Treatment Trials

105 Clinical Trials for Various Conditions

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COMPLETED
Docetaxel, Oxaliplatin, and Fluorouracil in Treating Patients With Metastatic or Unresectable Stomach Cancer, Gastroesophageal Junction Cancer, or Other Solid Tumor
Description

RATIONALE: Drugs used in chemotherapy, such as docetaxel, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel when given with oxaliplatin and fluorouracil and to see how well they work in treating patients with metastatic or unresectable stomach cancer, gastroesophageal junction cancer, or other solid tumor.

TERMINATED
Bortezomib, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Stomach Cancer
Description

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with fluorouracil and leucovorin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with fluorouracil and leucovorin works in treating patients with metastatic or unresectable stomach cancer.

Conditions
COMPLETED
Bryostatin 1 and Cisplatin in Treating Patients With Metastatic or Unresectable Stomach Cancer
Description

Phase II trial to study the effectiveness of bryostatin 1 and cisplatin in treating patients who have metastatic or unresectable stomach cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin 1 may increase the effectiveness of cisplatin by making tumor cells more sensitive to the drug. Combining cisplatin with bryostatin 1 may kill more tumor cells.

RECRUITING
Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors
Description

This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive and cyclin E amplified gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Azenosertib is in a class of medications called kinase inhibitors. It inhibits a protein called Wee1. Inhibition of the Wee1 protein can make tumor cells more vulnerable to chemotherapy drugs, leading to tumor cell death. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving azenosertib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or more effective in treating patients with locally advanced, metastatic, or unresectable HER2-positive gastric, gastroesophageal junction, or other solid tumors, compared to just trastuzumab deruxtecan alone.

RECRUITING
A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer
Description

Participants will receive study treatment with agenT-797, botensilimab, balstilimab, ramucirumab, and paclitaxel. When participants start each agent will depend on how their disease is affecting them.

ACTIVE_NOT_RECRUITING
Olaparib and Ramucirumab in Treating Patients With Metastatic or Locally Recurrent Gastric or Gastroesophageal Junction Cancer That Cannot Be Removed by Surgery
Description

This phase I/II trial studies the side effects and best dose of olaparib when given together with ramucirumab and how well they work in treating patients with gastric or gastroesophageal junction cancer that has spread to other places in the body (metastatic), has come back (recurrent), or cannot be removed by surgery (unresectable). Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as ramucirumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and ramucirumab may work better in treating patients with gastric or gastroesophageal junction cancer compared to ramucirumab and paclitaxel (a chemotherapy drug) or ramucirumab alone.

COMPLETED
Sorafenib, Docetaxel, and Cisplatin in Treating Patients With Metastatic or Advanced Gastric or Gastroesophageal Junction Cancer
Description

This phase II trial is studying how well giving sorafenib together with docetaxel and cisplatin works in treating patients with metastatic or locally advanced gastric or gastroesophageal junction cancer that cannot be removed by surgery. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with docetaxel and cisplatin may kill more tumor cells.

COMPLETED
Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
Description

Chemotherapy given together is a standard way to treat your cancer. One standard treatment includes a combination of docetaxel, cisplatin, and fluorouracil. However, the original combination of these three drugs can cause many side effects. This study is being done to find out if these three drugs can be given at lower doses more often, with fewer side effects and still maintain the same benefit as the standard way of giving this three drug combination. If your tumor overexpresses a protein called Her2, you are also eligible to receive trastuzumab with chemotherapy. Trastuzumab is a medicine that has been approved by the US Food and Drug Administration for the treatment of Her2 positive breast cancer. Trastuzumab is now also a standard treatment in combination with chemotherapy for the treatment of Her2 positive stomach cancer. If your tumor is Her2 positive, you would receive the modified administration schedule of docetaxel, cisplatin, and fluorouracil with trastuzumab.

COMPLETED
FOLFOX With Bevacizumab in Metastatic or Unresectable Gastroesophageal and Gastric Cancer
Description

This is a Phase II open-label study to determine the anti-tumor efficacy and tolerability of FOLFOX in combination with bevacizumab (Avastin(TM))in patients with metastatic or unresectable gastroesophageal and gastric adenocarcinoma. Our primary objective is to determine the time to progression in patients treated with FOLFOX in combination with bevacizumab.

TERMINATED
Capecitabine and Oxaliplatin in Treating Patients With Locally Advanced, Unresectable, or Metastatic Stomach Cancer
Description

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving capecitabine together with oxaliplatin works in treating patients with locally advanced, unresectable, or metastatic stomach cancer.

Conditions
COMPLETED
Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
Description

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.

