This trial is evaluating whether CC-122 will improve 1 primary outcome and 4 secondary outcomes in patients with Melanoma. Measurement will happen over the course of Up to 52 weeks.
This trial requires 23 total participants across 2 different treatment groups
This trial involves 2 different treatments. CC-122 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
Many treatments are used to treat melanoma, but treatment is more commonly related to the aggressiveness of the condition. While no single treatment can cure melanoma, treatment focused on minimizing the progression of disease rather than the specific type of treatment can be highly effective.
Melanomas can become evident from symptoms such as pain or itchiness, or from more extensive bleeding or discharge from the eye socket. Melanomas that metastasised may not cause symptom or sign changes.
Melanoma is a highly malignant (but rarely deadly) form of skin cancer that rarely recurs but is sometimes metastatic. Melanoma may be treated by removal of the skin and lymph nodes by a specialist dermatologist; sometimes neoadjuvant chemotherapy is used. Melanomas may be detected by routine visual examination of the sun-exposed parts of the body (e.g., the upperside of the hands and forearms) and darkly pigmented parts (e.g., the buttocks). They may also be detected by clinical examination and/or a skin scrapings.
Melanoma is a heterogeneous and complex disease that is only slowly amenable to effective treatment. Although small, localized and early- stage melanomas can be cured, much of the disease is incurable.
The number of people getting nevus-like conditions is estimated to be over 15 million in the United States annually. It would be prudent to follow these suspicious lesions routinely, such as with a dermatoscopy exam and/or a shave biopsy to diagnose melanoma as early as possible, if at all possible, as people with suspicious lesions deserve the best possible chance at the time when the cancer is most curable. If a person has a family history of melanoma, then this reinforces that they must be proactive by consistently looking for melanomas early, so that they will have the best possible chance of getting the cancer diagnosed and treated before it develops into a life-threatening malignancy that can't be cured.
Melanoma is an extremely rare cancer, as it is only found in individuals with the MC1R gene variant called albinism. This variant is a genetic deficiency which causes melanocytes to produce black pigment, resulting in the skin color known as albinism. The gene mutation of the MC1R gene occurs in over 80% of melanoma patients and only a minority of individuals who live in the southern hemisphere who do not have the genetic mutation have albinism, whereas individuals with the mutation who live in the north have an extremely high incidence of melanoma. However, melanomas do develop in people without the genetic mutation. The most likely factor is exposure to the sun throughout their life.
We show that cc-122 reduces the number and size of cutaneous tumors and induces more apoptosis in cutaneous lesions which are already established at the time of immunization. Although the mechanism is not yet known with certainty, it fits with the data showing an inhibition of the growth of cutaneous tumors. This effect was also seen for tumor size reduction. Interestingly, cc-122 also led to a significant antitumor effect without altering the immune system, at very low doses. In a recent study, findings suggest that cc-122 could be a promising immunotherapeutic drug for clinical translation.
Melanomas can enlarge rapidly and spread to other areas of the body after excision. The risk of lymph node involvement appears to rise rapidly, with some subjects showing lymph node involvement within two weeks of initial therapy for the disease.
Although sunlight is recognized as the cause by many, we have more than convincing evidence that UV light may not be sufficiently important since melanoma incidence has not changed substantially even over the last 75 years. Alternative theories have been proposed that are not based upon epidemiological evidence. The most plausible possibility we find so far appears to be that ultraviolet light from sunburns is important for the prevention of some types of skin cancer. The best evidence in the literature suggests that sunburned skin is protective against the most common type of melanoma, the uveal, cutaneous, and amelanotic melanomas. Some evidence indicates more sunburns may decrease the risk of melanoma in later stages.
Most of the patients with melanoma who are eligible for melanoma clinical trials are already treated. It could take an interventional approach, such as a systematic screening followed by a biopsy of the suspicious neoplasm, to see if a diagnosis of early-stage melanoma could be made. However, due to a lack of relevant randomized trials evaluating such an approach, the evidence-based response to this type of clinical trial remains questionable. Although some trials have supported such an approach, the presence of bias (bioethics issues) and confounding (e.g., the presence of an initial misdiagnosis that allowed patients to skip the screening phase) make an outcome of these trials inconclusive.
Although our analyses should not be considered definitive because of the small number of families studied, our results are in agreement with reports from the medical literature suggesting that familial melanoma is rare, although a large proportion of families with familial melanoma also have other types of cancers.
Given all the evidence, it might be argued that there are very few circumstances in which one might expect to be diagnosed with melanoma. Thus, if this diagnosis is suggested, the initial thought should be directed to the possibility that the cancer may be under-diagnosed or mis-diagnosed at the local level and that the most likely explanation for the disease is that it has developed from the pre-existing benign melanocytic lesion. For example, a non-neoplastic melanocytic lesion with a dark-coloured, irregular border, atypical cells and mitoses could be mis-diagnosed as a lentigo, an intra-epithelial neoplasm or a dermatofibroma.