Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Gemcitabine

Cisplatin

Pancrelipase

Sorafenib

Pancreatin

Protein Kinase Inhibitors

Enzyme Inhibitors

Sorafenib 400 mg po bid, continuously

Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days.

Gemcitabine 1000 mg/m2, Cisplatin 25 mg/m2 day 1, and 8 every 21 days

NEXAVAR\*112CPR RIV 200MG

Titolare AIC:

BAYER SpA

Numero di AIC dell'IMP:

037154010

Sorafenib 400 mg po bid, continuously

Gemcitabina 1000 mg/mq, Cisplatino 25 mg/mq day 1 and 8 every 21 days

Gemcitabina, Cisplatino

Stefano Cascinu, MProfessor

Silvia Rota, Data Manager

sandro Barni, MD

Alberto Sobrero, MD

Paolo Foa, MD

Gianfranco Pancera, MD

Donata Tabiadon, MD

Paolo Bidoli, MD

Stefano Cascinu, M.Pr

Roberto Labianca, MD

Francesco Di Costanzo, MD

Enrico Aitini, MD

Salvatore Siena, MPr

Stefano Cascinu, M.Professor

This is multicentre, open-label, randomized, phase II trial in patients with locally advanced or metastatic pancreatic cancer. Subjects will be randomized in a 1:1 ratio to receive gemcitabine/cisplatin in combination with Sorafenib (arm A) or gemcitabine/cisplatin alone (arm B), as first-line chemotherapy.

Up to date no standard treatment is available for pancreatic cancer. Although gemcitabine is commonly used in patients with pancreatic cancer with the purpose of symptom palliation, there is no clear evidence of efficacy in terms of survival increase or progression control. Furthermore, attempts at improving results by combining gemcitabine with other cytotoxic drugs failed to obtain any advantage. Recently, an EGFR inhibitor (erlotinib) showed a small survival advantage when combined with gemcitabine. results obtained with a combination of gemcitabine and oxaliplatin seem more promising. A meta-analysis of randomised trials comparing gemcitabine versus gemcitabine and platinum analogues showed a statistical significant survival advantage for the combination.

Sorafenib is an inhibitor of the RAS/RAF signalling pathway. Furthermore, sorafenib is able to inhibit both VEGFR and PDGFR.

Since RAS and RAF mutations are quite common in pancreatic cancer, Sorafenib could be useful in the management of these tumours. Furthermore, it may be combined with gemcitabine and cisplatin without any pharmacokinetic interaction or enhanced toxicity.

Metastatic Advanced Pancreas Sorafenib

A Randomized Phase II Study of Gemcitabine/Cisplatin With or Without Sorafenib to Evaluate the Efficacy and Safety in Patients With Locally Advanced or Metastatic Pancreatic Cancer. MAPS Trial

Mario Negri Institute for Pharmacological Research

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Stefano CASCINU, Medical Professor

Antirheumatic Agents

Paclitaxel

Albumin-Bound Paclitaxel

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Enrolled participants will be given a preconditioning regimen consisted of albumin-bound paclitaxel, cyclophosphamide and fludarabine before the infusion of CD70-CAR-T cells.

Enrolled patients in this arm will be administered CD70-CAR-T cells in 3+3 based escalation manner.

Dose escalation:

Dose1 (1×10\^6 cells/kg) , Dose 2(3×10\^6 cells/kg) ,Dose 3 (1×10\^7cells/kg);

Dose expansion: RP2D

Drug: Albumin-bound paclitaxel

Administered intravenously at dose of 100-200mg/m2 on day -5;

Drug: Cyclophosphamide

Administered intravenously at dose of 15-30mg/kg on day -3 and day -2;

Drug: Fludarabine

Administered intravenously at dose of 30mg/m2 on day -3 and day -2;

CD70-targeting CAR-T cells

Weidong Han, Ph.D

Yang Liu, M.D

Yangbin Zhao, Ph.D

In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive advanced/metastatic solid tumors . In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).

Currently, CAR-T cell therapy has already achieved tremendous success in the treatment of hematological malignancies,however, it remains a severe challenge to treat solid tumors due to multiple obstacles,such as absence of tumor specific antigens, complex immunosuppressive tumor microenvironment, and tumor heterogeneity.

