Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Immunomodulating Agents

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

nivolumab 3 mg/kg q3w + ipilimumab 1 mg/kg q3w for 4 injections followed by nivolumab 480 mg IV q4w until completion of 2 years total treatment or progression. Then treatment will be left at the investigator choice and continued until the 2nd progression.

encorafenib 450 mg QD + binimetinib 45 mg BID orally for 12 weeks followed, after a week of pause, by nivolumab 3 mg/kg q3w + ipilimumab 1 mg/kg q3w for 4 injections, followed by nivolumab 480 mg IV q4w until completion of 2 years total treatment or progression. Then patients will be rechallenged with encorafenib 450 mg QD + binimetinib 45 mg BID orally continuously until the 2nd progression.

nivolumab 3 mg/kg q3w + ipilimumab 1 mg/kg q3w for 4 injections followed by nivolumab 480 mg IV q4w until completion of 2 years total treatment or progression.

Nivolumab + Ipilimumab

encorafenib 450 mg QD + binimetinib 45 mg BID orally for 12 weeks

Encorafenib + Binimetinib

Caroline Robert

This is a multicenter, 2-arm open-label, randomized comparative phase II study. The objective of this trial is to prospectively evaluate whether a sequential approach with an induction period of 12 weeks with encorafenib + binimetinib followed by combination immunotherapy with nivolumab + ipilimumab improves progression free survival compared to combination immunotherapy nivolumab + ipilimumab alone in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib

Combination of Targeted Therapy (Encorafenib and Binimetinib) Followed by Combination of Immunotherapy (Ipilimumab and Nivolumab) vs Immediate Combination of Immunotherapy in Patients With Unresectable or Metastatic Melanoma With BRAF V600 Mutation : an EORTC Randomized Phase II Study (EBIN)

All publications must comply with the terms specified in the EORTC Policy 009 "Release of Results and Publication Policy".

PRS is defined as the time from the date of randomization until the first date of progression, or until date of death (whatever the cause), whichever occurs first. Progression will be assessed according to the RECIST criteria (version 1.1)

OS is defined as the time from the date of randomization to the date of death, whatever the cause.

CR will be assessed according to the RECIST criteria (version 1.1)

Time to CR is defined as the time from the date of randomization until the occurrence of first CR.

Duration of CR will be measured from the time measurement criteria for CR are first met until the first date that recurrence is objectively documented.

Best overall response will be assessed according to the RECIST criteria (version 1.1)

Time to best response is defined as the time from the date of randomization until the occurrence of the best response (CR or PR, whichever comes first). CR and PR will be assessed according to the RECIST criteria (version 1.1)

Best response duration will be measured from the time measurement criteria for CR/PR (whichever is first recorded) are first met until the first date that recurrent or progressive disease is objectively documented. CR and PR will be assessed according to the RECIST criteria (version 1.1)

This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting.

PFS2 is defined as the time from randomization to second objective disease progression, or death from any cause, whichever first. The second objective disease progression will be assessed according to the RECIST criteria (version 1.1)

European Organisation for Research and Treatment of Cancer - EORTC

LGX818 capsules will be administered orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.

LGX818

Paul Chapman, MD

The purpose of this phase II study is to find out if an investigational drug called LGX818 can stop the melanoma from growing.

BRAF Inhibitor, LGX818, Utilizing a Pulsatile Schedule in Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation

A Phase 2 Trial of the BRAF Inhibitor, LGX818, Utilizing a Pulsatile Schedule in Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation

Overall survival will be calculated for the start of treatment to the date of last death or follow-up.

PK parameters will be determined on PK profiles after the first dose and at steady-state using non-compartmental method(s) using WinNonlin

Efficacy for all patients will be evaluated by the study sites using RECIST v1.1 and response criteria based on contrast-enhanced CT. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Progression must also involve an increase in size of measurable lesions by at least 5 mm, to minimize the possibility that small changes in a small number of target lesions is falsely interpreted as progression.Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Response rate (defined as complete + partial response) and 95% confidence interval will be estimated.

Array BioPharma

Memorial Sloan Kettering Cancer Center

Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation will receive LGX818 capsules orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

The protocol was stopped after 7 participants were accrued due to intolerable toxicities.

