No Placebo-Only Group

The purpose of the study is to assess the safety, tolerability and effectiveness of experimental medication BMS-986016 administered alone and in combination with nivolumab in patients with solid tumors that have spread and/or cannot be removed by surgery.

The following tumor types are included in this study:

Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously been treated with immunotherapy.

An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors

Anti-LAG-3 + Anti-PD-1 Immunotherapy for Cancer

I have specific cancer types and am new to or have specific treatment histories with immuno-oncology agents.

I have tried at least one standard treatment without success or could not tolerate it.

I haven't had encephalitis, meningitis, or uncontrolled seizures in the last year.

My cancer has spread to my brain and is not under control.

I can take care of myself and am up and about more than half of my waking hours.

There may be additional criteria that need to be met or avoided as specified in the study guidelines.

I meet all previous criteria except for having cervical, ovarian, or colorectal cancer.

You have a disease where your immune system mistakenly attacks your own body.

BMS-986016

Nivolumab

Relatlimab

Pivotal Trial

The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.

An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer

Nivolumab for Esophageal Cancer

This study is evaluating whether a drug called Nivolumab can improve survival in people with cancer.

I had surgery for cancer with clear margins but still have some disease left.

I finished chemo and radiation before surgery.

My cancer is in the esophagus or where the stomach meets the esophagus, and it's at an advanced stage but not the most severe.

Placebo

This first-in-human open-label, multicenter, dose-escalation and expansion study is designed to evaluate the safety, tolerability, and PK of tiragolumab alone or in combination with atezolizumab and/or other anti-cancer therapies in participants with locally advanced, recurrent, or metastatic incurable tumors for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate, or for whom a clinical trial of an investigational agent is a recognized standard of care.

Safety and Pharmacokinetics (PK) of Escalating Doses of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Locally Advanced or Metastatic Tumors

Tiragolumab + Atezolizumab/Other Therapies for Cancer

This study is evaluating whether a drug which targets a specific protein may help treat cancer.

I haven't had any cancer treatment, including chemotherapy or radiotherapy, in the last 3 weeks.

I haven't had any other cancers in the last 5 years.

I have not had a severe infection in the last 4 weeks.

My blood and organs are functioning well.

My cancer is advanced and didn't respond well to standard treatments.

I am fully active or restricted in physically strenuous activity but can do light work.

I have a brain tumor or untreated brain cancer spread.

My cancer has spread to the lining of my brain and spinal cord.

I do not have active hepatitis B, C, or tuberculosis.

I have a history of lung scarring or inflammation.

Atezolizumab

Bevacizumab

Capecitabine

Carboplatin

Cisplatin

Paclitaxel

Pembrolizumab

Pemetrexed

Tiragolumab

The purpose of this study is to provide continued access to ixazomib and/or other study drugs from an ixazomib parent study.

Ixazomib Rollover Study

Continued Access to Ixazomib for Multiple Myeloma

This study is evaluating whether a drug can be used to treat multiple myeloma.

Ixazomib

This is a prospective, multicenter, open-label, randomized, controlled, parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics (PK), safety and efficacy of macitentan in children with pulmonary arterial hypertension (PAH).

A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)

Macitentan for Pulmonary Hypertension

This study is evaluating whether a drug called macitentan may help children with pulmonary arterial hypertension.

I haven't taken IV or SC prostanoids in the last 4 weeks, except for a specific test.

I am currently on more than two treatments for pulmonary arterial hypertension.

I have PAH linked to Eisenmenger syndrome or significant heart defects.

My liver is not working well (severe issues).

Your hemoglobin or hematocrit levels are very low.

Your blood test shows that your AST and/or ALT levels are more than three times the normal range.

I have been diagnosed with PAH confirmed by a heart catheter test.

I have low blood pressure that makes starting PAH treatment risky.

My kidneys are not working well (severe renal insufficiency).

My PAH is classified under Group 1 and may be related to a specific cause like heart disease or HIV.

I have been diagnosed with bronchopulmonary dysplasia.

I am not pregnant, will test monthly, and will use birth control until the study ends.

My PAH is caused by portal hypertension, schistosomiasis, or specific lung diseases.

Macitentan

Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 200 participants will take part in the study.

Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation

Ivosidenib + Azacitidine for Acute Myeloid Leukemia

This study is evaluating whether a combination of two drugs may help treat a type of leukemia.

I am currently pregnant or breastfeeding.

