Neoplasms

All Conditions

Blood and Lymph Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Myeloproliferative Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bone Marrow Diseases

Hematologic Diseases

Transitional Cell Carcinoma

Chronic Myeloproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Carboplatin

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.

Dean Bajorin, MD

Gemcitabine and carboplatin are two standard chemotherapy drugs used to treat tumors of the urothelial tract. These drugs do not shrink tumors in all patients and when they do, it is generally for a limited amount of time. This has led scientists to look for different ways to treat cancer.

New drugs have been developed to treat cancer that work differently than standard chemotherapy drugs. One new class of drugs are called 'angiogenesis-inhibitors'. These drugs attempt to decrease the blood supply to tumors. By doing so, this may limit the tumor's source of oxygen and nutrients and prevent the tumor from growing. Bevacizumab is an anti-angiogenic drug.

In some other cancers such as colon cancer and lung cancer, combining bevacizumab with standard chemotherapy shrinks tumors in a greater proportion of patients and makes patients live longer than using standard chemotherapy alone. This has never been tested in urothelial cancer and we do not know if bevacizumab will have the same effects in this disease. The purpose of this study is to find out what effects, good and/or bad, the combination of gemcitabine, carboplatin, and bevacizumab has on you and your cancer.

This is a phase II trial of gemcitabine, carboplatin, and bevacizumab in chemotherapy naïve patients with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.

Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma

Response and progression will be evaluated in this study using the international criteria by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee \[JNCI, 92(3):205-216, 2000\]. Changes in only the largest diameter (uni-dimensional measurement) are used in the RECIST criteria.

Memorial Sloan Kettering Cancer Center

Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.

Treatment

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Dr. Dean Bajorin

Time to Progression

Overall Survival

Evaluate the Time to Disease Progression

The Response Rate of Combination Therapy With Bevacizumab, Gemcitabine, and Carboplatin in Patients With Advanced/Metastatic TCC.

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Urethral Cancer

Vaccines

Immunomodulating Agents

Subjects received infusion of DN24-02, at 2-week intervals, for a total of 3 infusions.

Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.

DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.

DN24-02

Observation only until documentation of disease recurrence.

Standard of Care

Robert Israel, MD

This study was conducted to examine survival, disease-free survival, safety, and the magnitude of the immune response induced following administration of DN24-02 in subjects with HER2+ urothelial carcinoma.

Multicenter, open-label, Phase 2 study. Subjects were randomized to either the investigational product, DN24-02, or to standard of care. Subjects randomized to the experimental arm received DN24-02 at 2-week intervals, for a total of 3 infusions. The study evaluated survival, disease-free survival, safety and the magnitude of the immune response between these 2 subject groups.

DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

Overall survival is defined as the time from randomization to death due to any cause.

\*This study was terminated early due to administrative reasons.

Dendreon

Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.

Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.

Total

Age, Continuous

Race (NIH/OMB)

Baseline weight for one subject in standard of care group is missing.

Body weight

ECOG 0=Fully Active; No restrictions

ECOG 1= Restricted Strenuous Activity

ECOG 2=Ambulatory, capable of self-care; no work

ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about \>50% of waking hour; 3=Capable of limited self-care, confined to bed or chair \>50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead

Baseline ECOG data is missing for one subject in each group.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Shabnam Vaziri

Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.

Standard of Care: Standard of care

Intent to Treat (ITT) population.

\*This study was terminated early due to administrative reasons.

Ureteral Neoplasms

Pelvic Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Ureteral Diseases

unrelated adults accompanying patients to clinic

Urothelial Cancer Registry- Patients will complete a family history and urothelial cancer risk questionnaire, and will provide a buccal sample for germline DNA. If the cases have undergone germline sequencing as part of Protocol 12-245, they will not need to provide a buccal sample. If the cases have previously completed athe "the "Urothelial Baseline Questionnaire," in an MSKCC urology clinic they will not need to complete the urothelial cancer risk questionnaire.

saliva sample and questionaire

Urothelial Cancer Registry- These participants will be requested to complete the risk factor questionnaire and to provide a saliva sample for DNA extraction.

saliva sample, questionaire

Helena Furberg-Barnes, PhD

This study is being done to create a registry to help us learn more about urinary and other cancers. This will let us look at large groups of people who do and do not have this kind of cancer.

The investigators will look at risk factors to learn more about how these impact cancer. The investigators will also look at genetic markers. These are genes that are found in a known place. They are often associated with a particular trait. If the gene changes in some way, it may predict cancer or response to treatment. The investigators will look for markers in your saliva.

