CLINICAL TRIAL

KHK2455 for Carcinoma

Waitlist Available · 18+ · All Sexes · Iowa City, IA

This study is evaluating whether a combination of two drugs may help treat advanced bladder cancer.

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About the trial for Carcinoma

Eligible Conditions
Carcinoma · Transitional Cell, Carcinoma · Carcinoma, Transitional Cell

Treatment Groups

This trial involves 2 different treatments. KHK2455 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
KHK2455
DRUG
Avelumab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KHK2455
2016
Completed Phase 1
~40
Avelumab
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma or one of the other 2 conditions listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Subjects may be male or female and must be ≥ 18 years of age; have an ECOG PS of 0 or 1; and a life expectancy of > 3 months in the Investigator's judgment;
Subjects are able to understand and willing to sign the ICF, according to institutional standards, prior to the initiation of any study related procedures
Subjects must have histological or cytological evidence of metastatic or advanced urothelial carcinoma (including bladder, urethra, ureters, and renal pelvis that has predominantly transitional cell or urothelial features); and have measurable neoplastic disease according to RECIST v1.1 criteria
Subjects must have been previously treated with a platinum-based therapy and progressed; OR Been previously treated with platinum based adjuvant or neo-adjuvant therapy and relapsed or progressed; OR Be platinum-based chemotherapy intolerant or ineligible; OR Have progressed during or after treatment with approved PD-1/PD-L1 inhibitors
Subjects must have a tumor accessible for fresh biopsy at the baseline visit and for IDO assessment. If current circumstances prohibit the biopsy procedure (e.g., temporary hospital protocol restrictions, regulatory or local authority requirements, etc.) then archived tissue from previous biopsies (fresh frozen tissue < 9 months and formalin fixed-paraffin embedded [FFPE] block of ≤ 24 months) without intervening checkpoint inhibitors can substitute for a fresh baseline biopsy;
Subjects must be able to swallow the solid (encapsulated) dosage form of KHK2455
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to 24 months.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether KHK2455 will improve 1 primary outcome in patients with Carcinoma. Measurement will happen over the course of up to 24 months.

Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0
UP TO 24 MONTHS
To characterize the safety and tolerability of KHK2455 administered in combination with avelumab in subjects with locally advanced or metastatic urothelial carcinoma (including bladder, urethra, ureters, and renal pelvis).

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 are common treatments for carcinoma?

When given for carcinoma of any kind, conventional radiotherapy may be considered, because the overall 5-year survival for this malignancy has increased from 15% in 1987-88 to 35% in 1997-98 and is thought to be related to improvements in the treatment of metastatic disease and overall survival, including metastatic disease in the brain after radiation in the absence of chemotherapy. For other types of cancer, radiation therapy is usually only used before surgery or in postoperative situations. Intensity-modulated radiation therapy (IMRT) is a new type of radiation therapy that can deliver the right amount of radiation at the right place in the body to kill the appropriate tumour without damage to normal tissue.

Anonymous Patient Answer

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

The National Cancer Institute (NCI) estimated that 28,900 people were diagnosed with carcinoma of the skin in the United States in 2012. The actual cancer incidence is most probably underestimated because the vast majority of the cases are not diagnosed (see figure in "External Links"). Inadequate surveillance of sun exposure and increased obesity are other factors contributing to the increase in the number of people diagnosed with cancers of the skin. More research and public awareness are warranted to reduce the burden of this devastating disease.

Anonymous Patient Answer

What are the signs of carcinoma?

The signs are the result of malignant processes of tumour, which invade or compress surrounding tissues, such as muscle, skin, or lymph vessel; or that lead to the loss of functionality, as in obstruction and necrosis of nerves. The signs of carcinoma vary in degree of severity depending upon its location, size, and extent of invasion.\n

Anonymous Patient Answer

What is carcinoma?

The word carcinoma comes from two ancient Greek words, kainos (κάινος, meaning new) and caraine (καραίνειν, meaning to bear), which explains the origin of the two ancient terms on which this article depends, new cancer and old cancer.

Anonymous Patient Answer

Can carcinoma be cured?

The prognosis of carcinoma is determined more by the nature of the carcinoma and the stage of disease than by its cure. However, there is no evidence that cancer can be cured.

Anonymous Patient Answer

What causes carcinoma?

Most carcinomas are probably caused by environmental factors in the body and genetic factors during a person's lifetime. Smoking, and a family history of some forms of non-small cell [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) are two significant factors that increase risk. Lung cancer is a disease that affects millions worldwide with over a quarter of new cases in the United States being smokers. The number of deaths from lung cancer in the USA will exceed deaths from stroke, diabetes, and cancer combined. A decrease in tobacco use and smoking in developing countries would substantially reduce lung cancer prevalence. Smoking is the single biggest cause of lung cancer. Smoking decreases the ability of the body to control the growth of cancer cells in the lung.

Anonymous Patient Answer

Have there been any new discoveries for treating carcinoma?

There are a small number of drugs being studied [right now]. These include [vandetanib, nibratinib, and afatinib] which should be tested in combination with anti-neoplastic therapies. [Power] allows you to find clinical trials tailored to your condition that use these drugs to treat carcinoma. In some cases, [vandetanib] as monotherapy is being studied in combination with drugs such as docetaxel, oxaliplatin, and carboplatin to treat breast cancer, lung cancer, and metastatic colorectal cancer.

Anonymous Patient Answer

What is the latest research for carcinoma?

The current state of the art of carcinoma research is that there seems to be no single treatment so that everyone can live a full life. To that end there is research on many different treatment options. But the issue of survival, which seems to be the greatest concern for people, is still unresolved. The two greatest factors that influence the survival of people with [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer) and carcinoma are: 1) the stage of the cancer and 2) how far from the skin cancer or carcinoma there has been recurrence.

Anonymous Patient Answer

What are the latest developments in khk2455 for therapeutic use?

These data provide further insight into key properties of the antitumor phenotype and suggest that khh2455 could be an effective therapy in cancers where the tumor phenotype is defined by its intrinsic resistance to chemotherapy.

Anonymous Patient Answer

What is the survival rate for carcinoma?

The 5-year survival rate of patients diagnosed with Stage IV (Distant metastasis) carcinoma of the head and neck was 34%; for non-Distant metastasis carcinoma, the 5-year survival rate was 31%. The 5-year survival rate of patients with Stage IV carcinoma of the head and neck who had resected curative surgery in addition to radiation or chemotherapy was 37%. This demonstrates that carcinoma of the head and neck can lead to long-term survival if timely diagnosis and treatment are received.

Anonymous Patient Answer

How quickly does carcinoma spread?

Survival times continue to improve; however, survival rates from any given cancer diagnosis can vary widely depending on the stage of the cancer at the diagnosis and the type of treatment received (radiation and chemotherapy). When the spread of the cancer is poorly understood, cancer staging, which involves surgical, endoscopic, or other invasive procedures to identify spread, is the key to timely referral to the hospital's breast center or in referral to an oncology team that can help with treatment options.

Anonymous Patient Answer

How does khk2455 work?

This is the first in vivo study that demonstrates that Khk2455 has anti-tumor activity in a murine pancreatic tumor model. Results from a recent paper highlights the importance of the ability to characterize cancer models for the development of new and improved treatments. Our observations indicate that Khk2455 targets a growth factor/metastasis pathway that is independent of p53 or other known pathways. Results from a recent paper further illustrate the importance of considering complex mechanisms of action when designing targeted therapeutics for cancer treatment. In addition, our results also suggest that Khk2455 might be a promising lead compound for further development of novel compounds for treatment of pancreatic tumors.

Anonymous Patient Answer
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