Neoplasms

All Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Cisplatin

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Atezolizumab will be administered at a fixed dose of 1200 mg Q3W (1200 mg on Day 1 of each 21 day cycle),

Tiragolumab will be administered at a fixed dose of 600 mg intravenously Q3W on Day 1 of each 21-day cycle.

Tiragolumab

Padmanee Sharma, MD, PhD

To learn if the combination of atezolizumab and tiragolumab can help to control bladder cancer when it is given before surgery to remove the bladder and tumor.

Primary Safety Objective:

•To evaluate the safety and tolerability oftiragolumab and atezolizumab in patients with muscle-invasive, high-risk UC who are ineligible for neoadjuvant cisplatin-containing chemotherapies.

Secondary Efficacy Objectives:

* To evaluate pathologic T0 rate after neoadjuvant treatment with tiragolumab and atezolizumab in patients with muscle-invasive, high-risk UC comparing to historical data (about 10% in patients with high-risk disease).
* To evaluate relapse-free survival (RFS) and overall survival (OS).

Exploratory Biomarker Objective :

• To assess immunologic/molecular responses to tiragolumab and atezolizumab in patients with muscleinvasive, high-risk UC who are ineligible for neoadjuvant cisplatin-containing chemotherapies.

Neoadjuvant PD-1 Plus TIGIT Blockade in Patients With Cisplatin-Ineligible Operable High-Risk Urothelial Carcinoma

M.D. Anderson Cancer Center

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Tuberculosis

Pleural Effusion

Pleurisy

Communicable Diseases

Mycobacterium Infections

Bacterial Infections

Gram-Positive Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Pleural Diseases

Respiratory Tract Diseases

Respiratory Tract Infections

Four pleural biopsy specimens will be obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm) followed by 6-10 pleural biopsy specimens obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter).

Cryoprobe pleural biopsy first

Six to ten pleural biopsy specimens will be obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter) followed by four pleural biopsy specimens obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm)

Flexible forceps biopsy first

This is a prospective study to assess the yield of pleural biopsy obtained with the routine flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during semirigid thoracoscopy

Consecutive patients with exudative pleural effusions who are planned to undergo semirigid thoracoscopy will be enrolled in the study if they satisfy the inclusion criteria. They will be randomized in 1:1 ratio using a computer-generated randomization sequence to the following groups:

Group A: Four pleural biopsy specimens obtained using the flexible cryoprobe followed by eight pleural biopsy specimens obtained using the flexible thoracoscopic forceps OR Group B: The above two procedures will be performed in the reverse order The biopsies will be performed from different areas of the involved pleura with the two techniques. Thoracoscopy will be performed in the bronchoscopy suite on spontaneously breathing subjects (fasting for 8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete aseptic precautions.

Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy

A Study to Evaluate the Yield of Pleural Biopsy With a Flexible Cryoprobe Versus Flexible Forceps During Semirigid Thoracoscopy: a Comparative Study

The proportion of patients where a definitive histopathological diagnosis was obtained will be compared between the cryoprobe and flexible forceps biopsy

Size of biopsy specimens obtained with the two techniques

Time taken for the procedure with the two techniques

Ease of taking biopsy with the two techniques assessed using a visual analog scale

Number of patient speciemens with histopathologic artifacts with either technique including crush artefacts with the flexible forceps and freeze artifacts with the cryoprobe

Depth of the tissue obtained on histopathology

Number of participants with bleeding seen while taking biopsy categorised into "no bleeding", "minimal self limited ooze", "bleeding requiring prolonged suctioning" , "major hemorrhage requiring blood transfusion, causing hemodynamic instability or ICU admission"

Post Graduate Institute of Medical Education and Research, Chandigarh

Assistant Professor

Endothelial Growth Factors

Mitogens

Lucitanib

Teresa Helsten, MD

Lucitanib is an oral multi kinase inhibitor designed to block the action of certain molecules called "angiogenic factors" that may cause tumors to grow. These factors are called vascular endothelial growth factor (VEGF), platelet derived growth factor receptor (PDGFR) and fibroblast growth factor (FGF). Lucitanib is experimental and not approved by the FDA for the treatment of cancer.

