxolone	18 Years - 75 Years	Biogen
A Study of SEA-CD40 Given With Other Drugs in Cancers	NCT04993677	Melanoma Carcinoma, Non-...	SEA-CD40 pembrolizumab pemetrexed carboplatin	18 Years -	Seagen Inc.
RTA 408 in the Treatment of Advanced Solid Tumors (NSCLC & Melanoma) - DISCOVER	NCT02029729	Metastatic or I... Relapsed, Refra...	omaveloxolone	18 Years - 75 Years	Biogen

Spots Global Cancer Trial Database for relapsed melanoma