Dr. Paul Chapman MD

Number of Participants With Response According to RECIST v1.1 Criteria

LGX818 capsules will be administered orally on a once -daily schedule (QD) dosing at a dose of 300 mg/day, 2 weeks on followed by a 2 week break. This schedule of 2 weeks on, followed by 2 weeks off, will continue for the duration of time the patients remains on the clinical trial. After the follow up visit patients will be contacted approximately every 12 weeks until they have received a subsequent therapy or until they have been off treatment for a year to monitor their survival.

LGX818

Response Rate

Overall Survival

Pharmacokinetic (PK) Analysis: Geometric Mean of Maximum Observed Concentration (Cmax) of LGX818 at Steady State

Overall Study

Pharmaceutical Solutions

FMT includes a colonoscopy conducted by a gastroenterologist followed by stool capsules which will be swallowed by the patient.

Patients with metastatic melanoma who responded to immunotherapy will serve as the fecal implant donors. The tested fecal implant will be used for two different products. The first part of the tested stool will be mixed with a saline solution, strained and infused into your bowel using colonoscopy. The second part of the tested stool will be packed into capsules. These stool capsules are at the size of standard drug-containing capsules and can be swallowed in a standard manner. Stool capsules are a common method of FMT and has been used worldwide for several years. After the colonoscopy, you will be asked to swallow the capsules. Swallowing the capsules will be conducted at the clinic, and does not require any additional procedures.

Fecal Microbiota Transplant (FMT)

Gal N Markel, MD,PhD

Ben S Boursi, MD

Erez N Baruch, MD

Gal Markel, MD, PhD

Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients.

FMT includes both colonoscopy and stool capsules.

This is a phase I single-center study of fecal microbiota transplant (FMT) in melanoma patients who failed at least one line of PD-1 blockade.

Eligible patients must have a disease amenable to biopsy and lack of contra-indications to FMT.

Patients will undergo a baseline evaluation including imaging, tumor biopsy, blood samples and stool studies to confirm suitability for the study.

Eligible patients will undergo FMT. The FMT includes a colonoscopy followed by stool capsules.

Patients will undergo repeated evaluations including follow-up blood, stool and radiological testings.

The study will be conducted over a 24-week period.

Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy

Altering the Gut Microbiota of Melanoma Patients Who Failed Immunotherapy Using Fecal Microbiota Transplantation (FMT) From Responding Patients

Number of patients with objective responses divided by the total number of evaluable patients, according to imaging studies (RECIST 1.1) and iRECIST.

Number of patients with adverse events that emerged post FMT

Comparing of the patients' gut bacterial composition pre and post-FMT and in relation to their donors. Bacterial composition will be quantified by the operational taxonomic unit (OTU) in the stool

Changes in the relative abundance of different immune cell population (such as the proportion of CD8+ T cells) pre and post-FMT.

Changes in levels of proteins that represent immune activity against cancer (such as measurements of blood interferon gamma levels), pre and post FMT

Sheba Medical Center

Chief Scientist of The Ella Lemelbaum Institute of Immuno-Oncology, Principal Investigator, Associate Professor of Immunology

Temozolomide

Poly(ADP-ribose) Polymerase Inhibitors

10-((4-hydroxypiperidin-1-yl)methyl)chromeno(4,3,2-de)phthalazin-3(2H)-one

Enzyme Inhibitors

TMZ (at 150 mg/m2) will be administered orally according to the instructions on the product label, on Days 1 through 5 of the same 28-day cycle as E7016. TMZ capsules should be taken immediately after E7016. No food or drink intake, except water, will be allowed for 2 hours before or after administration.

E7016 capsules will be administered in the morning after at least a 2-hour fast. Subjects will be instructed not to eat or drink anything except water in the 2 hours prior and 2 hours after drug administration. Subjects will record the time at which they ate.

For the Single-Dose PK Period, 320 mg of E7016 will be administered once on Day -2. For the Multiple-Dose Treatment Cycle(s), 320 mg E7016 will be administered QD on Days 1 through 7 of each 28-day cycle.

E7016

Eisai Medical Services

This is a Phase 2, open-label, multicenter study to assess the PFS-6m of E7016 at the selected dose of 320-mg once daily (QD) in combination with 150-mg/m2 of Temozolomide (TMZ) in subjects with wt BRAF Stage IV or unresectable Stage III melanoma with disease progression. Eligible subjects must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST).

Phase 2 Study of the Poly(ADP-Ribose) Polymerase Inhibitor E7016 in Combination With Temozolomide in Subjects With Wild Type BRAF Stage IV or Unresectable Stage III Melanoma

The Progression Free Survival-6m rate defined as the proportion of subjects that are alive and progression-free at 6-months from the date of first dosing based on RECIST 1.1. PFS-6m rate will be estimated from Kaplan-Meier (K-M) product-limit estimate of PFS.

Eisai Inc.

Anti-Infective Agents

Analgesics

Aldesleukin

Cisplatin

Thalidomide

Vinblastine

Interferons

Interleukin-2

Interferon-alpha

Interferon alpha-2

Antiviral Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunologic Factors

Analgesics, Non-Narcotic

Immunosuppressive Agents

Anti-Bacterial Agents

Angiogenesis Inhibitors

Growth Inhibitors

Tubulin Modulators

Antimitotic Agents

Temozolomide 250 mg/m\^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m\^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m\^2 IV Days 1-4; + Interleukin-2 9 MIU/m\^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m\^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.

250 mg/m\^2 By Mouth Every 4 Hours x 3 Doses On Day 1

1.5 mg/m\^2 By Vein Over 15-30 Minutes On Days 1-4

Velban

20 mg/m\^2 By Vein Over 45-120 Minutes On Days 1-4

9 MIU/m\^2 By Vein Over 24 Hours x 4 Doses On Days 1-4

5 mu/m\^2 Subcutaneously (Under the skin) Daily On Days 1-5

Intron-A

Nicholas E. Papadopoulos, MD

The goal of this clinical research study is to learn if treatment with Temodar (temozolomide), Velban (vinblastine), Cisplatin, Proleukin (interleukin-2), Intron-A (interferon alpha), and thalidomide can help to control melanoma that has spread to other parts of the body. The safety of this treatment will also be studied.

Some of the drugs in this study have been used with DTIC (Dacarbazine) in the past to control Melanoma that has spread to other parts of the body. However, in most of those cases, the duration of these results are limited and ineffective to control or prevent spread of the disease into the brain, the membranes that cover the brain, the spinal cord, and the nerve roots. In this study, temozolomide is being used instead of DTIC. Temodar has been proven to be one of the most effective therapeutic agents to control malignancies in the brain. Thalidomide is designed to decrease the formation of new blood vessels that feed tumors.

The treatment plan for this study is divided in two parts. The first part of this study (induction therapy) is done to try to get your disease under control. The second part of this study (maintenance therapy) is to maintain or improve the results of the first part of the treatment plan.

Induction Therapy:

Induction therapy includes three 5-day courses of treatment with thalidomide, temozolomide, vinblastine, cisplatin, interleukin-2, and interferon-alpha. The courses are repeated in cycles of three to four weeks depending on recovery from side effects from the previous course of treatment.

All of the drugs that are given through a vein will be given through a catheter (plastic tube) inserted in a vein in one of your arms or into the vein that runs underneath the collar bone and threaded into the central vein in the upper part of the chest.

You will be admitted in the hospital on Day 0. You will start receiving liquids (hydration) and be prepared to start temozolomide on day 1 of the admission. It is anticipated that you will remain in the hospital for one week. Depending on degree of side effects a longer stay in the hospital may be required.

Temozolomide will be given by mouth on the first day of the treatment every 4 hours for three doses. A fourth dose may be considered with later courses of treatment if it is well tolerated.

Vinblastine will be given through the catheter on Days 1,2,3 and 4 of the cycle. The infusion should last between 15 to 30 minutes.

Cisplatin will be given through the catheter on Days 1,2,3 and 4 of the cycle. The infusion should last between 45 to 120 minutes. Care will be given to fully hydrate the body to decrease chances for kidney damage.

