Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

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

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Analgesics

Aldesleukin

Interferons

Interleukin-2

Interferon-alpha

Interferon alpha-2

Vemurafenib

Antiviral Agents

Immunologic Factors

Analgesics, Non-Narcotic

Anti-HIV Agents

Anti-Retroviral Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Starting dose of Vemurafenib 720 mg by mouth twice daily. Three dose levels of Vemurafenib evaluated in combination with interferon and IL-2. These doses are 480 mg, 720 mg and 960 mg. IL-2 given by continuous venous infusion at starting IL-2 dose of 7 million IU/m2 daily for 4 days (total of 96 hours, days 2-5) starting day 2. IL-2 dose levels are 5MU/m2/day, 7MU/m2/day and 9MU/m2 day. Doses of interferon remain constant at 5 MU/m2 subcutaneously daily for 5 days starting Day 1.

Phase I Starting dose: 720 mg by mouth twice a day for a 21 day cycle.

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

Phase I Starting Dose: 7 million IU/m2 by vein on Days 2 - 5 of a 21 day cycle.

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

IL-2

5 million U/m2 subcutaneously on Days 1 - 5 of a 21 day cycle.

Interferon Alpha-2b

Rodabe N. Amaria, MD

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of vemurafenib and Aldesleukin (interleukin-2) that can be given in combination with interferon alfa-2b in patients with advanced or metastatic melanoma. The safety of this combination will also be studied.

The goal of Phase II is to learn if this study drug combination can help to control advanced or metastatic melanoma.

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 4 groups of 6 participants will be enrolled in the Phase I portion of the study and up to 53 participants will be enrolled in Phase II.

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

If you are enrolled in the Phase II portion, you will receive vemurafenib and aldesleukin at the highest doses that were tolerated in the Phase I portion.

All participants will receive the same dose level interferon alfa-2b.

Study Drug Administration:

Each study cycle is 21 days.

You will take vemurafenib by mouth twice a day (1 time in the morning and 1 time in the evening) every day of each study cycle. Vemurafenib can be taken with or without food. If you miss a scheduled dose of vemurafenib, do not try to "make up" the dose by taking 2 doses at the next scheduled dosing time. Continue taking the study drug as scheduled.

You will receive aldesleukin by vein over 96 hours on Days 1-4 of each study cycle.

To receive aldesleukin, 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 place 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.

You will receive interferon alfa-2b as an injection under your skin on Days 1-5 of each study cycle.

Supportive Drugs:

You will be given other drugs to help lower 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:

The following tests and procedures will be performed:

On Day 1 (+/- 3 days) of each cycle:

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

Your skin will be checked for non-melanoma skin cancers on Day 1 of Cycle 1 (+/- 3 days) and then every 3 cycles.

Blood (about 1 teaspoon) will be drawn for routine tests on Days 1, 8, and 15 of each cycle. On Day 1 of each cycle, some of this blood will be used to check your liver and kidney function.

At the end of each cycle (Day 21), you will have a physical exam, including measurement of your weight. Any tumor that can be felt with the hands will be measured with measuring tape during the physical exam to see if it has changed size.

On Day 21 (+/- 7 days) of every 2 cycles, you will have a chest x-ray and a CT or MRI scan to check the status of the disease.

Anytime the doctor thinks it is needed, photos of any skin lesions you have 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 take the study drug combination for as long as the doctor thinks you are benefitting. 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 taking the study drug combination, the following tests and procedures will be performed:

* Your performance status will be recorded.
* You will have a physical exam, including measurement of your vital signs and weight.
* You will be asked about any drugs you may be taking and any side effects you may have had.

vBlood (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 3 months for up to 3 years, you will be contacted by phone or during a clinic visit to see how you are doing. The phone call should last about 5 minutes.

This is an investigational study. Vemurafenib, interferon alfa-2b, and Aldesleukin are FDA approved and commercially available to treat metastatic cancer. Giving these drugs in combination is investigational. The study doctor will tell you how the study drugs are designed to work.

Up to 71 patients will take part in this study. All will be enrolled at MD Anderson.

Systemic Therapy With Interferon, Interleukin-2 and BRAF Inhibitor

Systemic Therapy of Metastatic Melanoma With Multidrug Regimen Including Interferon, Interleukin-2 and BRAF Inhibitor

Maximum tolerated dose (MTD) defined as highest dose studied in which incidence of dose limiting toxicity (DLT) was less than 33%. DLT defined as any grade 3 or 4 non-hematological toxicity excluding manageable N/V, diarrhea and fatigue and manageable/replaceable grade 3 or 4 electrolyte abnormalities, and appearance of new squamous cell skin cancers. Toxicity that may result in delaying next course for more than 3 weeks. Any grade 4 neutropenia more than 7 days duration or Grade 4 thrombocytopenia lasting more than 7 days.

