Search Clinical Trials
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Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Ref1
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Multiple Myeloma
The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in
participants with relapsed or refractory multiple myeloma. expand
The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma. Type: Interventional Start Date: Mar 2024 |
A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants1
Sanofi
Chronic Graft Versus Host Disease
This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate
or severe chronic GVHD.
The study duration for a participant includes up to 4 weeks for screening; a treatment
period until clinically meaningful cGVHD progression (defined as progression requiring
addition of1 expand
This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically meaningful cGVHD progression (defined as progression requiring addition of new systemic treatment for cGVHD), relapse/recurrence of the underlying disease, participant starts new systemic treatment for cGVHD or experiences an unacceptable toxicity, at the request of the participants or the investigators, or until the end of study is reached, whichever comes first; at least 30 days follow-up of adverse events (AEs) after the last dose until resolution or stabilization, if applicable; and long-term follow-up until death or study close-out, whichever comes first. Type: Interventional Start Date: Jan 2024 |
Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
BicycleTx Limited
Metastatic Urothelial Cancer
This is a global, multicenter, randomized, open-label study, with an adaptive design. The
main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide
pevedotin) as monotherapy and in combination with pembrolizumab in participants with
locally advanced or metastatic urot1 expand
This is a global, multicenter, randomized, open-label study, with an adaptive design. The main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide pevedotin) as monotherapy and in combination with pembrolizumab in participants with locally advanced or metastatic urothelial cancer (UC). The study includes a dose selection phase followed by an adaptive design continuation. The study is comprised of 2 cohorts. Cohort 1 will include participants who have not received any prior systemic therapy for locally advanced or metastatic UC and are eligible to receive platinum-based chemotherapy, whereas Cohort 2 will include participants who have received ≥ 1 prior systemic therapy for locally advanced or metastatic UC. Type: Interventional Start Date: Jan 2024 |
Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS)
Direct Biologics, LLC
Acute Respiratory Distress Syndrome
ARDS
To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow
mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for
the treatment of hospitalized patients with moderate-to-severe Acute Respiratory Distress
Syndrome (ARDS). expand
To evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles (EVs), ExoFlo, versus placebo for the treatment of hospitalized patients with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). Type: Interventional Start Date: Jul 2022 |
Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozo1
NRG Oncology
Glioblastoma
Gliosarcoma
This phase III trial compares the effect of adding lomustine to temozolomide and
radiation therapy versus temozolomide and radiation therapy alone in shrinking or
stabilizing newly diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as
lomustine and temozolomide, work in different ways1 expand
This phase III trial compares the effect of adding lomustine to temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as lomustine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy photons to kill tumor cells and shrink tumors. Adding lomustine to usual treatment of temozolomide and radiation therapy may help shrink and stabilize glioblastoma. Type: Interventional Start Date: Nov 2021 |
Pyruvate Kinase Deficiency Global Longitudinal Registry
Agios Pharmaceuticals, Inc.
Pyruvate Kinase Deficiency
This study is an observational (ie, noninterventional), longitudinal, multicenter, global
registry for patients with pyruvate kinase (PK) deficiency, a rare nonspherocytic
hemolytic anemia.
This Registry will be open for enrollment for 7 years and all enrolled participants will
be followed prospec1 expand
This study is an observational (ie, noninterventional), longitudinal, multicenter, global registry for patients with pyruvate kinase (PK) deficiency, a rare nonspherocytic hemolytic anemia. This Registry will be open for enrollment for 7 years and all enrolled participants will be followed prospectively for a minimum of 2 years, and up to 9 years. Data will be collected from participating Registry Physicians, participants, and, where appropriate, parents/guardians who have provided informed consent or assent (where relevant) and authorization pursuant to applicable laws and regulations. Data should include demographic, clinical, and treatment data; and other data of relevance to the management of patients with PK deficiency. Annual chart review and data entry are expected in order to enhance longitudinal understanding of PK deficiency; however, no specific protocol schedule of assessment is required by this Registry protocol. Type: Observational [Patient Registry] Start Date: Apr 2018 |
RECOVER-AUTONOMIC Platform Protocol
Kanecia Obie Zimmerman
Long COVID
Long Covid19
Long Covid-19
This study is a platform protocol designed to be flexible so that it is suitable for a
wide range of settings within health care systems and in community settings where it can
be integrated into COVID-19 programs and subsequent treatment plans.
This protocol is a prospective, multi-center, multi-a1 expand
This study is a platform protocol designed to be flexible so that it is suitable for a wide range of settings within health care systems and in community settings where it can be integrated into COVID-19 programs and subsequent treatment plans. This protocol is a prospective, multi-center, multi-arm, randomized, controlled platform trial evaluating various interventions for use in the treatment of autonomic dysfunction symptoms, including cardiovascular complications and postural orthostatic tachycardia syndrome (POTS), in PASC participants. The interventions tested will include non-pharmacologic care and pharmacologic therapies with study drugs. Type: Interventional Start Date: Mar 2024 |
Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Protein1
Vertex Pharmaceuticals Incorporated
Proteinuric Kidney Disease
The purpose of this study is to evaluate the efficacy, safety, tolerability, and
pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein
L1 (APOL1)-mediated proteinuric kidney disease. expand
The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of VX-147 in adult and pediatric participants with apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease. Type: Interventional Start Date: Mar 2022 |
A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
CARGO Therapeutics
Cancer
Relapsed/Refractory Large B-cell Lymphoma (LBCL)
This is a prospective, open-label, multi-center clinical study designed to evaluate the
safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of
firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor
(CAR) T-cell therapy for the tr1 expand
This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL). Type: Interventional Start Date: Aug 2023 |
A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept)1
Pfizer
Multiple Myeloma
The main purpose of the study is to evaluate the safety and tolerability of the
combination of elranatamab and carfilzomib and dexamethasone or elranatamab and
maplirpacept.
There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of
elranatamab when given in combination w1 expand
The main purpose of the study is to evaluate the safety and tolerability of the combination of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept. There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of elranatamab when given in combination with carfilzomib plus dexamethasone. Part 2 has 2 arms. The first will evaluate the safety and tolerability of elranatamab when given in combination with maplirpacept. The second will identify the optimal dose(s) of elranatamab plus maplirpacept. All study medicines are given over 4-week cycles. Everyone taking part in this study will receive elranatamab as a shot under the skin. Participants in Part 1 will also receive weekly carfilzomib as an IV infusion (given directly into a vein) and dexamethasone either by mouth (as a pill) or by IV infusion. Participants in Part 2 will receive elranatamab in combination with maplirpacept as an IV infusion (given directly into a vein) The investigators will examine the experiences of people receiving the study medicines. This will help determine if the study medicines are safe and can be used for multiple myeloma treatment. Participants will take part in this study for about 2 years after the first dose. Type: Interventional Start Date: Dec 2022 |
A Study of CYP-001 in Combination With Corticosteroids in Adults With High-risk aGvHD
Cynata Therapeutics Limited
Graft Versus Host Disease, Acute
This study is a prospective randomized placebo-controlled phase 2 study to compare
CYP-001 plus corticosteroids (CS) to placebo plus CS in allogeneic hematologic stem cell
transplant recipients with HR-aGvHD. Severity of GvHD will be assessed at screening and
throughout the study using Mount Sinai1 expand
This study is a prospective randomized placebo-controlled phase 2 study to compare CYP-001 plus corticosteroids (CS) to placebo plus CS in allogeneic hematologic stem cell transplant recipients with HR-aGvHD. Severity of GvHD will be assessed at screening and throughout the study using Mount Sinai Acute GvHD International Consortium (MAGIC) guidelines. Eligible subjects will be randomized to receive either CYP-001 IV infusion on Days 0 and 4 or placebo on the same days. All subjects will receive ongoing CS therapy as appropriate per institutional guidelines. Subjects will have study visits up to Day 100 during the Primary Evaluation Period. During the Follow-Up Period, subjects will have study visits up to 24 months. Type: Interventional Start Date: Mar 2024 |
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-1
Alliance for Clinical Trials in Oncology
Anatomic Stage IA Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Anatomic Stage IIB Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in
preventing breast cancer from coming back (relapsing) in patients with high risk, HER2
positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a
