Treatment Trials

900 Clinical Trials for Various Conditions

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RECRUITING
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC
Description

The purpose of this study is to evaluate the efficacy and safety of adjuvant autogene cevumeran plus atezolizumab and modified leucovorin, 5-fluorouracil (5-FU), irinotecan, and oxaliplatin (mFOLFIRINOX) versus mFOLFIRINOX alone in participants with resected pancreatic ductal adenocarcinoma (PDAC) who have not received prior systemic anti-cancer treatment for PDAC and have no evidence of disease after surgery.

COMPLETED
Evaluation of PET/MRI in Patients With Pancreatic Adenocarcinoma
Description

This study will use PET/MRI in patients with adenocarcinoma of the pancreas to identify hidden metastatic disease or identify patients with borderline or locally advanced disease.

TERMINATED
Pilot, Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery, Adenocarcinoma of the Pancreas
Description

This study is for adult patients with adenocarcinoma of the pancreas. The purpose of this research study is to evaluate the safety and effectiveness of the drugs Gemcitabine and Abraxane in the treatment of adenocarcinoma of the pancreas before surgery. Subjects will have screening tests to determine if he or she is eligible to participate in this study.

COMPLETED
Phase 1 Study of Preoperative Gemcitabine Plus CP-870, 893 Followed by Addition of CP-870,893 to Standard -Of-care Adjuvant Chemoradiation for Patients With Newly Diagnosed Resectable Pancreatic Carcinoma
Description

This is a pilot study to evaluate the role of the addition of CP870, 893 to the neoadjuvant and adjuvant setting for patients with resectable pancreatic cancer. Patients will receive standard surgery followed by chemoradiation for their disease, but one dose of gem/cp 870,893 will be pre-op and 3 doses post-op.

COMPLETED
Mesothelin-Targeted Immunotoxin LMB-100 in Combination With Tofacitinib in Persons With Previously Treated Pancreatic Adenocarcinoma, Cholangiocarcinoma and Other Mesothelin Expressing Solid Tumors
Description

Background: The protein mesothelin is found on many kinds of tumors. The drug LMB-100 targets cancer cells that make this protein. Researchers want to see if LMB-100 combined with another drug can help people with these tumors. Objective: To find a safe dose of LMB-100 plus tofacitinib in people with pancreatic cancer, bile-duct cancer, and other solid tumors that make mesothelin. Eligibility: People ages 18 and older with pancreatic cancer, bile-duct cancer, or any other solid tumor with mesothelin that worsened after treatment or they could not receive standard treatment Design: Participants will be screened with: * Medical history * Tumor tissue sample. If they do not have a sample, they will have a biopsy. * Physical exam * Blood and heart tests * Scans and x-rays: They may have a dye injected for the scans. Participants will take the drugs in up to three 21-day cycles. They will take tofacitinib by mouth twice a day on days 1-10 of each cycle. They will have LMB-100 injected into the blood on days 4, 6, and 8 of every cycle. Patients that do not have a medi-port may need to have a central vein access line placed. Participants will take other drugs on the days they receive LMB-100. Participants will repeat screening tests during the study. They may have a biopsy at the start of the first 2 cycles. If participants must stop the study, they will have a safety visit 3-6 weeks after their last dose of the study drug. Some participants may then have visits every 6 weeks. After treatment, participants will be contacted about once a year. They will be asked about their cancer.

ACTIVE_NOT_RECRUITING
CAR T Cell Immunotherapy for Pancreatic Cancer
Description

Phase I study to establish the safety and feasibility of both intravenous administration and local delivery of lentiviral transduced huCART-meso cells in patients with histologically confirmed unresectable or metastatic pancreatic adenocarcinoma

COMPLETED
Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy
Description

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

RECRUITING
Small Intestinal Bacterial Overgrowth (SIBO) in Pancreatic Adenocarcinoma (PDAC)
Description

The purpose of this study is to prospectively analyze the prevalence of SIBO in patients with Pancreatic adenocarcinoma (PDAC) and understand its association with weight loss and pancreatic resection status. Each patient will be tested for SIBO using Lactulose Hydrogen Breath Test. 100 patients with diagnosed pancreatic adenocarcinoma and clinically diagnosed weight loss will be enrolled in this study.

