CC-122 for Melanoma

Phase-Based Estimates
1
Effectiveness
2
Safety
H Lee Moffitt Cancer Center and Research Institute, Tampa, FL
Melanoma
CC-122 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Melanoma

Study Summary

This study is evaluating whether a combination of CC-122 and Nivolumab will enhance the anti-cancer activity and prevent T-cell exhaustion.

See full description

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

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.

Up to 36 months
Overall Survival
Up to 52 weeks
Number of Participants who Experience Treatment Related Adverse Events
Objective Response Rate of CC-122 in combination with Nivolumab
Progression Free Survival
Tumor Response

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Control
CC-122 Plus Nivolumab

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.

CC-122 Plus NivolumabParticipants will take CC-122 orally at 2mg daily for 5 consecutive days every 7 days, with intravenous nivolumab (240mg) in days 1 and 15 within a 28-day cycle.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avadomide
Not yet FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 36 months for reporting.

Closest Location

H Lee Moffitt Cancer Center and Research Institute - Tampa, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Melanoma. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Unresectable or metastatic melanoma of cutaneous, mucosal, conjunctival, or unknown origin. Uveal melanoma is not permitted. Cohort 1: Naïve to anti-PD1 therapy Cohort 2: Progressed on previous anti-PD1 therapy. Subjects who have received anti-PD1 therapy in the adjuvant setting for previously resected melanoma are eligible for this cohort provided they have not received any intervening systemic therapy for the relapse
Be willing and able to provide written informed consent for the trial.
Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Females of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication.
Females of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study 28 days after last dose of avadomide or 5 months after the last dose of nivolumab, whichever is longer. Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >1 year.
Males should agree to use an adequate method of contraception starting with the first dose of study therapy through 3 months after the last dose of avadomide or 7 months after last dose of nivolumab, whichever is longer.
Adequate organ function

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for melanoma?

Add answer

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.

Unverified Answer

What are the signs of melanoma?

Add answer

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.

Unverified Answer

What is melanoma?

Add answer

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.

Unverified Answer

Can melanoma be cured?

Add answer

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.

Unverified Answer

How many people get melanoma a year in the United States?

Add answer

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.

Unverified Answer

What causes melanoma?

Add answer

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.

Unverified Answer

What is cc-122?

Add answer

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.

Unverified Answer

How quickly does melanoma spread?

Add answer

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.

Unverified Answer

What is the primary cause of melanoma?

Add answer

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.

Unverified Answer

Who should consider clinical trials for melanoma?

Add answer

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.

Unverified Answer

Does melanoma run in families?

Add answer

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.

Unverified Answer

What are the chances of developing melanoma?

Add answer

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.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Melanoma by sharing your contact details with the study coordinator.