Conditions
COMPLETED
Epacadostat and Pembrolizumab in Treating Patients With Metastatic or Unresectable Gastroesophageal Junction or Gastric Cancer
Description

This phase 2 trial evaluates the benefit of epacadostat plus pembrolizumab in combination to treat patients with gastroesophageal junction or gastric cancer that has spread to other parts of the body and cannot be removed by surgery. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving epacadostat and pembrolizumab may work better in treating patients with gastroesophageal junction or gastric cancer.

COMPLETED
Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer
Description

Purpose: There remains a great need for novel therapeutic agents and treatment strategies for advanced esophagogastric cancer. Preclinical and clinical studies have demonstrated increased EGFR expression in a significant proportion of both esophageal and gastric carcinomas. Inactivation of EGFR through use of a monoclonal antibody in preclinical models has resulted in inhibition of tumor growth. Agents designed to block the EGFR pathway have demonstrated disease control among previously treated patients with metastatic esophageal and gastric cancer. The proposed mechanism of action for cetuximab is its ability to effectively disrupt EGFR-mediated signal transduction pathways that ultimately leads to halting cell cycle progression, induces apoptosis, and also inhibits processes important for tumor growth, such as cell invasion and angiogenesis.

COMPLETED
Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer
Description

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining bryostatin 1 and paclitaxel in treating patients who have unresectable locally advanced or metastatic stomach cancer.

COMPLETED
Everolimus in Treating Patients With Previously Treated Unresectable or Metastatic Esophageal Cancer or Stomach Cancer
Description

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with previously treated unresectable or metastatic esophageal cancer or stomach cancer.

RECRUITING
Study of AU-007, A Monoclonal Antibody That Binds to IL-2 and Inhibits IL-2Rα Binding, in Patients With Unresectable Locally Advanced or Metastatic Cancer
Description

This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007 in patients with advanced solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin given every 2 weeks (Q2w). Once the recommended phase 2 dose (RP2D) of AU-007 plus aldesleukin is determined, AU-007 plus aldesleukin will also be administered with avelumab or nivolumab.

COMPLETED
Pralatrexate and Oxaliplatin in Treating Patients With Unresectable or Metastatic Esophageal, Stomach, or Gastroesophageal Junction Cancer
Description

This phase II trial studies how well pralatrexate and oxaliplatin work in treating patients with esophageal, stomach, or gastroesophageal junction cancer that cannot be removed by surgery or has spread from the primary site (place where it started) to other places in the body. Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, 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 pralatrexate with oxaliplatin may be an effective treatment for esophageal, stomach, or gastroesophageal junction cancer.

TERMINATED
Chemoembolization, Irinotecan Bead, Second Line Chemotherapy Treatment of Unresectable Metastatic Colorectal Cancer
Description

The primary objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in combination with intravenous chemotherapy versus intravenous chemotherapy alone in the treatment of unresectable liver metastases in patients with colorectal cancer. The results of this study are intended to be used in support of a PMA application for a combination device

UNKNOWN
Cyclophosphamide, Radiation Therapy, and Poly ICLC in Treating Patients With Unresectable, Recurrent, Primary, or Metastatic Liver Cancer
Description

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Poly ICLC may stop the growth of liver cancer by blocking blood flow to the tumor. Giving the drug directly into the arteries around the tumor may kill more tumor cells. Giving cyclophosphamide and radiation therapy together with poly ICLC may be an effective treatment for liver cancer. PURPOSE: This phase I/II trial is studying the side effects of giving cyclophosphamide, radiation therapy, and poly ICLC together and to see how well they work in treating patients with unresectable, recurrent, primary, or metastatic liver cancer.

COMPLETED
Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer
Description

RATIONALE: Hepatic arterial infusion uses a catheter to deliver anticancer substances directly into the liver. Drugs used in chemotherapy, such as melphalan, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving an hepatic arterial infusion of melphalan together with hepatic perfusion works in treating patients with unresectable liver cancer.

Conditions
COMPLETED
Alvespimycin Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors
Description

This phase I trial is studying the side effects and best dose of alvespimycin hydrochloride in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as alvespimycin hydrochloride, work in different ways to stop tumor cells from dividing so they stop growing or die.

