Sequential Treatment of Cabozantinib or Cabozantinib With Nivolumab for Advanced Renal Cell Carcinoma...
RCCRenal Cell CarcinomaThe goal of this clinical trial is to learn about the effects of a higher dose of cabozantinib or the effects of cabozantinib-nivolumab combination in patients with advanced renal cell carcinoma who have progressed on or after receiving cabozantinib treatment. The study will have two parts or "cohorts". Cohort 1: cabozantinib 80mg daily Cohort 2: cabozantinib 40mg daily with nivolumab The cohort assignment will be determined by investigator, based on how much cabozantinib the participant is able to safely receive.
Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer...
Clinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v88 moreThis study explores the role of T cells in monitoring disease status and response during anti-PD-1/PD-L1 treatment in patients with melanoma, lung and other cancer types. Measuring levels of specific targets such as Bim and soluble PD-L1 during therapy may help track treatment resistance and clinical outcomes. This information may also help researchers determine why some people with melanoma, lung and other cancer types respond to PD-1/PD-L1 treatment and others do not.
Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small...
Metastatic Lung Non-Small Cell CarcinomaRecurrent Lung Non-Small Cell Carcinoma1 moreThis phase I trial tests the safety, side effects, and best dose of osimertinib, cetuximab, and tucatinib in treating patients with EFGR-mutant non-small cell lung cancer that is stage IV or has come back (recurrent). Osimertinib and tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cetuximab is a chimeric human/mouse IgG1 monoclonal antibody that targets epidermal growth factor receptor (EGFR), a receptor overexpressed in many types of cancer, and may interfere with the ability of tumor cells to grow and spread. Giving osimertinib, cetuximab, and tucatinib may work better in treating patients with non-small cell lung cancer.
bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma
Liver DiseasesHepatocellular Carcinoma3 moreThis study intends to evaluate the efficacy and safety of blank- microsphere transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (bTAE-HAIC) plus Lenvatinib and Camrelizumab for patients with infiltrative hepatocellular carcinoma.
XH-30002 Capsule Combined With Afatinib Tablets for the Treatment of Squamous Cell Carcinoma
Esophageal Squamous Cell CarcinomaThis study is an exploratory clinical trial and does not involve statistical assumptions or sample size estimation. the mainly purpose for the study is to evaluate the safety of XH-30002 capsule combined with afatinib tablets in the treatment of locally advanced or metastatic esophageal squamous cell carcinoma.
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment...
Nasopharyngeal CarcinomaThis phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The usual approach of treatment is initial treatment with chemotherapy such as the combination of cisplatin (or carboplatin) and gemcitabine, along with immunotherapy such as nivolumab. After the initial treatment is finished, patients may continue to receive additional immunotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Giving BMS-986016 in addition to the usual immunotherapy after initial treatment may extend the time without the tumor cells grow or spread longer than the usual approach in patients with recurrent or metastatic nasopharyngeal cancer.
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum...
Ovarian NeoplasmsEndometrial Neoplasms4 moreMulticenter, randomized, open-label, phase II clinical study comparing Dostarlimab +/- Bevacizumab with standard chemotherapy in patients with gynecological clear cell carcinoma. 198 subjects will be enrolled in this study and will be assigned to three groups in a 1:1:1 ratio. Group A: Dostarlimab monotherapy First 3 cycles: Dostalimab 500mg every 3 weeks, IV 4 cycles ~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV Group B: Dostarlimab + Bevacizumab combination therapy First 3 cycles: Dostalimab 500mg every 3 weeks, IV 4 cycles ~ up to 24 months: Dostalimab 1000mg every 6 weeks, IV Bevacizumab administered IV at 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity Group C: General chemotherapy (one of doxorubicin, paclitaxel, and gemcitabine)
Neoadjuvant Radiotherapy Combined With Toripalimab for Locally Advanced Head and Neck Squamous Cell...
Locally Advanced Head and Neck Squamous Cell CarcinomaThis is a phase II study. Twenty-three patients with locally advanced head and neck squamous cell carcinoma were planned to be enrolled to assess the efficacy and safety of neoadjuvant immunotherapy combined with radiotherapy.
Study of ALE.C04 in Patients With Head and Neck Cancer
Head and Neck CancerHead and Neck Squamous Cell CarcinomaThe purpose of this study is to evaluate the safety profile of ALE.C04 monotherapy and in combination with pembrolizumab, to characterize pharmacokinetics profile of ALE.C04, recommended Phase II dose (RP2D) for ALE.C04 in combination with pembrolizumab and as monotherapy and to assess anti-tumor activity of ALE.C04 monotherapy and in combination with pembrolizumab in patients with Head and Neck Cancer.
Durvalumab and Tremelimumab in Resectable HCC
Hepatocellular CarcinomaHepatocellular Carcinoma (HCC) is the third most common cause of death from cancer world wide and the incidence is rising globally. Despite surgical resection in appropriate patients, many patients recur. The results of the IMbrave150 study have established PD-L1 inhibition in combination with VEGF inhibition as a new standard of care highlighting the role of immune checkpoint inhibition in advanced HCC. In addition, the combination of Tremelimumab and Durvalumab has demonstrated efficacy in advanced HCC; the HIMALAYA trial has now completed accrual in treatment naïve patients with advanced HCC. Furthermore the earlier use of immune checkpoint inhibitors in this disease are being explored with adjuvant combination strategies, including the EMERALD-2 trial (NCT03847428). Neoadjuvant treatment in HCC allows for delivery of treatment pre surgery and may enhance pathological responses and improve outcomes. The delivery of combination CTLA-4 and PD-L1 inhibition has demonstrated efficacy in other tumour types in the neoadjuvant setting where the impact on the tumour microenvironment has also been evaluated. The safety and feasibility of Durvalumab and Tremelimumab in resectable HCC has yet to be established. Hypotheses Pre-operative (pre-op) Durvalumab and Tremelimumab treatment is safe and feasible in pre surgical setting for upfront resectable HCC The combination of Durvalumab and Tremelimumab pre-op will result in changes in immune and molecular characteristics within the tumour microenvironment. Overall Study Design This is a phase II, open-label multi-centre study to assess safety of Durvalumab and Tremelimumab treatment in pre-op setting for upfront resectable HCC, followed by adjuvant Durvalumab. 28 patients are expected to enrol at three sites. Patients will receive pre-op: 1 dose Tremelimumab (300mg) (T300) with Durvalumab (1500mg) at cycle 1 and 1 further cycle of Durvalumab (1500mg) only. Post-surgical resection, adjuvant therapy will consist of Durvalumab Q4W for up to a maximum of 12 months in total or 13 cycles of Durvalumab (11 cycles post op). All participants will be treated until progressive disease or unacceptable toxicity or withdrawal of consent or another discontinuation criterion is met. All participants will be followed for survival until the end of study. No dose reductions of Tremelimumab and Durvalumab will be allowed. Statistics The primary objective of this study is to assess safety of pre-op treatment with Durvalumab and Tremelimumab. For safety, with the null proportion of patients who discontinue treatment due to AEs, imAEs or SAE is 30% versus the alternative proportion is 10% or less than 10%, a sample size of 28 provides 80% power to detect the proportion difference with a two-sided alpha level of 0.1. The sample size estimate is based on the two-sided exact test for binomial proportion considering Binomial Enumeration method.