Thalidomide will be given by mouth once a day throughout the cycle of treatment. It is given as a single dose starting on Day 0, the day before the start of the temozolomide, and then every day for the entire cycle.

Interleukin-2 will be given as continuous infusion through the catheter over 24 hours for four days in a row (over 96 hours). It will be given from Day 1 through Day 5 of the cycle.

Interferon alpha will be given as "an insulin-type injection" under the skin, into the fatty tissue, once a day on Days 1,2,3,4 and 5 of each cycle

You will receive up to 3 courses of induction therapy. The courses will be repeated in cycles of 3-4 weeks depending on adequate recovery from the side effects. If you have stable disease or improved disease, you will go on to receive maintenance therapy.

Maintenance Therapy:

Long-term daily treatment with the study drugs will be given for six 4-week cycles.

Temozolomide will be given by mouth daily for 21 days (3 weeks). This will be followed by one week without Temozolomide treatment. This makes up one cycle of treatment.

Interleukin-2 and interferon alpha will be given during the one week of rest from temozolomide. This will require one week of hospitalization. Interleukin-2 is given as a continuous infusion through the catheter over the first 5 days. The first day the dose will be high and it will be decreased slowly to a lower dose on the last 3 days. The interferon alpha will be given as an injection in the fatty tissues under the skin once a day for 5 days on the same days the interleukin-2 is given.

Thalidomide will be given by mouth once a day every day for the full 4-week cycle.

Supportive care with medications for fever, chills, nausea, vomiting, diarrhea, will be given during treatment. You will also be given fluids with appropriate electrolytes to replenish blood levels and to replenish blood volume to help the kidneys.

How you respond to treatment will be evaluated with computed tomography (CT) scans and magnetic resonance images (MRIs) of the brain. This will occur after the second course and third course of induction therapy and then after the third and sixth courses of maintenance therapy and periodically until off study.

You will be requested to complete a questionnaire to evaluate your quality of life before treatment starts, at the end of Cycles 2 and 3 of induction therapy, and at the end of Cycles 3 and 6 of maintenance therapy.

You will be taken off study if the disease gets worse or intolerable side effects occur. Should you be taken off study early, a long term follow-up will be requested.

For those patients who complete the treatment, radiographic evaluation with body CT scans and brain MRI will be done. They will have physical exams, and blood tests (1 to 2 tablespoons per visit) every 3 months for the first year, every 4 months for the second year, every 6 months up to the 5th year, and then once a year.

A total of 60 patients will take part in this study.

Biochemotherapy With Temozolomide for Metastatic Melanoma

Biochemotherapy With Temozolomide, Velban, Cisplatin, Interleukin-2, Interferon-alpha and Thalidomide for Metastatic Melanoma With Optional Intrathecal Interleukin-2 Treatment

TTP defined as the time from date of first dose of study medication to first documentation of objective tumor progression in days. Response evaluation by Response Evaluation Criteria in Solid Tumors (RECIST) done following 2 cycles and 3 cycles. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.

Response evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST).

M.D. Anderson Cancer Center

Biochemotherapy With Temozolomide

Nicholas E. Papadopoulos, MD / Professor

Time to Progression (TTP)

Number of Participants With Response

Anti-HIV Agents

Anti-Retroviral Agents

Ipilimumab starting 1 mg/kg by vein (IV) Day 1 each cycle; Temozolomide 200 mg/m\^2 orally Days 2-5 of Induction; Cisplatin 25 mg/m\^2 IV for Days 2-4 of Induction; Interferon alfa-2b 5 million U/m2 subcutaneously on Days 1-5 of each cycle Induction + Consolidation; and Interleukin-2 9 million IU/m\^2 IV as a continuous infusion on Days 2-5 of Induction + Consolidation.

Phase I Starting dose: 1 mg/kg by vein over 90 minutes on Day 1 of each 3 week cycle for Induction 12 weeks, then Day 1 of Cycle 1 for Consolidation 12 weeks and Day 1 of each 12 week cycle in Maintenance.

Phase II dose: Maximum tolerated dose (MTD) from Phase I.

