Pembrolizumab for Carcinoma, Transitional Cell

1
Effectiveness
1
Safety
Virginia Cancer Specialists, Fairfax, VA
Carcinoma, Transitional Cell+12 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Transitional Cell

Study Summary

This study is evaluating whether a new type of antibody may help treat cancer.

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Eligible Conditions

  • Carcinoma, Transitional Cell
  • Oral Squamous Cell Carcinoma
  • Carcinoma
  • Melanoma
  • Adenocarcinoma
  • Carcinoma, Renal Cell
  • Squamous Cell Carcinoma of Head and Neck
  • Non-small Cell Lung Cancer
  • Adenocarcinoma of the Stomach
  • Transitional Cell, Carcinoma
  • Renal Cell Adenocarcinoma
  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
  • Esophageal Adenocarcinoma (EAC)
  • Solid Metastatic Tumor

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Pembrolizumab will improve 3 primary outcomes, 5 secondary outcomes, and 1 other outcome in patients with Carcinoma, Transitional Cell. Measurement will happen over the course of Up to 2-3 years.

Up to 2-3 years
Anti-tumor activity of INBRX-105
Area under the serum concentration time curve (AUC) of INBRX-105
Frequency of adverse events of INBRX-105
Immunogenicity of INBRX-105
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-105
Maximum observed serum concentration (Cmax) of INBRX-105
Severity of adverse events of INBRX-105
Time to Cmax (Tmax) of INBRX-105
Trough observed serum concentration (Ctrough) of INBRX-105

Trial Safety

Trial Design

10 Treatment Groups

No Control Group
Combination Expansion Cohort Non-small Cell Lung Cancer

This trial requires 170 total participants across 10 different treatment groups

This trial involves 10 different treatments. Pembrolizumab is the primary treatment being studied. Participants will be divided into 10 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Combination Expansion Cohort Non-small Cell Lung CancerPatients will be treated with INBRX-105 in combination with Pembrolizumab.
Combination Expansion Cohort MelanomaPatients will be treated with INBRX-105 in combination with Pembrolizumab.
Single Agent Escalation
Drug
INBRX-105 will be escalated in patients with locally advanced or metastatic solid tumors.
Expansion Cohort PD-L1 Positive Basket
Drug
Patients with gastric or gastro-esophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma will be treated with single-agent INBRX-105 at either the MTD or RP2D.
Expansion Cohort Melanoma
Drug
Patients will be treated with single-agent INBRX-105 at either the MTD or RP2D.
Expansion Cohort Head and Neck Squamous Cell Carcinoma
Drug
Patients with head and neck squamous cell carcinoma will be treated with single-agent INBRX-105 at either the MTD or RP2D.
Expansion Cohort Non-small Cell Lung Cancer
Drug
Patients will be treated with single-agent INBRX-105 at either the MTD or RP2D.
INBRX-105 Escalation in Combination with PembrolizumabINBRX-105 will be escalated in combination with Pembrolizumab in pateitns with locally advanced or metastatic solid tumors.
Combination Expansion Cohort Cohort PD-L1 Positive BasketPatients with head and neck squamous cell carcinoma, gastro-esophageal junction adenocarcinoma, renal cell carcinoma, and urothelial (transitional) cell carcinoma will be treated with INBRX-105 in combination with Pembrolizumab.
Combination Expansion Cohort Treatment Naive Non-small Cell Lung CancerTreatment naive patients (PD-L1 IHC between 1 and 49%) will be treated with INBRX-105 in combination with Pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2-3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2-3 years for reporting.

Closest Location

Virginia Cancer Specialists - Fairfax, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Carcinoma, Transitional Cell or one of the other 12 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Parts 2 and 4 (expansion cohorts): Patients with non-small cell lung cancer, melanoma, head and neck squamous cell carcinoma, gastric or gastro-esophageal junction adenocarcinoma, renal cell carcinoma, or urothelial (transitional) cell carcinoma, with locally advanced or metastatic, non-resectable disease, which has progressed despite standard therapy or for whom no standard or clinically acceptable therapy exists.
Refractory or relapsed to anti-PD-1 or anti-PD-L1, and anti-CTLA4 if applicable (NOTE: For all tumor types with checkpoint inhibitor approvals) with exception of the treatment naive NSCLC cohort.
PD-L1 positivity by immunohistochemistry (IHC): Parts 1 and 3 (escalation cohorts) PD-L1 positivity is not required. Parts 2 and 4 (expansion cohorts): Combined Positive Score (CPS) or Tumor Proportion Score (TPS) above certain thresholds as defined per protocol.
You have a performance status of 0 or 1. show original
Patients with locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite standard therapy and for whom no further standard therapy exists. show original
Patients with locally advanced or metastatic, non-resectable NSCLC, who have not received prior systemic treatment, including CPI, for advanced or metastatic disease. show original
The patient must have hematologic, coagulation, hepatic and renal function as defined per protocol. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has pembrolizumab proven to be more effective than a placebo?