chemotherapy drug, called DM1. Tra1 expand
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. Type: Interventional Start Date: Jan 2021 |
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metast1
SWOG Cancer Research Network
Castration Levels of Testosterone
Metastatic Prostatic Adenocarcinoma
Stage IV Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
This phase III trial studies how well standard systemic therapy with or without
definitive treatment (prostate removal surgery or radiation therapy) works in treating
participants with prostate cancer that has spread to other places in the body. Addition
of prostate removal surgery or radiation the1 expand
This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading. Type: Interventional Start Date: Sep 2018 |
Behavioral Pharmacology of Cannabis in Older Adults
University of Arkansas
Health Services for the Aged
This study examines the effects of cannabis on mood, cognitive and psychomotor
performance, balance and vital signs in older adults. expand
This study examines the effects of cannabis on mood, cognitive and psychomotor performance, balance and vital signs in older adults. Type: Interventional Start Date: Dec 2024 |
Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer1
National Cancer Institute (NCI)
Metastatic Papillary Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8
This phase II trial compares the effect of atezolizumab in combination with usual
treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell
carcinoma that has spread to other places in the body (metastatic). Papillary renal cell
carcinoma (PRCC) is a type of kidney can1 expand
This phase II trial compares the effect of atezolizumab in combination with usual treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell carcinoma that has spread to other places in the body (metastatic). Papillary renal cell carcinoma (PRCC) is a type of kidney cancer that forms in the lining of the tiny tubes in the kidney that return filtered substances that the body needs back to the blood and remove extra fluid and waste as urine. Most papillary tumors look like long, thin finger-like growths under a microscope. It is also called papillary kidney cancer or PRCC. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of cancer cells. Combination therapy with atezolizumab and cabozantinib may shrink the cancer and allow a longer survival time in patients with metastatic renal cell carcinoma. Type: Interventional Start Date: Mar 2023 |
Optimizing the Use of Ketamine to Reduce Chronic Postsurgical Pain
NYU Langone Health
Chronic Postsurgical Pain
The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine
in reducing chronic post-mastectomy pain. Participants randomized to the first arm will
receive a 0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during
surgery (up to a maximum of 6 hours1 expand
The study utilizes a 3-arm placebo-controlled RCT to study the effectiveness of ketamine in reducing chronic post-mastectomy pain. Participants randomized to the first arm will receive a 0.35 mg/kg dose after induction, followed by a 0.25 mg/kg/hr infusion during surgery (up to a maximum of 6 hours) and continued for 2 hours postoperatively. Participants in the second arm will receive a single dose of 0.6 mg/kg of ketamine in the post-anesthesia care unit, and the final group will serve as the control group and receive saline (no ketamine). Type: Interventional Start Date: Jan 2022 |
Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Sta1
ECOG-ACRIN Cancer Research Group
Advanced Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8
Clinical Stage IV Cutaneous Melanoma AJCC v8
Melanoma of Unknown Primary
Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
This phase II trial investigates how well biomarkers on PET/CT imaging drive early
discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot
be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy
option for patients with unresectable mel1 expand
This phase II trial investigates how well biomarkers on PET/CT imaging drive early discontinuation of anti-PD-1 therapy in patients with stage IIIB-IV melanoma that cannot be removed by surgery (unresectable). Anti-PD-1 therapy has become a standard therapy option for patients with unresectable melanoma. This trial is being done to determine if doctors can safely shorten the use of standard of care anti-PD1 therapy for melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy. Type: Interventional Start Date: Feb 2021 |
International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)
Institute of Cancer Research, United Kingdom
Squamous Cell Carcinoma of the Penis, Usual Type
This is an international phase III trial, with a Bayesian design, incorporating two
sequential randomisations. It efficiently examines a series of questions that routinely
arise in the sequencing of treatment. The study design has evolved from lengthy
international consultation that has enabled us1 expand