200 mg/m\^2 by mouth 1 time a day on Days 2-5 of each Induction cycle (four 3 week cycles).

25 mg/m\^2 by vein over 1 hour on Days 2-4 of each Induction cycle (four 3 week cycles).

5 million U/m2 subcutaneously on Days 2-6 of each 3 week Induction cycle (four 3 week cycles) and each 4 week Consolidation cycle (three 4 week cycles).

Interferon Alfa-2b

9 million IU/m\^2 by vein as a continuous infusion on Days 2-5 of each 3 week Induction cycle (four 3 week cycles) and each 4 week Consolidation cycle (three 4 week cycles).

Rodabe N. Amaria, MD

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of the drug Yervoy (ipilimumab) that can be given with the drugs Temodar (temozolomide), Intron-A (interferon alfa-2b), Proleukin (aldesleukin, IL-2), and Platinol (cisplatin) to patients with metastatic melanoma. The safety of this combination will also be studied in Phase I. The goal of Phase II is to learn if this combination can help to control metastatic melanoma. Note: The study was closed following Phase I enrollment.

Ipilimumab, interferon alfa-2b, and aldesleukin are designed to block the activity of cells that decrease the immune system's ability to fight cancer.

Temozolomide is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells.

Cisplatin is designed to poison the cancer cells, which may cause them to die.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. Up to 6 groups of 3 participants will be enrolled in the Phase I portion of the study, and up to 46 participants will be enrolled in Phase II.

\*\*\*Study was halted early due to slow accrual in the Phase I portion without opening Phase II. \*\*\*

If you are enrolled in the Phase I portion, the dose of ipilimumab you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of ipilimumab. Each new group will receive a higher dose of ipilimumab than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of ipilimumab is found.

If you are enrolled in the Phase II portion, you will receive ipilimumab at the highest dose that was tolerated in the Phase I portion.

All participants will receive the same dose level of cisplatin, temozolomide, interferon alfa-2b and IL-2.

If you develop intolerable side effects while on study, your dose of IL-2 may be lowered 1-2 times until the side effects get better.

Catheter:

If you are found to be eligible to take part in this study, you will have a central venous catheter (CVC) inserted, if you do not already have one. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.

Study Drug Administration:

The study drugs will be given in 3 stages: induction, consolidation, and maintenance.

Induction:

Induction will last 12 weeks. You will receive the study drugs in up to four 3-week cycles:

* You will receive ipilimumab by vein over 90 minutes on Day 1 of each cycle.
* You will take temozolomide by mouth 1 time a day on Days 2-5 of each cycle. You should take temozolomide on an empty stomach at least 2 hours before or after a meal. Do not open the capsule, mix it with food, or chew it.
* You will receive cisplatin by vein over 1 hour on Days 2-4 of each cycle.
* You will receive aldesleukin by vein as a continuous infusion on Days 2-5 of each cycle.
* You will receive interferon alfa-2b as an injection under your skin on Days 2-6 of each cycle.

Consolidation:

Consolidation will last 12 weeks. You will receive the study drugs in three 4-week cycles.

* You will receive ipilimumab by vein over 90 minutes on Day 1 of consolidation.
* You will receive interferon alfa-2b as an injection under your skin on Days 1-5 of each cycle.
* You will receive aldesleukin by vein as a continuous infusion on Days 2-5 of each cycle.

Maintenance:

Maintenance will last about 1½ years. You will receive ipilimumab by vein over 90 minutes on Day 1 of up to six 12-week cycles.

Other Drugs:

You will be given other drugs to help decrease the risk of side effects. The study staff will tell you about these drugs, how they will be given, and the possible risks.

Study Visits:

Before each cycle (+/- 3 days):

* You will be asked about any drugs you may be taking and any side effects you may have had.
* Your performance status will be recorded.
* Your vital signs will be measured.
* If you are able to become pregnant, you will have a blood (about 1 teaspoon) or urine pregnancy test.

Every week, blood (about 1 teaspoon) will be drawn for routine tests. Before each cycle, some of this blood will be used to check your liver and kidney function.

