DSP-7888 Dosing Emulsion for Carcinoma, Renal Cell

Phase-Based Estimates
1
Effectiveness
1
Safety
Arizona Oncology Associates, PC - HOPE, Tucson, AZ
Carcinoma, Renal Cell+14 More
DSP-7888 Dosing Emulsion - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Renal Cell

Study Summary

This study is evaluating whether a drug which is designed to help the body's immune system fight cancer may help treat cancer.

See full description

Eligible Conditions

  • Carcinoma, Renal Cell
  • Carcinoma
  • Microsatellite Instability
  • Cancer
  • Oral Squamous Cell Carcinoma
  • Fallopian Tube Cancer
  • Ovary Cancer
  • Carcinoma, Transitional Cell
  • Carcinoma, Ovarian Epithelial
  • Neoplasms
  • Squamous Cell Carcinoma of Head and Neck
  • Renal Cell Adenocarcinoma
  • Serous Epithelial Ovarian Cancer
  • Fallopian Tubes Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Neoplasms
  • Platinum-resistant Ovarian Cancer (PROC)
  • Ovarian Neoplasms
  • Transitional Cell, Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether DSP-7888 Dosing Emulsion will improve 3 primary outcomes and 17 secondary outcomes in patients with Carcinoma, Renal Cell. Measurement will happen over the course of 6 weeks.

12 months
Phase Ib: Objective response rate (ORR)
Phase Ib: Overall survival (OS)
Phase Ib: Progression-free survival (PFS)
6 months
Phase II: 6 month PFS
Phase II: 6-month PFS
Phase Ib: 6-month PFS
Phase Ib: Disease control rate (DCR)
Phase Ib: Duration of response (DOR)
6 weeks
Phase Ib: Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs).
Phase Ib: Determination of the safety and tolerability of DSP-7888 Dosing Emulsion given intradermally with a checkpoint inhibitor (Nivolumab or Pembrolizumab) in adult patients with advanced solid tumors by assessing dose-limiting toxicities (DLTs).
Up to 24 months
Phase II: DCR
Phase II: DOR
Phase II: Evaluation of the preliminary antitumor activity of DSP-7888 Dosing Emulsion administered with pembrolizumab in terms of Objective Response Rate (ORR) in patients with platinum-resistant ovarian cancer (PROC).
Phase II: Evaluation of the safety and tolerability of DSP-7888 Dosing Emulsion administered with pembrolizumab.
Phase II: Immune disease control rate (iDCR)
Phase II: Immune objective response rate (iORR)
Phase II: Immune progression-free survival (iPFS)
Phase II: PFS
Phase II: immune DOR (iDOR)
Up to 48 months
Phase II: OS

Trial Safety

Trial Design

2 Treatment Groups

No Control Group
DSP-7888 Dosing Emulsion in combination with Nivolumab

This trial requires 84 total participants across 2 different treatment groups

This trial involves 2 different treatments. DSP-7888 Dosing Emulsion is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

DSP-7888 Dosing Emulsion in combination with Nivolumab
DSP-7888 Dosing Emulsion in combination with Pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
DSP-7888 Dosing Emulsion
2015
Completed Phase 1
~30
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 48 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 48 months for reporting.

Closest Location

Arizona Oncology Associates, PC - HOPE - Tucson, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Renal Cell or one of the other 14 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Pembrolizumab is used to treat various types of cancer, including melanoma, NSCLC, squamous cell carcinoma of the head and neck, urothelial carcinoma, MSI-H/dMMR solid tumors, gastric cancer, and cervical cancer. show original
, or any other form of systemic therapy The first phase of the trial will be for patients with locally advanced or metastatic renal cell cancer or urothelial carcinoma who have disease progression as determined by the iRECIST criteria (iCPD) during or within 3 months of their last dose of the most recent prior anti-PD-1/ PD-L1-based treatment, or any other form of systemic therapy. show original
(i) Patients progressed on their prior treatment before initiating treatment on current study show original
HLA-A*03:01
Nivolumab is a checkpoint inhibitor used to treat unresectable or metastatic melanoma, metastatic NSCLC, advanced RCC, recurrent or metastatic squamous cell carcinoma of the head and neck, locally advanced or metastatic urothelial carcinoma, hepatocellular carcinoma, and MSI-H/dMMR colorectal cancer. show original
Patients who are considered for potentially curative resection surgery must not have any other medical conditions which would prevent them from undergoing the surgery. show original
HLA-A*02:01
HLA-A*02:06
HLA-A*24:02
HLA-B*15:01

Patient Q&A Section

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

What causes carcinoma, renal cell?

