A PHASE 3 TRIAL OF FIANLIMAB (ANTI-LAG-3) AND CEMIPLIMAB VERSUS PEMBROLIZUMAB IN THE ADJUVANT SETTING IN PATIENTS WITH COMPLETELY RESECTED HIGH-RISK MELANOMA
This is a randomized, double-blind, phase 3 study in patients 12 years of age or older with completely resected high-risk melanoma in the adjuvant setting. There are 3 arms in the study. The study will enroll a total of approximately 1,530 patients, randomized 1:1:1. The study will be conducted globally, at approximately 200 sites in Europe, North America, Latin America (LATAM), and Australia. Patients will have had no prior systemic therapy for melanoma and have fully resected melanoma, of stages IIC, III or IV (American Joint Committee on Cancer [AJCC] v8). The trial will be stratified by the disease stage and geographical region. The study will be blinded, except for an unblinded pharmacist at each site. Primary Objective is to demonstrate superiority of fianlimab + cemiplimab compared to pembrolizumab, as measured by relapse-free survival (RFS).
A Phase 3 Two-stage Randomized Multi-center Controlled Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy after Autologous Stem Cell Transplantation (ASCT) in Participants with Newly Diagnosed Multiple Myeloma (NDMM)
This is a two-stage, Phase 3, randomized, multi-center, controlled, open-label study comparing iberdomide maintenance to lenalidomide maintenance therapy after ASCT in participants with newly diagnosed multiple myeloma.The primary objective of this study is to compare the efficacy of iberdomide to that of lenalidomide maintenance after ASCT in participants with NDMM, as measured by PFS.
A Phase 3b Multicenter Randomized Double-blind Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneously Administered Guselkumab in Improving the Signs and Symptoms and Inhibiting Radiographic Progression in Participants with Active Psoriatic Arthritis.
Participants who satisfy all inclusion and exclusion criteria will be randomly assigned to one of the following 3 treatment groups in a 7:5:7 ratio using permuted block randomization with stratification defined by a combined factor of baseline radiographic variability, corticosteroid use, number of joints with erosion, and the most recent available C-reactive protein (CRP) value prior to randomization into 4 strata levels (high radiographic variability [HRV], no progression [NP], low to moderate progression [LMP], and rapid progression [RP]). All participants with HRV will be assigned to the HRV stratum, and the rest of participants will be assigned to the other strata based on probability of NP, LMP, and RP. • Group I (n=350): Participants will receive subcutaneous (SC) guselkumab 100 mg at Weeks 0, 4, 12, 20, 28, 36 and 44 and placebo at Weeks 8, 16, 24, 32, 40 and 48 to maintain the blind.• Group II (n=250): Participants will receive SC guselkumab 100 mg at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48.• Group III (n=350): Participants will receive SC placebo at Weeks 0, 4, 8, 12, 16 and 20, and will cross over at Week 24 to receive SC guselkumab 100 mg at Weeks 24, 28, 32, 36, 40, 44 and 48. At Week 16, all participants in Groups I, II, and III with
A Phase I Multicenter Open-label First-in Human Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination with Anti-cancer Agents in Patients with Advanced Solid Tumors
This is a first-in-human modular Phase 1, open-label, multi-center study to evaluate the safety and tolerability and identify a recommended phase 2 dose (RP2D) of AZD9592 alone and with a specific combination treatment, in EGFR and cMET expressing tumors, initially NSCLC EGFR mut (L858R/ex19del) and wild type, as well as HNSCC. The study will also evaluate the preliminary efficacy, PK, PD and immunogenicity of AZD9592.
A phase I open-label multi-center study of KFA115 as a single agent and in combination with pembrolizumab in patients with select advanced cancers
This study is a FIH, open-label, phase I, multi-center study that consists of two treatment arms in dose escalation: single-agent KFA115 (Arm A escalation) and KFA115 in combination with pembrolizumab preceded by a KFA115 run-in for 1 cycle (Arm B escalation). In expansion, the study consists of three treatment arms: single-agent KFA115 (Arm A expansion), KFA115 in combination with pembrolizumab after single-agent KFA115 run-in (Arm B expansion), and KFA115 to be initiated with pembrolizumab concurrently (Arm C expansion).
