Ipilimumab: Cohort 2 (Ocular) for Metastatic Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Minnesota Masonic Cancer Center, Burnsville, MN
Metastatic Melanoma+1 More
Ipilimumab: Cohort 2 (Ocular) - Drug
Eligibility
18+
All Sexes
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Study Summary

Radiation and Combination Immunotherapy for Melanoma

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Eligible Conditions

  • Metastatic Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Metastatic Melanoma

Study Objectives

This trial is evaluating whether Ipilimumab: Cohort 2 (Ocular) will improve 3 primary outcomes and 2 secondary outcomes in patients with Metastatic Melanoma. Measurement will happen over the course of 6 Month.

12 Month
Overall Survival (OS)
2 Year
Objective Response Rate (ORR)
Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of adverse events)
Safety and Tolerability of Sequential Combination Immunotherapy (Incidence of stopping rule events)
6 Month
Progression-Free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Metastatic Melanoma

Trial Design

2 Treatment Groups

Cohort 1: Nivolumab
1 of 2
Cohort 2: Nivolumab & Ipilimumab
1 of 2
Experimental Treatment

This trial requires 4 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ipilimumab: Cohort 2 (Ocular) is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Cohort 1: Nivolumab
Cohort 2: Nivolumab & Ipilimumab

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 year for reporting.

Closest Location

University of Minnesota Masonic Cancer Center - Burnsville, MN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Biopsy-proven unresectable, metastatic melanoma refractory to standard immunotherapy drugs or regimens, including prior treatment with Aldesleukin (IL-2), GM-CSF, Ipilimumab, Nivolumab, Pembrolizumab, and/or Imlygic (T- VEC).
Prior clinical trial participation or treatment with molecularly targeted agents (i.e. Vemurafenib/Cobimetinib, Dabrafenib/Trametinib) or chemotherapy (i.e. Temozolomide, Dacarbazine, Platinum, or Taxanes) is permitted.
Patients with ocular melanoma may enroll (Cohort 2) without prior therapy as there is no standard 1st line therapy for this subset of melanoma.
Must have a minimum of 3 radiographically distinct (>1.5 cm) lesions measurable by RECIST 1.1 at time of study enrollment (>5 preferred).
A maximum of 2 metastases per treated organ may be targeted for palliative radiation, but must be separated by more than 5 cm of normal tissue
At least 2 non-irradiated lesions are required for systemic response assessments
Pulmonary metastases: Pulmonary metastasis permissible. Appropriate candidates with lung lesions may be considered for ablative hypofractionation using SBRT.
Hepatic metastases: Hepatic metastasis permissible. Appropriate candidates with metastasis to liver may be considered for ablative hypofractionation using SBRT .
Brain metastases: Brain metastases may be treated using Gamma Knife Radiosurgery (GKR) or whole brain radiation therapy (WBRT) per the treating radiation oncologist. Total radiation dose and number of fractions will be determined by the treating radiation oncologist based on anatomic and dosing constraints. MRI of the vertebral column is required for all patients with suspected epidural tumor extension.
Must have sufficient archival tissue block material (1.5 x 1.5 x 1.5 cm) and/or newly obtained core or excisional biopsy of tumor tissue; minimum of 2 cores.

Patient Q&A Section

What are the signs of melanoma?

"The major signs of malignant melanoma include: 1 – the changes in size and size variation; 2 – the colour changes; 3 – the presence of telangiectases." - Anonymous Online Contributor

Unverified Answer

What causes melanoma?

"Most causes suggested may have some role in melanoma development which has not yet been fully elucidated. Melanoma is thought to have a genetic component, although a large number of hereditary conditions are known. There are several genetic syndromes which may be linked to melanoma, although conclusive evidence is lacking. It has been recently suggested that ultraviolet rays may have a part in the formation of melanoma. Some hereditary conditions worsen cancer risk, including familial melanoma and melanoma-associated nevi and melanomas. The development of melanomas in people with these conditions may be associated with mutations in the p53 tumor suppressor gene, of which, many different mutations are known to cause cancer in individuals who inherited the mutated gene from their parents." - Anonymous Online Contributor

Unverified Answer

What are common treatments for melanoma?