NOT_YET_RECRUITING
9-ING-41 Combined with Retifanlimab, Plus Modified FOLFIRINOX for Patients with Advanced Pancreatic Adenocarcinoma (RiLEY)
Description

This is a study of the combination of 9 ING-41 (elraglusib) and retifanlimab plus mFOLFIRINOX in patients with pancreatic cancer without prior systemic therapy for advanced disease. The safety lead-in cohort will consist of 6 patients, followed by dose de-escalation if necessary, based on safety assessments. After evaluating the safety and tolerability at the initial dose level, the study will proceed to an expansion cohort at the determined safe dose level, with the total maximum enrollment not exceeding 12 patients for the entire study.

RECRUITING
Maintenance Niraparib Plus Ipilimumab in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy
Description

The main goal of this study is to look at the effectiveness and anti-tumor activity (preventing growth of the tumor) of the drugs niraparib and ipilimumab, on the patients and their pancreatic cancer. This study will involve two different treatment arms. In Arm A, patients will receive niraparib plus ipilimumab. In Arm B, patients will receive standard chemotherapy. The main questions the study aims to answer are: * Does niraparib plus ipilimumab slow down tumor growth in patients with pancreatic cancer? * What medical problems do participants have when taking niraparib plus ipilimumab? Participants will: * Undergo screening procedures to evaluate their cancer, overall health, and suitability for the study * After passing screening, will be randomized to Arm A or B and be scheduled to receive niraparib plus ipilimumab (Arm A) or chemotherapy (Arm B) * Receive niraparib plus ipilimumab every 3 weeks (Arm A) * Receive chemotherapy every 2 weeks (Arm B) * Visit the clinic for regular checkups and tests

RECRUITING
Hyperpolarized C Pyruvate Magnetic Resonance Imaging, and Blood-Based Biomarkers for Early Detection of Pancreatic Adenocarcinoma in Patients with Intraductal Papillary Mucinous Neoplasms
Description

The purpose of this study is for researchers to find ways of detecting pancreatic ductal adenocarcinoma/PDAC early to avoid the invasive procedure of surgery. The study researchers think a combination of imaging and a series of blood tests may be an effective way to detect PDAC early. In this study, researchers will look at whether a combination of the following types of imaging with blood tests can detect PDAC in pancreatic cysts: * The ImmunoPET scan (immune-positron emission tomography scan) with the imaging agent 89Zr-DFO-HuMab-5B1 * The HP MRI scan (hyperpolarized pyruvate magnetic resonance imaging scan)

Conditions
NOT_YET_RECRUITING
Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC)
Description

The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable.

WITHDRAWN
CAPEcitabine eXtension of Adjuvant Therapy for Pancreatic Adenocarcinoma: (CAPE-X)
Description

* This study is being done to find out if extending adjuvant chemotherapy for patients by giving additional chemotherapy can lengthen the amount of time before their cancer comes back. The additional chemotherapy is called capecitabine. * Capecitabine is an oral drug (taken by mouth). It is approved by the US Food and Drug Administration (FDA) for adjuvant treatment of adults with pancreatic cancer and also for the treatment of other types of cancer

TERMINATED
Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma
Description

This trial is designed as a Phase I/randomized Phase II open-label trial of modified(m) FOLFIRINOX ± BNT321 for adjuvant therapy in pancreatic ductal adenocarcinoma (PDAC) patients post R0 or R1 resection. The Phase I, dose escalation part of this trial will be a limited evaluation of two planned BNT321 dose levels in combination with mFOLFIRINOX chemotherapy (24 weeks) followed by BNT321 monotherapy (24 weeks). Following determination of the combination recommended Phase II dose (RP2D), the Phase II (randomized treatment) part of this trial will be initiated as an open-label 2-arm evaluation of mFOLFIRINOX ± BNT321 (24 weeks) followed by BNT321 monotherapy (24 weeks) in the combination arm only to complete the adjuvant therapy course. Treatment cycles are every 2 weeks (14 days).