Conditions
Male Breast CancerRecurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Basal Cell Carcinoma of the LipRecurrent Breast CancerRecurrent Colon CancerRecurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityRecurrent Gastric CancerRecurrent Inverted Papilloma of the Paranasal Sinus and Nasal CavityRecurrent Lymphoepithelioma of the NasopharynxRecurrent Lymphoepithelioma of the OropharynxRecurrent MelanomaRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Ovarian Epithelial CancerRecurrent Prostate CancerRecurrent Renal Cell CancerRecurrent Salivary Gland CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavityStage III Adenoid Cystic Carcinoma of the Oral CavityStage III Basal Cell Carcinoma of the LipStage III Colon CancerStage III Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityStage III Gastric CancerStage III Inverted Papilloma of the Paranasal Sinus and Nasal CavityStage III Lymphoepithelioma of the NasopharynxStage III Lymphoepithelioma of the OropharynxStage III MelanomaStage III Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityStage III Mucoepidermoid Carcinoma of the Oral CavityStage III Ovarian Epithelial CancerStage III Renal Cell CancerStage III Salivary Gland CancerStage III Squamous Cell Carcinoma of the HypopharynxStage III Squamous Cell Carcinoma of the LarynxStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the NasopharynxStage III Squamous Cell Carcinoma of the OropharynxStage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage III Verrucous Carcinoma of the LarynxStage III Verrucous Carcinoma of the Oral CavityStage IIIB Breast CancerStage IIIC Breast CancerStage IV Adenoid Cystic Carcinoma of the Oral CavityStage IV Basal Cell Carcinoma of the LipStage IV Breast CancerStage IV Colon CancerStage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityStage IV Gastric CancerStage IV Inverted Papilloma of the Paranasal Sinus and Nasal CavityStage IV Lymphoepithelioma of the NasopharynxStage IV Lymphoepithelioma of the OropharynxStage IV MelanomaStage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityStage IV Mucoepidermoid Carcinoma of the Oral CavityStage IV Ovarian Epithelial CancerStage IV Prostate CancerStage IV Renal Cell CancerStage IV Salivary Gland CancerStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the OropharynxStage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IV Verrucous Carcinoma of the LarynxStage IV Verrucous Carcinoma of the Oral CavityUnspecified Adult Solid Tumor, Protocol SpecificUntreated Metastatic Squamous Neck Cancer With Occult Primary
COMPLETED
7-Hydroxystaurosporine and Irinotecan Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Triple Negative Breast Cancer (Currently Accruing Only Triple-negative Breast Cancer Patients Since 6/8/2007)
Description

This phase I trial is studying the side effects and best dose of giving 7-hydroxystaurosporine together with irinotecan hydrochloride in treating patients with metastatic or unresectable solid tumors, including triple-negative breast cancer (currently enrolling only patients with triple-negative breast cancer since 6/8/2007). Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving 7-hydroxystaurosporine together with irinotecan hydrochloride may help kill more cancer cells by making tumor cells more sensitive to the drug.

Conditions
Advanced Adult Primary Liver CancerCarcinoma of the AppendixEstrogen Receptor-negative Breast CancerExtensive Stage Small Cell Lung CancerGastrointestinal Stromal TumorHER2-negative Breast CancerMetastatic Gastrointestinal Carcinoid TumorOvarian SarcomaOvarian Stromal CancerProgesterone Receptor-negative Breast CancerRecurrent Adenoid Cystic Carcinoma of the Oral CavityRecurrent Adult Primary Liver CancerRecurrent Anal CancerRecurrent Basal Cell Carcinoma of the LipRecurrent Borderline Ovarian Surface Epithelial-stromal TumorRecurrent Breast CancerRecurrent Cervical CancerRecurrent Colon CancerRecurrent Endometrial CarcinomaRecurrent Esophageal CancerRecurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityRecurrent Extrahepatic Bile Duct CancerRecurrent Gallbladder CancerRecurrent Gastric CancerRecurrent Gastrointestinal Carcinoid TumorRecurrent Inverted Papilloma of the Paranasal Sinus and Nasal CavityRecurrent Lymphoepithelioma of the NasopharynxRecurrent Lymphoepithelioma of the OropharynxRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityRecurrent Mucoepidermoid Carcinoma of the Oral CavityRecurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorRecurrent Pancreatic CancerRecurrent Prostate CancerRecurrent Rectal CancerRecurrent Salivary Gland CancerRecurrent Small Cell Lung CancerRecurrent Small Intestine CancerRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityRecurrent Verrucous Carcinoma of the LarynxRecurrent Verrucous Carcinoma of the Oral CavitySmall Intestine AdenocarcinomaSmall Intestine LeiomyosarcomaSmall Intestine LymphomaStage IV Adenoid Cystic Carcinoma of the Oral CavityStage IV Anal CancerStage IV Basal Cell Carcinoma of the LipStage IV Borderline Ovarian Surface Epithelial-stromal TumorStage IV Breast CancerStage IV Colon CancerStage IV Endometrial CarcinomaStage IV Esophageal CancerStage IV Esthesioneuroblastoma of the Paranasal Sinus and Nasal CavityStage IV Gastric CancerStage IV Inverted Papilloma of the Paranasal Sinus and Nasal CavityStage IV Lymphoepithelioma of the NasopharynxStage IV Lymphoepithelioma of the OropharynxStage IV Midline Lethal Granuloma of the Paranasal Sinus and Nasal CavityStage IV Mucoepidermoid Carcinoma of the Oral CavityStage IV Non-small Cell Lung CancerStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell TumorStage IV Pancreatic CancerStage IV Prostate CancerStage IV Rectal CancerStage IV Salivary Gland CancerStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the OropharynxStage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IV Verrucous Carcinoma of the LarynxStage IV Verrucous Carcinoma of the Oral CavityStage IVA Cervical CancerStage IVB Cervical CancerTriple-negative Breast CancerUnresectable Extrahepatic Bile Duct CancerUnresectable Gallbladder CancerUnspecified Adult Solid Tumor, Protocol SpecificUntreated Metastatic Squamous Neck Cancer With Occult Primary
COMPLETED
Epirubicin, Carboplatin, and Capecitabine in Treating Patients With Unresectable Locally Advanced, Metastatic, or Recurrent Solid Tumor
Description