I have been treated with a drug to modify my DNA for MDS.

I have waited the required time after my last dose of an experimental MDS treatment.

I am willing and able to undergo strong chemotherapy for my AML.

I have been cancer-free for over a year, except for MDS or myeloproliferative disorder.

I am experiencing severe, life-threatening complications from leukemia.

I can switch from or be monitored for my QT-prolonging medication before the study.

I have been diagnosed with progressive multifocal leukoencephalopathy.

I have been treated with an IDH1 inhibitor before.

I have had serious heart problems in the last 6 months.

I have symptoms or a diagnosis of leukemia in my brain or spinal cord.

I have trouble swallowing or absorbing pills.

I am not eligible for intensive chemotherapy due to my age, health condition, or specific medical issues.

My leukemia has not been treated and my bone marrow shows a high number of cancer cells.

I have an ongoing infection that hasn't improved with treatment.

I have been treated for AML, but only with hydroxyurea.

I can take care of myself and am up and about more than half of the day.

I have a condition that could affect my heart's rhythm.

AG-120 (Ivosidenib)

Azacitidine

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

Seladelpar for Primary Biliary Cholangitis

This study is evaluating whether a drug called Seladelpar may help treat Primary Biliary Cholangitis.

My liver disease is advanced, with low albumin and high bilirubin levels.

My liver function score is 12 or higher, considering my anticoagulation medication.

You have previously participated in a study involving the drug seladelpar for PBC (primary biliary cholangitis).

I haven't had cancer or been treated for it in the last 2 years, except for certain skin or cervical cancers.

My kidney function is reduced, with an eGFR of 45 or less.

I haven't taken colchicine, methotrexate, azathioprine, or long-term steroids in the last 2 months.

I am using two forms of birth control during and 90 days after the study.

I am currently using or have used obeticholic acid in the last 3 months.

I have a known history of alpha-1-antitrypsin deficiency.

I am currently using or have used fibrates in the last 3 months.

I have been diagnosed with primary sclerosing cholangitis.

I am taking medications that may affect my liver or how I absorb medications, or I have had a gastric bypass.

I stopped taking seladelpar for PBC due to side effects.

I haven't used any experimental treatments for PBC in the last 3 months.

I am not currently on any immunosuppressant therapies.

I have a history of chronic viral hepatitis.

I don't have any health issues that would interfere with the study.

Seladelpar

Long-term safety and efficacy follow-up for participants with Hemophilia B who were previously treated in the C0371005 (formerly SPK-9001-101) study, and a dose-escalation sub-study evaluating safety, tolerability, and kinetics of a higher dose with long-term safety and efficacy follow-up. Participants in the substudy do not need to have participated in C0371005.

Long-term Safety and Efficacy Study and Dose-Escalation Substudy of PF 06838435 in Individuals With Hemophilia B

PF-06838435 for Hemophilia B

This study is evaluating whether a new treatment for hemophilia B is safe and effective.

If you're a male, you will need to avoid having sex or use reliable barrier contraception until three consecutive semen samples show no signs of the study's drug.

I don't have factor IX inhibitors and never had them.

You understand what the study is about and agree to follow its rules.

I have been treated with factor IX products for 50 days or more.

I am a male aged 18-65 with severe hemophilia B.

PF-06838435

The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

A Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

BMS-986249 + Nivolumab for Cancer

This study is evaluating whether a drug may help treat solid tumors.

I have tried at least one standard treatment for my advanced cancer but it didn't work or I couldn't tolerate it.

I do not have brain cancer or cancer that has only spread to my brain.

I have another cancer that needs treatment at the same time.

My cancer is advanced, can't be removed by surgery, and has at least one tumor that can be biopsied.

I have had cancer treatments like chemotherapy or radiotherapy before.

I am fully active or can carry out light work.

I have received an organ transplant from another person.

BMS-986249

This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.

A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Tiragolumab + Atezolizumab for Non-Small Cell Lung Cancer

This study is evaluating whether a drug combination can improve the survival of people with lung cancer.

My lung cancer is advanced, cannot be surgically removed, and has been confirmed by lab tests.

You have a positive test for HIV, active hepatitis B or C, or active tuberculosis.

I agree to either not have sex or use birth control, and not donate sperm.

My NSCLC has a specific mutation in the EGFR gene or an ALK fusion.

My spinal cord compression hasn't been treated or stabilized for 2 weeks.

I frequently need procedures to remove excess fluid from my chest or abdomen.