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This data could be considered as the main argument for further randomized trials with pembrolizumab combined with standard chemotherapy for the treatment of patients with metastatic TCC.

Unverified Answer

What causes carcinoma, transitional cell?

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Transitional cell cancers and adenocarcinomas have been shown to be heritable to a certain degree. Although the exact cause remains unknown, environmental factors that decrease the expression of specific tumor suppressor genes on the chromosome 9 of the tumor are likely candidates with the exception of carcinoma, transitional cell tumors that form within organs. However, tumors exhibiting an abrupt pattern of development can also be heritable.

Unverified Answer

What are the signs of carcinoma, transitional cell?

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Symptoms related to the bladder include a sudden need to urinate at night because the bladder becomes full, frequent and urgent urination, a feeling that there is not enough urine to do this in the daytime, and the presence of blood, pus or other fluid, known as dysuria, in the urine. Symptoms related to the kidney include sudden weight loss, a gradual loss of appetite, and blood in the urine. Symptoms related to the ureters include pain extending from the lower back to the pubic area and a sudden need to urinate. Pain from the kidney, which can occur in severe cases, and pain from the ureters can lead to kidney failure. Symptoms concerning the bladder may also indicate a bladder cancer.

Unverified Answer

How many people get carcinoma, transitional cell a year in the United States?

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We provide the first estimates to U.S. healthcare professionals on the incidence of carcinoma, transitional cell. This estimate highlights the need for further investigation regarding the etiology of carcinoma, transitional cell.

Unverified Answer

What is carcinoma, transitional cell?

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Carcinoma, transitional cell is a cancer that develops from the cells found in the bladder wall. For patients with cancer, the risk of dying from the cancer is not greater than the risk of dying from other causes. The best way to control bladder cancer and prevent its cancer spreading to the rest of the body is to visit your doctor regularly and have regular screening.\n

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Can carcinoma, transitional cell be cured?

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Most, or perhaps all, patients with carcinoma, transitional cell appear to have metastases. Given that the mortality rate from carcinoma, transitional cell is low (about 2%), these findings suggest that it may be possible to cure carcinoma, transitional cell in selected cases. However, further prospective trials are needed to define the most successful approach.

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What are common treatments for carcinoma, transitional cell?

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Although urologist experience and treatment algorithms evolve, the most common treatments for carcinoma, transitional cell remain surgery, chemotherapy, radiotherapy and combined therapy. It will likely continue to be difficult to determine specific treatments that will result in a survival advantage and prolong time to recurrence.

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Does pembrolizumab improve quality of life for those with carcinoma, transitional cell?

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PBT may reduce anxiety and depression but it did not improve HRQoL. This suggests that pembrolizumab does not seem to reduce symptoms associated with cachexia and that it might be beneficial for QoL, particularly in people with carcinoma, transitional cell.

Unverified Answer

How serious can carcinoma, transitional cell be?

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Although transitional cell carcinoma in patients without endoscopic or pathologic evidence of TCC are rare, carcinoma of the bladder has a high mortality in the US. There is an urgent, urgent need for more research regarding transitional cell carcinoma and bladder cancer.

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Is pembrolizumab safe for people?

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The risk of serious adverse events, especially for those ≥65 years old, was higher than in studies of conventional treatment. Serious cardiotoxicity and pneumonitis in combination with chemotherapy-related events were more frequent in patients with lung cancer and previous chemotherapy history. Patients with ≥5 medicines were associated with higher serious adverse events.

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Have there been any new discoveries for treating carcinoma, transitional cell?

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A meta-analysis of randomized controlled prospective trials was performed. There is a significant mortality in this group of patients. New treatments are constantly being studied to prolong survival of these patients during the first few weeks of treatment and maybe also in long-term treatment plans.

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What is the latest research for carcinoma, transitional cell?

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There are currently many clinical trials for the use of immunomodulators as a treatment. A key issue is whether they can induce remission and stop chemotherapy within patients, or whether their effects will be limited in this group of patients. Clin Cancer Res; 10(13); 2500-9. ©2014 AACR.

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