Clinical trials: Treatment naïve
Multiple Myeloma
Study of Lenalidomide and Dexamethasone With or Without Pembrolizumab (MK-3475) in Participants With Newly Diagnosed Treatment Naive Multiple Myeloma (MK-3475-185/KEYNOTE-185)
The purpose of this study is to compare the efficacy of lenalidomide and low dose dexamethasone with pembrolizumab (MK-3475) to that of lenalidomide and low dose dexamethasone without pembrolizumab in terms of progression-free…
- Trial name
- NCT02579863
- Testing
- Pembrolizumab, Lenalidomide, Dexamethasone
- Volunteers
- 310 people
- Sponsor
- Merck Sharp & Dohme LLC
Pancreatic Neoplasms
A Randomized Phase 2 Study of ARQ 197 Versus Gemcitabine in Treatment-Naïve Patients With Unresectable Locally Advanced or Metastatic Pancreatic Adenocarcinoma
This is a multi-center, open-label randomized phase 2 study designed to assess the progression free survival (PFS) of patients with untreatment and unresectable pancreatic cancer following treatment with either ARQ 197 or…
- Trial name
- NCT00558207
- Testing
- ARQ 197, gemcitabine
- Where
- 6 sites in Poland
- Volunteers
- 43 people
- Sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Chronic Hepatitis C
Efficacy and Safety of the Combination Vitamin D With Standard of Care in Egyptian Patients With Untreated Chronic Hepatitis C
The purpose of this study is to show the superiority of a 4 weeks lead-in phase of Vitamin D followed by a 48 weeks combination of Vitamin D with PEG-IFN plus RBV in comparison with standard PEG-IFN + RBV in untreated Egyptian…
- Trial name
- ViZIR (NCT02099604)
- Testing
- Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin
- Where
- Egypt
- Sponsor
- ANRS, Emerging Infectious Diseases
Infection, Human Immunodeficiency Virus, HIV Infections
Open-label Study of Dolutegravir (DTG) or Efavirenz (EFV) for Human Immunodeficiency Virus (HIV) - Tuberculosis (TB) Co-infection
HIV/Tuberculosis (TB) co-infection have profound effects on the host's immune system. TB is the most common cause of death in patients with HIV worldwide.
- Trial name
- NCT02178592
- Testing
- DTG 50 mg, EFV 600 mg
- Where
- 28 sites in Argentina, Brazil and 5 more
- Volunteers
- 113 people
- Sponsor
- ViiV Healthcare
Hepatitis C, HIV
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients.
This study consists of 2 parts, Part A and Part B. Part A, the Phase 1 drug interaction/early viral kinetic study, will evaluate the effect of selected antiretroviral therapies on the safety, viral kinetics, and pharmacokinetics…
- Trial name
- NCT01565889
- Testing
- SOF, EFV/FTC/TDF, EFV
- Where
- Puerto Rico
- Volunteers
- 52 people
- Sponsor
- Gilead Sciences
Castrate Resistant Prostate Cancer, Chemotherapy Naive Prostate Cancer
Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer
This is an open label randomized phase II study for prostate cancer patients who have disease progression after hormonal therapy.
- Conditions
- Castrate Resistant Prostate Cancer, Chemotherapy Naive Prostate Cancer, Prostate Cancer
- Trial name
- NCT01313559
- Testing
- Pasireotide, Everolimus, Laboratory biomarker analysis
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Chronic Hepatitis C
GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype
This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon…
- Trial name
- NCT01384383
- Testing
- GS-5885, GS-9451, RBV
- Where
- 55 sites in United States, Australia and 2 more
- Volunteers
- 248 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus
Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA < LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3
- Trial name
- MAGNITUDE (NCT01741545)
- Testing
- Pegylated-Interferon-lambda, Ribavirin, Daclatasvir
- Where
- 32 sites in United States, Australia and 6 more
- Volunteers
- 71 people
- Sponsor
- Bristol-Myers Squibb
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer
This phase II trial tests the safety, side effects, and whether dendritic cell-based treatment and pembrolizumab work in treating patients with triple negative breast cancer that has spread to other places in the body…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma, Unresectable Triple-Negative Breast Carcinoma
- Trial name
- NCT05539365
- Testing
- Alpha-type-1 Polarized Dendritic Cells, Biopsy, Computed Tomography
- Where
- United States
- Sponsor
- Roswell Park Cancer Institute
Carcinoma, Non-Small-Cell Lung
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in…
- Trial name
- NCT04165070
- Testing
- Pembrolizumab, Carboplatin, Paclitaxel
- Where
- 47 sites in United States, Canada and 8 more
- Volunteers
- 450 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1 Infection
Doravirine/Islatravir (DOR/ISL) in Pediatric Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are <18 Years of Age and Weigh ≥35 kg (MK-8591A-028)
This is a phase 2, single-group, multi-site, open-label study of an islatravir/doravirine (ISL/DOR, MK-8591A) fixed dose combination (FDC) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric…
- Trial name
- NCT04295772
- Testing
- DOR/ISL
- Where
- 17 sites in United States, Italy and 3 more
- Volunteers
- 42 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV-1-infection
Dolutegravir-Lamivudine for naïve HIV-Infected Patients With ≤200 CD4/mm3
Protocol Title: DOLCE: Dolutegravir-Lamivudine for naïve HIV-Infected Patients with ≤200 CD4/mm3 Protocol Number: FH-57 Study Objectives: To assess the antiviral activity at week 48 of DTG+3TC among naïve HIV patients with a CD4…
- Trial name
- DOLCE (NCT04880395)
- Testing
- Intervention Arm: dolutegravir/lamivudine, Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)
- Where
- 11 sites in Argentina, Brazil
- Volunteers
- 265 people
- Sponsor
- Fundación Huésped
AML, Adult
A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia
This is a prospective, single-arm, multi-center clinical trial to evaluate the efficacy and safety of selinexor in combination with azacitidine and venetoclax for untreated acute myeloid leukemia.