CD70 is a member of the tumor factor superfamily and has been found to be highly expressed on the surface of several solid and hematological tumors, correlating with inferior prognosis.Targeting CD70 has emerged as potential novel immunotherapeutic strategy. Investigators have developed CD70-CAR-T cells that could effectively expand and survive，producing strong anti-tumor effects in animal models. Based on the preclinical data, we conduct this clinical trial in order to test the the safety profiles and anti-tumor activities of CD70-CAR-T cells in vivo. In dose escalation period, at least 12 eligible patients will be enrolled and receive 3 doses of CD70-CAR-T cell therapy (1 × 10\^6 cells/kg, 3 × 10\^6 cells/kg, 1 × 10\^7 cells/kg) according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell infusion at dose of RP2D, which is determined by data from dose escalation period, including occurrence of dose limiting toxicities (DLT), pharmacokinetics/pharmacodynamics, efficacy and other parameters, to furtherly evaluate the safety and efficacy profiles of CD70-CAR-T cell therapy.

CD70 Targeted CAR-T Cells in CD70 Positive Advanced/Metastatic Solid Tumors

Phase I/II Study of CD70 Targeted CAR-T Cell Treatment in CD70 Positive Advanced/Metastatic Solid Tumors

AE is defined as any adverse medical event from the date of randomization to 12 months after CD70-CAR-T cell infusion. Among them, CRS and ICANS were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0.

DLT was defined as CD70-CAR-T cells-related events with onset within first 28 days following infusion: The development of Grade (G) 3 or higher grade CRS lasting \> 2 weeks; All G4 non-hematologic toxicities.

MTD is defined as the highest dose level of less than or equal to 2 DLT among the 6 subjects finally determined.

Number and copy number of CD70-CAR-T cells are evaluated by number in peripheral blood and tumor tissue.

Objective response rate includes complete response and partial response defined by investigators according to RECIST 1.1or iRECIST criteria.

Progression Free Survival is defined as the time from the initiation of CD70-CAR-T cell therapy to documented disease progression or death.

Time to response is defined as the time from the initiation of CD70-CAR-T cell therapy to first assessed CR or PR by investigators according to RECIST 1.1or iRECIST criteria.

Duration of response is defined as the time from objective response until documented tumor progression among responders.

Overall Survival is defined as the time from the initiation of CD70-CAR-T cell therapy to documented disease progression or death.

The cytokines mainly include interleukin-2 (IL-2 ), IL-6, IL-8, IL-10, tumor necrosis factor-α (TNF-α), C reactive protein (CRP), ferritin. Peak was defined as the maximum post-baseline level of the cytokine.

UTC Therapeutics Inc.

Chinese PLA General Hospital

Director of Biotherapeutic Department

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Disease Progression

Carcinoma

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

NGR-hTNF+Pegylated Liposomal Doxorubicin or Doxorubicin

Pegylated Liposomal Doxorubicin or Doxorubicin

NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion weekly or every 3 or 4 weeks until confirmed evidence of disease progression or unacceptable toxicity occurs

NGR-hTNF

50 mg/m² iv every 4 weeks until confirmed evidence of disease progression

Pegylated liposomal doxorubicin

60 mg/m² iv every 3 weeks for a maximum of 8 cycles

Antonio Lambiase, MD

The primary objective of this randomized phase II trial is to compare progression-free survival (PFS) in patients randomized to NGR-hTNF plus an anthracycline versus patients randomized to an anthracycline alone

Considering the safety/toxicity profile of NGR-hTNF characterized by mild-to-moderate constitutional symptoms, the reversibility of these adverse events generally occurring only during the infusion time; the absence of overlapping toxicities with chemotherapeutic agents; the safety and preliminary antitumor activity observed in previous trial with doxorubicin; and the objective response rate (RR) registered in a phase II trial in previously treated ovarian cancer patients seems justified to evaluate in a randomized phase II trial the efficacy of NGR-hTNF against a doxorubicin-based option in advanced ovarian cancer patients progressing or recurrent after a standard platinum/taxane-based chemotherapy.

Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer

NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer

Defined as the time from the date of randomization until disease progression, or death

defined as the time from the date of randomization until death due to any cause.

defined as the percentage of patients who have a best-response rating of complete or partial response, according to standard RECIST criteria.

defined as the percentage of patients who have a best-response rating of complete response, partial response, or stable disease, according to standard RECIST criteria.

measured from the date of randomization until disease progression, or death due to any cause.

To evaluate safety and toxicity profile related to NGR-hTNF

AGC Biologics S.p.A.