Progression-free survival estimated using the method of Kaplan-Meier. It will be determined from the start of the study until disease progression or death, whichever is first.

M.D. Anderson Cancer Center

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphosarcoma

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Tubulin Modulators

Antimitotic Agents

All 3 study drugs will start on day 1 of cycle 1. Cycle defined as 3 weeks. On day 1, paclitaxel and carboplatin will be administered first, and the vemurafenib administration will start in the evening that day.

Starting dose of Paclitaxel: 100 mg/m2 by vein every 3 weeks.

Starting dose of Carboplatin: AUC 5 by vein every 3 weeks.

Starting dose of Vemurafenib: 480 mg by mouth mouth in the evening on Day 1 of Cycle 1, then twice a day starting on Day 2 for a 3 week cycle.

Starting dose of Vemurafenib: 480 mg by mouth mouth in the evening on Day 1 of Cycle 1, then twice a day starting on Day 2 for a 3 week cycle.

Starting dose of Carboplatin: AUC 5 by vein every 3 weeks.

Starting dose of Paclitaxel: 100 mg/m2 by vein every 3 weeks.

Filip Janku, MD, PHD

The goal of this clinical research study is to find the highest tolerable dose of vemurafenib that can be given in combination with carboplatin and paclitaxel patients with advanced cancer. The safety of the study drug combination will also be studied.

Vemurafenib is designed to block a protein (called mutated BRAF) that is only found in moles (spots) of the skin and certain types of cancer cells. This drug may slow the growth of or kill these cells.

Carboplatin is designed to slow the growth of cancer cells by stopping them from making new DNA (the genetic material of cells).

Paclitaxel is designed to slow the growth of cancer cells by stopping them from dividing into new cells.

Study Groups:

If you are found to be eligible and decide to take part, you will be assigned to a study group based on when you join this study. Up to 8 groups of 3-6 participants will be enrolled in this study.

The dose of vemurafenib and the doses of carboplatin and paclitaxel you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of vemurafenib, carboplatin, and paclitaxel. Each new group will receive a higher dose level of the study drug combination than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the combination is found. After that, 10 additional participants will be enrolled.

Study Drug Administration:

Each study cycle is 3 weeks.

You will start taking paclitaxel and carboplatin on Day 1 of Cycle 1. Paclitaxel will be given by vein over 3 hours, and carboplatin will be given by vein over 30-60 minutes. You may be given medications to reduce the risk of nausea and allergic reaction before these study drugs are given. Both paclitaxel and carboplatin will be given every 3 weeks.

You will start taking vemurafenib by mouth in the evening on Day 1 of Cycle 1. You will then take vemurafenib twice a day, every day starting with Day 2 of Cycle 1.

Study Visits:

At every study visit, you will be asked about any drugs you may be taking, how you are feeling, and if you have had any side effects.

On Day 1 of Cycle 1:

* You will have a physical exam, including measurement of your weight and vital signs if not done in the past 8 days.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests if this was not done in the past 10 days.

On Day 8 of Cycle 1:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.

On Day 1 of Cycles 2 and beyond:

* You will have a physical exam, including measurement of your weight and vital signs.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* In Cycle 2 only, you will have an ECG.

After Cycle 4, if you are tolerating the study drug combination well and the study doctor agrees, you may have your Day 1 visit every other cycle.

Every 6 weeks (every 2 cycles), you will have a CT scan, MRI scan, bone scan, and/or x-ray to check the status of the disease.

Length of Study Participation:

You may continue taking the study drug combination for as long as the doctor thinks it is in your best interest.

You will no longer be able to take the study drugs if the disease gets worse, if you start having other health problems, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over when you have completed the End-of-Study Visit.

End-of-Study Visit:

Within 4 weeks after your last dose of study drugs:

* You will have a physical exam, including measurement of your weight and vital signs.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will have an ECG.
* You will have a CT scan, MRI scan, bone scan, and/or x-ray to check the status of the disease.

This is an investigational study. Vemurafenib is FDA approved and commercially available to treat advanced melanoma with mutated BRAF. Carboplatin and paclitaxel are FDA approved for certain types of cancers, including lung and ovarian cancers. Using the study drug combination to treat advanced cancer with a BRAF mutation is considered investigational.