RECRUITING
Study of TROP2 CAR Engineered IL15-transduced Cord Blood-derived NK Cells Delivered Intraperitoneally for the Management of Platinum Resistant Ovarian Cancer, Mesonephric-like Adenocarcinoma, and Pancreatic Cancer
Description

To find the recommended dose of TROP2- CAR-NK given intraperitoneally (directly into the abdominal cavity) to patients with highgrade serous ovarian cancer that has not responded to previous treatment or is resistant to treatment.

RECRUITING
Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma
Description

This is a prospective, multicenter, non-randomized, open label light dose escalation phase I trial to evaluate the safety and preliminary efficacy of Padeliporfin vascular targeted photodynamic therapy (VTP) applied via endovascular fiber placement within a dilatation catheter, through the superior mesenteric artery (SMA) in patients with stage III, locally advanced (LA) unresectable pancreatic ductal adenocarcinoma (PDAC). The investigators will evaluate safety and preliminary efficacy of Padeliporfin VTP administered endovascularly using light dose escalation.

RECRUITING
Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
Description

The objective of this research is to find out what effects (good and bad), the sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX, the standard chemotherapy for pancreatic cancer, has on participants and their condition. Gemcitabine - Abraxane (nab-Paclitaxel) and mFOLFIRINOX has been approved by the US Food and Drug Administration (FDA) as first line treatment for advanced pancreatic cancer. The sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX has not been approved by the FDA for treatment of pancreatic cancer.

RECRUITING
Zimberelimab and Quemliclustat in Combination with Chemotherapy for the Treatment of Patients with Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
Description

This phase I/II study tests how well zimberelimab and quemliclustat work in combination with chemotherapy (mFOLFIRINOX) in treating patients pancreatic adenocarcinoma that may or may not be able to be removed by surgery (borderline resectable) or that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as zimberelimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Quemliclustat acts as a blocker for adenosine. Adenosine is a chemical produced in the body that can lead to a decrease in the immune system's response towards cancer. Quemliclustat has the potential to decrease the amount of adenosine, allowing the immune system to recognize and act against the cancer. Chemotherapy drugs, such as oxaliplatin, irinotecan, leucovorin, and fluorouracil, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy in combination with zimberelimab and quemliclustat may kill more cancer cells than chemotherapy alone.

RECRUITING
A Study of NovoTTF-200T(P) in Combination With Gemcitabine and Nab-Paclitaxel for Resectable Pancreatic Adenocarcinoma
Description

This is a single arm phase II study. All patients will receive 3 cycles of the treatment of nab-paclitaxel (Days 1, 8 and 15), gemcitabine (Days 1, 8 and 15), and TTFields (worn every day for at least 18 hours). Following the initial 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment, patients will undergo restaging by CT or MRI. Patients with stable disease or better will undergo surgery for resection within 8 weeks following completion of initial chemotherapy although enrolling sites are encouraged to perform resection within 4 weeks of Cycle 3 D15 of therapy. If resection yields R0 or R1, patients will begin an additional 3 cycles of gemcitabine/nab-paclitaxel/TTFields treatment within 8 weeks of surgery. Based on available literature, it is expected that a percentage of patients will not undergo resection either due to disease progression or due to toxicities/ complications of the neoadjuvant segment of therapy. These patients will be included in the evaluable patients for both co-primary endpoints as well as the secondary endpoints including ORR, adverse events, and OS.

RECRUITING
Pressure Enabled Intrapancreatic Delivery of SD-101 With Checkpoint Blockade for Locally Advanced Pancreatic Adenocarcinoma
Description

This study is an open-label, phase 1/1b study of the pressure-enabled intrapancreatic infusion of SD-101, a TLR 9 agonist, alone or in combination with intravenous checkpoint blockade in adults with locally advanced pancreatic cancer.

RECRUITING
Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects With Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma
Description

This is a Phase 1, Open-Label, Dose Escalation and Expansion, Multicenter Study of Claudin 18.2-Targeted Chimeric Antigen Receptor T-cells in Subjects with Unresectable, Locally Advanced, or Metastatic Gastric, Gastroesophageal Junction (GEJ), Esophageal, or Pancreatic Adenocarcinoma

TERMINATED
Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma
Description

This trial will assess the MTD and RP2D of SOT102 administered as monotherapy (Part A) and in combination with first-line SoC treatment (nab-paclitaxel/ gemcitabine; Part B) and efficacy of SOT102 administered as monotherapy (Part C) and in combination with first-line SoC treatment (Part D) in patients with advanced or metastatic pancreatic adenocarcinoma.