This is an international phase III trial, with a Bayesian design, incorporating two sequential randomisations. It efficiently examines a series of questions that routinely arise in the sequencing of treatment. The study design has evolved from lengthy international consultation that has enabled us to build consensus over which questions arise from current knowledge and practice. It will enable potential randomisation for the majority of patients with inguinal lymph node metastases and will provide data to inform future clinical decisions. InPACT-neoadjuvant patients are stratified by disease burden as assessed by radiological criteria. Treatment options are then defined according to the disease burden strata. Treatment is allocated by randomisation. Patients may be allocated to one of three initial treatments: A. standard surgery (ILND); B. neoadjuvant chemotherapy followed by standard surgery (ILND); or C. neoadjuvant chemoradiotherapy followed by standard surgery (ILND). After ILND, patients are defined as being at low or high risk of recurrence based on histological interpretation of the ILND specimen. Patients at high risk of relapse are eligible for InPACT-pelvis, where they are randomised to either: P. prophylactic PLND Q. no prophylactic PLND Type: Interventional Start Date: May 2017 |
Neural Enabled Prosthesis for Upper Limb Amputees
University of Arkansas, Fayetteville
Amputation Arm and Hand, Unilateral Right
Amputation Arm and Hand, Unilateral Left
Prosthesis User
This study is designed to evaluate the feasibility of The Adaptive Neural Systems
Neural-Enabled Prosthetic Hand (ANS-NEPH) system. expand
This study is designed to evaluate the feasibility of The Adaptive Neural Systems Neural-Enabled Prosthetic Hand (ANS-NEPH) system. Type: Interventional Start Date: Dec 2017 |
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Tr1
NRG Oncology
Prostate Adenocarcinoma
This phase III trial uses the Decipher risk score to guide intensification (for higher
Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to
better match therapies to an individual patient's cancer aggressiveness. The Decipher
risk score evaluates a prostate cancer1 expand
This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading. Type: Interventional Start Date: Nov 2021 |
Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy Aft1
NRG Oncology
Prostate Adenocarcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage IIA Prostate Cancer AJCC v8
Stage IIB Prostate Cancer AJCC v8
This phase III trial studies whether adding apalutamide to the usual treatment improves
outcome in patients with lymph node positive prostate cancer after surgery. Radiation
therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male
sex hormones, can cause the growth o1 expand
This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach. Type: Interventional Start Date: Mar 2020 |
Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
Nationwide Children's Hospital
Ductus Arteriosus, Patent
Patent Ductus Arteriosus is a developmental condition commonly observed among preterm
infants. It is a condition where the opening between the two major blood vessels leading
from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is
the normal part of the circulatory1 expand
Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward. Type: Interventional Start Date: Feb 2023 |
A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Canc1
Verastem, Inc.
Low Grade Serous Ovarian Cancer
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination
with defactinib versus Investigator's choice of treatments (ICT) in subjects with
recurrent LGSOC who have progressed on a prior platinum-based therapy. expand
This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy. Type: Interventional Start Date: Mar 2024 |
A Study Comparing Talquetamab in Combination With Daratumumab or in Combination With Daratumumab an1
Janssen Research & Development, LLC
Relapsed or Refractory Multiple Myeloma
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC)
in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in
combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination
with pomalidomide and dexamethasone (1 expand
The purpose of the study is to compare the efficacy of talquetamab subcutaneous(ly) (SC) in combination with daratumumab SC and pomalidomide (Tal-DP) and talquetamab SC in combination with daratumumab SC (Tal-D), respectively, with daratumumab SC in combination with pomalidomide and dexamethasone (DPd). Type: Interventional Start Date: Oct 2022 |
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (1
Genmab
Follicular Lymphoma (FL)
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type
of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional
treatment and the disease recurs in almost all patients. This study will assess how safe
and effective epcoritamab is in com1 expand
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires. Type: Interventional Start Date: Sep 2022 |
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