I haven't had any cancer other than NSCLC in the last 5 years, or if I did, it was not serious and was treated.

I have a history of lung scarring or inflammation not caused by infections.

I have high calcium levels that need ongoing treatment.

I have pain from my cancer that isn't relieved by treatment.

I haven't had major surgery in the last 4 weeks.

You are expected to live for at least 12 more weeks.

I have not received a live vaccine in the last 4 weeks.

You have a disease that can be measured using a specific set of guidelines.

I have brain metastases that are untreated or getting worse.

I haven't had any systemic treatment for my advanced lung cancer.

You have had an autoimmune disease in the past.

You have had serious allergic reactions to certain types of medications made from animals or cells, or have allergies to specific components of atezolizumab.

I have had a bone marrow or organ transplant in the past.

This clinical trial is an open label, dose-ranging study designed to evaluate gene therapy to treat patients who are APOE4 homozygotes with clinical diagnosis varying from mild cognitive impairment due to Alzheimer's, mild dementia due to Alzheimer's disease, and moderate dementia due to Alzheimer's disease.

Gene Therapy for APOE4 Homozygote of Alzheimer's Disease

Gene Therapy for Alzheimer's Disease

This study is evaluating whether a gene therapy may help treat Alzheimer's disease.

I have no allergies to the study drug or related medications.

I do not have major health issues like heart, liver, kidney failure, cancer, or HIV.

I have a high fever, increased white blood cells, and lung issues on an x-ray.

I have been diagnosed with early or moderate Alzheimer's disease.

I haven't taken part in any experimental drug trials for the last 4 weeks.

I don't need general anesthesia for procedures, except for the gene therapy.

I do not have any active infections, including hepatitis or HIV.

I am not on any immunosuppressants, steroids, or specific anti-amyloid drugs, and can stop taking anticoagulants if needed.

LX1001

The main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment.

Participants will receive soticlestat twice a day. Participants will visit the study clinic every 2-6 months throughout the study.

Study treatments may continue as long as the participant is receiving benefit from it.

A Study of Soticlestat in Adults and Children With Rare Epilepsies

Soticlestat for Rare Epilepsies

This study is evaluating whether a drug may help reduce seizures in patients with epilepsy.

My doctor thinks my condition makes me unfit for this study.

Soticlestat

TAK-935

Approximately 30 sites that enrolled participants in the MAVERICK-HCM (MYK-461-006) study in the United States (US) will initiate this study.

Approximately 90 sites that enrolled participants in the EXPLORER-HCM (MYK-461-005) study in the US, Europe, and Israel will initiate this study.

Note: Approximately 30 centers overlap between MAVERICK and EXPLORER.

A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM

Mavacamten for Hypertrophic Cardiomyopathy

This study is evaluating whether a drug called MYK-461 can improve the health of people with hepatitis C.

I have developed a significant cancer since joining the initial study.

Your blood and urine test results are within the normal range according to the lab's standards.

You have a history of fainting or a specific type of heart rhythm issue during exercise.

I am currently taking or plan to take disopyramide or ranolazine.

I haven't taken any experimental drugs or used investigational devices recently, except in the MAVERICK-HCM or EXPLORER-HCM studies.

I am not pregnant or breastfeeding and will use effective birth control during and 90 days after the trial.

My heart can be clearly seen on ultrasound.

My heart's pumping ability is normal or above normal.

You have a history of a specific type of serious heart problem that required a device to shock your heart back to a normal rhythm.

You have a heart condition that could be risky for your safety, like a specific abnormal heart rhythm.

Mavacamten

The main aim of the study is to determine if SHP611 given by injection into the spinal fluid that surrounds the brain and spinal cord (intrathecal; IT) prolongs the time for children with Metachromatic Leukodystrophy (MLD) to retain the ability to move from place to place. Other aims of the study are to determine the effects of intrathecal administration of SHP611 on movement and speech functions and to learn how well SHP611 injected in the spinal fluid that surrounds the brain and spinal cord is tolerated.

Study participants will receive SHP611 for about 2 years with the possibility of an extended treatment period.

A Study of Intrathecal SHP611 in Children With Metachromatic Leukodystrophy

Intrathecal SHP611 for Metachromatic Leukodystrophy

This study is evaluating whether intrathecal administration of SHP611 is safe and effective in children with metachromatic leukodystrophy.

I have had a bone marrow, stem cell transplant, or gene therapy.

PPD Clinical Trials 2022

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