- Trial name
- SAV (NCT05736965)
- Testing
- Selinexor, Azacitidine, Venetoclax
- Where
- 19 sites in China
- Volunteers
- 58 people
- Sponsor
- Shanghai Tong Ren Hospital
Treatment-naïve, Sputum Smear-positive Patients With Drug-sensitive Pulmonary TB
A Phase 2 Study to Evaluate Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of Telacebec (Q203)
This is a Phase IIa, open-label, randomized study in treatment-naïve, sputum smear-positive patients with drug-sensitive pulmonary TB to assess the early bactericidal activity of telacebec (Q203).
- Trial name
- NCT03563599
- Testing
- Telacebec (Q203), Rifafour e-275
- Where
- 2 sites in South Africa
- Volunteers
- 60 people
- Sponsor
- Qurient Co., Ltd.
Spasticity Related to Any Cause Except Cerebral Palsy
A Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.
The aim of the study is to describe treatment outcomes of abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) treatments, after one injection of either treatment, in toxin-naïve adult patients with upper and/or…
- Trial name
- NCT04396704
- Where
- United Kingdom
- Volunteers
- 114 people
- Sponsor
- Ipsen
Hepatitis C
Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus
The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients…
- Trial name
- RHACE 1 (NCT02098616)
- Testing
- DCV/ASV/BMS-791325, DCV/ASV/BMS-791325 + RBV
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Timothy Morgan, MD
Liposarcoma, Dedifferentiated
Brightline-4: A Study to Test How Well Brigimadlin is Tolerated by People With a Type of Cancer Called Dedifferentiated Liposarcoma
This study is open to adults with a type of cancer called dedifferentiated liposarcoma (DDLPS). They can join the study if their tumours are positive for MDM2.
- Trial name
- NCT06058793
- Testing
- Brigimadlin
- Where
- 56 sites in United States, Argentina and 5 more
- Volunteers
- 138 people
- Sponsor
- Boehringer Ingelheim
Adenocarcinoma of the Prostate
Study With IMC-A12 (Cixutumumab) in Patients Who Have Not Previously Been Treated With Chemotherapy With Metastatic Prostate Cancer
This single arm, multicenter, open-label, Phase II study will enroll chemotherapy-naive participants with metastatic, histologically-confirmed adenocarcinoma of the prostate (stage M1 D2).
- Trial name
- NCT00520481
- Testing
- IMC-A12 (Cixutumumab)
- Where
- 3 sites in United States
- Volunteers
- 41 people
- Sponsor
- Eli Lilly and Company
High-risk Localized Prostate Cancer
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
Researchers are looking for a better way to treat men who have high-risk localized prostate cancer, which refers to a type of prostate cancer that is still confined to the prostate gland but has certain characteristics that make…
- Trial name
- CHINANEO (NCT07450599)
- Testing
- Darolutamide, ADT
- Where
- 23 sites in China
- Volunteers
- 250 people
- Sponsor
- Bayer
Diabetic Macular Edema
Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in Diabetic Macular Edema
Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina. The retina is like the film of a camera and is located in the back of the eye.
- Trial name
- NCT02441907
- Testing
- aflibercept
- Where
- Canada
- Volunteers
- 16 people
- Sponsor
- Unity Health Toronto