Up to 96 participants will be enrolled in this study. All will take part at MD Anderson.

Study of Vemurafenib, Carboplatin, and Paclitaxel

Phase I Study of the Combination of Vemurafenib With Carboplatin and Paclitaxel in Patients With Advanced Malignancy

Maximum tolerated dose (MTD) defined as highest dose studied in which the incidence of the dose limiting toxicity (DLT) is \< 33%. If at any time more than or equal to one third of participants at a dose level experience DLT, that dose is considered to be above the MTD.

RECIST version 1.1 used to evaluate the response rate. Response rate calculated using point estimate, together with 95% confidence interval (CI). Overall response rate at end of study also calculated. Overall survival (OS) and time to progression (TTP) also calculated using Kaplan-Meier method. Kaplan-Meier method used to estimate progression free survival (PFS) time. PFS defined as time interval between start of treatment to date of disease progression, or death.

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Thyroid Cancer, Papillary

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Papillary Thyroid Carcinoma

All Groups: Vemurafenib 960 mg by mouth 2 times a day for 56 days prior to surgery (patients not planned for surgical resection will have a core biopsy at day 56 +/- 7 days).

Vemurafenib 960 mg by mouth two times a day 2 weeks post-surgery, or if patients have not sufficiently recovered at that point, as soon as their condition permits. Patients in Group A restaged 8 weeks after resuming drug. If patients in Group A demonstrate either stable or regressing disease, they will continue on vemurafenib with restaging occurring every 8 weeks until no longer benefitting from the drug.

Post Surgery - Group B: Patients discontinue vemurafenib after surgery but will be restaged with CT neck 8 weeks after surgery.

Patients not scheduled for surgical resection undergo a CT scan and core biopsy at day 56, Vemurafenib 960 mg by mouth twice a day unless there is evidence of progressive disease on day 56 CT scan. Patients evaluated for resectability after each CT scan is performed. If scheduled for resection, patient continues vemurafenib until surgery and follows same treatment schema as patients in Groups A and B.

960 mg by mouth 2 times a day 56 days prior to surgery (patients not planned for surgical resection will have a core biopsy at day 56.

Vemurafenib (All Groups)

Group A: 960 mg by mouth twice a day 2 weeks post-surgery. Restaged 8 weeks after resuming drug. If patients demonstrate either stable or regressing disease, they will continue on vemurafenib with restaging occurring every 8 weeks until they are no longer benefitting from the drug.

Group C: Patients not scheduled for surgical resection undergo a CT scan and core biopsy at day 56. Vemurafenib 960 mg by mouth twice a day, continued unless there is evidence of progressive disease on day 56 CT scan. Patients restaged every 8 weeks and continue vemurafenib until no longer benefitting from the drug. Patients evaluated for resectability after each CT scan is performed. If patient is scheduled for resection, then patient will continue vemurafenib until surgery and will follow the same treatment schema as patients in Groups A and B.

Vemurafenib (Post Surgery) - Group A + C

Patients who have had a complete surgical resection, and who do not have evidence of metastatic disease will discontinue vemurafenib after surgery. Patients restaged with CT neck 8 weeks after surgery.

Post Surgery - Group B

Maria E. Cabanillas, MD

The goal of this clinical research study is to learn about how vemurafenib may affect certain biomarkers in patients with PTC. Biomarkers are in the blood/tissue and may be related to your reaction to the study drug. The safety of this drug will also be studied.

Vemurafenib is designed to block the BRAF gene mutation. This mutation causes cancer and cancer growth. By blocking this mutation, the drug may kill the cancer cells with the mutation and/or stop the tumor from growing.

Study Drug Administration and Groups:

If you are found to be eligible to take part in this study, you will take 4 tablets of vemurafenib by mouth 2 times each day for 56 days. You should take each dose about 12 hours apart. If you miss taking the drug at a scheduled time by more than 4 hours, you should skip that dose and wait until the next dose.

After 56 days, the treatment you receive will depend on what group you are assigned to:

* If the disease has spread outside the neck, you will be in Group A.
* If the disease is able to be entirely removed through surgery, you will be in Group B.
* If the disease is unable to be operated on, you will be in Group C.

Study Visits:

At all visits, you will be asked about any side effects you may be having and about any other drugs you may be taking.