"Recent findings showed the prevalence of common treatment approaches for melanoma. All of these treatment approaches may be used concurrently or sequentially in the treatment of a melanoma patient. However, many of our patients undergo only topical treatment, indicating the need to increase patient education about the management of their benign tumors." - Anonymous Online Contributor

Unverified Answer

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

"About 12% of people in the US are at risk of getting melanoma a year at some point in their lives. The number of people diagnosed annually with melanoma is about 3,300 and the number of cancer-related deaths is about 10,000." - Anonymous Online Contributor

Unverified Answer

Can melanoma be cured?

"Melanoma can not be cured. However, a large percentage (25/28) of stage III patients with a metastasis survived for four years or more. It therefore may be possible to delay death in many or possibly all patients." - Anonymous Online Contributor

Unverified Answer

What is melanoma?

"There are many definitions of melanoma and it may be a more accurate term used, and to be used when referring to patients with nevi. A better understanding of the clinical significance of nevi will help to refine the differential diagnosis of melanocytic nevi." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for melanoma?

"Melanoma patients were found to have favorable survival rates after adjusting for several prognostic clinical factors, as well as other tumoral characteristics, which can be related to patient age and tumor location. We observed no overall improved survival for black melanoma patients after adjusting for racial disparity." - Anonymous Online Contributor

Unverified Answer

Is nivolumab: cohort 2 (ocular) safe for people?

"• Ocular toxicity was the only type of toxicity identified in patients treated with the second course of nivolumab. • No other eye side effects or hypersensitivity reactions (e.g. conjunctivitis) were elicited. • All of the ocular side effects reported occurred within the first three months of treatment. This is consistent with early development of inflammatory conjunctival lesions reported in patients treated with nivolumab up to the present. • In this cohort, ocular events occurred sooner (up to 8 weeks) than those previously reported for clinical trial patients." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets melanoma?

"Average melanoma age was 61 years, with an estimated prevalence rate of 15/100,000. We have confirmed the existence of a female predominance. The melanoma incidence was 4.6 per million per year. In the last decade, incidence has increased by 20% (to 6.0/100,000). It will require close examination of this observation to exclude bias due to a higher use of melanoma detection tests in the past decade." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing melanoma?

"Melanoma is a very important condition. The key to survival is early diagnosis, as early as possible, because treatment is much more effective if done in time. The incidence rates of melanoma increases with age. It is estimated that the annual incidence of skin melanoma is about 40 per 100,000. The likelihood of developing melanoma is increased with advancing age, greater education, and light skin-coloured or mixed-race ethnicity. In the USA black individuals are estimated to develop melanoma about six times as often as white individuals. Melanoma risk is increased for those with a family history of it. Melanoma is more than merely a skin cancer. It has a high mortality rate when not detected early." - Anonymous Online Contributor

Unverified Answer

Has nivolumab: cohort 2 (ocular) proven to be more effective than a placebo?

"In patients treated with Nivo (pembrolizumab) in the second cohort (OC2) of this study, there were fewer patients needing systemic steroid treatment than in those treated with a placebo (n=28 vs. n=29, respectively; p-value ≤0.0001). This benefit was sustained over the course of the trial. The lower rate of systemic steroid use with Nivo OC2 was due to a lesser percentage of ocular-related treatment-emergent conjunctivitis requiring corticosteroid treatment versus patients treated with placebo (8% vs. 34%; p-value ≤0.0001)." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of melanoma?

"Overall, sun exposure is the most important cause of melanoma in the UK, and it is highly likely that ultraviolet radiation from the Sun plays a significant role in the development of melanoma in the US." - Anonymous Online Contributor

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