Clinical Trial Report

Sponsored by NewLink Genetics Corporation, the main objective of this study is to determine the safety and clinical response rate of the administration of ipilimumab with or without HyperAcute ^® Melanoma (HAM) immunotherapy for patients with stage IV, metastatic melanoma.

Despite the best clinical efforts and breakthroughs in biotechnology, most patients diagnosed with advanced stage melanoma continue to die from their disease. Resistance to one type of chemotherapy often rapidly leads to resistance to many other chemotherapy drugs. These major causes of cancer progression are usually discussed when considering treatment options for patients with a disease that continues to grow and spread. However, another important part of the body should also be considered – the immune system. This human clinical trial proposes a new way to make the immune system recognize the cancer cells, and encourages it to attack and destroy them.

Patients who have known stage IV, metastatic melanoma who have known stage IV, metastatic melanoma are given 4 injections of ipilimumab 3 weeks apart x 4 injections with or without HAM immunotherapy. The investigators hypothesize that compared with the use of ipilimumab alone, this form of combinatorial immunotherapy will result in tumor stabilization or shrinkage, as well as a significant prolongation of progressionfree, disease-free, or overall survival.

Across the USA, Skin of Color (SOC) clinics have been established with the goal of providing medical care and supporting research related to patients with skin of color. There have been no formal studies evaluating why patients seek medical care at SOC clinics, or treatment outcomes. Reasons may include past experiences with other providers, the perception that providers working in these clinics have a special interest or knowledge in caring for patients with skin of color, the expectation of cultural sensitivity, the hope that their provider may have a similar ethnic background, and/or ease of communication with their provider. Through focus group discussions, the study aims to identify the factors influencing a patient's choice to seek medical care at a SOC clinic and to gain insight into the presence and impact of racial concordance between provider and patient. The current study will focus on self-identified African American patients, with an interest in conducting similar sessions with patients of other ethnicities and races in the future.

Transcripts of focus group discussions will be transcribed and then analyzed via a “long-hand” inductive approach by 2 dermatologists and 1 psychologist. For each of the 8 posed focus group questions, the reviewers will independently induce a common thematic response.

This is a multi-center, open-label, non-comparative safety and efficacy study with 52 weeks of treatment on the face and trunk for acne vulgaris. Its purpose is to determine the safety and efficacy of CD5789 50 μg/g cream in the longterm treatment of subjects with acne vulgaris. Efficacy will be evaluated as a secondary objective. Assessment of local tolerability and adverse events will be assessed at each visit in a timeframe of up to 52 weeks.

To be included in the study, the subject must have a facial acne severity grade of IGA grade 3 (moderate) and a minimum of 20 inflammatory lesions and 25 non-inflammatory lesions at screening and baseline visits. Alternatively, he/she must