At the end of each cycle, you will have a physical exam, including measurement of your weight. Any tumor that can be felt with the hands will be measured during the physical exam to see if it has changed size.

Every 2 cycles (+/- 7 days), you will have a chest x-ray and CT or MRI scans to check the status of the disease.

Anytime the doctor thinks it is needed, photos of the skin lesions will be taken. Your private areas will be covered (as much as possible), and a picture of your face will not be taken unless there are lesions on your face.

Length of Study:

You may continue taking the study drugs for up to 2 years. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over once you have completed the end-of-treatment visit and follow-up.

End-of-Treatment Visit:

Within 14 days after you stop the study therapy, the following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs and weight.
* Your performance status will be recorded.
* You will be asked about any drugs you may be taking and any side effects you may have had.
* Blood (about 2 tablespoons) will be drawn for routine tests.
* If the doctor thinks it is needed, you will have a CT or MRI scan.

Follow-Up:

Every 2 months for up to 3 years, you will be contacted by phone or during a clinic visit to see how you are doing.

This is an investigational study. Temozolomide, cisplatin, ipilimumab, interferon alfa-2b, and aldesleukin are FDA approved and commercially available to treat metastatic cancer. However, it is investigational to give temozolomide to patients with metastatic melanoma.

Up to 64 patients will take part in this study. All will be enrolled at MD Anderson.

IPI Biochemotherapy for Chemonaive Patients With Metastatic Melanoma

IPI-Biochemotherapy for Chemonaive Patients With Metastatic Melanoma

Tumor assessments using irRC modified World Health Organizations (WHO) criteria: Immune-Related Complete Response (irCR): Complete disappearance of all tumor lesions. Immune-Related Partial Response (irPR): decrease of 50% or greater. Immune-Related Progressive Disease (irPD): At least 25% increase in sum of products of all index lesions over baseline sum of products of diameters (SPD) calculated for index lesions. Assessment include photographic measurement of skin lesions, computed tomography scans and/or magnetic resonance imaging tumor assessments until documented tumor progression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib	NCT03235245	Unresectable St... Stage IV Melano...	Nivolumab + Ipi... Encorafenib + B...	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
BRAF Inhibitor, LGX818, Utilizing a Pulsatile Schedule in Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation	NCT01894672	Melanoma	LGX818	18 Years -	Memorial Sloan Kettering Cancer Center
Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy	NCT03353402	Melanoma Stage ... Unresectable St...	Fecal Microbiot...	18 Years -	Sheba Medical Center
BRAF Inhibitor, LGX818, Utilizing a Pulsatile Schedule in Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation	NCT01894672	Melanoma	LGX818	18 Years -	Memorial Sloan Kettering Cancer Center
BRAF Inhibitor, LGX818, Utilizing a Pulsatile Schedule in Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation	NCT01894672	Melanoma	LGX818	18 Years -	Memorial Sloan Kettering Cancer Center
Phase 2 Study of the Poly(ADP-Ribose) Polymerase Inhibitor E7016 in Combination With Temozolomide in Subjects With Wild Type BRAF Stage IV or Unresectable Stage III Melanoma	NCT01605162	Wild Type BRAF ... Unresectable St...	TMZ E7016	18 Years -	Eisai Inc.
Biochemotherapy With Temozolomide for Metastatic Melanoma	NCT00505635	Melanoma	Temozolomide Velban Cisplatin Interleukin-2 Intron-A Thalidomide	18 Years - 65 Years	M.D. Anderson Cancer Center
Biochemotherapy With Temozolomide for Metastatic Melanoma	NCT00505635	Melanoma	Temozolomide Velban Cisplatin Interleukin-2 Intron-A Thalidomide	18 Years - 65 Years	M.D. Anderson Cancer Center
IPI Biochemotherapy for Chemonaive Patients With Metastatic Melanoma	NCT01409174	Melanoma	Ipilimumab Temozolomide Cisplatin Interferon Alfa... Interleukin-2	18 Years - 65 Years	M.D. Anderson Cancer Center
BRAF Inhibitor, LGX818, Utilizing a Pulsatile Schedule in Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation	NCT01894672	Melanoma	LGX818	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for unresectable stage iii melanoma