Lajuna Hills, California

S1803, Lenalidomide +/- Daratumumab/rHuPh20 as Post-ASCT Maintenance for MM w/MRD to Direct Therapy Duration

Transforaminal Lumbar Interbody Fusion (TLIF)

Post Approval Study (PAS) of the OPTIMIZER Smart and CCM Therapy

The Impulse Dynamics OPTIMIZER Smart Pre-Market Application (PMA) clinical data confirmed that CCM therapy delivered with the Optimizer meaningfully improved health outcomes in patients with NYHA class III heart failure symptoms and left ventricular ejection fraction of 25-45%. CCM has shown significant improvements in quality of life measures, with an average improvement of >11 points in MLHWFQ incremental to the improvement of a randomized control group with no device. Six minute hall walk and functional class also showed improvements in the PMA data. The post-approval study (PAS) protocol has been designed to evaluate long term safety and efficacy of the OPTIMIZER Smart in a real-world setting.

JNJ-90301900 (NBTXR3) Activated by Radiotherapy With or Without Cetuximab in LA-HNSCC

Participants will undergo a screening assessment over a period of less than or equal to (<=) 28 days to determine eligibility. Eligible participants will be treated by the Investigator's choice of RT alone or RT in combination with cetuximab. Following the Investigator's choice, participants will be randomized in a 1:1 ratio: - Arm A: JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab - Arm B: Investigator's choice of RT alone or RT in combination with cetuximab All participants (Arm A and Arm B) will receive 70 Gy in 35 fractions over a 7 week period. An EOT visit will be performed 4 weeks after the completion of RT. Follow-up visits will start at 12 weeks post-RT completion, and will continue every 12 weeks for 2 years, and then every 24 weeks thereafter until death; the participant is determined to be lost to follow up; withdrawal of consent; or the end of the study, whichever occurs first. Participants who have received further anti-cancer therapy for the study disease and/or have had disease progression/recurrence will be followed only for survival information

Clarifying the Optimal Application of SLT Therapy Trial

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

Currently, there are no biomarkers validated prospectively in randomized studies for resected colon cancer to determine need for adjuvant chemotherapy. However, circulating tumor DNA (ctDNA) shed into the bloodstream represents a highly specific and sensitive approach (especially with serial monitoring) for identifying microscopic or residual tumor cells in colon cancer patients and may outperform traditional clinical and pathological features in prognosticating risk for recurrence. Colon cancer patients who do not have detectable ctDNA (ctDNA-) are at a much lower risk of recurrence and may not need adjuvant chemotherapy. Furthermore, for colon cancer pts with detectable ctDNA (ctDNA+) who are at a very high risk of recurrence, the optimal adjuvant chemotherapy regimen has not been established. We hypothesize that for pts whose colon cancer has been resected, ctDNA status may be used to risk stratify for making decisions about adjuvant chemotherapy.

Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2

Neurotrophic keratopathy (NK) is a degenerative corneal disease that occurs as a result of partial or total impairment of trigeminal innervation. The resulting loss of corneal sensitivity (anesthesia) leads to a reduction in lacrimation and a decline in status, metabolism, and mitosis of corneal epithelial cells.

Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)

Patients (N=600) with surgically resected (R) brain tumors of any pathology who have undergone STaRT are eligible. Data collected will include local control, overall survival, QOL, neurocognition, functional decline, and surgical and radiation associated AE's. Data will be collected at 1, 3, 6, 9,12, 18 and 24 months, then every 6 months through 5 years. RESULT: Data will be used to benchmark clinical outcomes of STaRT therapy and allow for comparisons to existing standard-of-care treatments. This will be the first observational registry study of R+STaRT, delivered by Cs-131 sources in permanently implanted resorbable collagen tile carriers. The outcome measures captured will allow for evaluation of the potential risks and benefits of this treatment approach for patients in a real-world setting.

TRUEBEAM Stereotactic Body Radiotherapy for Localized Prostate Cancer

1.0 BACKGROUND 1.1 Prostatic adenocarcinoma is one of the most common forms of malignancy in men. Every year over 200000 patients are diagnosed with prostate cancer in the United States. Treatment options for these patients include active surveillance, radical prostectomy, external beam radiation therapy, permanent source interstitial brachytherapy and high dose rate (HDR) brachytherapy. 1.2 Each of these treatment options vary in regards to the logistics, anticipated outcomes, and potential side effects of therapy. 1.3 High-dose rate (HDR) brachytherapy has been used in the treatment of prostate cancer since the 1980's with good results. Catheters are placed temporarily in the prostate, and then loaded with a high-dose Iridium-192 source, delivering a few fractions of very high-dose RT. Brachytherapy allows the delivery of conformal, high-dose radiotherapy to the prostate, with a rapid dose fall-off outside of the region. It also takes advantage of low alpha/beta ratio of prostate cancer by using a hypofractionated approach. 1.4 The TrueBeam is a noninvasive radiosurgical system, capable of treating any part of the body from multiple targeting angles, creating a highly conformal three-dimensional radiosurgical treatment volume, guided by orthogonal X-ray-based targeting feedback, and delivering radiation by a highly collimated, robotically controlled linear accelerator. The TrueBeam system targets implanted fiducial markers with sub-millimeter set-up accuracy. 1.5 From a dosimetry standpoint, TrueBeam Stereotactic radiosurgery is capable of producing a dose distribution comparable to that created by prostate HDR brachytherapy treatment, without the need for invasive transperineal catheters, anesthesia, or inpatient admission. It would therefore be possible to deliver the HDR boost portion of a patient's treatment in a non-invasive fashion. As such, the TrueBeam prostate dose fractionation schedule prescribed in this study is based upon prior published prostate HDR brachytherapy experience both as a monotherapy and as a boost to external beam radiation therapy in patients with higher risk disease. The therapeutic volume in this study will also be made to resemble prostate HDR brachytherapy therapeutic volume, with similar dose limitation objectives to the adjacent tissues, including the rectum, bladder and urethra. It is theorized that such an approach should result in similar cancer control rates while lowering overall morbidity and improving the patient's comfort and convenience. 1.6 The feasibility of stereotactic body radiation therapy for treating localized prostate cancer was first described by King at Stanford University. Their phase I protocol delivered 36.25Gy in 5 fractions of 7.25Gy. In a recent report of acute and 18-month late toxicity in 26 "low-risk" patients, no patient experienced grade 3 or 4 acute or late toxicity, and only one patient experienced a grade 2 late morbidity (urethral stricture). Toxicity was less than that reported in MD Anderson's external beam dose escalation trial. Mean PSA 18 months after treatment was 0.22ng/ml. Naples Community Hospital reported a series of more than 70 low and intermediate risk patients treated with the SBRT. The prostate received 35 Gy in 5 fractions of 7 Gy each; acute toxicity was minimal. San Diego Cyberknife, which used a virtual HDR technique, reported a series of more than 124 low and intermediate risk patients treated. The prostate received 38Gy in 4 fractions of 9.5Gy each; acute toxicity was minimal. 1.7 Another potential benefit of stereotactic body radiosurgery relative to HDR brachytherapy is possibly better preservation of potency, even if the radiation distribution is essentially identical between these modalities. This is so because needle trauma has been identified as a potentially significant contributory factor to erectile dysfunction with brachytherapy, including HDR-based monotherapy technique, presumably due to direct physical injury to the neurovascular bundle and/or bulb of the penis, particularly when greater than 13 needle insertions are performed. By comparison, stereotactic body radiosurgery is noninvasive, and so removes this particular erectile dysfunction risk factor.