Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma

Neoplasms, Unknown Primary

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasm Metastasis

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Arm 1 - Pembrolizumab injection dosed at 200 mg given Q3 weeks by IV infusion on Day 1 of each 3 week cycle.

Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W.

Pembrolizumab Injection

Jose Monzon, MD

Abbreviated Title: Pembrolizumab in Patients with Poor-Prognosis Carcinoma of Unknown Primary Site (CUP) Trial Phase: 2 Clinical Indication: Treatment naïve patients with poor prognosis carcinoma of unknown primary site Trial Type: Single arm phase 2 Type of control: Not applicable Route of administration: Intravenous Trial Blinding: Not applicable Treatment Groups: 1) Pembrolizumab 200 mg IV every 3 weeks for up to 24 months. Total Number of trial subjects:25 Estimated enrollment period: 24 months Estimated duration of trial: 48 months Duration of Participation: 24 months

This is a multi-centre, single arm phase 2 study of Pembrolizumab (Keytruda™ or MK-3475) in treatment naïve patients with poor prognosis carcinoma of unknown primary site (CUP). Participants will receive Pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for up to 24 months. Patients will be evaluated for response every 9 weeks. Patients with objective response to treatment and those with stable disease will continue to receive Pembrolizumab. Patients with tumor progression will be discontinued from the study. Patients with progressive disease (PD), but showing a clinical benefit, may continue on Pembrolizumab, as per the discretion of the responsible Qualified Investigator. Response will be evaluated as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

This is a multi-centre, single arm phase 2 study of Pembrolizumab (Keytruda™ or MK-3475) in treatment naïve patients with poor prognosis carcinoma of unknown primary site (CUP).

Pembrolizumab in Patients With Poor-Prognosis Carcinoma of Unknown Primary Site (CUP)

A Multi-Centre, Single Arm, Phase 2 Trial of Pembrolizumab in Treatment Naïve Patients With Poor-Prognosis Carcinoma of Unknown Primary Site

The objective response rate will be assessed by RECIST 1.1

Treatment related adverse events will be assessed using CTCAE v4.0.

OS is the time from treatment initiation to death due to any cause

Progression will be assessed by RECIST 1.1

Tom Baker Cancer Centre

AHS Cancer Control Alberta

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Belinostat

Tubulin Modulators

Antimitotic Agents

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Group A: belinostat 1000 mg/m² administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat 2000 mg administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel 175 mg/m² administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.

Group B: paclitaxel 175 mg/m² administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.

belinostat, carboplatin, paclitaxel

carboplatin, paclitaxel

e-mail contact via enquires@topotarget.com

The purpose of this study is to assess efficacy and safety of belinostat in combination with carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown primary.

This is an open-label, multinational, multicenter, randomized, comparative efficacy and safety study in previously untreated patients with carcinoma of unknown primary. Patients meeting inclusion and exclusion criteria will be randomized to treatment in Arm A (BelCaP) or Arm B (CaP).

Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary

An Open-label Randomized Phase II Trial of Belinostat (PXD101) in Combination With Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Previously Untreated Carcinoma of Unknown Primary

Time from the date of randomization to the time of disease progression or death due to any cause, measured by RECIST criteria (Response Evaluation Criteria In Solid Tumors).

The best overall response in an individual patient according to the RECIST criteria (Eisenhauer 2009 ) is the best response recorded from the start of the treatment until disease progression/recurrence. Objective response is defined as best overall response of complete response (CR) or partial response (PR)

Time from the date of randomization to the date of death

For patients with overall best response being CR or PR, time to response was measured as the time from randomization to the first time when the measurement criteria for CR or PR (whichever status is recorded first) were met

Duration of overall response was measured from the time that measurement criteria were first met for CR or PR (whichever status was recorded first) until the first date that PD (\[Progressive Disease\]) or death was documented

Time from the date of randomization to the time of disease progression

Spectrum Pharmaceuticals, Inc

Valerio Therapeutics

Safety population consist of 86 of 89 included patients. 3 patients (2 in Arm A and 1 in Arm B) did not receive study medication

Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.

Arm A - BelCaP

Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.

Arm B - CaP

Total

Age, Categorical

Sex: Female, Male

PRS Administrator Gunilla Emanuelson

Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population, 12 patients (5 in Arm A and 7 in Arm B) were censored due to lack of efficacy

Progression Free Survival

Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population.

Best Overall Response

Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 18 patients (10 in Arm A and 8 in Arm B) were censored.

Overall Survival (OS)

Patients with overall best response being either complete response or partial response.

