Clinical Trials

Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects = 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 study.

This is a multi-center, open-label, Phase Ib dose escalation / Phase II study in recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) patients considered to be resistant, ineligible or intolerant to platinum-based chemotherapy. The first aim of the Phase Ib is to determine the Maximum Tolerated Dose(s) (MTD(s)) and/or the Recommended Phase II Dose(s) (RP2D(s)) for BYL719 in combination with cetuximab This part will include two different arms using two different administration methods of BYL719 tablets together with cetuximab as recommended by the label: Arm A - whole tablets will be administered to patients able to swallow the tablets vs. Arm B - a drinkable suspension prepared from crushed tablets will be administered to patients with swallowing dysfunction. The second aim of the Phase Ib is to compare the pharmacokinetics (PK) of the new dispersible tablet formulation of BYL719 in combination with cetuximab. A third arm will be opened: Arm C, which will use a suspension from a dispersible tablet administered via gastric feeding tube (G tube). The safety, tolerability, PK, PD, and efficacy will be investigated separately in the Phase Ib arms. The MTD/RP2D will only be investigated independently for Arm A and B. The one of Arm B will be compared to that of Arm A. If the MTD/RP2D is the same, then both administration methods of BYL719 may be used in Phase II. If the MTD/RP2D is different, then only the administration of BYL719 whole tablets will be allowed in the Phase II. Arm C is an independent relative bioavailability study of the new dispersible tablet formulation of BYL719, which will begin at the starting dose/RP2D identified with a safety cohort followed by an expansion cohort. There will be no dose escalation or de-escalation in this Arm. If either the safety or pharmacokinetic profile of the RP2D of 300 mg QD in Arm C is not comparable with Arm A, then enrollment in Arm C will cease and the dispersible tablet will not be implemented in Phase II.

The Phase Ib dose escalation part is expected to enroll approximately 12 patients for Arm A and B and will be guided by a Bayesian logistic regression model (BLRM). The available safety, tolerability, PK, PD and efficacy data, as well as the recommendations from the BLRM, are used to determine the dose combination for the next cohort(s). The Phase II part of the study will commence upon MTD/RP2D declaration of Arm A in Phase Ib, regardless of the progress of Arm B and C.

The Phase II part will assess the clinical efficacy of BYL719 in combination with cetuximab in two patient populations: patients will be assigned to one of two schemes of enrollment based on prior therapy with cetuximab.

Patients considered cetuximab naïve per protocol will be assigned to Scheme 1. The primary purpose of this scheme is to assess the anti-tumor activity of BYL719 in combination with cetuximab (Arm 1) vs. cetuximab as single-agent (Arm 2) in RM HNSCC patients' naïve to cetuximab. Patients in scheme 1 will be randomized in a 2:1 ratio via IRT in two Phase II arms: BYL719 in combination with cetuximab (Arm 1) vs. cetuximab as single-agent (Arm 2). Patients randomized to Arm 2 (cetuximab monotherapy) will have the opportunity to cross-over to combination treatment with BYL719 + cetuximab after experiencing disease progression. Arm 1 will consist of approximately 66 patients and Arm 2 of approximately 33 patients.

Patients having received prior cetuximab per protocol will be assigned to Scheme 2. The primary purpose of this scheme is to assess the anti-tumor activity of BYL719 in combination with cetuximab in RM HNSCC cetuximab resistant patients (Arm 3). Patients in this scheme will not be randomized. 40 patients will be enrolled. Phase II will further characterize the safety and PK of the drug combination.

Patients will be treated until progression of disease (except for phase II Arm 2), unacceptable toxicity, or withdrawal of informed consent, whichever occurs first. Patients enrolled in Arm 2 experiencing disease progression will have the opportunity to crossover to the combination treatment (Arm 2B) and they will continue until they experience unacceptable toxicity that precludes any further treatment, until disease progression, and/or until treatment is discontinued at the discretion of the Investigator or by patient refusal. In the follow-up period all patients must complete the safety follow-up assessments 30 days after the last dose of the study treatment. Patients who have not progressed at the time of discontinuation of study treatment should be radiologically followed for disease status until disease progression, initiation of subsequent anticancer therapies, or death, whichever occurs first. In addition, all patients enrolled in Phase II will be followed for survival.

The purpose of this study is to see whether a drug called regorafenib might be effective in treating angiosarcoma. This study is for patients who have angiosarcoma that has gotten worse after they received chemotherapy. Regorafenib is a type of drug called a kinase inhibitor. Regorafenib interferes with how some kinase proteins work. Some of these kinases in cancer cells might normally help the cancer cells grow or form new blood vessels that could feed a growing tumor. By blocking these proteins, regorafenib may help stop the growth of certain cancers.

This is an expanded access program (EAP) for participants who have progressed after prior systemic therapy including ipilimumab, and V-raf murine sarcoma viral oncogene homolog B1 (BRAF) inhibitor or mitogen-activated protein kinase (MEK) enzyme inhibitor when indicated. Participants cannot be eligible for or have participated in any pembrolizumab (MK-3475) clinical trial with the exception of a participant enrolled in the pembrolizumab protocol MK-3475-006 who received treatment on the ipilimumab treatment arm and progressed; such participants will be eligible to participate in the EAP, regardless of prior treatment with a BRAF/MEK inhibitor, as long as all other eligibility criteria for MK-3475-030 are met.

This randomized phase II trial studies how well lenalidomide improves immune response to pneumococcal 13-valent conjugate vaccine in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, or monoclonal B cell lymphocytosis. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Lenalidomide may also improve the effectiveness of pneumococcal 13-valent conjugate vaccine that is used to prevent infection.

This phase II trial studies how well Avatar-directed chemotherapy works in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that does not respond to platinum anti-cancer drugs. Drugs used in chemotherapy, such as paclitaxel, gemcitabine hydrochloride, pegylated liposomal doxorubicin hydrochloride, topotecan hydrochloride, 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. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Using an Avatar, a living tumor sample with similar genetic characteristics to the original tumor, may help determine which chemotherapy is most effective. 

The purpose of this study is to explore the transformative potential of spiritually aligned mindfulness practices tailored for Black adult cancer survivors. Recognizing the unique cultural and spiritual needs of this group, the research seeks to develop and evaluate a faith-based Mindfulness Based Intervention (MBI) model designed to enhance resilience and improve Quality of Life (QoL) during cancer survivorship. This goal will be achieved through two objectives: (i)develop a culturally modified MBSR curriculum that is adapted to align with congruent faith-based religious practices; (ii) test the impact of the developed culturally modified MBI intervention on improvement of wellbeing and QoL. 

This is a feasibility study to evaluate the impact of local delivery of Yamani-15/5 (combination of L-Lactic acid 15% and D-Gluconic acid 5%) on vascular calcification of lower extremities in patients with severe peripheral arterial disease who were deemed to have unreconstructable arterial disease and who have already been scheduled to undergo below knee or above knee amputation.

Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.

Part A: (ADXS11-001 + MEDI4736 Combination Therapy) will determine the safety and tolerability of the combination and to identify a RP2D.

Part B: Phase 2 design which will randomize subjects 1:1 to either MEDI4736 alone or MEDI4736+ADXS11-001 in subjects who have failed at least 1 prior systemic treatment for their recurrent/persistent or metastatic cervical cancer.