Ibrutinib for Stage IIIB Cutaneous Melanoma AJCC v7

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mayo Clinic in Rochester, Rochester, MN
Stage IIIB Cutaneous Melanoma AJCC v7+8 More
Ibrutinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of ibrutinib and pembrolizumab is safe and effective in treating patients with stage III-IV melanoma.

See full description

Eligible Conditions

  • Stage IIIB Cutaneous Melanoma AJCC v7
  • Stage IIIC Cutaneous Melanoma AJCC v7
  • Stage III Cutaneous Melanoma AJCC v7
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Metastatic Melanoma
  • Unresectable Melanoma
  • Stage IIIA Cutaneous Melanoma AJCC v7

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Stage IIIB Cutaneous Melanoma AJCC v7

Study Objectives

This trial is evaluating whether Ibrutinib will improve 2 primary outcomes and 3 secondary outcomes in patients with Stage IIIB Cutaneous Melanoma AJCC v7. Measurement will happen over the course of Up to start of second course of treatment.

Year 5
Overall survival
Year 5
Progression-free survival
Up to 5 years
Tumor response (dose expansion cohort)
Tumor response evaluated according to Response Evaluation Criteria in Solid criteria (RECIST)
Up to start of second course of treatment
Maximum tolerated dose (Phase I)

Trial Safety

Safety Progress

1 of 3

Other trials for Stage IIIB Cutaneous Melanoma AJCC v7

Trial Design

1 Treatment Group

Treatment (ibrutinib, pembrolizumab)
1 of 1
Experimental Treatment

This trial requires 23 total participants across 1 different treatment group

This trial involves a single treatment. Ibrutinib 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 1 and are in the first stage of evaluation with people.

Treatment (ibrutinib, pembrolizumab)Patients receive ibrutinib PO daily on days 1-28 of cycle 1 and days 1-21 of cycle 2 and subsequent cycles. Patients also receive pembrolizumab IV over 30 minutes on day 8 of cycle 1 and day 1 of cycle 2 and subsequent cycles. Cycle 1 continues for 28 days and subsequent cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Mayo Clinic in Rochester - Rochester, 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:
Histologic or cytologic confirmation of unresectable stage III or metastatic melanoma (stage IV) not amenable to local therapy
PRE-REGISTRATION- INCLUSION CRITERIA
Diagnosis of unresectable stage III or metastatic melanoma (stage IV) not amenable to local therapy
At least one non-nodal lesion considered measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (that is, a lesion whose longest diameter can be accurately measured as >= 1.0 cm with computed tomography [CT] scan, CT component of a positron emission tomography [PET]/CT, or magnetic resonance imaging [MRI]) or at least one malignant lymph node is considered measurable by RECIST criteria (that is, its short axis is >= 1.5 cm when assessed by CT scan)
NOTE: tumor lesions in a previously irradiated area are not considered measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Provide informed written consent
Patient is willing to undergo treatment and monitoring at the enrolling institution
Willing to provide tissue and blood samples for correlative research purposes
REGISTRATION- INCLUSION CRITERIA

Patient Q&A Section

What are the signs of melanoma?

"The signs and symptoms of melanoma are variable in number and intensity, often appearing and disappearing rapidly. Allowing an open mind and regular observation for melanoma is vital and can contribute to early diagnosis and improved prognosis for these conditions." - Anonymous Online Contributor

Unverified Answer

What is melanoma?

"There has been a dramatic increase in the worldwide incidence of melanoma in recent years (increasing more than fivefold between 1976 and 1998). A majority (70%) of patients are diagnosed with Stage I disease, which carries a median survival of up to 10 years. Overall 5-year and 10-year mortality are 24% and 49%, respectively. Tumor thickness and lymph node evaluation are strong indicators of outcome. Overall 5-year and 10-year survival in the US are 85% and 53%, respectively. Current staging practices differ from those used in earlier studies because of a lack of consensus regarding whether staging should occur in all patients, or only in subset patients." - Anonymous Online Contributor

Unverified Answer

Can melanoma be cured?