This registry will help us develop better methods of:

Preventing these cancers. Diagnosing these cancers. Treating these cancers.

Cases will be invited to provide a saliva sample and tissue

A Genotype-Phenotype Urothelial Cancer Registry

University of Chicago

Fox Chase Cancer Center

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Adenocarcinoma

Stomach Neoplasms

Breast Neoplasms

Triple Negative Breast Neoplasms

Esophageal Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Renal Cell

Head and Neck Neoplasms

Endometrial Neoplasms

Genital Diseases

Genital Diseases, Female

Genital Neoplasms, Female

Kidney Neoplasms

Kidney Diseases

Uterine Neoplasms

Uterine Diseases

Breast Diseases

Skin Diseases

Stomach Cancer

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Hematinics

Micronutrients

Anti-Infective Agents

Irinotecan

Immune Checkpoint Inhibitors

Docetaxel

Abiraterone Acetate

Cisplatin

Oxaliplatin

Atezolizumab

Liver Extracts

Iodine

Cadexomer iodine

Subjects will accrue in cohorts of 3-6 subjects for evaluation of cabozantinib tablet dose of either 20 mg, 40 mg, and 60 mg orally qd in combination with standard dosing regimen of atezolizumab (1200 mg infusion q3w). A standard "3 plus 3" design will be utilized to determine a recommended combination dosing regimen for the Expansion Stage.

RCC subjects with clear cell histology who have not received prior systemic anticancer therapy.

UC subjects (including bladder, renal pelvis, ureter, urethra) who have progressed on or after platinum-containing chemotherapy.

UC subjects (including bladder, renal pelvis, ureter, urethra) who are ineligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.

UC subjects (including bladder, renal pelvis, ureter, urethra) eligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.

UC subjects (including renal pelvis, ureter, urinary bladder, urethra) who have radiographically progressed on or after one prior immune check-point inhibitor (ICI) (anti-PD1 or anti-PD-L1) therapy.

CRPC subjects who have radiographically progressed in soft tissue on or after enzalutamide and/or abiraterone acetate for metastatic disease.

Stage IV non-squamous NSCLC subjects who have radiographically progressed on or after treatment with one prior immune checkpoint inhibitor (ICI) (anti-PD-1 or anti-PD-L1) therapy.

Stage IV non-squamous NSCLC subjects with positive PD-L1 expression and without prior systemic anticancer therapy.

Stage IV nonsquamous NSCLC subjects with sensitizing EGFR mutation who have radiographically progressed during or following prior treatment with an EGFR-targeting TKI. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.

RCC subjects with non-clear cell histology who have had up to one prior VEGFR-targeting TKI therapy.

TNBC subjects who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.

OC subjects (including primary peritoneal cancer and fallopian tube cancer) who have platinum-resistant or refractory disease who have had up to two lines of prior systemic anticancer therapy.

EC subjects (serous or endometrioid histology) who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy.

HCC subjects (Child-Pugh score A) who have not received prior systemic anticancer therapy.

GC/GEJC/LEC subjects who have radiographically progressed during or following platinum-containing or fluoropyrimidine-containing chemotherapy.

CRC subjects who have radiographically progressed during or following systemic chemotherapy that contained fluoropyrimidine in combination with oxaliplatin or irinotecan.

H\&N cancer subjects who have radiographically progressed during or following prior platinum-containing chemotherapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.

DTC subjects (follicular, papillary, and poorly differentiated histologies) who are radioactive iodine (RAI) refractory or deemed ineligible for treatment with RAI.

UC subjects (including renal pelvis, ureter, urinary bladder, urethra) who have radiographically progressed on or after one prior ICI (anti-PD-1 or anti-PD-L1). Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.

Stage IV non-squamous NSCLC subjects who have radiographically progressed on or after treatment with one prior ICI (anti-PD-1 or anti-PD-L1). Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.

Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC. Subjects may be allowed to receive combination therapy at the Cohort Review Committee recommended dose following radiographic disease progression.

Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with one, and only one, novel hormonal therapy (NHT) (eg, abiraterone, enzalutamide, apalutamide, daralutamide) for CSPC, mCRPC, or non-metastatic CRPC

Metastatic CRPC (mCRPC) subjects who have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features who have had prior treatment with at least one NHT and have received docetaxel for mCRPC

Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.

cabozantinib

Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).

atezolizumab

Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage

Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd

This is a multicenter Phase 1b, open-label study to assess safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of cabozantinib taken in combination with atezolizumab in subjects with multiple tumor types, including advanced urothelial carcinoma (UC) (including bladder, renal pelvis, ureter, urethra), renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC), non-small-cell lung cancer (NSCLC), triple negative breast cancer (TNBC), ovarian cancer (OC), endometrial cancer (EC), hepatocellular cancer (HCC), gastric cancer/gastroesophageal junction cancer/lower esophageal cancer (GC/GEJC/LEC), colorectal cancer (CRC), head and neck (H\&N) cancer, and differentiated thyroid cancer (DTC). The study consists of two stages: in the Dose Escalation Stage, an appropriate recommended cabozantinib dose for the combination with standard dosing regimen of atezolizumab will be established; in the Expansion Stage, tumor-specific cohorts will be enrolled in order to further evaluate the safety and efficacy of the combination treatment in these tumor indications. Three exploratory single-agent cabozantinib (SAC) cohorts may also be enrolled with UC, NSCLC, or CRPC subjects. One exploratory single-agent atezolizumab (SAA) cohort may also be enrolled with CRPC subjects. Subjects enrolled in the SAC cohorts and SAA cohort may receive combination treatment with both cabozantinib and atezolizumab after they experience radiographic progressive disease per the Investigator per RECIST 1.1. Due to the nature of this study design, some tumor cohorts may complete enrollment earlier than others.

* Dose Escalation Stage: to determine the schedule and maximum tolerated dose (MTD) and/or recommended Expansion Stage dose of cabozantinib when taken in combination with a standard dosing regimen of atezolizumab (1200 mg infusion, once every 3 weeks).
* Expansion Stage: to determine the preliminary efficacy (objective response rate \[ORR\] per RECIST 1.1) and safety of the recommended combination dose of cabozantinib with atezolizumab in eighteen tumor-specific cohorts including subjects with advanced UC, RCC, CRPC, NSCLC, TNBC, OC, EC, HCC, GC/GEJC/LEC, CRC, H\&N, and DTC.
* Exploratory SAC Cohorts: Descriptive efficacy, safety, PK, and biomarker analyses of single-agent cabozantinib in UC, NSCLC, and CRPC subjects. Descriptive efficacy and safety analyses of combination therapy after progression on single-agent therapy
* Exploratory SAA Cohort: Descriptive efficacy, safety, PK, and biomarker analyses of single-agent atezolizumab in CRPC subjects. Descriptive efficacy and safety analyses of combination therapy after progression on single-agent therapy

Dose Escalation followed by Dose Expansion

Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors

To determine the maximum tolerated dose (MTD) and/or recommended dose and schedule for the subsequent Expansion Stage of daily oral administration of cabozantinib in subjects with solid tumors when taken in combination with atezolizumab.

To evaluate preliminary efficacy by estimating the Objective Response Rate (ORR) as assessed by the Investigator per RECIST 1.1.

To assess safety for the combination therapy through the evaluation of incidence and severity of nonserious adverse events (AEs) and serious adverse events (SAEs), including immune-related adverse events (irAEs).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Trial of Gemcitabine, Carboplatin, and Bevacizumab in Chemotherapy Naive Patients With Advanced/Metastatic Urothelial Carcinoma	NCT00588666	Myeloproliferat... Urothelial Carc... Cancer	Bevacizumab Carboplatin Gemcitabine	18 Years -	Memorial Sloan Kettering Cancer Center
DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma	NCT01353222	Urothelial Carc...	DN24-02 Standard of Car...	18 Years -	Dendreon
A Genotype-Phenotype Urothelial Cancer Registry	NCT00902590	Urothelial Canc... Renal Pelvis Ca... Ureter Cancer Bladder Cancer	saliva sample a... saliva sample, ...	18 Years -	Memorial Sloan Kettering Cancer Center
A Genotype-Phenotype Urothelial Cancer Registry	NCT00902590	Urothelial Canc... Renal Pelvis Ca... Ureter Cancer Bladder Cancer	saliva sample a... saliva sample, ...	18 Years -	Memorial Sloan Kettering Cancer Center
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors	NCT03170960	Urothelial Carc... Renal Cell Carc... Non-Small Cell ... Castration-resi... Triple Negative... Ovarian Cancer Endometrial Can... Hepatocellular ... Gastric Cancer Gastroesophagea... Colorectal Canc... Head and Neck C... Differentiated ... Lower Esophagea...	cabozantinib atezolizumab cabozantinib cabozantinib	18 Years -	Exelixis
DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma	NCT01353222	Urothelial Carc...	DN24-02 Standard of Car...	18 Years -	Dendreon

Spots Global Cancer Trial Database for renal pelvis

Every month we try and update this database with for renal pelvis 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.