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining epirubicin, carboplatin, and capecitabine in treating patients who have unresectable locally advanced, metastatic, or recurrent solid tumor.

RECRUITING
Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Description

This is a Phase II, open-label, multi-drug, multi-centre study designed to assess the efficacy, safety, tolerability, pharmacokinetics, and immunogenicity of novel combination therapies in participants with locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma.

Conditions
RECRUITING
mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma
Description

This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) to modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) for the treatment of advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, and gastric adenocarcinoma. The usual approach for patients is treatment with FOLFOX chemotherapy. Chemotherapy drugs 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. Fluorouracil stops cells from making DNA and it may kill tumor cells. Leucovorin is used with fluorouracil to enhance the effects of the drug. Oxaliplatin works by killing, stopping, or slowing the growth of tumor cells. Some patients also receive an immunotherapy drug, nivolumab, in addition to FOLFOX chemotherapy. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Irinotecan blocks certain enzymes needed for cell division and DNA repair, and it may kill tumor cells. Adding irinotecan to the FOLFOX regimen could shrink the cancer and extend the life of patients with advanced gastroesophageal cancers.

ACTIVE_NOT_RECRUITING
A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants with Advanced Unresectable or Metastatic Solid Tumors
Description

This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors

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
CYNK-101 in Combination with Trastuzumab and Pembrolizumab in Patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma
Description

This study will find the maximum tolerated dose (MTD) of CYNK-101 which contains Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded. CYNK-101 will be administered as first-line treatment, following induction therapy consisting of Pembrolizumab, Trastuzumab and a Fluoropyrimidine / Platinum based Chemotherapy regimen. Patients are required to undergo a biopsy for confirmation of HER2 positivity defined as either IHC 3+ or IHC 2+ with a positive fluorescent in-situ hybridization (FISH) or FISH + alone. The safety of this treatment will be evaluated, and researchers will want to learn if NK cells will help in treating patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma.

RECRUITING
CA-4948 in Combination With FOLFOX/PD-1 Inhibitor +/- Trastuzumab for Untreated Unresectable Gastric and Esophageal Cancer
Description

This is a phase I trial of CA-4948 in combination with FOLFOX/PD-1 inhibitor with or without trastuzumab for unresectable gastric, GEJ, and esophageal cancer. During the Dose Escalation portion of the study, different dose levels of CA-4948 in combination with FOLFOX/nivolumab will be evaluated by BOIN algorithm. Dose Expansion will include Cohorts A and B. Expansion Cohort A will enroll up to 12 patients with HER2 negative gastric, GEJ, and esophageal cancer at the expansion dose of CA-4948 determined during Dose Escalation and will use the same treatment regimen of FOLFOX/nivolumab. Expansion Cohort B will investigate CA-4948 at the dose determined during Dose Escalation in combination with FOLFOX/pembrolizumab and trastuzumab in up to 12 patients with HER2 positive disease; however, the initial 6 patients will be considered safety lead-in to confirm the safety and tolerability of this combination; if determined to be safe, an additional 6 patients will be enrolled for a total of 12 in Cohort B.

RECRUITING
Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma
Description

This early phase I trial studies the effect of pembrolizumab and lenvatinib in treating patients with gastroesophageal adenocarcinoma that has spread to other places in the body (advanced/metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and lenvatinib may kill more tumor cells.

Conditions
Advanced Gastric AdenocarcinomaAdvanced Gastroesophageal Junction AdenocarcinomaClinical Stage III Gastric Cancer AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IVA Gastric Cancer AJCC v8Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IVB Gastric Cancer AJCC v8Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Metastatic Gastric AdenocarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaPathologic Stage III Gastric Cancer AJCC v8Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIA Gastric Cancer AJCC v8Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIB Gastric Cancer AJCC v8Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIC Gastric Cancer AJCC v8Pathologic Stage IV Gastric Cancer AJCC v8Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Unresectable Gastric AdenocarcinomaUnresectable Gastroesophageal Junction Adenocarcinoma