Add answer

The vast majority of renal cell cancers (95%) arose as carcinoma in situ. A small number of these in situ cancers (3.8%) grew in a more invasive manner.

Unverified Answer

What are common treatments for carcinoma, renal cell?

Add answer

The general principles of treating carcinoma, renal cell, have remained unchanged. However, advances in diagnostic and management techniques have improved patient survival and quality of life.

Unverified Answer

What are the signs of carcinoma, renal cell?

Add answer

The presenting signs and symptoms are mainly due to the sites of cancer: kidney: pain, dysuria, haematuria, haemorrhagic mass (cancer of kidney), ascites, ascites, oedema/distension, and/or peritoneal/retroperitoneal/psoas haemorrhage. Other symptoms include: pain with coughing, epistaxis, constipation, and anaemia of kidney cancer. Symptoms of metastases of renal cell cancer include: bone pain, a non-specific abdominal pain, vomiting, and loss of appetite.

Unverified Answer

Can carcinoma, renal cell be cured?

Add answer

There is no absolute cure for renal cell carcinoma. With minimal or no treatment of metastatic spread, the mortality risk decreases by 60%. In the absence of specific treatments, survival may increase by a mean of 4.7 months. Renal cell carcinoma may be cured only in the early stage.

Unverified Answer

What is carcinoma, renal cell?

Add answer

Data from a recent study emphasize the importance of accurate histopathological assessment. A good agreement was obtained between the clinical diagnosis and the final histopathological report. This would reassure physicians that they are not overestimating the prognosis of the renal carcinoma. Clinicians should be prepared for the possibility of a false-negative surgical pathology report.

Unverified Answer

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

Add answer

These data suggest that, on a population basis, the total incidence of renal cell cancer, as well as its histologic subtypes are rising. This is in line with previously reported increases in the incidence in situ/invasive urothelial cancers as a whole, especially in women and older patients.

Unverified Answer

What are the common side effects of dsp-7888 dosing emulsion?

Add answer

The most common side effects of dsp-7888 dosing emulsion are headache, dizziness, and mild nausea. The most common side effects of dsp-7888 dosing emulsion are headache, dizziness, and mild nausea. The frequency of all side effects reported with dsp-7888 dosing emulsion in more than 1% of subjects was greater than that observed in clinical trials with other emulsion injectable drugs. The occurrence of headaches in more than 1% of subjects taking the compound was greater than the occurrence of headaches in clinical trials of other injectable drugs and is potentially due to the higher frequency of injection and/or the faster rate of injection of dsp-7888 compared to other injectable drugs.

Unverified Answer

What is the average age someone gets carcinoma, renal cell?

Add answer

The life expectancy of a person who has contracted carcinoma, renal cell carcinoma, is around 68 years old (compared to 59 years in the United States). Although survival and prognosis in the United States differ, people who suffer from carcinoma, renal cell carcinoma, still survive for a longer period.

Unverified Answer

Have there been other clinical trials involving dsp-7888 dosing emulsion?

Add answer

The data presented here, combined with our previously reported data, strongly support the initiation of a large phase II trial evaluating this regimen in patients with newly-diagnosed aggressive malignancies.

Unverified Answer

What is the latest research for carcinoma, renal cell?

Add answer

Carcinoma and renal cell are common neoplasms in South Korea. There was a lot of research done with tumor markers such as CA-125. In other words, there was a significant increase in the number of publications since 2010 from about 2 to 14 publications per year. However, the quality of these articles has improved over time, which indicates that there will be a decline in the number of articles published in the future. There was a significant increase in the volume of articles between 2010 and 2014. There was also a similar trend in the number of papers published annually since 2010, but with little to no change in the number of articles published.

Unverified Answer

How does dsp-7888 dosing emulsion work?

Add answer

DSP-7888 is a potent chemotherapeutic agent for tumors of both renal and lung origin. We believe that this dosing technique will improve the efficacy and duration of survival in patients treated with DSP-7888.

Unverified Answer

Is dsp-7888 dosing emulsion safe for people?

Add answer

Dsp-7888 is a new synthetic, water-in-oil emulsion for inhalation that is absorbed from the nose and airway without the risks of particulate matter or hyperresponsiveness associated with conventional inhalation solutions. Dsp-7888 dosing emulsion is generally safe. The safety profile is similar to those of other inhaled agents, except for potential transient bronchospasm. This safety profile will be clarified in a number of short- to medium-term trials. However, as with all research, potential for adverse effects should be included in the informed consent process.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Carcinoma, Renal Cell by sharing your contact details with the study coordinator.