CyPep-1 for Oral Squamous Cell Carcinoma

1
Effectiveness
1
Safety
AP-HM - Hôpital de la Timone, Marseille, France
+7 More
CyPep-1 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Oral Squamous Cell Carcinoma

Study Summary

A Study to Evaluate the Safety and Efficacy of CyPep-1 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic Cancers

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Eligible Conditions

  • Oral Squamous Cell Carcinoma
  • Carcinoma, Squamous Cell
  • Carcinoma
  • Breast Cancer
  • Melanoma
  • Squamous Cell Carcinoma of Head and Neck
  • Advanced Head and Neck Squamous Cell Carcinoma
  • Advanced Melanoma
  • Breast Neoplasms
  • Advanced Breast Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CyPep-1 will improve 3 primary outcomes and 2 secondary outcomes in patients with Oral Squamous Cell Carcinoma. Measurement will happen over the course of 2 weeks.

2 weeks
Incidence, frequency, and seriousness of TEAEs
3 months
OS
6 weeks
Incidence of DLTs
8 weeks
ORR based on radiological assessment according to the RECIST v1.1
PFS

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

No Control Group
Arm C: advanced or metastatic TNBC

This trial requires 90 total participants across 3 different treatment groups

This trial involves 3 different treatments. CyPep-1 is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Arm C: advanced or metastatic TNBCThe safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic TNBC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).
Arm A: advanced or metastatic HNSCCThe safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic HNSCC. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).
Arm B: advanced or metastatic melanomaThe safety and tolerability of CyPep-1 in combination with pembrolizumab will be evaluated in a cohort of 30 subjects in total with advanced or metastatic melanoma. CyPep-1 will be administered every 2 weeks (Q2W) and pembrolizumab will be administered following a Q6W schedule as per standard of care (SoC).

Trial Logistics

Trial Timeline

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

Closest Location

University of Pittsburgh Medical Center - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
General Inclusion Criteria
Is 18 years of age or older on the day of signing informed consent;
Has measurable disease as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1;
Has at least 1 non-ulcerated, measurable, and accessible lesion for intra-tumoral (IT) injection with a maximum diameter of 5 cm;
Female patients of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before screening), post-menopausal, defined as spontaneous amenorrhea for at least 2 years, or with follicle-stimulating hormone in the post-menopausal range at screening;
Female patients of childbearing potential (defined as <2 years after last menstruation or not surgically sterile) must have a negative serum pregnancy test at screening and agree to use a highly effective method for contraception from the time of signing the ICF until at least 120 days after the last administration of CyPep-1.
You are able to comply with study procedures and assessments. show original
You are able to provide tissue from a core or excisional biopsy at screening or have an acceptable stored tumor sample available that was collected within 90 days prior to screening. show original
Has a performance status of 0 or 1. show original
You have a life expectancy of 3 months or more. 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 breast cancer a year in the United States?

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The annual incidence of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in women is 24 per 100,000 women. Since incidence is based on breast cancer testing from breast pain, we estimate that approximately 7% of US women will be diagnosed with the disease during their lifetime. In addition, it is estimated that 1% of all breast cancer cases are diagnosed when women are less than 50 years old, and that 25% of breast cancer patients have more aggressive tumors. These statistics suggest that breast cancer screening may reduce lifetime risk due to the early detection of disease.

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What is breast cancer?

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Breast cancer is the most fatal type of cancer in women. This is the most common cancer in Britain. It is also common in other European countries. It begins in the breast tissues and can often be felt or seen. It is a disease that is difficult to detect before it has become life-threatening. Breast cancer is treated by doctors with surgery, chemotherapy and radiation therapy. The National Institute for Health and Clinical Excellence advises surgery and radiation for most people with early breast cancer. The American Joint Committee on Cancer advises surgery, chemotherapy and radiation therapy for all people with a limited number of clinical features. Breast cancer is not contagious.

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What are common treatments for breast cancer?

