Testing the Addition of Copanlisib to Eribulin for the Treatment of Advanced-Stage Triple Negative...
Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v82 moreThis phase I/II trial studies the side effects and best dose of copanlisib and how well it works when given together with eribulin in treating patients with triple negative breast cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as eribulin, 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. Giving copanlisib and eribulin may work better in treating advanced stage triple negative breast cancer compared to eribulin alone.
A Phase 1B/2 Study of RP1 in Solid Organ Transplant Patients With Advanced Cutaneous Malignancies...
Cutaneous Squamous Cell CarcinomaMerkel Cell Carcinoma2 moreThis Phase 1B/2 study is a multicenter, open-label, study of RP1 to investigate the (a) objective response rate, in addition to (b) safety and tolerability of RP1 for the treatment of advanced cutaneous malignancies in up to 65 evaluable organ transplant recipients. This will include patients with either previous renal, hepatic, heart, lung, or other solid organ transplantation or hematopoietic cell transplant and experiencing subsequent documented locally advanced or metastatic cutaneous malignancies. The study will enroll a total of 65 evaluable patients. Patients will participate up to approximately 3 years including a 28-day screening period, up to approximately 1 year treatment period, and a 2-year follow-up period.
A Study of SGN-B6A in Advanced Solid Tumors
CarcinomaNon-Small Cell Lung11 moreThis trial will look at a drug called SGN-B6A alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study SGN-B6A to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SGN-B6A works to treat solid tumors. The study will have four parts. Part A of the study will find out how much SGN-B6A should be given to participants. Part B will use the dose found in Part A to find out how safe SGN-B6A is and if it works to treat solid tumors. Part C of the study will find out how safe SGN-B6A is in combination with these other drugs. Part D will include people who have not received treatment. This part of the study will find out how safe SGN-B6A is in combination with these other drugs and if these combinations work to treat solid tumors. In Parts C and D, participants will receive SGN-B6A with either: Pembrolizumab or, Pembrolizumab and carboplatin, or Pembrolizumab and cisplatin.
Intratumoral Administration of Daromun in Non-melanoma Skin Cancer Patients
CarcinomaBasal Cell2 moreThis clinical phase II study is designed to investigate the efficacy of intratumorally administered L19IL2/L19TNF in patients with injectable lesions of BCC or cSCC. Favorable tumor responses following intralesional treatment with L19IL2/L19TNF have been observed in patients with injectable melanoma lesions of stage III or IV, for injected and non-injected lesions. The proposed clinical phase II study plans to investigate the intralesional administration of 6.5 Mio IU of L19IL2 (~1.08 mg) and 200 µg of L19TNF to be administered in an approximate volume of 1.0 mL as a single or multiple intratumoral injections in patients with high-risk BCC or cSCC. There is a high medical need for non-invasive therapeutic strategies with a comparable good response rate and high recurrence free survival for treatment of patients with BCC or cSCC, who cannot be treated by or refuse surgery. Surgery is not always applicable, as it may not be feasible due to the anatomic location, may have a poor cosmetic outcome for the patient or is generally not accepted as treatment strategy by the patient. However, current non-surgical treatment strategies have a considerably reduced response rate and recurrence free survival. Based on the favorable results for injected and non-injected lesions obtained in the phase II study of L19IL2/L19TNF and the good safety profile seen in the subsequent phase III study, both in stage III or IV melanoma patients, we believe, that patients with BCC or cSCC will profit from intralesional treatment with L19IL2/L19TNF.
Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Cisplatin and Capecitabine for Locally Advanced...
Esophageal Squamous Cell CarcinomaSurgical resection is currently the major treatment for esophageal carcinoma while disease progression still occurred in most cases within 3 years. The rate of local recurrence and distant metastases could reach nearly 40% to 60%. The neoadjuvant chemotherapy could significantly improve resection rate and overall survival after surgery. Squamous cell carcinoma is the most common histology in Asia. JCOG9907 trial performed in Japan confirmed that compared to surgery plus adjuvant chemotherapy, the combination of neoadjuvant chemotherapy and surgery could further prolong overall survival. The regimen of cisplatin and fluorouracil is a classic effective option in combination therapy for esophageal carcinoma. Nanoparticle albumin-bound (nab)-paclitaxel is a novel taxane and has better efficacy in esophageal carcinoma treatment. We try to evaluate the efficacy and safety of neoadjuvant chemotherapy with nab-paclitaxel plus cisplatin and capecitabine for locally advanced thoracic esophageal squamous cell carcinoma patients.
Safety and Efficacy of ASN-002 Combined With a Hedgehog Pathway Inhibitor
Basal Cell CarcinomaBasal Cell Nevus SyndromeThe primary objectives are to: Evaluate the safety and tolerability of intralesional ASN-002 when administered in combination with oral vismodegib in patients with Basal Cell Carcinomas (BCC)s; Evaluate the efficacy of intralesional ASN-002 in target tumours when administered in combination with oral vismodegib in patients with BCCs. The secondary objective is to: 1) Evaluate the efficacy of intralesional ASN-002 in non-target tumours when administered in combination with oral vismodegib in patients with BCCs. The exploratory objective is to: 1) Evaluate immunological biomarkers during the course of treatment.
Talazoparib and Axitinib for People With Previously Treated Advanced Kidney Cancer
Kidney CancerRenal Cell Carcinoma2 moreResearchers are doing this study to find out if the combination of the drugs axitinib and talazoparib is a safe and effective treatment for people with your previously treated advanced kidney cancer. Researchers will look for the highest dose of talazoparib that causes few or mild side effects when given in combination with a standard dose of axitinib.
NBTXR3 and Radiation Therapy for the Treatment of Inoperable Recurrent Non-small Cell Lung Cancer...
Recurrent Lung Non-Small Cell CarcinomaStage I Lung Cancer AJCC v812 moreThis phase I trial investigates the best dose and side effects of NBTXR3 when given together with radiation therapy for the treatment of non-small cell lung cancer that cannot be treated by surgery (inoperable) and has come back (recurrent). NBTXR3 is a radio-enhancer designed to increase the radiotherapy energy dose deposition inside tumor cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving NBTXR3 and radiation therapy may increase radiation-dependent tumor cell killing without increasing the radiation exposure of healthy surrounding tissues.
A Study of Pembrolizumab+ sEphB4 in Metastatic Urothelial Carcinoma
Metastatic Urothelial CarcinomasEphB-HSA may prevent tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. The purpose of this study is to evaluate the combination of Pembrolizumab + sEphB4-HSA in the population of patients with previously untreated advanced (metastatic or recurrent) urothelial carcinoma who are chemotherapy ineligible or who refuse chemotherapy.
Pre-Operative Pembrolizumab + Chemoradiation in Patients With Locally Advanced Esophageal Squamous...
Esophageal Squamous Cell CarcinomaTo investigate the safety and activity of preoperative pembrolizumab combined with chemoradiotherapy for resectable esophageal squamous cell carcinoma (ESCC) ,20 patients enrolled in Phase Ib PALACE-1(NCT03792347).The results showed that preoperative pembrolizumab with concurrent chemoradiotherapy was safe, did not delay surgery and induced a pCR in 55.6% of resected tumors. In this multicentre prospective study(PALACE-2),the investigators will evaluate the efficacy of preoperative pembrolizumab with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma.