IK-175 and nivolumab for Carcinoma

Phase-Based Estimates
1
Effectiveness
1
Safety
Banner Health- MD Anderson Cancer Center, Gilbert, AZ
Carcinoma+21 More
IK-175 and nivolumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma

Study Summary

This study is evaluating whether a drug may help treat advanced or metastatic solid tumors.

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Eligible Conditions

  • Carcinoma
  • Urinary Bladder Cancer
  • Urinary Bladder Diseases
  • Neoplasm Metastasis
  • Cancer
  • Carcinoma, Transitional Cell
  • Tumors, Solid
  • Solid Tumors, Adult
  • Solid Tumors, Advanced Solid Tumors
  • Cancer, Advanced
  • Urinary Bladder Neoplasms
  • Neoplasms, Bladder
  • Transitional Cell, Carcinoma
  • Urothelial Neoplasm
  • Bladder Diseases
  • Solid Carcinoma
  • Metastatic Cancers
  • Neoplasms, Malignant
  • Metastatic Ureter Urothelial Carcinoma
  • Neoplasms
  • Bladder Cancer, Cancer
  • Metastatic Bladder Cancer
  • Locally Advanced Solid Tumors
  • Bladder transitional cell carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether IK-175 and nivolumab will improve 2 primary outcomes and 9 secondary outcomes in patients with Carcinoma. Measurement will happen over the course of Up to 100 days after the end of study treatment..

12 months
Disease control rate (DCR) of IK-175 as a single agent and in combination with nivolumab
Duration of response (DOR) of IK-175 as a single agent and in combination with nivolumab
Duration of treatment (DOT) of IK-175 as a single agent and in combination with nivolumab
Objective response rate (ORR) of IK-175 as a single agent and in combination with nivolumab
Progression-free survival (PFS) of IK-175 as a single agent and in combination with nivolumab
Approximately 6 months
To determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD), and to characterize the dose-limiting toxicities (DLTs) of IK-175 as a single agent and in combination with nivolumab.
Month 4
Pharmacokinetics of IK-175: Area Under the Curve (AUC)
Pharmacokinetics of IK-175: Maximum Serum Concentration (Cmax)
Pharmacokinetics of IK-175: half-life (t1/2)
Day 21
Pharmacodynamic immune effects of IK-175 as a single agent and in combination with nivolumab on tumor-infiltrating cytotoxic T cells
Day 100
Safety and tolerability of IK-175 as a single agent and in combination with nivolumab including acute and chronic toxicities, in determining a recommended phase 2 dose (RP2D) of IK- 175.

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

4 Treatment Groups

No Control Group
IK-175 and nivolumab Combination Dose Escalation

This trial requires 93 total participants across 4 different treatment groups

This trial involves 4 different treatments. IK-175 And Nivolumab is the primary treatment being studied. Participants will be divided into 4 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.

IK-175 and nivolumab Combination Dose Escalation
Drug
Approximately 2 dose escalation steps are planned during the Combination Treatment dose escalation phase of the study.
IK-175 Single Agent Dose Expansion
Drug
A Single Agent Treatment dose expansion phase will be performed in patients with urothelial carcinoma with IK-175 after completion of the dose escalation to confirm the RP2D.
IK-175 and nivolumab Combination Dose Expansion
Drug
A Combination Treatment dose expansion phase will be performed in patients with urothelial carcinoma with IK-175 after completion of the dose escalation to confirm the RP2D.
IK-175 Single Agent Dose Escalation
Drug
Approximately 5 dose escalation steps are planned during the Single Agent Treatment dose escalation phase of the study. (COMPLETE)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

Banner Health- MD Anderson Cancer Center - Gilbert, AZ

Eligibility Criteria

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 21 conditions listed above. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with cancer that has spread or come back, and that doesn't respond to standard treatments, or who can't have standard treatments, may be eligible for this study. show original
Eligible patients for the Combination Treatment arm of the study must have urothelial carcinoma that is confirmed by pathology, and the cancer must be unresectable or have progressed following all standard of care therapies show original
There are many types of birth control that are very effective at preventing pregnancy. show original
Time since the last dose of prior therapy to treat underlying malignancy (including other investigational therapy): 9a. Systemic cytotoxic chemotherapy: ≥ the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all, except 6 weeks for systemic nitrosourea or systemic mitomycin-C). 9b. Biologic therapy (eg, antibodies): ≥ 3 weeks or their dosing interval if shorter than 3 weeks (e.g. q2w therapy would require a 2-week washout). 9c. Small molecule therapies: ≥ 5 × half-life. 9d. Investigational Agent: ≥4 weeks or ≥5 × half-life, whichever is shorter
Patients who are at least 18 years old. show original
Have a disease that can be measured. show original
A person with an ECOG performance status of 0 to 1 is generally healthy and is able to carry out all normal activities. show original
The person has adequate organ function if their organs are working properly. show original
The tumor is accessible and can be safely accessed for multiple core biopsies 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.

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

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About 11.5 million people are diagnosed with carcinoma each year in the United States. The sex ratio for most types of carcinoma is slightly lower.

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What are the signs of carcinoma?

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There are a variety of signs that may suggest a suspicion of carcinoma, but none are definitive. Patients with a history of tobacco smoking and a family history of cancer are most likely to have carcinoma.

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What causes carcinoma?

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Cigarette smoking is the most significant cause of carcinoma as well as malignancy. Exposure to pesticides, organic solvents, and many other pollutants may also increase the risk. A review of the evidence of carcinoma causation is presented.

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What are common treatments for carcinoma?

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There are several options available for treatment of carcinoma. This involves surgery, radiation therapy, chemotherapy or hormone therapy, depending on the nature of the disease. There are treatments for specific types of carcinoma in breast, liver, colon, lung, skin, ovarian and thyroid cancer. Appropriate treatment, often combined with a cure, should strive for the best chance of survival with the least chance of re-occurrences. The goals of treatment of carcinoma are similar to those for other diseases.

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What is carcinoma?

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Carcinomas are neoplasms defined by malignant transformation of cells, which is an abnormal growth of cell that invade into and break apart from surrounding normal physiological structures and tissues. Carcinomas of the breast are most common in women. The epithelial cells of the lining of the lung tissue (airways or alveoli) become progressively more abnormal as carcinomas develop. Carcinomas of the prostate tend to form nodules that gradually grow. Carcinomas of the ovary develop mainly as epithelial cell tumors.\n\nThere is no single cause of cancer, and many types cannot be prevented. Some can be prevented by not smoking, and some can be prevented by eating a healthy diet.

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Can carcinoma be cured?

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There is a statistically significant difference in overall survival of patients after curative surgery or postoperative external beam radiation, for nonsmall cell carcinoma, but the overall survival was similar in patients undergoing surgery or radiation. A similar, but not statistically significant, difference was observed in patients after surgery or radiation for adenocarcinoma.

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What are the chances of developing carcinoma?

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In males the two risk factors are smoking and large prostatic size. In females smoking increases the risk. This is contrary to what is found in other studies. Smoking is so commonplace in male patients that it is practically impossible to establish an association between it and risk of developing carcinoma. Larger prostates are a significant risk factor for developing carcinoma in females even if smoking does not play a role.

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How serious can carcinoma be?

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Carcinoma is one in a small group of illnesses that can rapidly result in death. Many patients survive for many months and years after their diagnosis, but for some reason, the cancer remains unchecked by treatment. The prognosis is a life after death. Some patients have a chance of returning to some form of cancer surveillance, and others will always have this disease. Once the diagnosis has been made, and treatments have been started, the cancer will run its course in its allotted time. It is important to realize that some patients will have a more serious cancer and will need more intensive treatment, but others will be asymptomatic and be cured simply by the fact that their cancer has been diagnosed.

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Is ik-175 typically used in combination with any other treatments?

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After a long duration of treatment with Ik-175 the patient had a significantly lower frequency of progression or relapse. However, we did not find any convincing evidence that Ik-175 has the ability to prolong life at the last presentation. More data are needed to compare the effectiveness of Ik-175 with other treatments in metastatic and nonmetastatic carcinoma.

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Who should consider clinical trials for carcinoma?

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Clinical trials can be considered for patients with stage II or III carcinoma without metastasis at all ages. However, younger individuals should not be denied the possibility, because the risk of relapse is much lower for younger patients. More research is needed to provide clear recommendations for the clinical trial decision for these people.

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What are the latest developments in ik-175 for therapeutic use?

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Treatment with Ik-175 for patients with metastatic renal cancer is well tolerated. The most common side effect requiring treatment interruption and/or outpatient care is fatigue. The study population consists of patients selected by conventional criteria and we found no significant difference between the cohorts treated with Ik-175 in phase III trials or patients treated in the present study with regard to progression-free survival duration or progression-free time to response. In addition, no significant difference in terms of overall survival was observed between the placebo and Ik-175 treated patients. Hence, Ik-175 appears to be as effective and as well tolerated as previous ik-drugs.

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What is the average age someone gets carcinoma?

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In a recent study, findings indicated that the average age of first carcinoma detection was 55.2 and 52.9 years for male and female patients, respectively. The patients' age is the main parameter involved in deciding regarding clinical trials and the selection of treatment regimes in future researches.

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