RECRUITING
CPI-613 (Devimistat) in Combination With Chemoradiation in Patients With Pancreatic Adenocarcinoma
Description

This is a single-center, open-label, phase I study designed to determine the maximum tolerated dose (MTD) and safety profile of CPI-613® when used concomitantly with chemoradiation for local control of pancreatic adenocarcinoma (PDAC).

RECRUITING
A Study of Ivaltinostat Plus Capecitabine or Capecitabine in Metastatic Pancreatic Adenocarcinoma
Description

This study is a Phase 1b/2, dose-escalation, randomized, multicenter study to assess the efficacy, safety, tolerability, and PK of ivaltinostat in combination with capecitabine and capecitabine monotherapy in patients with metastatic pancreatic adenocarcinoma whose disease has not progressed on a first line fluoropyrimidine-based chemotherapy (e.g., FOLFIRINOX). In Phase 1b, 3 dose levels of ivaltinostat will be studied in combination with a fixed dose of capecitabine to determine the RP2D of ivaltinostat. In Phase 2, patients will be randomized in a 1:1 ratio to the combination of ivaltinostat and capecitabine or to capecitabine monotherapy. A fixed dose for capecitabine 1000 mg/m2 orally twice daily will be taken on Days 1 to 14, and the RP2D of ivaltinostat will be administered intravenously once a week for 2 weeks, followed by 1 week of rest. One cycle consists of 21 days. Tumor response during study treatment will be assessed every 6 weeks up to Cycle 10, then every 9 weeks afterwards using RECIST v1.1 criteria.

RECRUITING
Stimulation With Bethanechol in Combination With Gemcitabine and Nab-paclitaxel in Pancreatic Adenocarcinoma
Description

The primary objective of this study is to assess the impact of bethanechol therapy on R0 resection rates. The safety objective will be assessment of the safety and tolerability of bethanechol in combination with gemcitabine and nab-paclitaxel. The exploratory objective will be to evaluate genomic biomarkers associated with parasympathetic stimulation in pancreatic cancer, and the ability to reduce tumor growth rate.

Conditions
ACTIVE_NOT_RECRUITING
9-ING-41 Plus Retifanlimab and Gemcitabine/Nab-Paclitaxel in Patients With Advanced Pancreatic Adenocarcinoma
Description

This trial examines how Pancreatic Adenocarcinoma reacts to the addition of 9-ING-41 and retifanlimab to the standard of care chemotherapy treatment, to see if using this combination will help and is able to effect disease progression.

RECRUITING
Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma
Description

This study is a single-arm, phase I trial, up to 16 participants with resectable PDA. The study will examine the efficacy of the mutant IDH1 inhibitor ivosidenib, in conjunction with standard-of-care mFOLFIRINOX in the neoadjuvant setting.

RECRUITING
Intraoperative Radiation Therapy After Stereotactic Body Radiation Therapy and Chemotherapy in Treatment of Pancreatic Adenocarcinoma
Description

This study is designed to investigate the safety of intraoperative radiation therapy (IORT) in patients with localized pancreatic cancer undergoing surgical resection after neoadjuvant chemotherapy and stereotactic body radiation therapy (SBRT).

ACTIVE_NOT_RECRUITING
Trial of Immunotherapy With Avelumab and Pepinemab As Second Line For Patients With Metastatic Pancreatic Adenocarcinoma
Description

This trial will assess the safety and tolerability of Pepinemab in combination with Avelumab in patients with metastatic pancreatic adenocarcinoma that has progressed after first line chemotherapy. Phase 2 will assess the efficacy of this combination therapy.

RECRUITING
Safety of Cyberknife in Patients With Borderline Resectable or Locally Advanced Pancreatic Adenocarcinoma
Description

The hypothesize that SBRT will limit or reverse tumor growth and thereby convert the borderline resectable disease or locally advanced disease in to a resectable tumor. Furthermore, we want to assess whether SBRT leads to an improved quality of life compared to IMRT.