Before you take the study drug (Baseline):

* You will have a procedure called a laryngoscopy, in which a tube with a small camera in inserted into the nose to inspect your sinus, throat, and voice box.
* You will have a colonoscopy if you have a history of abnormal growth in the bowel (polyps or colon cancer). During this procedure a tube with a small camera is inserted in the anus to inspect your large bowel.

At Day 28:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* You will have an EKG.
* Blood (about 1 tablespoon) will be drawn for routine tests.

Within 1 week before Day 56, you will have CT scans of the neck, chest, and abdomen to check the status of the disease.

At Day 56, if you are in Group A or B, you will have surgery to remove the tumor. You will sign a separate consent form that describes this surgery and its risks. If you are in Group C, you will have a core biopsy. During the surgery/biopsy, blood (about 1 teaspoon) will also be collected for biomarker testing.

Follow-Up:

Your follow-up after the surgery/biopsy will depend on which study group you are in.

Groups A and C:

If you are in Group A, you will stop taking the study drug for about 2-4 weeks after you have surgery. If you are in Group C, you will not stop taking the study drug. Every 4 weeks (after you resume taking the study drug if you are in Group A, and after the biopsy if you are in Group C):

* You will have a physical exam, including measurement of your vital signs and a skin exam.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will be asked about any other drugs you may be taking and about any side effects you may be having.
* If you are in Group A, these tests will also be performed the day you start taking the study drug again. You will also have an EKG.

Additionally, every 8 weeks (if you are in Group A or C), you will have CT scans of the neck, chest, and abdomen to check the status of the disease. Blood (about 1 teaspoon) will also be drawn for biomarker testing at the first of these visits.

About 1 year after your laryngoscopy and colonoscopy, these procedures will be performed again to check for side effects related to the study drug. If you did not receive a baseline colonoscopy, this procedure will be performed about 1 year after starting vemurafenib. If you continue on study drug for more than a year, you will have a laryngoscopy every 12 months.

At any time the study doctor thinks it is needed, you will have a colonoscopy and laryngoscopy.

About 1 year after the surgery/biopsy, you will return to clinic to check if the disease has come back. At this visit, you will have a CT scan or ultrasound of the neck, and blood (about 1 tablespoon) will be drawn for tests of your thyroid function.

If after 4 months the study doctor thinks it is in your best interest, you will only need to have study visits every 8 weeks. You will still have blood (about 1 tablespoon) drawn for routine tests at a local lab and you will be called by the study staff to check on you. Each call will last about 5-10 minutes.

If you are in Group C, and if during follow-up the study doctor decides that the disease can be operated on, you will be crossed over to Group A or B. You will have surgery and have the follow-up visits described for that study group.

Group B:

If you are in Group B, you will have a follow-up visit about 2 weeks after surgery. The following tests and procedures will be performed:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* You will be asked about any other drugs you may be taking and about any side effects you may be having.

You will have a second follow-up visit about 8 weeks after surgery. You will have a CT scan of the neck to check the status of the disease. You will have the option of continuing to receive vemurafenib if your doctor thinks it is in your best interest. If you do continue on vemurafenib, you will follow the Group A follow-up schedule (above).

About 1 year after your laryngoscopy and colonoscopy, these procedures will be performed again to check for side effects related to the study drug. If you did not receive a baseline colonoscopy, this procedure will be performed about 1 year after starting vemurafenib.

At any time the study doctor thinks it is needed, you will have a colonoscopy and laryngoscopy.

About 1 year after the surgery/biopsy, you will return to clinic to check if the disease has come back. At this visit, you will have a CT scan or ultrasound of the neck, and blood (about 1 tablespoon) will be drawn for tests of your thyroid function.

Length of Study:

If you are in Group A or C, you will continue to take the study drug for as long as the study doctor thinks it is in your best interest. If you are in Group B, you will take the study drug for 56 days and will no longer take it after surgery. You will no longer be able to take the study drug 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 when you have completed the follow-up visits.

End-of-Study Visit/Call:

After you stop taking the study drug, you will have an end-of-study visit or phone call. You will be asked about any other drugs you may be taking and about any side effects you may have had. If you are called, the call will last about 5-10 minutes.

This is an investigational study. Vemurafenib is FDA approved and commercially available for the treatment of late-stage melanoma. It is investigational to use this drug to treat thyroid cancer.

Up to 22 patients will take part in this study. All will be enrolled at MD Anderson.

Vemurafenib Neoadjuvant Trial in Locally Advanced Thyroid Cancer

Pharmacodynamic Study of Vemurafenib in the Neoadjuvant Setting in Patients With Locally Advanced Thyroid Cancer

ERK phosphorylation and tumor size measured at baseline before first dose of Vemurafenib and again after 56 days of Vemurafenib. We will test whether correlation between percent change in ERK phosphorylation and percent change in tumor size is different from 0 with a t-test.

Objective response rate defined as proportion of patients who have had a partial response (PR) or complete response (CR) after initiation of therapy with Vemurafenib, using RECIST 1.1. All patients who complete baseline and day 56 scans evaluable for this endpoint.

Genentech, Inc.

Participants will receive placebo orally once daily on Days 1-21 of each 28-day cycle plus vemurafenib 960 milligrams (mg) orally twice a day on Days 1-28 of each 28-day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.

Participants will receive cobimetinib 60 mg orally once daily on Days 1-21 of each 28-day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28-day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.

Placebo

Cobimetinib

Clinical Trials

To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.

A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma

A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

Progression-free survival was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using Response Evaluation Criteria in Solid Tumors v1.1, or death from any cause, whichever came first. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of existing non-target lesions; or (3) the appearance of 1 or more new lesions.

Overall survival was defined as the time from randomization until the date of death from any cause.

An objective response was defined as a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors v1.1. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.

Duration of response was defined as the time from first occurrence of a documented confirmed objective response until the time of disease progression, as determined by investigator review of tumor assessments using Response Evaluation Criteria in Solid Tumors v1.1 or death from any cause during the study. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of existing non-target lesions; or (3) the appearance of 1 or more new lesions.

Hoffmann-La Roche

1 participant was randomized in Placebo + Vem but did not receive any study treatment, 1 participant randomized in Cobi+ Vem but did not receive any study treatment, two participants were randomized in Placebo + Vem but received the Cobi+Vem.

All-cause Mortality is reported for the ITT population, SAEs and AEs are reported for the safety population. 1 participant died after 30 days from the last dose of treatment, after crossing over from the Placebo + Vem to the Cobi+Vem arm.

Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.

Cobimetinib + Vemurafenib

Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.

Placebo + Vemurafenib

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Asian

More than one race

Native Hawaiian or other Pacific Islande

Black or African American

White

Unknown or Not Reported

Other

Race/Ethnicity, Customized

Hispanic or Latino

Not Hispanic or Latino

Not Stated

Unknown

Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received.

Medical Communications

Post hoc Efficacy Analysis: 16 January 2015

Primary Analysis: 9 May 2014

Extended 5-Year Analysis: 21 July 2019

Progression-free Survival

Primary Analysis 9 May 2014

Post hoc Analysis 16 January 2015

Final Analysis 28 August 2015

Extended 5-year Analysis 21 July 2019

Overall Survival

Percentage of Participants With an Objective Response

Intent-to-treat population: All randomized participants, regardless of whether or not study treatment was received. Only participants with an objective response were included in the analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Systemic Therapy With Interferon, Interleukin-2 and BRAF Inhibitor	NCT01603212	Melanoma	Vemurafenib IL-2 Interferon Alph...	18 Years - 65 Years	M.D. Anderson Cancer Center
Study of Vemurafenib, Carboplatin, and Paclitaxel	NCT01636622	Advanced Cancer...	Vemurafenib Carboplatin Paclitaxel	12 Years -	M.D. Anderson Cancer Center
Vemurafenib Neoadjuvant Trial in Locally Advanced Thyroid Cancer	NCT01709292	Thyroid Cancer	Vemurafenib (Al... Vemurafenib (Po... Post Surgery - ...	18 Years -	M.D. Anderson Cancer Center
Vemurafenib Neoadjuvant Trial in Locally Advanced Thyroid Cancer	NCT01709292	Thyroid Cancer	Vemurafenib (Al... Vemurafenib (Po... Post Surgery - ...	18 Years -	M.D. Anderson Cancer Center
Study of Vemurafenib, Carboplatin, and Paclitaxel	NCT01636622	Advanced Cancer...	Vemurafenib Carboplatin Paclitaxel	12 Years -	M.D. Anderson Cancer Center
A Study Comparing Vemurafenib Versus Vemurafenib Plus Cobimetinib in Participants With Metastatic Melanoma	NCT01689519	Malignant Melan...	Placebo Vemurafenib Cobimetinib	18 Years -	Hoffmann-La Roche

Spots Global Cancer Trial Database for plx4032

Every month we try and update this database with for plx4032 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for plx4032

Every month we try and update this database with for plx4032 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for plx4032 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.