Time to Response

Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. Three patients, 2 in Arm A and 1 in Arm B, were not treated with study medication

Duration of Response

Intent-to-treat (ITT) population: All patients randomized to one of the two treatment groups were included in the ITT population. 26 patients (12 in Arm A and 14 in Arm B) were censored. One patient in each arm had no information reported.

Time to Progression (TTP)

Overall Study

Frank A Greco, M.D.

This will be a retrospective review of 30 patients with unknown primary cancer who have had commercially available RT-PCR assays performed on biopsied tumors, in order to determine if the assay results are consistent with clinical features and useful for planning initial therapy or changing therapy.

Review of Molecular Profiling-Real Time Polymerase Chain Reaction (Rt-Pcr) in Unknown Primary Cancer

Review of Molecular Profiling-Real Time Polymerase Chain Reaction (Rt-Pcr) in Unknown Primary Cancer: Role in Clinical Management and Primary Site Prediction

Biotheranostics, Inc.

SCRI Development Innovations, LLC

Digestive System Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Pancreatic Neoplasms

Pleural Effusion

Stomach Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ascites

Pleural Diseases

Mesothelioma

Mesothelioma, Malignant

Peritoneal Neoplasms

Pseudomyxoma Peritonei

Gallbladder Neoplasms

Appendiceal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Adenoma

Neoplasms, Mesothelial

Respiratory Tract Diseases

Pancreatic Diseases

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Adenocarcinoma

Adenocarcinoma, Mucinous

Neoplasms, Cystic, Mucinous, and Serous

Cecal Neoplasms

Cecal Diseases

Pancreatic Cancer

Ovarian Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Gallbladder Cancer

Malignant Mesothelioma

Pharmaceutical Solutions

Gemcitabine

Oxaliplatin

Doxorubicin

Liposomal doxorubicin

Cisplatin

Mitomycins

Mitomycin

A chemotherapeutic solution is aerosolized into the expanded abdominal cavity during laparoscopy, under pressure. This allows a relatively homogeneous repartition of the drug and an effective tissue penetration.

PIPAC

Sabine Rhode

Laura Lay, MD

Craig Lynch, MD

Tarkan Jäger, MD

Woulter Willaert, MD

Martin Graversen, MD

Catherine Arvieux, MD

Clarisse Eveno

Olivier Glehen, MD

Olivia Sgarbura, MD

Verena Schlaich

Marco Vaira, MD

Maciej Nowacki, MD

Vladimir Khomyakov, MD

Janelle Phua

Juan Torrent, MD

Martin Huebner, MD

Philipp Horvath, MD

Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria.

All data entered into the registry documenting the patient cohort characteristics (disease, demography, therapy) are analyzed using descriptive statistics. Survival data are analyzed with Kaplan-Meier statistics. Multivariate Cox Proportional Hazard Models are used to identify potential prognostic and predictive factors. In particular, a risk- adjusted comparison of the outcome criteria with a propensity score is planned.

The data are stored in a SQL-based online database. Patient data are pseudoanonymized. The registry has received approval of the data protection officer of the State of Northrhine-Westphalia.

The study steering committee is blinded towards the identity of the participating institutions. Each participating institution receives an annual report with own data vs. benchmark. Scientific analysis can be proposed by the steering committee, by a participating institution or by other scientists, subjected to the approval of the independent scientific advisory board.

An export function has been built in to allow data exchange with the HIPEC Registry of the German Society for General and GI surgery (http://www.dgav.de/studoq/studoqhipec.html).

International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)

Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases

Requests can be addressed to the Scientific Advisory Board, AnInstitut für Qualitässicherung in der operativen Medizin gGmbH, Leipziger Str. 44, 39120 MAGDEBURG, Germany

according to RECIST criteria (CR + PR + SD)

according to the Peritoneal Regression Grading Score (PRGS)

Ruhr University of Bochum

Coordinator

Post-mortem oncological patients (within 2-6 hrs from death, maximum time for tissue preservation).

Proteomic analysis of tissues collected from all sites of disease, guided by either imaging performed prior to the patient's death or post-mortem findings. Peripheral blood mononuclear cells (PBMC) will be collected with the purpose of identifying somatic changes occurring specifically in the tumor cells and not in normal DNA of the same patient.

