Clinical trials: De-escalation
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Kidney Transplantation
A Dose Escalation Study in de Novo Renal Transplantation
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
- Trial name
- NCT04311632
- Testing
- TCD601, Tacrolimus (TAC), Corticosteroids (CS)
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- ITB-Med LLC
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Chronic Myelomonocytic Leukemia
Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders
This phase II trial studies the side effects and best dose of total-body irradiation when given together with fludarabine phosphate followed by a donor peripheral stem cell transplant in treating patients with myelodysplastic…
- Conditions
- Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndrome, Essential Thrombocythemia
- Trial name
- NCT00397813
- Testing
- Cyclosporine, Fludarabine Phosphate, Laboratory Biomarker Analysis
- Where
- 3 sites in United States
- Volunteers
- 77 people
- Sponsor
- Fred Hutchinson Cancer Center
Ulcerative Colitis
A Study Evaluating the Effect of Filgotinib Dose De-escalation in Participants With Ulcerative Colitis (UC) in Remission
Participants who were in clinical remission on 200 milligram (mg) filgotinib once daily for at least 2 consecutive quarterly visits in the ongoing SELECTION-LTE study (GS-US-418-3899, NCT02914535), were planned to be rolled over…
- Trial name
- CAPYBARA (NCT05479058)
- Testing
- Filgotinib
- Where
- 50 sites in United States, Belgium and 11 more
- Volunteers
- 22 people
- Sponsor
- Lakefront Biotherapeutics NV
Human Papilloma Virus, Squamous Cell Carcinoma
De-Escalation Therapy for Human Papillomavirus Negative Disease
This study is looking to see if nivolumab, an immunotherapy drug, given with carboplatin and paclitaxel (2 chemotherapy agents) during induction therapy in advanced stage HPV negative patients can significantly shrink the…
- Conditions
- Human Papilloma Virus, Squamous Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck, HPV-Related Squamous Cell Carcinoma
- Trial name
- DEPEND (NCT03944915)
- Testing
- Carboplatin, Paclitaxel, Nivolumab
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Chicago
Myelodysplastic Syndromes
Clofarabine, Cytarabine, and G-CSF in Treating Patients With Myelodysplastic Syndromes
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00503880
- Testing
- filgrastim, clofarabine, cytarabine
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Nebraska
Malaria
Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali
Background: Malaria affects many people in Mali and other parts of Africa. It is spread by mosquito bites. Malaria can make people sick or can lead to death.
- Trial name
- NCT03917654
- Testing
- Pfs230D1M-EPA/AS01, HAVRIX, TYPHIM Vi (Salmonella typhi vaccine)
- Where
- Mali
- Volunteers
- 1,301 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Unresectable Stage IIIB-IV Malignant Melanoma
Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma
There are 2 fold of purposes for this study. 1 is to evaluate safety and tolerability and the other is to study the anti-tumor effects of talimogene laherparepvec in Japanese participants with unresectable stage IIIB-IV malignant…
- Trial name
- NCT03064763
- Testing
- Talimogene laherparepvec
- Where
- 9 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Amgen
Plasmodium Falciparum Infection, Malaria
Anti-malaria MAb in Kenyan Children
The purpose of this study is to evaluate the safety and tolerability of one-time subcutaneous (SC) administration of monoclonal antibody (MAb) L9LS in healthy Kenyan children aged 5 months to 10 years, as well as the protective…
- Trial name
- NCT05400655
- Testing
- L9LS
- Where
- Kenya
- Volunteers
- 912 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma
Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma
This phase I trial studies the side effects and best dose of gemcitabine and cisplatin when given together with ivosidenib or pemigatinib in treating patients with cholangiocarcinoma that cannot be removed with surgery…
- Conditions
- Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma, Unresectable Cholangiocarcinoma
- Trial name
- NCT04088188
- Testing
- Cisplatin, Gemcitabine, Ivosidenib
- Where
- 7 sites in United States
- Volunteers
- 8 people
- Sponsor
- Academic and Community Cancer Research United
Oropharyngeal Squamous Cell Cancer
Phase II Treatment Stratification Trial Using Neck Dissection-Driven Selection to Improve Quality of Life for Low Risk Patients With HPV+ Oropharyngeal Squamous Cell Cancer
Investigators will determine whether a treatment paradigm of up-front neck dissection, to more accurately pathologically stage patients, minimizing the number of treatment modalities in patients with low risk oropharyngeal…
- Trial name
- NCT02784288
- Testing
- Neck Dissection, Standard-of-Care (SOC) Transoral Surgery of Primary Site, SOC Radiation
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Michigan Rogel Cancer Center
Fanconi Anemia
TBI Dose De-escalation for Fanconi Anemia
This is a single arm, total body irradiation (TBI) trial. All patients will be prescribed TBI 300 cGy with the goal of evaluating secondary endpoints.