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Breast cancer is frequently treated through a variety of modes, and often persists after this first treatment has been applied. This persistence has multiple factors. Early identification and management of pain may prevent this persistent pain. Cancer is often treated with adjuvant radiotherapy and chemotherapy prior to mastectomy, which has multiple factors. Pain is often treated for cancer cachexia through multidisciplinary team management. This treatment also includes palliative care, which may be in the form of hospice service. Patients' lives are often impacted by cancer, and this treatment is important for both patient care and disease management. Depression is commonly treated with medications only. These treatments are also used in various combinations in the treatment of the cancer.

Unverified Answer

What are the signs of breast cancer?

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Symptoms usually associated with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include lump, nodule, or lump and a 'lumpectomy' or 'lumpsmith' diagnosis (that is, women undergoing breast-cancer screening with biopsy). Other signs of breast cancer include nipple discharge or a change to the breast's size or shape, and unexplained weight loss. Symptoms associated with the spread of breast cancer include a change in menstrual cycles, breast pain, nipple discharge, and lump. Other signs include nipple retraction in a woman of childbearing age or in men or a change in breast size in women over 50 or changes in the appearance of the face.

Unverified Answer

Can breast cancer be cured?

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Currently available research findings suggest that a patient's ability to live a full life with few, if any, symptoms of breast cancer can usually be ensured through careful surveillance, early treatment, and adequate adjuvant treatment. However, when breast cancer does recur at a later date, it most often is in a more advanced stage when it will be highly resistant to current treatment and/or recurrent. For this reason, the primary goal of breast cancer treatment is to prevent the development of secondary tumors. However, there may be hope for adjuvant breast cancer therapy to be effective in preventing the development of distant breast cancer.

Unverified Answer

What causes breast cancer?

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The cause of breast cancer is complex and multifactorial. However, the risk is increased for young women, as well as for women with certain family histories or other predisposing factors. Lifestyle factors can be modified in ways which reduce breast cancer risk, and can be achieved through lifestyle modifications, with exercise a key example.

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Does breast cancer run in families?

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An initial case-control study in North American families suggests that breast cancer may run in families, and may, however, be unrelated to the presence of a history of breast cancer. Additional confirmation in prospective family-cases design of this finding is necessary.

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Does cypep-1 improve quality of life for those with breast cancer?

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Cypep-1 therapy for six months did not improve HRQOL except for a slight advantage in pain/emotional symptoms. It is more likely that the benefit to pain/emotional symptoms is related to the natural fluctuation of disease progression during the six month treatment period. Results from a recent clinical trial suggest that Cypep-1 therapy is not useful for improving HRQOL.

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What are the common side effects of cypep-1?

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Cypep-1 is well tolerated by patients. Most patients with BCP/BCOP had noticeable improvement in symptoms or stabilization. The most frequent side effects were moderate to severe nausea, abdominal pain and constipation. Overall, the common side effects were infrequent and manageable.

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What is the primary cause of breast cancer?

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It is possible to observe a strong relationship between some environmental conditions and the risk of developing breast cancer, suggesting a direct relationship between the two phenomena. It is recommended to prevent these agents through health education and public information focusing on avoiding and maintaining a good body weight, and reducing exposure to x ray and other carcinogenic agents. The role that diet and lifestyle play to prevent the development of breast cancer is, at present, still being studied.

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What are the latest developments in cypep-1 for therapeutic use?

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There is no reliable cypep-1-test with a high discriminatory and sensitivity to diagnose and diagnose breast cancer, especially in preclinical applications. Thus, other biomarkers are needed, e.g., serum biomarkers, but there are indications that non-invasive diagnostic tests employing a combination of serum biomarkers or other diagnostic biomarkers with imaging and tissue biomarkers or tissue analysis are possible.

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What is the average age someone gets breast cancer?

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The average age someone gets breast cancer is 51. At age 90, there are 16 new cases per 100,000 a year in America, and the average age on death is 77. On May 4, 2006, I was diagnosed and I have received treatment, so I live a long life. I look forward to the day when my own death will be from breast cancer.

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