Renal Insufficiency

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Urologic Neoplasms

Transitional Cell Carcinoma

Carboplatin

Tubulin Modulators

Vinblastine

Antimetabolites

Antimitotic Agents

* Vinflunine 280 or 250 mg/m2, IV administration over 20 minutes (starting dose based on baseline creatinine clearance value), Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal
* Gemcitabine 750 or 1000 mg/m2, IV administration over 30 minutes (starting dose based on baseline creatinine clearance value), Day 1 and 8 every 3 weeks up to progression or unacceptable toxicity or patient's refusal

Vinflunine, Gemcitabine

* Vinflunine 280 or 250 mg/m2, IV administration over 20 minutes (starting dose based on baseline creatinine clearance value), Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal
* Carboplatin AUC 4.5, IV administration over 60 minutes, Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal

Vinflunine, Carboplatin

Maria De Santis, MD

Stéphane Culine, MD

This study is assessing the combination of well known cytotoxics with a novel anti-cancer agent that could be administered as monotherapy without renal toxicity in patients with renal impairment presenting with advanced or metastatic urothelial carcinoma previously treated with a platinum-based regimen. The intent of this study is to clarify the benefit/risk ratio of the two most promising associations of cytotoxics including the novel therapeutic agent, vinflunine: vinflunine-gemcitabine and vinflunine-carboplatin.

Gemcitabine and carboplatin have been the most studied and used anticancer agents in cisplatin-unfit patients with advanced urothelial carcinoma. Both agents previously demonstrated clinical activity as single agent and/or as part of combination regimen in patients with advanced or metastatic disease even if clinical benefits and survival remains limited in this setting for this population.

The purpose of this study is to test in a randomized trial enrolling patients with renal impairment or moderate congestive heart failure two combinations of a novel cytotoxic agent, vinflunine, one with gemcitabine and another with carboplatin in order to determine the most promising combination in the first line treatment of advanced/metastatic urothelial carcinoma.

JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin

Randomized Phase II Study Assessing the Combination of Vinflunine With Gemcitabine and Vinflunine With Carboplatin in Patients Ineligible to Cisplatin With Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

Assessment of lesions (measurable and non-measurable) should be performed at baseline and every 6 weeks (assessment interval).

Evaluable patients: all baseline lesions must have been assessed at least once after the second cycle (6 weeks); patients who progress before the first evaluation will be considered as early progression.

Primary analysis is planned on the intent to treat population, secondary analysis being performed on the evaluable population.

Assessment of lesions (measurable and non-measurable) should be performed at baseline and every 6 weeks (assessment interval).

Evaluable patients: all baseline lesions must have been assessed at least once after the second cycle (6 weeks); patients who progress before the first evaluation will be considered as early progression.

Tumor assessment at baseline and then every 6 weeks, until tumor progression. Duration of disease control according to investigator will be calculated among the responders and stable patients from the date of randomisation until the documentation of progression or death due to any cause. Patients who are lost to follow-up without progression, or reach the time point of analysis without a known record of progression or death will have the duration of disease control censored at the date of last tumour assessment or last contact of a follow-up showing no progression, whichever occur last.

Tumor assessment at baseline and then every 6 weeks, until tumor progression. Duration of response will be calculated among the responders (i.e. CR and PR) . Patients who are lost to follow-up, or reach the time point of analysis without a known record of progression or death will have the duration of response censored at the date of last tumour assessment or last contact of a follow-up showing no progression, whichever occur last.

Tumor assessment at baseline and then every 6 weeks. Will be calculated among the responders (i.e. CR and PR)

Tumor assessment (RECIST) every 6 weeks. Patients who reach the time point of analysis without failure as defined above will have the time to treatment failure censored at the date of last tumour assessment or last contact of a follow-up not showing progression. Patients who discontinued treatment for other reason and who are lost to follow-up will be censored at the date of last contact.

Tumor assessment every 6 weeks (RECIST).Patients who are lost to follow-up, or reach the time point of analysis without a known record of progression or death will have the progression-free survival censored at the date of last tumour assessment or last contact of a follow-up showing no progression, whichever occur last.

Data recording every 3 months. For patients who have not died, survival time will be censored at the date of last news (i.e: date of last administration, tumor assessment, clinical examination, haematological or biochemistrical assessment or date of last contact).

Population: all treated patients unless the patient is lost to follow-up immediately after the start of the treatment. The patients will be analysed in the treatment arm they actually received.

The NCI-CTC classification version 2.0 will be used to classify toxicities. Maximum grade or severity will be reported by cycle and by patient for each MedDRA Preferred Term. Analyses will be performed both regardless the relationship to treatment and related to treatment.

Biochemical toxicities: the worst CTCAE version 2.0 grade will be analysed according to the grade present at baseline.

