Study on the Safety and Effectiveness of SKB264 and Pembrolizumab for Patients with Cervical, Urothelial, Ovarian, or Prostate Cancer

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a new treatment for certain types of cancer, specifically cervical cancer, urothelial carcinoma, ovarian cancer, and prostate cancer. The treatment being tested combines two medications: SKB264 and pembrolizumab. SKB264 is an experimental drug, while pembrolizumab is a medication already used in cancer treatment. The purpose of this study is to determine if this combination can effectively treat these cancers.

Participants in the study will receive the treatment over a period of up to 24 months. The treatment involves administering the medications through an intravenous infusion, which means they are given directly into the bloodstream through a vein. Throughout the study, participants will be monitored for any side effects and to see how well the treatment is working. This includes regular check-ups, blood tests, and other assessments to ensure the safety and effectiveness of the treatment.

The study will also involve a comparison with a placebo to better understand the effects of the treatment. The main focus will be on the safety of the treatment, looking at any side effects that occur, and its effectiveness, such as whether the cancer shrinks or stops growing. The study aims to provide valuable information that could lead to new treatment options for these types of cancer in the future.

1 initial assessment

Upon joining the study, an initial assessment will be conducted. This includes a review of medical history and a physical examination to confirm eligibility.

Tests such as blood work, imaging scans, and other necessary evaluations will be performed to establish a baseline for your health status.

2 treatment administration

The treatment involves the administration of two medications: SKB264 and pembrolizumab. Both are given as a solution for infusion, which means they are delivered directly into the bloodstream through a vein.

SKB264 and pembrolizumab will be administered according to the study schedule, which will be explained in detail by the medical team. The frequency and dosage will be determined based on the study protocol.

3 monitoring and follow-up

Regular monitoring will be conducted to assess the safety and effectiveness of the treatment. This includes checking vital signs, conducting physical examinations, and performing laboratory tests.

Additional tests such as electrocardiograms (to check heart function) and imaging scans may be done to monitor the response to treatment.

4 evaluation of treatment response

The response to the treatment will be evaluated by measuring changes in tumor size and other relevant health indicators.

The study will also assess the duration of response, progression-free survival (time during which the disease does not worsen), and overall survival.

5 completion of study participation

Upon completion of the study, a final assessment will be conducted to evaluate overall health and any changes since the start of the trial.

Participants will receive information about their health status and any necessary follow-up care.

Who Can Join the Study?

  • Participants must be 18 years or older.
  • Both men and women can join the study.
  • Participants must have a diagnosis of one of the following cancers: Cervical cancer, Urothelial carcinoma (a type of bladder cancer), Ovarian cancer, or Prostate cancer.
  • The cancer must be locally advanced (spread to nearby areas) or metastatic (spread to other parts of the body), or it must have come back after treatment.

Who Cannot Join the Study?

  • Patients with any other type of cancer not listed in the study.
  • Patients who have had a severe allergic reaction to similar medications in the past.
  • Patients with uncontrolled medical conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received certain treatments recently that might affect the study results.
  • Patients with a history of certain heart conditions.
  • Patients with active infections that require treatment.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures for any reason.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Jean Perrin Clermont Ferrand France
Centr Georges Francois Leclerc Dijon France

Other Sites

Site Name City Country Status
Grand Hopital De Charleroi Charleroi Belgium
Virgen del Rocío University Hospital Sevilla Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Pratia S.A. Skorzewo Poland
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Centre Hospitalier Universitaire De Poitiers Poitiers France
Algemeen Ziekenhuis Klina Brasschaat Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Hospital Universitari Dexeus Grupo Quironsalud Barcelona Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Centre Francois Baclesse Caen France
Cprtjbhph Ufyzzhukcwqwzr Sunxjsjkp Woluwe-Saint-Lambert Belgium
Aarqfyolpt Porihmaa Hdqitldx Dw Ptbct Paris France
Sjnjsqcc Polmeakpx Ssn z oszu Gdynia Poland
Hbayvmlj Vqgx dtgqbqzc Barcelona Spain
Ixhmikbi Pdqwanuohynhcwb Caxmji Cvpuxk Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.06.2023
France France
Not recruiting
01.06.2023
Poland Poland
Not recruiting
01.06.2023
Spain Spain
Not recruiting
01.06.2023

Trial locations

SKB264 is a new experimental drug being tested to see if it can help treat certain types of solid tumors. In this study, researchers are looking at how well SKB264 works when used together with another medication. The goal is to find out if this combination can help shrink tumors or stop them from growing, and to see if it is safe for patients to use.

Pembrolizumab is a medication that helps the body’s immune system fight cancer. It works by blocking a specific protein that cancer cells use to hide from the immune system. By blocking this protein, pembrolizumab helps the immune system recognize and attack cancer cells. In this study, it is being used in combination with SKB264 to see if the two drugs together can be more effective in treating certain solid tumors.

Cervical cancer – Cervical cancer is a type of cancer that occurs in the cells of the cervix, which is the lower part of the uterus connecting to the vagina. It typically begins with precancerous changes in the cervical cells, often caused by persistent infection with certain types of human papillomavirus (HPV). As the disease progresses, these abnormal cells can develop into cancerous cells and invade deeper tissues of the cervix and surrounding areas. In advanced stages, the cancer may spread to other parts of the body, including the bladder, rectum, and distant organs. The progression from precancerous changes to invasive cancer can take several years, allowing for potential early detection through screening.

Urothelial carcinoma – Urothelial carcinoma, also known as transitional cell carcinoma, is the most common type of bladder cancer. It originates in the urothelial cells that line the inside of the bladder and can also occur in other parts of the urinary tract, such as the ureters and renal pelvis. The disease often begins as superficial tumors that affect only the inner lining of the bladder. Over time, these tumors can grow deeper into the bladder wall and potentially spread to nearby lymph nodes and other organs. The progression of the disease can vary, with some tumors remaining non-invasive while others become more aggressive.

Ovarian cancer – Ovarian cancer is a type of cancer that begins in the ovaries, which are the female reproductive glands responsible for producing eggs. It often starts in the outer layer of the ovaries and can spread to other parts of the pelvis and abdomen. The disease is known for its subtle symptoms in the early stages, which can lead to delayed diagnosis. As ovarian cancer progresses, it can invade nearby tissues and organs, and eventually spread to distant parts of the body. The progression can be rapid or slow, depending on the type and grade of the cancer cells.

Prostate cancer – Prostate cancer is a common cancer that occurs in the prostate gland, which is a small gland in men that produces seminal fluid. It often begins as small clusters of cancerous cells within the prostate and can grow slowly over many years. In some cases, the cancer may remain confined to the prostate, while in others, it can grow more aggressively and spread to nearby tissues and bones. The progression of prostate cancer can vary widely, with some forms being slow-growing and others more aggressive. Early stages may not cause noticeable symptoms, but as the disease advances, it can lead to urinary and other systemic symptoms.

Trial ID:
2022-502654-14-00
Protocol code:
SKB264-II-06
NCT ID:
NCT05642780
Trial Phase:
Therapeutic exploratory (Phase II)

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