- Trial name
- NCT00352976
- Testing
- Cyclophosphamide, Fludarabine, Total Body Irradiation
- Where
- United States
- Volunteers
- 83 people
- Sponsor
- Masonic Cancer Center, University of Minnesota
Typhoid Fever
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
This phase 2 trial is aimed to obtain information on the safety and immunogenicity of the Vi-CRM197 in subjects from various age groups in India and Pakistan where Typhoid Fever is highly endemic and an efficacious vaccine…
- Trial name
- NCT01229176
- Testing
- Vi-CRM197 vaccine, Vi Polysaccharide (PS) vaccine, Pneumococcal conjugate vaccine
- Where
- 2 sites in India, Pakistan
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Novartis
SARS-CoV-2
A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age
The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injection in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an…
- Trial name
- NCT04796896
- Testing
- mRNA-1273, mRNA-1273.214
- Where
- 91 sites in United States, Canada
- Volunteers
- 11,942 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Advanced Non CNS Tumors
Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors
This is a phase 1 study to evaluate the safety of intralesional talimogene laherparepvec administration in pediatric subjects with advanced non-CNS tumors that are amenable to direct injection
- Trial name
- NCT02756845
- Testing
- Talimogene Laherparepvec
- Where
- 22 sites in United States, Belgium and 5 more
- Volunteers
- 15 people
- Sponsor
- Amgen
Acute Coronary Syndrome
MT1002 Phase II Study in ACS Patients With PCI
This is an open-label, sequential-dose escalation/de-escalation trial testing 3 dose levels of MT1002 in patients undergoing PCI due to ACS with NSTEMI.
- Trial name
- NCT04723186
- Testing
- MT1002 for Injection
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Advanced Malignant Solid Neoplasm, Anal Carcinoma
Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
This phase I trial studies the side effects and best dose of nivolumab when given with ipilimumab in treating patients with human immunodeficiency virus (HIV) associated classical Hodgkin lymphoma that has returned after a period…
- Conditions
- Advanced Malignant Solid Neoplasm, Anal Carcinoma, HIV Infection, Kaposi Sarcoma
- Trial name
- NCT02408861
- Testing
- Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography
- Where
- 34 sites in United States, Australia
- Volunteers
- 79 people
- Sponsor
- National Cancer Institute (NCI)
Graft Versus Host Disease, Leukemia
Clofarabine, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk and/or Advanced Hematologic Cancer or Other Disease
RATIONALE: Giving chemotherapy, such as clofarabine, melphalan, and thiotepa, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells.
- Conditions
- Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes
- Trial name
- NCT00423514
- Testing
- filgrastim, clofarabine, melphalan
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Oropharyngeal Cancer
De-Escalation Radiotherapy in Patients With Low-Risk HPV-Related Oropharyngeal Squamous Cell Carcinoma
The purpose of this study is to find out whether radiotherapy to some of the lymph node areas can be safely omitted to decrease side effects without increasing the risk of the tumour coming back.
- Trial name
- EVADER (NCT03822897)
- Testing
- Radiation, Cisplatin
- Where
- 14 sites in Canada
- Volunteers
- 103 people
- Sponsor
- Canadian Cancer Trials Group
Kidney Transplantation
A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
- Trial name
- NCT06365437
- Testing
- TCD601, Tacrolimus (TAC), Corticosteroids (CS)
- Where
- 7 sites in Austria, Spain and 1 more
- Volunteers
- 33 people
- Sponsor
- ITB-Med LLC