Proteomic analysis

Salvatore Siena, MD

DONUM is an observational prospective independent protocol for patients with advanced lung cancer, colorectal cancer or cancer of unknown primary, willing to donate their tumor tissue samples post mortem for biomedical research purposes. All patients who fulfill the inclusion criteria will be eligible for the study after giving their Informed consent. Informed Consent will be obtained in two steps. During the pre-information step patients will be acquainted with the existence of a post-mortem cancer tissue donation research program governed by the DONUM protocol. If the patients manifest interest to participate into the program (in writing) during the pre-information step, they will proceed to step 2 and undergo the final informed consent process.

Despite the recent technological advancement in genomic and proteomic, the molecular understanding of clonal evolution in solid tumor patients is hampered by intra tumor heterogeneity (ITH), while remaining essential to the effective treatment of patients. Recent evidence suggests that branched evolutionary tumor growth may contribute to ITH both within a primary tumor and between primary and metastatic tumors. To study the full extent and consequences of ITH, and grasp clonal evolution, the investigators need to have access not only to circulating biomarkers (circulating tumor DNA) but also, simultaneously and separately, to the primary tumor and all its derived metastases. However multiple biopsies in live patients are neither medically feasible, nor ethical acceptable. A lesser known tissue collection method is through rapid tissue donation (RTD), which is the procurement of 'fresh' tissue within 2 hrs following the death of a patient. RTD-based research provides an effective way to investigate advance tumors biology in a manner not possible by any other means. With an RTD approach, the full extent and consequences of tumor heterogeneity can be evaluated by deep sequencing and global analysis of genetic alterations at the protein level of simultaneous core biopsies from several areas of the primary tumor and metastases and correlation with clinical outcome. To investigators' knowledge, no such studies have been done in Italy and are currently being pursued only in selected USA and UK cancer centers.

Primary and metastatic tissues and peripheal blood samples

Donation of Post Mortem Tumor Tissues

Donation of Post Mortem Tumor Tissues to Unravel Cancer Heterogeneity

Procure primary and metastatic tissue of selected solid tumor patients shortly after death in order to investigate ITH (intratumor heterogeneity), using integrated genomic and proteomic analysis

Study ITH as a results of anticancer drugs exposure in order to forecast its potential impact on subsequent lines of therapy

Study how the genomic landscape provided by the determination of the circulating free tumor DNA (ctDNA) compare to the genomic landscape from all tumor tissues, considered as gold standard

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pembrolizumab in Patients With Poor-Prognosis Carcinoma of Unknown Primary Site (CUP)	NCT03391973	Carcinoma of Un...	Pembrolizumab I...	18 Years -	AHS Cancer Control Alberta
Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary	NCT00873119	Carcinoma of Un...	belinostat, car... carboplatin, pa...	18 Years -	Valerio Therapeutics
Pembrolizumab in Patients With Poor-Prognosis Carcinoma of Unknown Primary Site (CUP)	NCT03391973	Carcinoma of Un...	Pembrolizumab I...	18 Years -	AHS Cancer Control Alberta
Review of Molecular Profiling-Real Time Polymerase Chain Reaction (Rt-Pcr) in Unknown Primary Cancer	NCT00876408	Unknown Primary...		18 Years -	SCRI Development Innovations, LLC
International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)	NCT03210298	Peritoneum Canc... Peritoneum Neop... Pleural Cancer Pleural Effusio... Pleural Mesothe... Ovarian Cancer Gastric Cancer Appendix Cancer Pseudomyxoma Pe... Colorectal Canc... Pancreas Cancer Gallbladder Can... Ascites CUP Chemotherapeuti...	PIPAC	10 Years -	University of Magdeburg
International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)	NCT03210298	Peritoneum Canc... Peritoneum Neop... Pleural Cancer Pleural Effusio... Pleural Mesothe... Ovarian Cancer Gastric Cancer Appendix Cancer Pseudomyxoma Pe... Colorectal Canc... Pancreas Cancer Gallbladder Can... Ascites CUP Chemotherapeuti...	PIPAC	10 Years -	University of Magdeburg
Donation of Post Mortem Tumor Tissues	NCT03385980	NSCLC Stage IV CRC CUP	Proteomic analy...	-	Niguarda Hospital
Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary	NCT00873119	Carcinoma of Un...	belinostat, car... carboplatin, pa...	18 Years -	Valerio Therapeutics
Review of Molecular Profiling-Real Time Polymerase Chain Reaction (Rt-Pcr) in Unknown Primary Cancer	NCT00876408	Unknown Primary...		18 Years -	SCRI Development Innovations, LLC

Spots Global Cancer Trial Database for cup

Every month we try and update this database with for cup cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cup

Every month we try and update this database with for cup cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cup cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.