Pierre Fabre Medicament

NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs

The primary objective of this extension protocol is to evaluate the early safety of a new schedule of NGR-hTNF given weekly, instead of every 3 or 4 weeks, in a cohort of 12 patients randomized to the experimental arm A, as compared to a reference cohort of 12 patients randomized to an anthracycline alone

In this extension protocol IPR/26 of completed IPR/24 study, considering the relatively short half-life of approximately 1 hour and the favourable toxicity profile of NGR-hTNF, characterized by transient constitutional symptoms occurring during the first day of administration, an additional cohort of 24 patients will be randomized and the 12 patients enrolled in arm A will receive the same dose of NGR-hTNF 0.8 mcg/m2 given as 60 minutes infusion every week. the weekly schedule of NGR-hTNF 0.8 mcg/m2 has previously been tested in several studies

NGR-hTNF in Combination With an Anthracycline in Platinum-resistant Ovarian Cancer (NGR018)

To evaluate safety profile related to NGR-hTNF

defined as the time from the date of randomization until death due to any cause

defined as the percentage of patients who have a best-response rating of complete or partial response, according to standard RECIST criteria

defined as the percentage of patients who have a best-response rating of complete response, partial response, or stable disease, according to standard RECIST criteria

measured from the date of randomization until disease progression, or death due to any cause

Stomach Neoplasms

Adenocarcinoma

Stomach Diseases

Stomach Cancer

Esophageal Cancer

Nivolumab

Participants with previously untreated advanced or metastatic gastric cancer (GC), gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma (EAC)

BMS Study Connect Contact Center www.BMSStudyConnect.com

First line of the email MUST contain NCT # and Site #.

Site 0001

Bristol-Myers Squibb

The purpose of this observational study is to assess the effectiveness and safety of nivolumab in participants with previously untreated advanced or metastatic Gastric Cancer (GC), Gastro-oesophageal Junction (GEJ) Adenocarcinoma, or Oesophageal Adenocarcinoma (EAC).

A Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric Cancer

A National, Prospective, Non-interventional Study (NIS) of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Patients With HER2 Negative Advanced or Metastatic Gastric, Gastro-oesophageal Junction or Oesophageal Adenocarcinoma Whose Tumours Express PD-L1 With a CPS ≥5

Defined as time since initial diagnosis and treatment with nivolumab to either the first disease progression date or last known tumour assessment date, or death due to any cause, whichever occurs first.

Defined as investigator assessed complete response, partial response, stable disease, or progressive disease.

Defined as time from response to progression

Defined as time since initial diagnosis and treatment with nivolumab until date of death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Metastatic Advanced Pancreas Sorafenib	NCT00758381	Locally Advance...	Sorafenib 400 m... Gemcitabina, Ci...	18 Years - 75 Years	Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
CD70 Targeted CAR-T Cells in CD70 Positive Advanced/Metastatic Solid Tumors	NCT05947487	Solid Tumor, Ad...	CD70-targeting ...	18 Years - 75 Years	Chinese PLA General Hospital
Phase II Study of NGR-hTNF in Combination With Doxorubicin in Platinum-resistant Ovarian Cancer	NCT01358071	Ovarian Cancer	NGR-hTNF Pegylated lipos... Doxorubicin	18 Years -	AGC Biologics S.p.A.
JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin	NCT01599013	Bladder Transit...	Vinflunine, Gem... Vinflunine, Car...	18 Years - 79 Years	Pierre Fabre Medicament
NGR-hTNF in Combination With an Anthracycline in Platinum-resistant Ovarian Cancer (NGR018)	NCT03804866	Ovarian Cancer	NGR-hTNF Pegylated lipos... Doxorubicin	18 Years -	AGC Biologics S.p.A.
JAVLOR Association Study in CDDP-unfit Patients With Advanced Transitional Cell Carcinoma: Gemcitabine Versus Carboplatin	NCT01599013	Bladder Transit...	Vinflunine, Gem... Vinflunine, Car...	18 Years - 79 Years	Pierre Fabre Medicament
A Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric Cancer	NCT05165264	Gastric Cancer		18 Years -	Bristol-Myers Squibb
CD70 Targeted CAR-T Cells in CD70 Positive Advanced/Metastatic Solid Tumors	NCT05947487	Solid Tumor, Ad...	CD70-targeting ...	18 Years - 75 Years	Chinese PLA General Hospital
Metastatic Advanced Pancreas Sorafenib	NCT00758381	Locally Advance...	Sorafenib 400 m... Gemcitabina, Ci...	18 Years - 75 Years	Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Metastatic Advanced Pancreas Sorafenib	NCT00758381	Locally Advance...	Sorafenib 400 m... Gemcitabina, Ci...	18 Years - 75 Years	Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
A Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric Cancer	NCT05165264	Gastric Cancer		18 Years -	Bristol-Myers Squibb

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