"Results from a recent clinical trial highlights the complexity of the tumour-microenvironment interactions. It highlights the need for the development of adjuvant vaccines to treat Stage IV and metastatic melanoma." - Anonymous Online Contributor

Unverified Answer

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

"We estimate roughly 70,000 new cases of melanoma will be diagnosed in the U.S. in 2017. Melanoma is currently one of the most deadly, but non-communicable, cancers in the United States. Because melanoma-related deaths are highly preventable, our data highlight the urgent need for better and more accurate tools for monitoring melanoma incidence." - Anonymous Online Contributor

Unverified Answer

What causes melanoma?

"Melanoma is caused by abnormal pigmentation of the skin, more specifically the formation of melanin pigment in the epidermal layer of the skin. It is more likely in men than women and starts on sun-exposed areas of the skin later in life. There is also a genetic predisposition to melanoma. There is evidence that exposure to ultraviolet light between the ages of 15–59 prevents melanoma during a person's lifetime in the absence of other, unrelated factors. The risk of developing melanoma can be reduced by avoiding sun exposure, UV-protection clothing and the use of sunscreen with a SPF no lower than 30." - Anonymous Online Contributor

Unverified Answer

What are common treatments for melanoma?

"Treatments for melanoma are dependent on several factors which must be considered when determining management. Common treatments include surgery, radiation, topical agents, chemotherapy, immunotherapy and immunobiology." - Anonymous Online Contributor

Unverified Answer

Has ibrutinib proven to be more effective than a placebo?

"(1) Ibrutinib (brand name Ikblis) is an effective anti-cancer agent for patients with advanced phase III-resistant or refractory mantle cell lymphoma (MCL) in the second-line setting. (2) Ibrutinib produced durable responses in patients who had received one or more previous therapies for MCL and advanced stage III chronic lymphocytic leukemia (CLL). (3) Ibrutinib was associated with favorable safety and tolerability. Findings from a recent study support further exploration of ibrutinib in second-line treatment of MCL." - Anonymous Online Contributor

Unverified Answer

What is the latest research for melanoma?

"After a long period of declining incidence trends, an upward trend in incidence is expected to continue for the next 10 years. In order to improve screening programs, more efforts should be made to increase awareness of melanoma disease and promotion of detection programs." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for melanoma?

"Patient education regarding the value of early detection, particularly of moles, combined with a balanced appraisal of the level of evidence linking treatment to survival and the relative benefits and risks of treatment, constitute important considerations for clinicians when making their decisions about patient eligibility for clinical trials. The role of clinical trials as a valid tool to determine the best management approach for individuals with malignant melanoma warrants further investigation, and a high-quality, adequately designed, prospective trial comparing current management with new agents and/or treatment modalities would represent a valuable contribution to the knowledge needed to optimize therapy for this disease." - Anonymous Online Contributor

Unverified Answer

What is ibrutinib?

"ibrutinib was safe and well tolerated in patients with advanced solid tumors including non-small cell lung cancers. The FDA approval of ibrutinib in the first-line treatment of patients with chronic lymphocytic leukemia can advance the treatment of patients with solid tumors, including non-small cell lung cancers." - Anonymous Online Contributor

Unverified Answer

How does ibrutinib work?

"In vitro, ibrutinib inhibited the growth of both erythroleukemia and melanoma by inducing differentiation of erythroleukemia cells through erythropoietin-independent mechanisms. These antitumor effects were not enhanced by c-Kit/FGF signaling pathway inhibition, suggesting the applicability of ibrutinib for CLL by targeting the erythropoietin pathway in vitro." - Anonymous Online Contributor

Unverified Answer

Does melanoma run in families?

"Melanoma run through families, but whether genetic or environmental, neither can explain the rarity of familial melanoma. The high prevalence and the relatively young age profile of melanoma in Caucasian family members and siblings strongly suggest an inherited genetic etiology instead." - 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.
See if you qualify for this trial
Get access to this novel treatment for Stage IIIB Cutaneous Melanoma AJCC v7 by sharing your contact details with the study coordinator.