Clinical Trials

This is a Phase II therapeutic trial combining Decitabine days 1-5 with oral Vorinostat twice daily days 6-15 followed by a single infusion of CD3-/CD19- enriched donor natural killer (NK) cells on day 17 and a short course of Interleukin-2 (IL-2) to facilitate NK cell survival and expansion. Two courses of treatment will be given separated by 6-8 weeks. The intent is to administer all treatment in the outpatient setting.

You are being asked to take part in this research study because you are going to be treated with oxaliplatin chemotherapy as part of your standard care. Oxaliplatin commonly causes neuropathy (numbing, tingling and/or pain).The purpose of this study is to compare the effects, good and/or bad, of venlafaxine with a placebo (an inactive agent) on oxaliplatin-induced neuropathy (numbing, tingling and/or pain)

Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Azacitidine is a hypomethylating agent (HMA) used to treat MDS. In this study, patients with intermediate- or high-risk MDS will receive treatment with mocetinostat and azacitidine to evaluate the safety of the study treatment. Safety assessments will include echocardiograms, electrocardiograms and routine safety laboratory studies (hematology and serum chemistry). In addition, clinical response to treatment will be monitored using bone marrow aspirates or biopsies, and other routine methods.

The purpose of this research is to see if MR-guided cryoablation can effectively treat prostate tumor recurrences.

This partially randomized phase III clinical trial is studying different combinations of risk-adapted chemotherapy regimens and their side effects and comparing how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.

Evaluating the efficacy of ION-682884 after administration for 65 weeks, as compared to the historical control of the placebo cohort (inotersen) in the NEURO-TTR trial, based on the change from Baseline in serum TTR concentration, mNIS+7 and in the Norfolk Quality of Life.

Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) in patients with hATTR. To evaluate the efficacy of ION-682884, as compared to the placebo cohort in the NEURO-TTR  trial, based on the change from Baseline in the following measures:

• Neuropathy Symptom and Change Score (NSC)
• Physical component summary (PCS) score of 36-Item Short Form Survey (SF-36)
• Polyneuropathy disability (PND) score
• Modified body mass index (mBMI)

To evaluate safety and tolerability in hATTR-PN patients treated with ION-682884 including the change from Baseline in platelet count and renal function, the presence of adverse events (AEs). To evaluate the efficacy of ION-682884 in mNIS+7 at Week 85, compared to Baseline.

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.

Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of BAY 1251152 in patients with solid tumors and aggressive non-hodgkin's lymphoma (NHL).

This research trial studies how well pre-test genetic education and remote genetic counseling works in communicating tumor profiling results to patients with advanced cancer. Web-based genetic education before receiving tumor profiling results and remote genetic counseling for patients with potential germline mutations may increase genetic knowledge and reduce distress for patients with advanced cancer.

This study tests the safety of a drug called SGN-CD352A, to find out what its side effects are. SGN-CD352A will be given every 4 weeks to a small group of patients with multiple myeloma.