A PHASE I RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED SINGLE-CENTER STUDY OF SAFETY AND EFFECTIVENESS OF INNATE IMMUNITY STIMULATION VIA TLR9 IN MILD COGNITIVE IMPAIRMENT OR EARLY AD
This single-center, double-blind, placebo-controlled study will recruit in total 39 participants with either Mild Cognitive Impairment due to Alzheimer’s disease (MCI) or Mild Alzheimer’s disease dementia (mild AD). There will be 3 Dose levels. An initial cohort of 13 subjects will be randomized to a Dose level 1 (0.1 mg/kg vs. placebo) lasting 8 weeks. An additional 13 subjects will be recruited and randomized into Dose level 2 (0.25 mg/kg vs. placebo) for 8 weeks and 13 subjects for the last Dose level 3 (0.5 mg/kg vs. placebo) for 8 weeks. Primary ObjectivesEvaluate the safety and tolerability of 3 escalating dose levels of CpG 1018 (dose level 1: 0.1 mg/kg vs. placebo; dose level 2: 0.25 mg/kg vs. placebo; dose level 3: 0.5 mg/kg vs. placebo) as 3 subcutaneous (s.c.) injections in patients with MCI or mild AD.Secondary ObjectivesKey secondary objectives:• To evaluate drug effect on immunostimulatory responses• To evaluate drug effect on disease progression An independent unblinded Data Safety Monitoring Board (DSMB) will convene at regular intervals to monitor the overall safety of the study and to make recommendations to the PI related to study safety as appropriate.
A Phase I Study of ExoFlo an ex vivo Culture-expanded Adult Allogeneic Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicle Isolate Product for the Treatment of Medically Refractory Ulcerative Colitis
Patients with Ulcerative Colitis are often managed with corticosteroids, immunomodulators and monoclonal antibodies, all fraught with potential side effects. The advent of the biologic era for the treatment of moderate to severe Ulcerative Colitis was marked by the Federal Drug Administration (FDA) and European Medicine Agency’s (EMA) approval of infliximab, an anti-tumor necrosis-alpha (TNF) inhibitor, in 1998. Despite its known safety and efficacy, clinically significant rates of primary non-response and secondary non-response to anti-TNF agents has driven research to develop biologic therapies with alternative mechanisms of action.[1-7]Despite the number of monoclonal antibodies available, the rates of medically refractory disease requiring abdominal surgery has not significantly changed. As such, the need for alternative therapies with a safer profile and improved efficacy has become a priority. MSCs have recently demonstrated safety and improved efficacy for Ulcerative Coliti. However, cell-based therapy has logistical hurdles to successfully treat thousands of at need patients. Extracellular vesicles can overcome many cell-therapy logistical challenges related to shipping, thawing and shelf life.
A PHASE I/IB SINGLE ARM STUDY OF TWO FRACTION SBRT WITH DOMINANT LESION SIB FOR THE TREATMENT OF LOCALIZED PROSTATE CANCER
Phase I/IB, single arm trial of Two-Fraction SBRT with an MRI directed, dominant intraprostatic lesion, simultaneous integrated boost based on genomic classification in the treatment of localized prostate cancer. Primary endpoint will be physician-reported grade 2 or higher CTCAE toxicity. Secondary endpoints are: EPIC quality of life, PSA Nadir, and Phoenix Definition Biochemical failures as well as Disease Free Survival, Overall Survival, and MFS.
A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
A Phase I/II Study of M3814 and Avelumab in Combination with Hypofractionated Radiation in Patients with Advanced/Metastatic Solid Tumors and Hepatobiliary Malignancies
A Phase I/II Study of TheraT Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers
From sponsor:As background, this protocol started as a Phase I Dose Escalation and is now a Phase I/II Escalation/Expansion. This protocol has increased in complexity in each version and protocol version 6.0 is now a more streamlined protocol version with focus on Dose Expansion. To note:• All groups are closed. Phase 1 is completed.• Phase II Group B -enrolled 3 patients (HB-201 + pembrolizumab); closed to recruitment• Focus is Phase II Groups E&F o HB-200 two-vector therapy + pembrolizumab