The purpose of this study is to look at the effects of lucitanib in cancer patients whose cancers harbor aberrations in FGFR, VEGFR, PDGFR or other markers predicted to be sensitive to lucitanib. This study will also look for biomarkers in samples of blood and tumor tissue to identify patients most likely to respond to lucitanib. Biomarkers are substances such as genetic material (DNA and RNA) and proteins found in blood and tumor tissue that might show if a cancer patient will respond or not respond to a drug.

Lucitanib is an oral multi kinase inhibitor designed to block the action of certain molecules called "angiogenic factors" that may cause tumors to grow. These factors are called vascular endothelial growth factor (called VEGF), platelet derived growth factor receptor (PDGFR) and fibroblast growth factor (called FGF). Lucitanib is experimental and not approved by the FDA for the treatment of cancer.

The purpose of this clinical trial is to study the following in cancer patients whose cancers harbor aberrations in FGFR, VEGFR, PDGFR, or other biomarkers predicted to be sensitive to lucitanib:

* To look at the effects of lucitanib on their disease at 10 mg once daily.
* To look for biomarkers in samples of blood and tumor tissue to identify patients most likely to respond to lucitanib.
* To look at the safety of lucitanib in these patients

This is a two-center, open-label, non-randomized Phase II study of lucitanib in adult subjects with advanced cancers. Treatment will consist of daily oral administration of 10mg of lucitanib in 28-day cycles.

All patients providing informed consent will be screened for eligibility. Baseline assessments will include vital signs, physical exam, blood hematology and chemistries, ECG, and ECHO. If not done within the prior 4 weeks, a PET/CT scan, MRI, and/or CT scan will be performed for radiological evaluation of disease.

Clinical evaluations include physical exam, vitals, ECG (obtained once every month throughout treatment); blood hematology and chemistries (obtained every two weeks for the first three months and then once every month throughout treatment); radiologic evaluations (PET/CT, CT and/or MRI, +/- bone imaging as clinically appropriate) will be performed every 8 weeks.

This study may last up to approximately 4 years or longer, depending on whether or not the study doctor feels that continuing lucitanib dosing is in the patient's best interest. Once a patient finishes study treatment with lucitanib, patients will need to complete an End of Study visit. Each of the study visits can last from approximately 2 to 8 hours.

Lucitanib (E3810) in Patients With Advanced Cancer and FGFR, VEGFR, or PDGFR Pathway Aberrations

Histology-Independent Study of the Multikinase Inhibitor Lucitanib (E3810) in Patients With Advanced Cancer and Fibroblast Growth Factor Receptor (FGFR), Vascular Endothelial Growth Factor Receptors (VEGFR), or Platelet Derived Growth Factor Receptor (PDGFR) Pathway Aberrations

Clinical Benefit will be defined as SD ≥ 6 cycles and PR/CR of any duration.

Toxicities will be described according to the NCI-CTCAE Version 4.3. Unacceptable toxicity is defined as any clinically significant Grade 3 or 4 toxicity including expected toxicities definitely, probably, or possibly related to the study medication that are not amenable to dose reduction

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant PD-1 Plus TIGIT Blockade in Patients With Cisplatin-Ineligible Operable High-Risk Urothelial Carcinoma	NCT05394337	Metastatic Mali...	Atezolizumab Tiragolumab	18 Years -	M.D. Anderson Cancer Center
Neoadjuvant PD-1 Plus TIGIT Blockade in Patients With Cisplatin-Ineligible Operable High-Risk Urothelial Carcinoma	NCT05394337	Metastatic Mali...	Atezolizumab Tiragolumab	18 Years -	M.D. Anderson Cancer Center
Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy	NCT02500277	Pleural Effusio... Pleurisy Tuberculosis Metastatic Mali...	Cryoprobe pleur... Flexible forcep...	12 Years - 79 Years	PGIMER
Lucitanib (E3810) in Patients With Advanced Cancer and FGFR, VEGFR, or PDGFR Pathway Aberrations	NCT02747797	Advanced Cancer	Lucitanib	18 Years -	University of California, San Diego

Spots Global Cancer Trial Database for metastatic malignancy